510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD December 2021
DEVICE: Rheonix STI Tri-Plex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit, Rheonix Swab Specimen Collection Kit
Rheonix, Inc 510(k) NO: K193081(Traditional)
ATTN: Richard Montagna PHONE NO : 607 2571242
10 Brown Road, Suite 103 SE DECISION MADE: 17-DEC-21
Ithaca NY 14850 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Colibri System
COPAN WASP S.r.l. 510(k) NO: K193138(Traditional)
ATTN: Catalano Giovanna PHONE NO : 39 030 2687211
Via F. Perotti 18 SE DECISION MADE: 27-DEC-21
Brescia IT 25125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Contour® next GEN Blood Glucose Monitoring System
Ascensia Diabetes Care 510(k) NO: K193407(Traditional)
ATTN: Colleen Burdel PHONE NO : 914 2962880
100 Summit Lake Drive SE DECISION MADE: 23-DEC-21
Valhalla NY 10595 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREEDOM Integrated Syringe Infusion System
Repro-Med Systems, Inc., dba KORU 510(k) NO: K200176(Traditional)
ATTN: Cynthia Lacatena PHONE NO : 845 4692042
24 Carpenter Road SE DECISION MADE: 15-DEC-21
Chester NY 10918 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blood Collection Needles
Vacutest Kima Srl 510(k) NO: K200932(Traditional)
ATTN: Monica Vianello PHONE NO : 39 049 9719511
Via dell'Industria 12 SE DECISION MADE: 14-DEC-21
Arzegrande IT 35020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System
CIRCA Scientific, LLC 510(k) NO: K200943(Traditional)
ATTN: Fred Piazza PHONE NO : 303 9518767
14 Inverness Drive East, Suite H-1SE DECISION MADE: 17-DEC-21
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Molecular Flow Simulations
Therataxis, LLC 510(k) NO: K201435(Traditional)
ATTN: Raghu Raghavan PHONE NO : 443 5629944
Johns Hopkins Eastern Building SuiSE DECISION MADE: 03-DEC-21
Baltimore MD 21218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28
Kangfu Medical Equipment Factory 510(k) NO: K201600(Traditional)
ATTN: Jixiang Zhang PHONE NO : 86 0577 55775583
No.380 Ningkang East Road, LechengSE DECISION MADE: 10-DEC-21
Wenzhou CN 325699 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infinity Acute Care System (IACS) Monitoring Solution
Draeger Medical Systems, Inc. 510(k) NO: K201764(Traditional)
ATTN: Tom Hirte PHONE NO : 978 3796461
6 Tech Dr. SE DECISION MADE: 09-DEC-21
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2
Accriva Diagnostics, Inc. 510(k) NO: K202101(Traditional)
ATTN: Brian James PHONE NO : 858 2632350
6260 Sequence Drive SE DECISION MADE: 29-DEC-21
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OxyLight 2.0
Raja Trading Company, Inc. 510(k) NO: K202175(Traditional)
ATTN: Christine K. Powers PHONE NO : 561 8684600
2801 Juniper Street, Suite 2 SE DECISION MADE: 02-DEC-21
Fairfax VA 22031 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Skypro, SP02 Mask (3)
Skypro Medical Supplies Company 510(k) NO: K202255(Traditional)
ATTN: Cyrus Wong PHONE NO : 852 27110882
C301, Tsing Yi Industrial Centre PSE DECISION MADE: 24-DEC-21
Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BoneMRI
MRIguidance B.V 510(k) NO: K202404(Traditional)
ATTN: Roel Raatgever PHONE NO :
Gildstraat 91a SE DECISION MADE: 22-DEC-21
Utrecht NL 3572 EL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMG PMP Infant
Eurosets S.r.l. 510(k) NO: K202510(Traditional)
ATTN: Katia Vescovini PHONE NO : 39 0535 660334
Strada Statale 12, n°143 SE DECISION MADE: 10-DEC-21
Medolla IT I-41036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mpact® 3D Metal Implants - DMLS Technology
Medacta International SA 510(k) NO: K202568(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 20-DEC-21
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sonomed IV, Sonomed V
Carci Industria E Comercio De Apar510(k) NO: K202788(Traditional)
ATTN: Orlando Orlandi PHONE NO : 55 11 33462100
R. Padre Machado, 82 SE DECISION MADE: 23-DEC-21
Sao Paulo BR 04127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical face mask: F-Y1-A
Jiande Chaomei Daily Chemicals Co.510(k) NO: K202794(Traditional)
ATTN: Zhu Lipin PHONE NO : 86 18 858158190
Shangshan Village, Yang Cunqiao ToSE DECISION MADE: 13-DEC-21
Jiande CN 310000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Activmotion S DTO
Newclip Technics 510(k) NO: K202803(Traditional)
ATTN: Gaelle LUSSORI PHONE NO : 33 2 28213712
PA de la Lande Saint Martin- 45 ruSE DECISION MADE: 16-DEC-21
HAUTE-GOULAINE FR 44115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Voyant Fine Fusion Device (EB230)
Applied Medical 510(k) NO: K202818(Traditional)
ATTN: Blake Stacy PHONE NO : 918 2771108
22872 Avenida Empresa SE DECISION MADE: 16-DEC-21
Rancho Santa Margarita CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Helianthus
Metaltronica Spa 510(k) NO: K202822(Traditional)
ATTN: Gloria Pesce Delfino PHONE NO : 39 066 6160206
66 via delle Monachelle SE DECISION MADE: 15-DEC-21
Pomezia RM IT CAP 00071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Innomed NPWT Silicone Foam Dressing
Zhejiang Longterm Medical Technolo510(k) NO: K202823(Traditional)
ATTN: Chloie Zsang PHONE NO : 1 416 2769555
No. 493 North Huancheng Road, MogaSE DECISION MADE: 15-DEC-21
Deqing CN 313200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S2 Pigment Removal System
Lightsense Technologies Ltd 510(k) NO: K202848(Traditional)
ATTN: Deganit Barak PHONE NO : 972 545 905954
727-729 High Road SE DECISION MADE: 14-DEC-21
London GB N12 OBP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tzoar 207 Negative Pressure Wound Therapy (NPWT) System
Lightstone Medical Products (Ningb510(k) NO: K202898(Traditional)
ATTN: Julian Zhu PHONE NO : 86 574 56579003
Room 61-408, No. 99 Jiangbei Road SE DECISION MADE: 30-DEC-21
Ningbo CN 315032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wesper Lab
Wesper Inc. 510(k) NO: K203343(Traditional)
ATTN: Amir Reuveny PHONE NO : 516 6544166
234 5th Avenue SE DECISION MADE: 21-DEC-21
New York NY 10001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2
Qura S.r.l. 510(k) NO: K203424(Traditional)
ATTN: Raffaella Tommasini PHONE NO : 39 0535 1803050
Via di Mezzo, 23 SE DECISION MADE: 17-DEC-21
Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TCAT TKA Instrument Tray
THINK Surgical, Inc. 510(k) NO: K203468(Traditional)
ATTN: George J. Prendergast PHONE NO : 510 2492323
47201 Lakeview Boulevard SE DECISION MADE: 20-DEC-21
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fixone hybrid knotless anchor
AJU Pharm Co., Ltd. 510(k) NO: K203523(Traditional)
ATTN: Kim Tae Hoon PHONE NO : 82 31 7654420
A-207, 697, Pangyo-ro SE DECISION MADE: 25-DEC-21
Seongnam-si KR 13511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)
Unicoglobal, Inc. 510(k) NO: K203539(Traditional)
ATTN: Yoonsok Park PHONE NO :
#904, Woolim Pangyo W-City 9-22, PSE DECISION MADE: 10-DEC-21
Seongnam KR 13486 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay
Immunalysis Corporation 510(k) NO: K203564(Traditional)
ATTN: Wenying (Jessica) Zhu PHONE NO : 909 4820480
829 Towne Center Drive SE DECISION MADE: 22-DEC-21
Pomona CA 91767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental Scaler and Air Polisher
Guilin Woodpecker Medical Instrume510(k) NO: K203615(Traditional)
ATTN: Yiwei Wang PHONE NO : 86 773 2350532
Information Industrial Park, GuiliSE DECISION MADE: 10-DEC-21
Guilin CN 541004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay
Immunalysis Corporation 510(k) NO: K203647(Traditional)
ATTN: Wenying (Jessica) Zhu PHONE NO : 909 4820480
829 Towne Center Drive SE DECISION MADE: 22-DEC-21
Pomona CA 91767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRI-matrix Implant Line
TRI Dental Implants Int. AG 510(k) NO: K203660(Traditional)
ATTN: Sandro Venanzoni PHONE NO : 41 32 5101606
Boesch 80A / Postfach 419 SE DECISION MADE: 21-DEC-21
Huenenberg CH 6331 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NObreath®
Bedfont Scientific Ltd 510(k) NO: K203695(Traditional)
ATTN: Louise Bateman PHONE NO : 440 1622 851122
Station Road, Harrietsham SE DECISION MADE: 17-DEC-21
Maidstone, Kent GB ME17 1JA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty
NuVasive, Incorporated 510(k) NO: K203714(Traditional)
ATTN: Jessica LeBlanc PHONE NO : 951 8160973
7475 Lusk Blvd. SE DECISION MADE: 23-DEC-21
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System
Smith and Nephew Medical Limited 510(k) NO: K203716(Traditional)
ATTN: Steeve Lamvohee PHONE NO : 44 0 7583048727
101 Hessle Road SE DECISION MADE: 14-DEC-21
Hull GB HU3 2BN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Branchor Balloon Guide Catheter
Asahi Intecc Co., Ltd 510(k) NO: K203723(Traditional)
ATTN: Yasuyuki Kawahara PHONE NO : 81 561 561859
3-100 Akatsuki-cho SE DECISION MADE: 10-DEC-21
Seto JP 489-0071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml
Thermo Fisher Scientific 510(k) NO: K203741(Traditional)
ATTN: Cynthia Knapp PHONE NO : 800 87189093 224117
1 Thermo Fisher Way SE DECISION MADE: 20-DEC-21
Oakwood Village OH 440146 510(k) STATEMENT
DEVICE: EXA
Konica Minolta Healthcare Americas510(k) NO: K203743(Special)
ATTN: Carolyn Russell PHONE NO : 919 9726420 2351
2217 Us Highway 70 E Garner SE DECISION MADE: 10-DEC-21
Garner NC 27529 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AURORA Evacuator +Coag
Rebound Therapeutics 510(k) NO: K203745(Traditional)
ATTN: Naomi Gong PHONE NO : 949 3789483
13900 Alton Pkwy Suite 120 SE DECISION MADE: 02-DEC-21
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Donagamex Blue Performance Protective Gown
Dong Nai Garment Corporation (Dona510(k) NO: K203821(Traditional)
ATTN: Bui The Kich PHONE NO : 84 0253 836147
Road 2, Bien Hoa Industrial Zone 1SE DECISION MADE: 17-DEC-21
Bien Hoa City VN 810000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: i8 Tanning Booth
Ultrasun International B.V. 510(k) NO: K210004(Traditional)
ATTN: Tim Leusink PHONE NO : 31 06 52291044
Granaatstraat 6 SE DECISION MADE: 10-DEC-21
Hengelo NL 7554 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MED RF 4000
F Care Systems USA LLC 510(k) NO: K210077(Traditional)
ATTN: Patrick Danciu PHONE NO : 768 2880740
11098 Biscayne BLVD Suite 301 SE DECISION MADE: 17-DEC-21
Miami FL 33161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Meticuly Patient-Specific Titanium Mesh Implant
Meticuly Co., Ltd. 510(k) NO: K210099(Traditional)
ATTN: Peeranoot Lohwongwatana PHONE NO : 6688 834 7777
32/77, Soi Samakkee 58/20, SamakkeSE DECISION MADE: 21-DEC-21
Muang Nonthaburi TH 11000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Topwide Surgical Face Mask
Topwide Medical Products Manufactu510(k) NO: K210102(Traditional)
ATTN: Shoucheng Zhang PHONE NO : 86 728 2713333
19 Xianhong Road, Xin Li Ren Kou SE DECISION MADE: 17-DEC-21
Xiantao CN 433012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%
The Ritedose Corporation 510(k) NO: K210126(Traditional)
ATTN: Linda Valentine PHONE NO : 803 9354114
1 Technology Circle SE DECISION MADE: 03-DEC-21
Columbia SC 29203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield
Unicoglobal, Inc. 510(k) NO: K210147(Traditional)
ATTN: Yoonsok Park PHONE NO :
#904, Woolim Pangyo W-City 9-22, PSE DECISION MADE: 22-DEC-21
Seongnam KR 13486 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair
Psychemedics Corporation 510(k) NO: K210212(Traditional)
ATTN: Neil Stowe PHONE NO : 310 2167776
5832 Uplander Way SE DECISION MADE: 15-DEC-21
Culver City CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Transcutaneous Electrical Nerve Stimulator
Top-Rank Health Care Co.,Ltd. 510(k) NO: K210223(Traditional)
ATTN: James Zhou PHONE NO : 86 18 021553315
Checun Village, Dongguan St. ShangSE DECISION MADE: 15-DEC-21
Shaoxing CN 312352 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ImplaStation
Prodigident, Inc. 510(k) NO: K210241(Traditional)
ATTN: Andrii Gromov PHONE NO : 305 2907190
1350 Lake Street, Suite 1B SE DECISION MADE: 03-DEC-21
Roselle IL 60172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulse Oximeter
Dongguan Lingxin Technologies Co.,510(k) NO: K210305(Traditional)
ATTN: Cony Tang PHONE NO : 86 755 86905029
Room 301, No. 3 Liantang Road, AosSE DECISION MADE: 22-DEC-21
Dongguan CN 523129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CardiaMend Pericardial and Epicardial Reconstruction Matrix
Helios Cardio Inc. 510(k) NO: K210331(Traditional)
ATTN: Yiannis Monovoukas PHONE NO : 617 8184008
11 Dellbrook Road SE DECISION MADE: 21-DEC-21
Weston MA 02493 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Gown, Model: surgical gown-hp-3
Weihai Dishang Medical Technology 510(k) NO: K210355(Traditional)
ATTN: Ricky Xia PHONE NO : 86 18 663126766
Room 406-409, Block C, No.213 TorcSE DECISION MADE: 16-DEC-21
Weihai CN 264209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color
Mexpo International Inc. 510(k) NO: K210388(Traditional)
ATTN: Tim Thai PHONE NO : 510 4896800
2828 Faber Street SE DECISION MADE: 13-DEC-21
Union City CA 94587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProTEC-USA EZDoff Gown
Cadillac Products, Inc. 510(k) NO: K210405(Traditional)
ATTN: Andrew Stone PHONE NO : 248 8138200
5800 Crooks Road, Suite 100 SE DECISION MADE: 15-DEC-21
Troy MI 48098 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Instant 20s Indicator
True Indicating LLC 510(k) NO: K210481(Traditional)
ATTN: Thomas Riha PHONE NO : 248 9826492
946 Kane St SE DECISION MADE: 14-DEC-21
Toledo OH 43612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATOZ Mini-Screw
MK Meditech Inc. 510(k) NO: K210559(Traditional)
ATTN: SungChul Moon PHONE NO : 82 31 7592885
Room# 511, 54, Changeop-ro, SujeonSE DECISION MADE: 19-DEC-21
Seongnam-si KR 13449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BU-CAD
TaiHao Medical Inc. 510(k) NO: K210670(Traditional)
ATTN: Hsin Hung PHONE NO : 886 2 27365679
6F.-1, No.100, Sec. 2 Heping E. RdSE DECISION MADE: 21-DEC-21
Taipei TW 10663 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neocis Guidance System (NGS) with Yomi Plan v2.0.1
Neocis Inc. 510(k) NO: K210711(Traditional)
ATTN: Dayana Manganese PHONE NO : 786 4720545
2800 Biscayne Blvd. Suite 600 SE DECISION MADE: 22-DEC-21
Miami FL 33137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Mask
Chongqing Pa Xijia Biotechnology C510(k) NO: K210744(Traditional)
ATTN: Zheng Tao PHONE NO : 86 23 68085022
No. 27-5, Fengsheng Road, JiulongpSE DECISION MADE: 14-DEC-21
Chongqing CN 400053 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C&B 5.0 Hybrid
Arum Dentistry Co., Ltd 510(k) NO: K210817(Traditional)
ATTN: Yongsup Lee PHONE NO : 82 42 9353644
44, Techno 8-ro, Yuseong-gu SE DECISION MADE: 08-DEC-21
Daejeon KR 34028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Revitive Medic Coach (Model Number 5575AQ)
Actegy, Ltd. 510(k) NO: K210825(Traditional)
ATTN: Lawrence Brookfield PHONE NO : 44 013 44236037
Reflex, Cain Road SE DECISION MADE: 17-DEC-21
Bracknell GB RG12 1HL 510(k) STATEMENT
DEVICE: ZEPTO Precision Capsulotomy System
Centricity Vision, Inc. 510(k) NO: K210827(Traditional)
ATTN: Neal Hartman PHONE NO : 858 3826550
1939 Palomar Oaks Way, Suite A SE DECISION MADE: 14-DEC-21
Carlsbad CA 92011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VerSys Cemented Revision/Calcar
Zimmer, Inc. 510(k) NO: K210842(Traditional)
ATTN: Rhonda Myer PHONE NO : 574 3778280
1800 W. Center Street SE DECISION MADE: 10-DEC-21
Warsaw IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UltraClear Fractional Laser System
FA International, LP 510(k) NO: K210847(Traditional)
ATTN: Sharon Timberlake PHONE NO : 617 9571434
614 George Washington Highway SE DECISION MADE: 10-DEC-21
Lincoln RI 02865 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PDO Max Suture with Dual Needle
PDO MAX, Inc. 510(k) NO: K210871(Traditional)
ATTN: Giovanna McCarthy PHONE NO : 315 7089913
4971 Bear Road SE DECISION MADE: 17-DEC-21
Liverpool NY 13088 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Syringe for Single Use
Jiangsu Suyun Medical Material Co.510(k) NO: K210914(Traditional)
ATTN: Guangning Xu PHONE NO : 86 518 85462073
No.18 Jinqiao Road, Dapu IndustriaSE DECISION MADE: 17-DEC-21
Lianyungang CN 222000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PVmed Contouring Software
Perception Vision Medical Technolo510(k) NO: K210916(Traditional)
ATTN: Chuanji Huang PHONE NO : 86 20 34329782
Room 306, First Phase Office BuildSE DECISION MADE: 03-DEC-21
Guangzhou CN 510530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Libby IAAA v1.0
Dyad Medical, Inc. 510(k) NO: K210931(Traditional)
ATTN: Ronny Shalev PHONE NO : 617 4809569
215 Brighton Avenue, Suite 203 SE DECISION MADE: 17-DEC-21
Boston MA 02134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sphincterotome / short-wire compatible, Sterile Sphincterotome
Micro-Tech (Nanjing) Co., Ltd. 510(k) NO: K210934(Traditional)
ATTN: Sally He PHONE NO : 86 25 58646395
No. 10 Gaoke Third Road, Nanjing NSE DECISION MADE: 01-DEC-21
Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: reVive Light Therapy Essentials
LED Technologies, Inc. 510(k) NO: K210965(Traditional)
ATTN: Lloyd Nelson PHONE NO : 303 7480545
12821 Starkey Rd., Suite 4900 SE DECISION MADE: 15-DEC-21
Largo FL 33773 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: reVive Light Therapy Essentials
LED Technologies, Inc. 510(k) NO: K210968(Traditional)
ATTN: Lloyd Nelson PHONE NO : 303 7480545
12821 Starkey Rd., Suite 4900 SE DECISION MADE: 21-DEC-21
Largo FL 33773 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Curian Campy
Meridian Bioscience, Inc. 510(k) NO: K210976(Traditional)
ATTN: Heather Planck PHONE NO : 513 2713700 378
3471 River Hills Drive SE DECISION MADE: 23-DEC-21
Cincinnati OH 45244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle
Becton, Dickinson and Company 510(k) NO: K210978(Traditional)
ATTN: Nikita Abirami Mahendra KumaPHONE NO : 201 7854383
1 Becton Drive SE DECISION MADE: 22-DEC-21
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Altech® Exhalation Valve (Single Limb and Dual Limb)
Meditera Tibbi Malzeme San Ve TIC 510(k) NO: K210992(Traditional)
ATTN: Cenk Kilic Kalkan PHONE NO : 90 2325135110 177
Ibni Melek OSB Mah, TOSHI Yol 4 SoSE DECISION MADE: 23-DEC-21
Tire Izmir TR 35900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims.
Central Medicare Sdn Bhd 510(k) NO: K211022(Traditional)
ATTN: Muhammad Abdul Rahman PHONE NO : 605 6290000
PT 2609-2620, Batu 8, Jalan ChangkSE DECISION MADE: 22-DEC-21
Teluk Intan MY 36000 510(k) STATEMENT
DEVICE: BIT-Motion
DDE MRI Solutions LTD 510(k) NO: K211039(Traditional)
ATTN: Moti Sokolov PHONE NO : 971 54 4802526
2 Boeur Avraham SE DECISION MADE: 15-DEC-21
Tel Aviv IL 6912702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Progreat Lambda
Terumo Clinical Supply Co., Ltd. 510(k) NO: K211078(Traditional)
ATTN: Vaibhav Sivaramakrishan PHONE NO : 609 6133958
3, Kawashima-Takehayamachi SE DECISION MADE: 21-DEC-21
Kakamigahara JP 501-6024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Progen™ Trochanteric Nail System
Ortho Development Corporation 510(k) NO: K211086(Traditional)
ATTN: Divya Palan PHONE NO : 617 4599652
12187 South Business Park Drive SE DECISION MADE: 21-DEC-21
Draper UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N1 TiUltra TCC Implant System
Nobel Biocare Services AG 510(k) NO: K211109(Traditional)
ATTN: Bernice Jim PHONE NO : 41 79 8550073
Balz Zimmermann-Str. 7 SE DECISION MADE: 21-DEC-21
Kloten CH 8302 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Will3D
HDX WILL CORP. 510(k) NO: K211114(Traditional)
ATTN: Kim In-Young PHONE NO : 82 2 20035021
#105, 106, 201, 202, 203, 204, 38,SE DECISION MADE: 15-DEC-21
Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONVIVO In Vivo Pathology Suite
Carl Zeiss Meditec AG 510(k) NO: K211156(Traditional)
ATTN: Juergen Berger PHONE NO :
Goeschwitzer Strasse 51-52 SE DECISION MADE: 29-DEC-21
Jena DE D-07445 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: eco-x Series (eco-x, eco-x-s)
HDX WILL Corp. 510(k) NO: K211159(Traditional)
ATTN: Myoung-Joon Lee PHONE NO : 82 43 7107318
#105,106,201,202,203,204,38,OsongsSE DECISION MADE: 30-DEC-21
Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single Use Electrosurgical Knife with Fluid Pump System
Micro-Tech (Nanjing) Co., Ltd. 510(k) NO: K211172(Traditional)
ATTN: Sally He PHONE NO : 86 25 58646395
No.10 Gaoke Third Road, Nanjing NaSE DECISION MADE: 17-DEC-21
Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Home Use Hair Removal Device
Shenzhen Beauty Every Moment intel510(k) NO: K211185(Traditional)
ATTN: Luo Huajun PHONE NO : 86 0755 33253598
Rm. 501, Bldg. 4, Haoer Jiashitai SE DECISION MADE: 20-DEC-21
Shenzhen CN 518100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves
Hycare International Co., Ltd 510(k) NO: K211209(Traditional)
ATTN: Tippawan Phongpheaw PHONE NO : 6674 5526556
1197 Moo 3, Asia Highway SE DECISION MADE: 17-DEC-21
Khuanlang Hatyai TH 90110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Profound Matrix
Candela Corporation 510(k) NO: K211217(Traditional)
ATTN: Jeffrey Churchill PHONE NO : 339 2220524
251 Locke Dr SE DECISION MADE: 16-DEC-21
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intrelief
EasyMed Instruments Co., Ltd. 510(k) NO: K211263(Traditional)
ATTN: Jeffery (Tingjie Wu) Wu PHONE NO : 86 757 28091300
3F, 5F-6F, Blk A, Gupo Gongmao BldSE DECISION MADE: 30-DEC-21
Foshan CN 528300 510(k) STATEMENT
DEVICE: Theia NPWT Foam Wound Dressing Kit
Clear Choice Therapeutics, Inc. 510(k) NO: K211277(Traditional)
ATTN: Bret Batchelder PHONE NO : 919 3451836
530 W Cloverhurst Ave. SE DECISION MADE: 16-DEC-21
Athens GA 30306 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: endomina system
Endo Tools Therapeutics S.A. 510(k) NO: K211309(Traditional)
ATTN: Marine Rouyer PHONE NO : 32 71 919409
Rue Auguste Piccard 48 SE DECISION MADE: 07-DEC-21
Gosselies BE 6041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LM Surgical Mask Level 3, LM Surgical Mask Level 2,
Liberty Mask LLC 510(k) NO: K211378(Traditional)
ATTN: Will Kincaid PHONE NO : 214 9152133
1819 Firman Drive Suite 101 SE DECISION MADE: 16-DEC-21
Richardson TX 75081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses
Pegavision Corporation 510(k) NO: K211448(Traditional)
ATTN: Estela Lin PHONE NO : 886 3 3298808
2F-1, No.5, Shing Yeh St. SE DECISION MADE: 06-DEC-21
Taoyuan TW 33341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Encevis
Austrian Institute of Technology G510(k) NO: K211452(Traditional)
ATTN: Tilmann Kluge PHONE NO : 43 505 504203
Giefinggasse 4 SE DECISION MADE: 02-DEC-21
Vienna AT 1210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)
Ammex Corporation 510(k) NO: K211457(Traditional)
ATTN: Sasitharan Nair PHONE NO : 425 2514000
1019 W James St, Suite 200 SE DECISION MADE: 18-DEC-21
Kent WA 98032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers
Ningbo VeryKind Medical Device Co.510(k) NO: K211458(Traditional)
ATTN: Pengfei Hong PHONE NO : 86 158 88523540
#100 Jinghua Road, High-tech IndusSE DECISION MADE: 30-DEC-21
Ningbo CN 315040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Balanced Knee System Uni
Ortho Development Corporation 510(k) NO: K211471(Traditional)
ATTN: Divya Palan PHONE NO : 617 4599652
12187 South Business Park Drive SE DECISION MADE: 16-DEC-21
Draper UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAF Guard
MAF Clothing Pvt Ltd Unit-3 510(k) NO: K211487(Abbreviated)
ATTN: Kirit Jagani PHONE NO : 91 951 3696166
Sy. No59/3, 59/4, Rajathadripura, SE DECISION MADE: 08-DEC-21
Karnataka IN 572114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG)
3M Health Care Business Group 510(k) NO: K211521(Traditional)
ATTN: Margaret Marsh PHONE NO : 210 255648
6203 Farinon Dr SE DECISION MADE: 20-DEC-21
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cordless Prophy System, Model: i-Polish
Guilin Woodpecker Medical Instrume510(k) NO: K211531(Traditional)
ATTN: Ning Jiakang PHONE NO : 86 773 2350532
Information Industrial Park, GuiliSE DECISION MADE: 17-DEC-21
Guilin CN 541004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL
Thermo Fisher Scientific 510(k) NO: K211539(Traditional)
ATTN: Cynthia Knapp PHONE NO : 800 8718909 322411
1 Thermo Fisher Way SE DECISION MADE: 15-DEC-21
Oakwood Village OH 44146 510(k) STATEMENT
DEVICE: Airvo Nebulizer Adapter
Fisher & Paykel Healthcare Limited510(k) NO: K211560(Traditional)
ATTN: Reena Daken PHONE NO : 64 957 40100
15 Maurice Paykel Place, East TamaSE DECISION MADE: 10-DEC-21
Auckland NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)
Covidien, llc 510(k) NO: K211561(Traditional)
ATTN: Megan Elliott PHONE NO : 720 4021643
6135 Gunbarrel Avenue SE DECISION MADE: 05-DEC-21
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aesculap Slim Clip Applier
Aesculap, Inc 510(k) NO: K211572(Traditional)
ATTN: Paul Amudala PHONE NO : 610 4170839
3773 Corporate Parkway SE DECISION MADE: 13-DEC-21
Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline UNITE REFLEX Dynamic Discs
Medline Industries, Inc. 510(k) NO: K211612(Traditional)
ATTN: Jennifer Mason PHONE NO : 847 6433652
Three Lakes Drive SE DECISION MADE: 10-DEC-21
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: USA Gloves Nitrile Powder Free Exam Gloves
USA Gloves 510(k) NO: K211624(Abbreviated)
ATTN: Zishan Momin PHONE NO : 281 8273691
12505 Reed Rd Ste 110 SE DECISION MADE: 18-DEC-21
Sugar Land TX 77478 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared forehead thermometer LD-FT-100B
Honsun (Nantong) Co., Ltd 510(k) NO: K211629(Traditional)
ATTN: Iris Du PHONE NO : 86 513 80580127
No.8, Tongxing Road, Nantong EconoSE DECISION MADE: 08-DEC-21
Nantong CN 226009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultrast Gel
Ultrast, Inc. 510(k) NO: K211691(Traditional)
ATTN: Howard Levine PHONE NO : 516 6061754
3286 Balsam St SE DECISION MADE: 22-DEC-21
Oceanside NY 11572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PS System
Inter-Med, INC. 510(k) NO: K211721(Traditional)
ATTN: Brett Arand PHONE NO : 262 6315313
2200 South Street SE DECISION MADE: 02-DEC-21
Racine WI 53404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)
National Bridge Industrial (S.Z.) 510(k) NO: K211750(Traditional)
ATTN: Yang Haixiong PHONE NO : 86 135 02801741
Phase 2, N.B.I. Building, No. 501-SE DECISION MADE: 20-DEC-21
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electric Breast Pump
Zhejiang Carebao Co., Ltd. 510(k) NO: K211755(Traditional)
ATTN: Yan Xie PHONE NO : 86 574 87902421
3, No.1, Chuangye 4th Road, NingboSE DECISION MADE: 01-DEC-21
Ningbo CN 315000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R3ACT Stabilization System
Paragon 28, Inc. 510(k) NO: K211770(Traditional)
ATTN: Haylie Hertz PHONE NO : 303 7200017
14445 Grasslands Dr. SE DECISION MADE: 25-DEC-21
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PMW01 Procedure Mask Level 1
Defender Safety Inc. 510(k) NO: K211772(Abbreviated)
ATTN: Nahal Islam PHONE NO : 1 855 6433336
30 Skyline Drive SE DECISION MADE: 06-DEC-21
Plainview NY 11803 510(k) STATEMENT
DEVICE: Single-use Surgical Mask
Taiwan Seafood and Fish Corporatio510(k) NO: K211773(Traditional)
ATTN: Eric Ly PHONE NO : 213 6242927
733 Gladys Avenue SE DECISION MADE: 02-DEC-21
Los Angeles CA 90021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Independent Corneal Viewing Chamber (IVC-21)
Bausch + Lomb, Incorporated 510(k) NO: K211786(Traditional)
ATTN: Heather Christie PHONE NO : 585 3565422
3365 Tree Court Industrial BoulevaSE DECISION MADE: 03-DEC-21
St. Louis MO 63122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HealthPPT
Zebra Medical Vision Ltd. 510(k) NO: K211803(Traditional)
ATTN: Shlomit Cymbalista PHONE NO : 972 9 8827795
Shefayim Commercial Center, PO BoxSE DECISION MADE: 15-DEC-21
Sefayim IL 6099000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3Delta Crown
DeltaMed GmbH 510(k) NO: K211804(Traditional)
ATTN: Michael Zimmermann PHONE NO : 004 960 31728317
Raiffeisenstrasse 8a SE DECISION MADE: 06-DEC-21
Friedberg DE 61169 510(k) STATEMENT
DEVICE: Servator M SALF Solution
S.A.L.F. spa 510(k) NO: K211842(Traditional)
ATTN: Carmelo Gagliano PHONE NO : 39 035 940097
Via Marconi 2 SE DECISION MADE: 20-DEC-21
Cenate Sotto IT 32069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AdVance XP Male Sling System
Boston Scientific Corporation 510(k) NO: K211847(Traditional)
ATTN: Anuja Bhatt PHONE NO : 510 3141862
300 Boston Scientific Way SE DECISION MADE: 20-DEC-21
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Liao Ning Shangwei Medical Product510(k) NO: K211865(Traditional)
ATTN: Zhu Hongqing PHONE NO : 86 024 76518888
No.210 Management Committee OfficeSE DECISION MADE: 20-DEC-21
Tieling CN 112700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clivia series Diagnostic Ultrasound System
Shenzhen Wisonic Medical Technolog510(k) NO: K211886(Traditional)
ATTN: Jiang Xiaosan PHONE NO : 86 755 86007788
1st, 2nd, 5th & 6th Floor, NO.6 BuSE DECISION MADE: 02-DEC-21
Shenzhen CN 518055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20
Asahi Intecc Co., Ltd. 510(k) NO: K211898(Special)
ATTN: Tomoya Eguchi PHONE NO : 81 561 561859
3-100 Akatsuki-cho SE DECISION MADE: 08-DEC-21
Seto JP 489-0071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iCOquit® Smokerlyzer®
Bedfont Scientific Ltd 510(k) NO: K211918(Third Party - Traditional)
ATTN: Louise Bateman PHONE NO : 44 0162 2851122
Station Road, Harrietsham SE DECISION MADE: 21-DEC-21
Maidstone GB ME17 1JA 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)
Shenzhen OSTO Technology Company L510(k) NO: K211942(Traditional)
ATTN: Li Yang PHONE NO : 86 755 29769546
No.43 Longfeng Road, Xinsheng CommSE DECISION MADE: 13-DEC-21
Shenzhen CN 518116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AirStrip ONE Web Client with Alarm Communication Management (ACM)
AirStrip Technologies, Inc. 510(k) NO: K211949(Special)
ATTN: JF Lancelot PHONE NO : 858 8485556
2915 West Bitters Road, Suite 215 SE DECISION MADE: 09-DEC-21
San Antonio TX 78248 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Milli Vaginal Dilator
Materna Medical 510(k) NO: K211959(Traditional)
ATTN: Kelly Ashfield PHONE NO : 866 4336933
2495 Hospital Drive Suite 300 SE DECISION MADE: 01-DEC-21
Mountain View CA 94040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads
Intuitive Surgical, Inc. 510(k) NO: K211997(Traditional)
ATTN: Amrit Jaggi PHONE NO : 949 6908799
1266 Kifer Road SE DECISION MADE: 10-DEC-21
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOSPA TKR System
Corentec Co., Ltd. 510(k) NO: K212034(Traditional)
ATTN: Seungri Kim PHONE NO : 82 41 4107117
12, Yeongsanhong 1-gil, Ipjang-MyeSE DECISION MADE: 09-DEC-21
Cheonan-si KR 31056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NGM WAVE PLIF Cage
NGMedical GmbH 510(k) NO: K212050(Traditional)
ATTN: Stella Hahn PHONE NO : 49 6873 99997100
Talsperrenblick 5 SE DECISION MADE: 01-DEC-21
Nonnweiler DE 66620 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Connected OR Hub with Device and Voice Control
Stryker Corporation 510(k) NO: K212055(Traditional)
ATTN: Eugene Perelshteyn PHONE NO : 469 4704312
5900 Optical Ct SE DECISION MADE: 16-DEC-21
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask
Zhongshan Saifute Labor Protective510(k) NO: K212059(Traditional)
ATTN: Qionghua Ke PHONE NO : 86 138 02652169
No.7, Xihuan 4th road, Southern DiSE DECISION MADE: 17-DEC-21
Zhongshan CN 528400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: neXus Ultrasonic Surgical Aspirator System
Misonix Inc. 510(k) NO: K212060(Traditional)
ATTN: John Salerno PHONE NO : 1 631 6949555
1938 New Highway SE DECISION MADE: 13-DEC-21
Farmingdale NY 11735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ShurFit Lumbar Interbody System
Precision Spine, Inc. 510(k) NO: K212075(Traditional)
ATTN: Michael Dawson PHONE NO : 601 4204244
2050 Executive Dr. SE DECISION MADE: 08-DEC-21
Pearl MS 39208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Siam NTD+ Nitrile Powder-Free Examination gloves
Siam NTD Corporation Co., Ltd. 510(k) NO: K212085(Traditional)
ATTN: Taweesak WaideemaneetrakoonPHONE NO : 668 992 68831
120/259 Moo 1 SE DECISION MADE: 11-DEC-21
Bueng Yitho Thanyaburi TH 12130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Integrity Implants Navigated Instruments
Integrity Implants Inc. 510(k) NO: K212088(Traditional)
ATTN: Lauren Kamer PHONE NO : 561 5293861
354 Hiatt Drive SE DECISION MADE: 23-DEC-21
Palm Beach Gardens FL 33418 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-Clever
LG Electronics.Inc 510(k) NO: K212137(Traditional)
ATTN: Jin-Hwan Jun PHONE NO : 82 31 80665641
77, Sanho-Daero, Gyeongbuk SE DECISION MADE: 10-DEC-21
Gumi-Si KR 39381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TheraFace LED
Theragun, Inc. 510(k) NO: K212155(Traditional)
ATTN: Jaime Sanchez PHONE NO : 310 5708341
6100 Wilshire Blvd, Suite 200 SE DECISION MADE: 21-DEC-21
Los Angeles CA 90048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CINtec Histology
Ventana Medical Systems, Inc. 510(k) NO: K212176(Traditional)
ATTN: Stacci Cronk PHONE NO : 520 3022193
1910 E Innovation Park Drive SE DECISION MADE: 10-DEC-21
Tucson AZ 85755 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Iconic Nitrile Glove
Iconic Medicare Sdn Bhd 510(k) NO: K212182(Traditional)
ATTN: Tan Cho Chia PHONE NO : 60 4 504159
1-2 Jalan Icon City, 14000 Bukit MSE DECISION MADE: 11-DEC-21
Kuala Lumpur MY 14000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Philips Radiology Smart Assistant
Philips Medical Systems DMC GmbH 510(k) NO: K212186(Traditional)
ATTN: Connie Pascual PHONE NO : 1 978 6592440
Roentgenstrasse 24-26 SE DECISION MADE: 13-DEC-21
Hamburg DE 22335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AHI System
Fifth Eye Inc. 510(k) NO: K212219(Traditional)
ATTN: Jennifer A. Baird PHONE NO : 734 2604800
110 Miller Avenue, Suite 300 SE DECISION MADE: 03-DEC-21
Ann Arbor MI 48104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer
Diazyme Laboratories Inc. 510(k) NO: K212221(Traditional)
ATTN: Chao Dou PHONE NO : 858 4554763
12889 Gregg Court SE DECISION MADE: 13-DEC-21
Poway CA 92064 510(k) STATEMENT
DEVICE: Surgical Face Mask
Shanghai Yunqing Industrial Co., L510(k) NO: K212235(Traditional)
ATTN: Hulin No Last Name ProvidedPHONE NO : 86 159 21265138
2nd building 1818, Shangsu Road, FSE DECISION MADE: 06-DEC-21
Shanghai CN 210000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Cardiovascular Procedure Kit
Medline Industries, Inc. 510(k) NO: K212258(Traditional)
ATTN: Stephanie Augsburg PHONE NO : 847 6433690
Three Lakes Drive SE DECISION MADE: 03-DEC-21
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIX-C PEEK Anterior Cervical Interbody System
Jeil Medical Corporation 510(k) NO: K212266(Traditional)
ATTN: Dajung Lee PHONE NO : 82 2 8503591
702, 703, 704, 705, 706, 804, 805,SE DECISION MADE: 21-DEC-21
Seoul KR 08378 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electrical Neuromuscular Stimulator (Cure Trio MC-130 iOS, Cure Trio MC-310 Android)
Oriental Inspiration Limited 510(k) NO: K212285(Traditional)
ATTN: Francis Ko PHONE NO : 852 26873496
Unit D (01), 14/F.,Block 1,Tai PinSE DECISION MADE: 22-DEC-21
Hong Kong CN 510(k) STATEMENT
DEVICE: 21HQ513D
LG Electronics Inc. 510(k) NO: K212295(Traditional)
ATTN: Jinhwan Jun PHONE NO : 82 31 80665641
77, Sanho-daero SE DECISION MADE: 03-DEC-21
Gumi-si KR 39381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYLAB 3-Ply Surgical Mask (BEACON I)
Baylab USA, LLC 510(k) NO: K212302(Traditional)
ATTN: Ashley Park PHONE NO : 214 9072527
2230 Lyndon B Johnson Freeway, SuiSE DECISION MADE: 07-DEC-21
Dallas TX 75234 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EyeBOX (Model EBX-4)
Oculogica, Inc. 510(k) NO: K212310(Traditional)
ATTN: Rosina Samadani PHONE NO : 484 3932694
33 Irving Place SE DECISION MADE: 22-DEC-21
New York NY 10003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AC Cream - Conductive paste
Spes Medica S.r.l 510(k) NO: K212326(Traditional)
ATTN: Giorgio Facco PHONE NO : 0039 0828 614191
Via Europa-Zona industriale SE DECISION MADE: 01-DEC-21
Battipaglia IT 84091 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Plasma IQ
Neauvia North America, Inc 510(k) NO: K212329(Traditional)
ATTN: Joy Willard PHONE NO : 984 7775296
8480 Honeycutt Road SE DECISION MADE: 09-DEC-21
Raleigh NC 27615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBOGUARD Balloon Guide Catheter
Neuravi Limited 510(k) NO: K212340(Traditional)
ATTN: Niall Fox PHONE NO : 353 86 1730678
Block 3, Ballybrit Business Park SE DECISION MADE: 17-DEC-21
Galway IE H91 K5YD 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves
Medi Legion Sdn.Bhd 510(k) NO: K212349(Traditional)
ATTN: N.S. Kumar PHONE NO : 60 10 2369523
No.6D, Plot 4, Pt 427, Jalan Waja SE DECISION MADE: 10-DEC-21
Kuala Langat MY 42500 510(k) STATEMENT
DEVICE: Revolution Peripheral Atherectomy System
Rex Medical, L.P. 510(k) NO: K212351(Traditional)
ATTN: Colin Valentis PHONE NO : 610 9400665
555 East North Lane, Suite 5035 SE DECISION MADE: 15-DEC-21
Conshohocken PA 19428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VersaTap, VersaLat, DueLock, VersaTi, MiniTi
Ortho-Design (Pty) Ltd 510(k) NO: K212381(Traditional)
ATTN: Dian Peach PHONE NO : 27 128 071902
472 Botterklapper Street, Die WilgSE DECISION MADE: 06-DEC-21
Pretoria ZA 0184 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StealthStation S8 Cranial v2.0
Medtronic Navigation 510(k) NO: K212397(Traditional)
ATTN: Carey Brenner PHONE NO : 720 3521146
826 Coal Creek Circle SE DECISION MADE: 22-DEC-21
Louisville CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask (Non-sterile)
Hubei Kimsoul Industrial Co., Ltd 510(k) NO: K212398(Traditional)
ATTN: Faming Zhang PHONE NO : 86 177 07273453
NO. 1, Industrial Zone, Guohe TownSE DECISION MADE: 15-DEC-21
Xiantao CN 433013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIVI Q Distal Access Catheter
MIVI Neuroscience, Inc. 510(k) NO: K212402(Special)
ATTN: Janel Hurtado PHONE NO : 612 5185800
6545 City West Parkway SE DECISION MADE: 16-DEC-21
Eden Prairie MN 55443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio
Brainlab AG 510(k) NO: K212420(Traditional)
ATTN: Chiara Cunico PHONE NO : 49 899 915680
Olof-Palme-Str. 9 SE DECISION MADE: 16-DEC-21
Munich DE 80809 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Centerpiece Plate Fixation System
Medtronic Sofamor Danek 510(k) NO: K212428(Traditional)
ATTN: Diamond Wallace PHONE NO : 901 3993133
1800 Pyramid Place SE DECISION MADE: 13-DEC-21
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Comprehensive Humeral Fracture Positioning Sleeves
Biomet Inc. 510(k) NO: K212435(Traditional)
ATTN: Aishwarya Pandey PHONE NO : 1 574 3733740
56 East Bell Drive SE DECISION MADE: 10-DEC-21
Warsaw IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NBR Synthetic Nitrile Examination Gloves
Shandong Langtai International Tra510(k) NO: K212436(Traditional)
ATTN: Ping Wang PHONE NO : 86 155 50323002
8/F,office Building,Weiqiao AluminSE DECISION MADE: 23-DEC-21
Binzhou CN 256206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Comfortpro
Thai Rubber Industry Company Limit510(k) NO: K212438(Abbreviated)
ATTN: Chawalit Tiyadechachai PHONE NO : 66 81 6298773
738 Moo 5, Manam Koo SE DECISION MADE: 07-DEC-21
Pluakdaeng TH 21140 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cydar EV (Series B) and Cydar EV Maps
Cydar Ltd. 510(k) NO: K212442(Traditional)
ATTN: Vanisha Mistry PHONE NO : 44 1223 778020
Bulbeck Mill, Mill Lane SE DECISION MADE: 03-DEC-21
Barrington GB CB22 7QY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LVivo Seamless
DiA Imaging Analysis Ltd 510(k) NO: K212466(Traditional)
ATTN: Michal Yaacobi PHONE NO : 972 77 7648318
77 Haenergia Street SE DECISION MADE: 09-DEC-21
Beer-Sheva IL 8470912 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Frax 1940 for Nordlys and Frax Pro
Candela Corporation 510(k) NO: K212492(Traditional)
ATTN: Rina Ordonez PHONE NO : 508 8346072
251 Locke Drive SE DECISION MADE: 20-DEC-21
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ArtiSential Trocar
LivsMed Inc. 510(k) NO: K212500(Traditional)
ATTN: Dong Wook Lee PHONE NO : 82 70 77094993
#304, D-dong, 700, Pangyo-ro, BundSE DECISION MADE: 03-DEC-21
Seongnam-si KR 13516 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anteralign Spinal System with Titan nanoLOCK Surface Technology
Medtronic Sofamor Danek USA, INC. 510(k) NO: K212524(Traditional)
ATTN: Elizabeth Hamilton PHONE NO : 901 3993395
1800 Pyramid Place SE DECISION MADE: 08-DEC-21
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Powder Free Blue Examination Gloves, Non-Sterile
Mah Sing Healthcare Sdn Bhd 510(k) NO: K212535(Traditional)
ATTN: Azlan Hashim PHONE NO : 603 33962288
Wisma Mah Sing, Penthouse Suite 1,SE DECISION MADE: 04-DEC-21
Kuala Lumpur MY 57100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DESS Dental Implants
Terrats Medical SL 510(k) NO: K212538(Traditional)
ATTN: Roger Terrats PHONE NO : 34 935 646006
Carrer Mogoda 75-99 SE DECISION MADE: 14-DEC-21
Barberà del Vallès ES 08210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quick-Start Screws
Innovate Orthopaedics Limited 510(k) NO: K212547(Traditional)
ATTN: Alex Gutteridge PHONE NO : 44 7713 958351
3M Buckley Innovation Centre FirthSE DECISION MADE: 30-DEC-21
Huddersfield GB HD1 3BD 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUXEN CL Dental Liquid
DENTALMAX Co., Ltd. 510(k) NO: K212548(Traditional)
ATTN: Park Seung Bum PHONE NO : 82 41 5233580
50-7, Pungsesandan 2-Ro, Pungse-MySE DECISION MADE: 06-DEC-21
Cheonan-Si KR 31217 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PicoLO Premium
Laseroptek Co., Ltd. 510(k) NO: K212573(Special)
ATTN: Hong Chu PHONE NO : 82 31 80235150
#203 & #204 Hyundai I valley, 31, SE DECISION MADE: 08-DEC-21
Seongnam-si KR 13212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask
Xiantao Deming Healthcare products510(k) NO: K212574(Traditional)
ATTN: Gan Jing PHONE NO : 86 159 08610172
198# Pengchang ave, Pengchang townSE DECISION MADE: 14-DEC-21
Xiantao CN 433018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DESS Dental Smart Solutions
Terrats Medical SL 510(k) NO: K212577(Traditional)
ATTN: Roger Terrats PHONE NO : 34 935 646006
Carrer Mogoda 75-99 SE DECISION MADE: 10-DEC-21
Barbera del Valles ES 08210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile disposable examination gloves
Xingyu Medical Tech Co., Ltd. 510(k) NO: K212578(Traditional)
ATTN: Cathrine Luan PHONE NO : 86 182 63618867
No. 2189 Yaoqian Road, Gaomi EconoSE DECISION MADE: 02-DEC-21
Weifang CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non Absorbable Surgical Nylon Suture
Shandong Haidike Medical Product C510(k) NO: K212603(Traditional)
ATTN: Lili Xu PHONE NO : 86 530 4660062
Tianfu Road, Dongcheng District, SSE DECISION MADE: 22-DEC-21
Heze CN 274300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue)
Koon Seng Sdn Bhd 510(k) NO: K212613(Traditional)
ATTN: Jennifer Yeo PHONE NO : 60 3 77331388
PTD 16058, Kawasan Perindustrian TSE DECISION MADE: 21-DEC-21
Tangkak MY 84900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Koios DS
Koios Medical, Inc. 510(k) NO: K212616(Traditional)
ATTN: Patricia Setti-Laperch PHONE NO : 732 5295755
242 West 38th Street, 14th Floor SE DECISION MADE: 16-DEC-21
New York NY 10018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo
Ellex Medical Pty Ltd 510(k) NO: K212630(Traditional)
ATTN: Rashmi Pillay PHONE NO : 61 8 70748105
3-4 Second Avenue Mawson Lakes SE DECISION MADE: 16-DEC-21
Adelaide AU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Nitrile Examination Gloves (Non sterile)
Jiangsu Nanfang Medical Co., Ltd 510(k) NO: K212639(Traditional)
ATTN: Xia Li PHONE NO : 1 396 1257758
No. 1 Guoxiang Rd, Wujin Economic SE DECISION MADE: 08-DEC-21
Changzhou CN 213149 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AT
AT Glove Engineering SDN. BHD 510(k) NO: K212645(Traditional)
ATTN: L. A. Choong PHONE NO : 0060 124 055026
No. 9, Jalan Chepor 11/7 SE DECISION MADE: 16-DEC-21
Kawasan Perusahaan Seramik Chepor 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flexible Intubation Video Endoscope – Sterile (FIVE-S)
KARL STORZ Endoscopy America 510(k) NO: K212656(Special)
ATTN: Mario Trujillo PHONE NO : 424 2188184
2151 E. Grand Avenue SE DECISION MADE: 29-DEC-21
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aspira Peritoneal Drainage System
Merit Medical Systems, Inc. 510(k) NO: K212675(Special)
ATTN: Jennifer Webb PHONE NO : 801 2084247
1600 West Merit Parkway SE DECISION MADE: 14-DEC-21
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: qXR-BT
Qure.ai Technologies 510(k) NO: K212690(Traditional)
ATTN: Bunty Kundnani PHONE NO : 91 22 68505800
Level 7, Commerz II, InternationalSE DECISION MADE: 21-DEC-21
Mumbai IN 400063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard
Splintek, Inc. 510(k) NO: K212706(Traditional)
ATTN: Thomas W. Brown PHONE NO : 816 5312008
15555 West 108th Street SE DECISION MADE: 13-DEC-21
Lenexa KS 66219 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vy Spine ClariVy Cervical IBF System
Vy Spine, LLC 510(k) NO: K212715(Traditional)
ATTN: Jordan Hendrickson PHONE NO : 866 4897746
2236 Capital Circle NE, Suite 103-SE DECISION MADE: 20-DEC-21
Tallahassee FL 32308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dermoaroma Disposable Nitrile Examination Glove
ChuZhou Harmony Gloves Medical Tec510(k) NO: K212716(Traditional)
ATTN: WeiHong Ou PHONE NO : 86 186 89321491
Technology Road 6, Branching StreaSE DECISION MADE: 27-DEC-21
Chuzhou CN 239236 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BellaTek Encode Emergence Healing Abutments
Biomet 3i LLC 510(k) NO: K212730(Special)
ATTN: Krupal Patel PHONE NO : 561 776 6923
4555 Riverside Drive 4555 RiversidSE DECISION MADE: 21-DEC-21
Palm Beach Gardens FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Puravita Medical Fold Flat Surgical Mask
Puravita M, LLC 510(k) NO: K212740(Traditional)
ATTN: Jefferson Nemelka PHONE NO : 801 8367940
1287 W 300S SE DECISION MADE: 02-DEC-21
Lindon UT 84042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SleepRight Select-Comfort Dental Guard
Splintek, Inc. 510(k) NO: K212767(Traditional)
ATTN: Thomas W. Brown PHONE NO : 816 5312008
15555 West 108th Street SE DECISION MADE: 22-DEC-21
Lenexa KS 66219 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vision
SoftSmile, Inc. 510(k) NO: K212770(Traditional)
ATTN: Khamzat Asabaev PHONE NO :
16192 Coastal Highway SE DECISION MADE: 21-DEC-21
Lewes DE 19958 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
Innovative Health, LLC. 510(k) NO: K212776(Traditional)
ATTN: Rick Ferreira PHONE NO : 877 4003740
1435 North Hayden Road, Suite 100 SE DECISION MADE: 20-DEC-21
Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate
Spinal Simplicity LLC 510(k) NO: K212781(Traditional)
ATTN: Adam Rogers PHONE NO : 913 4514414
6600 College Blvd, Suite 220 SE DECISION MADE: 15-DEC-21
Overland Park KS 66211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
5R MED Instruments (CHENGDU) Co., 510(k) NO: K212789(Traditional)
ATTN: Yuzhang Pan PHONE NO : 86 139 28606563
Building 9, Section 1, No.618 of WSE DECISION MADE: 01-DEC-21
Chengdu CN 611130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: powder free nitrile examination glove - white, non-sterile
Hong Seng Gloves Sdn Bhd 510(k) NO: K212802(Traditional)
ATTN: Ho Chia Yao PHONE NO : 604 4211555
LOT 97, Jalan 10, Kawasan PerusahaSE DECISION MADE: 02-DEC-21
Sungai Petani MY 08000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder free nitrile examination glove- blue, non-sterile
Hong Seng Gloves Sdn Bhd 510(k) NO: K212804(Traditional)
ATTN: Ho Chia Yao PHONE NO : 604___ 4211555
LOT 97, Jalan 10, Kawasan PerusahaSE DECISION MADE: 01-DEC-21
Sungai Petani MY 08000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alcon (serafilcon A) soft contact lenses for daily wear
Alcon Laboratories, Inc 510(k) NO: K212806(Traditional)
ATTN: Alicia Plesnarski PHONE NO : 678 4153924
6201 South Freeway SE DECISION MADE: 28-DEC-21
Fort Worth TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Masks
Weihai Hongyu Nonwoven Fabric Prod510(k) NO: K212807(Traditional)
ATTN: Bin Dong PHONE NO : 86 1566 2383633
No. 567 Gushan Road, Area of EconoSE DECISION MADE: 03-DEC-21
Weihai CN 264205 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Merit Siege Vascular Plug
Merit Medical System, Inc. 510(k) NO: K212817(Traditional)
ATTN: Mark Mullaney PHONE NO : 353 91 703700 3061
1600 West Merit Parkway SE DECISION MADE: 15-DEC-21
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs
JR Engineering & Medical Technolog510(k) NO: K212827(Abbreviated)
ATTN: Ganesan Subramaniam PHONE NO : 603 60572081
Lot 8 &10, Jalan Zurah 3 & Lot 1&3SE DECISION MADE: 06-DEC-21
Hulu Selangor MY 44200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CT3000Pro
SRS Medical 510(k) NO: K212830(Traditional)
ATTN: Lee Brody PHONE NO : 978 6632800
76 Treble Cove Road, Building #3 SE DECISION MADE: 21-DEC-21
North Billerica MA 01862 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TimeWaver Frequency
TimeWaver Production GmbH 510(k) NO: K212832(Traditional)
ATTN: Babak Jafarian PHONE NO : 49 3391 4002211
Schloss Kraenzlin, Darritzer StrasSE DECISION MADE: 14-DEC-21
Kraenzlin DE 16818 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)
Siyang Threeguard Medical Supplies510(k) NO: K212834(Traditional)
ATTN: Guo Hua PHONE NO : 8 613 485097856
East of Nanhai Road and South of GSE DECISION MADE: 30-DEC-21
Suqian CN 223799 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Gloves (Model: NE01)
BYD Auto Industry Company Limited 510(k) NO: K212840(Traditional)
ATTN: Liu Jiangling PHONE NO : 86 136 32994277
No.3001,3007, Pingshan Hengping HiSE DECISION MADE: 11-DEC-21
Shenzhen CN 518119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Latex Surgical Gloves Powder Free
Pentavest Holdings Sdn Bhd 510(k) NO: K212848(Abbreviated)
ATTN: Teng Boon Joo PHONE NO : 601 22332689
No. 9574-9578, Jalan PTB 2 , KawasSE DECISION MADE: 27-DEC-21
Batu MY 76400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ComfortPro Blue Nitrile Examination Gloves Powder Free
Thai Rubber Industry Company Limit510(k) NO: K212850(Abbreviated)
ATTN: Supawadee Phoungthong PHONE NO : 66 098 2520209
738 Moo 5, Manam Koo SE DECISION MADE: 10-DEC-21
Pluakdaeng TH 21140 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle
Micro-Tech(Nanjing) Co., Ltd. 510(k) NO: K212852(Traditional)
ATTN: Cecilia Sun PHONE NO : 86 255 8646395
No.10 Gaoke Third Road, Nanjing NaSE DECISION MADE: 06-DEC-21
Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: First Relief
DyAnsys, Inc. 510(k) NO: K212859(Traditional)
ATTN: Srini Nageshwar PHONE NO : 408 4804700
300, North Bayshore Boulevard SE DECISION MADE: 20-DEC-21
San Mateo CA 94401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Gown, Reinforced Surgical Gown
Wuhan Zonsen Medical Products Co.,510(k) NO: K212861(Traditional)
ATTN: Cynthia Ye PHONE NO : 86 027 82737771
No.8 Jinchao Road Zhucheng Street SE DECISION MADE: 15-DEC-21
Wuhan CN 431400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T
Philips Healthcare (Suzhou) Co., L510(k) NO: K212864(Traditional)
ATTN: Seaman Shao PHONE NO : 86 139 13116320
No.258, ZhongYuan Road, Suzhou IndSE DECISION MADE: 01-DEC-21
Suzhou CN 215024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Surgical Mask
Nanchang Kanghua Health Materials 510(k) NO: K212867(Traditional)
ATTN: Jiamin Wang PHONE NO : 86 791 85621388
Moonlight Road,Medical Device TechSE DECISION MADE: 11-DEC-21
Nanchang CN 331700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Gown, Disposable Reinforced Surgical Gown
Fugou County Shenxiang Manufacturi510(k) NO: K212869(Traditional)
ATTN: Carina Si PHONE NO : 86 215 4889822
Industrial Clusters,No.2 Road,FugoSE DECISION MADE: 13-DEC-21
Zhoukou CN 461300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avenger Radial Head System
In2Bones USA, LLC 510(k) NO: K212872(Traditional)
ATTN: Christine Scifert PHONE NO :
6000 Poplar Ave, Suite 115 SE DECISION MADE: 17-DEC-21
Memphis TN 38119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nyquist.IQ
Omega Medical Imaging, LLC 510(k) NO: K212890(Traditional)
ATTN: John Newman PHONE NO : 407 3239400
3400 St. Johns Parkway, Suite 1020SE DECISION MADE: 13-DEC-21
Sanford FL 32771 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs
Rimba Glove SND BHD 510(k) NO: K212898(Traditional)
ATTN: Zahari Bin Darus PHONE NO : 605 5483688
Plot 37, Medan Tasek, Tasek IndustSE DECISION MADE: 16-DEC-21
IPOH MY 31400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Vinyl/Nitrile Blend Medical Examination Gloves
Bytech(Dongtai) Co., Ltd. 510(k) NO: K212899(Traditional)
ATTN: Wang Cheng PHONE NO : 860 180 21873188
XinYuan Industrial Park,TangYang TSE DECISION MADE: 11-DEC-21
DongTai CN 224233 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPACT Sacroiliac Joint Fixation System
Life Spine, Inc. 510(k) NO: K212903(Traditional)
ATTN: Angela Batker PHONE NO : 847 8846117___
13951 S. Quality Drive SE DECISION MADE: 15-DEC-21
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SeaSpine WaveForm C Interbody System
SeaSpine Orthopedics Corporation 510(k) NO: K212904(Traditional)
ATTN: Hong Phan PHONE NO : 760 421 2793
5770 Armada Drive SE DECISION MADE: 14-DEC-21
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aimanfun Lumea Comfort, A-2789/A-3588
Kam Yuen Plastic Products Ltd. 510(k) NO: K212907(Special)
ATTN: Anna Dan PHONE NO : 86 400 9621668
No. 2, Heng Feng Two Road, Pu Jin SE DECISION MADE: 02-DEC-21
ZhongShan CN 518100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Glovmaster Nitrile Examination Glove Powder Free
Glovmaster SDN. BHD. 510(k) NO: K212914(Traditional)
ATTN: Zarina binti Hamid PHONE NO : 601 35928225
154, Jalan 4, Kawasan PerindustriaSE DECISION MADE: 22-DEC-21
Banting MY 42700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Heat StimPlus
Famidoc Technology Co., Ltd. 510(k) NO: K212918(Traditional)
ATTN: Amos Zou PHONE NO : 86 769 89272488
No.212 Yilong Road, Hexi IndustriaSE DECISION MADE: 13-DEC-21
Dongguan CN 523853 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
Jiujiang Taixin Technology Co., Lt510(k) NO: K212919(Traditional)
ATTN: Li Xiaojie PHONE NO : 86 186 02030622
Zone A, Ruichang Science and TechnSE DECISION MADE: 15-DEC-21
Ruichang City CN 332200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Golves Powder Free
Jiangsu Standard Health Co.,Ltd 510(k) NO: K212921(Traditional)
ATTN: Lu Tao PHONE NO : 86 0512 58585333
19F Fortune Tower, No.1 Wangxi RoaSE DECISION MADE: 24-DEC-21
Zhangjiagang City CN 215600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Gloves
HSK Medical Apparatus Foshan China510(k) NO: K212922(Traditional)
ATTN: Zhao Zhongheng PHONE NO : 86 189 88689788
Shitang Road, Shishan Town, NanhaiSE DECISION MADE: 10-DEC-21
Foshan CN 528234 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Gloves
Shanxi Nacosa Medical Technology C510(k) NO: K212924(Traditional)
ATTN: Lu Yingying PHONE NO : 86 159 55123917
Chengxi Industrial Park, Wenxi EcoSE DECISION MADE: 13-DEC-21
Yuncheng City CN 043800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Gown
Henan Robestain Medical Products C510(k) NO: K212925(Traditional)
ATTN: Yonghong Liu PHONE NO : 86 373 8701888
No.590, Zhangnan Industrial Zone, SE DECISION MADE: 13-DEC-21
Changyuan CN 453440 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray
Nobel Biocare Services AG 510(k) NO: K212932(Traditional)
ATTN: Nick Lewis PHONE NO : 41 799 416817
BOX 5190, SE-402 26, Vastra HamngaSE DECISION MADE: 18-DEC-21
Goteborg SE SE-411 17 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Mask
Heilongjiang Yinjia Medical Equipm510(k) NO: K212944(Traditional)
ATTN: Zhu Hongwei PHONE NO : 86 451 58673917
F3-4, Plant 6, No.10, Hanan 12th RSE DECISION MADE: 15-DEC-21
Harbin CN 150000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJIFILM Video Laparoscope EL-R740M30
FUJIFILM Corporaton 510(k) NO: K212950(Traditional)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 02-DEC-21
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MRIdian Linac System
ViewRay, Incorporated 510(k) NO: K212958(Traditional)
ATTN: Sean Delaney PHONE NO : 650 2520920
815 E. Middlefield Road SE DECISION MADE: 14-DEC-21
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Injectable Root Canal Bioceramic Sealer
Beijing C-Root Dental Medical Devi510(k) NO: K212983(Traditional)
ATTN: Bingmin Wu PHONE NO : 86 18 601290788
Room 301, Building 10, Yard 12, MiSE DECISION MADE: 08-DEC-21
Beijing CN 101300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 6MP Color LCD Monitor CL-S600
JVCKENWOOD Corporation 510(k) NO: K212985(Traditional)
ATTN: Hideki Tengeiji PHONE NO : 81 454 502715
3-12, Moriya-cho, Kanagawa-ku SE DECISION MADE: 16-DEC-21
Yokohama JP 221-0022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vinyl Examination Gloves
Taian Hengchang Medical Technology510(k) NO: K213006(Traditional)
ATTN: Jing Li PHONE NO : 86 159 63319855
NO.88 Central Road, Sunbo Town IndSE DECISION MADE: 21-DEC-21
Taian City CN 271607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATM Glove
Phu Duc Huy Production Trading Ser510(k) NO: K213016(Traditional)
ATTN: Tran Xuan Kiem PHONE NO : 84 91 3134359
Hamlet 8, Luong Hoa Commune SE DECISION MADE: 28-DEC-21
Ben Luc District VN 82000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL hair removal machine
Shenzhen Borria Technology Co.,Ltd510(k) NO: K213020(Traditional)
ATTN: Li Zhenqiang PHONE NO : 86 755 83176765
22A, Tianmian City Building, No.40SE DECISION MADE: 16-DEC-21
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oren LED Perioral Light Therapy System
Shenzhen Kaiyan Medical Co Ltd 510(k) NO: K213024(Traditional)
ATTN: Alain Dijkstra PHONE NO : 86 755 82129361
40A Fuxin Road, Fuyong SubdistrictSE DECISION MADE: 22-DEC-21
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Gloves (Powder free, Blue)
Weihai Hongyu Nonwoven Fabric Prod510(k) NO: K213029(Traditional)
ATTN: Dong Bin PHONE NO : 86 1566 2383633
No.567, Gushan Road, Area of EconoSE DECISION MADE: 14-DEC-21
Weihai CN 264207 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console
Zoll Circulation, Inc. 510(k) NO: K213031(Traditional)
ATTN: Elizabeth Haines PHONE NO : 978 5696862
200 Ringwood Avenue SE DECISION MADE: 20-DEC-21
San Jose CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TearCare System
Sight Sciences, Inc. 510(k) NO: K213045(Traditional)
ATTN: Edward J. Sinclair PHONE NO : 650 2189149
4040 Campbell Ave., Suite 100 SE DECISION MADE: 21-DEC-21
Menlo Park CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)
Huayuan Medical Technology(Shangqi510(k) NO: K213048(Traditional)
ATTN: Huamei Wang PHONE NO : 86 137 05111918__
In The North Yard of West 1000m RoSE DECISION MADE: 18-DEC-21
Shangqiu CN 476000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)
Yunnan Huazhiyuan Medical Technolo510(k) NO: K213051(Traditional)
ATTN: Yun Gao PHONE NO : 86 182 52909158
Yangjie Industrial Park, Jianshui SE DECISION MADE: 18-DEC-21
Honghe Hani and Yi Autonomous Pref510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solero Microwave Tissue Ablation (MTA) System and Accessories
AngioDynamics, Inc. 510(k) NO: K213067(Special)
ATTN: Kasey E Newcomb PHONE NO : 508 6587913
26 Forest Street SE DECISION MADE: 03-DEC-21
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoLink NeoFuse Plating System
In2Bones USA, LLC 510(k) NO: K213069(Traditional)
ATTN: Christine Scifert PHONE NO :
6000 Poplar Ave, Suite 115 SE DECISION MADE: 13-DEC-21
Memphis TN 38119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Goody Gloves, Wincare, TBG Gloves
Thai Rubber Gloves Co., Ltd 510(k) NO: K213073(Abbreviated)
ATTN: Chalongkwan Wongsasuthikul PHONE NO : 66 213 06356
680 Moo 2 Banbueng-Klaeng Rd. SE DECISION MADE: 29-DEC-21
Nongyai TH 20190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AspenMed+
Aspen Glove Sdn. Bhd. 510(k) NO: K213076(Abbreviated)
ATTN: Iskandar Basha Bin Abdul KadPHONE NO : 604 2275000
Aspen House, 300, JLN Macalister, SE DECISION MADE: 20-DEC-21
Georgetown MY 10450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cellusheet, Cellufil
Human Biosciences, Inc. 510(k) NO: K213092(Special)
ATTN: Jigar Patel PHONE NO : 301 7401893
940 Clopper Rd. SE DECISION MADE: 15-DEC-21
Gaithersburg MD 20878 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ID-500 iRestore Hair Growth System
Freedom Laser Therapy, Inc. 510(k) NO: K213094(Traditional)
ATTN: Wei-Chih (Kevin) Chen PHONE NO : 714 6699888
16782 Von Karman Avenue, Unit 15 SE DECISION MADE: 22-DEC-21
Irvine CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Al-Rad Companion (Pulmonary)
Siemens Medical Solutions USA, Inc510(k) NO: K213096(Traditional)
ATTN: Alaine Medio PHONE NO : 865 2060337
810 Innovation Drive SE DECISION MADE: 06-DEC-21
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHENA-C Spacer System
Kahtnu Surgical, Inc 510(k) NO: K213115(Special)
ATTN: Craig Wilcox PHONE NO : 907 2023111
170 E. Corral Ave. Suite 1 SE DECISION MADE: 06-DEC-21
Soldotna AK 99669 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Everyway Incontinence Stimulation System
Everyway Medical Instruments Co., 510(k) NO: K213116(Traditional)
ATTN: Paul Hung PHONE NO : 886 2 26620038
3FL., No. 5, Lane 155, Section 3, SE DECISION MADE: 03-DEC-21
Shenkeng District, New Taipei City510(k) STATEMENT
DEVICE: Restoration Modular 115mm Conical Distal Stem
Howmedica Osteonics Corp., dba Str510(k) NO: K213129(Traditional)
ATTN: Allison Byrne PHONE NO : 201 8315969
325 Corporate Drive SE DECISION MADE: 21-DEC-21
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CPL Surgical Face Mask
Control Print Limited 510(k) NO: K213136(Traditional)
ATTN: Pankaj Sharma PHONE NO : 91 980 5020592
Village Bhatian, Near TVS Factory,SE DECISION MADE: 24-DEC-21
District Solan IN 174101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGmatic S15 L Pro
KaVo Dental GmbH 510(k) NO: K213139(Traditional)
ATTN: Kerstin Henseler PHONE NO : 49 7351 562431
Bismarckring 39 SE DECISION MADE: 21-DEC-21
Biberach DE 88400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Claritas iPET
Claritas HealthTech Pte Ltd 510(k) NO: K213140(Traditional)
ATTN: Devika Dutt PHONE NO : 65 979 51921
20A Tanjong Pagar Road SE DECISION MADE: 22-DEC-21
Singapore SG 088443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors
Shen Wei USA Inc. 510(k) NO: K213144(Traditional)
ATTN: Cheryl Reep PHONE NO : 510 4298692
33278 Central Ave Ste 102 SE DECISION MADE: 22-DEC-21
Union City CA 94587 510(k) STATEMENT
DEVICE: VOCO Retraction Paste
Voco GmbH 510(k) NO: K213149(Traditional)
ATTN: M Th Plaumann PHONE NO : 49 47217190
Anton-Flettner-Str. 1-3 SE DECISION MADE: 09-DEC-21
Cuxhaven DE 27472 510(k) STATEMENT
DEVICE: RT-Mind-AI
MedMind Technology Co., Ltd. 510(k) NO: K213155(Traditional)
ATTN: Shaobin Wang PHONE NO : 86 10 58352266
A502-503, Techart Plaza, No.30, XuSE DECISION MADE: 15-DEC-21
Beijing CN 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Nano 2nd Gen Pen Needle
Becton, Dickinson and Company 510(k) NO: K213156(Special)
ATTN: Mark William PHONE NO : 737 5275008
1 Becton Drive SE DECISION MADE: 08-DEC-21
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Encore System
Siesta Medical, Inc. 510(k) NO: K213159(Traditional)
ATTN: Michael Kolber PHONE NO : 408 5056626
101 Church Street SE DECISION MADE: 22-DEC-21
Los Gatos CA 95030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Powder-Free Examination Gloves
Anhui Zhong Lian Latex Gloves Manu510(k) NO: K213176(Traditional)
ATTN: Kitty Xu PHONE NO : 86 138 53370291
Guzhen Economic Development Zone SE DECISION MADE: 13-DEC-21
Bengbu CN 233799 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sheath, Stopcock Accessory
Olympus Winter & Ibe GmbH 510(k) NO: K213207(Traditional)
ATTN: Katharina Campbell PHONE NO : 49 40 669662997
Kuehnstr. 61 SE DECISION MADE: 22-DEC-21
Hamburg DE 22045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Twist Drills
Biomet Microfixation 510(k) NO: K213208(Traditional)
ATTN: Mark Wladkowski PHONE NO : 904 7414400
1520 Tradeport Drive SE DECISION MADE: 23-DEC-21
Jacksonville FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device
K1 Medical LLC 510(k) NO: K213209(Traditional)
ATTN: Walt Oko PHONE NO : 203 9134161
56 Newton Road SE DECISION MADE: 28-DEC-21
Woodbridge CT 06525 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vy Spine™ VyWasher™ Buttress System
Vy Spine, LLC 510(k) NO: K213219(Traditional)
ATTN: Jordan Hendrickson PHONE NO : 866 4897746
2236 Capital Circle NE, Suite 103-SE DECISION MADE: 23-DEC-21
Tallahassee FL 32308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diode Laser System GP900A8, Diode Laser System GP900Q8
Shenzhen GSD Tech Co., Ltd. 510(k) NO: K213225(Traditional)
ATTN: Huifang Yao PHONE NO : 86 150 18526594
Building A, JUNSD Hi-Tech Park, WeSE DECISION MADE: 22-DEC-21
Shenzhen CN 518106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Inspan ScrewLES Fusion System
LESpine Innovations, LLC 510(k) NO: K213266(Traditional)
ATTN: John Sullivan PHONE NO : 978 2323990
350 Main Street, 2nd Floor SE DECISION MADE: 03-DEC-21
Malden MA 02148 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EchoGo Core (2.0)
Ultromics Limited 510(k) NO: K213275(Traditional)
ATTN: Jaco Jacobs PHONE NO : 077 865 65167
4630 Kingsgate, Cascade Way OxfordSE DECISION MADE: 20-DEC-21
Oxford GB OX4 2SU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InCore Subtalar System
Nextremity Solutions, Inc. 510(k) NO: K213301(Traditional)
ATTN: Elise Fox PHONE NO : 574 3762062
1195 Polk Drive SE DECISION MADE: 21-DEC-21
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42
Infraredx, Inc. 510(k) NO: K213303(Traditional)
ATTN: Stephen Sum PHONE NO : 781 3459651
28 Crosby Drive, Suite 100 SE DECISION MADE: 07-DEC-21
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation 510(k) NO: K213305(Traditional)
ATTN: Janine F. Reyes PHONE NO : 714 6697853
1385 Shimoshigami SE DECISION MADE: 01-DEC-21
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM
Nihon Kohden Corporation 510(k) NO: K213316(Special)
ATTN: Sandra Gadeyne PHONE NO : 949 3563401
1-31-4 Nishiochiai, Shinjuki-Ku SE DECISION MADE: 29-DEC-21
Tokyo JP 161-8560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SeaSpine WaveForm, C Interbody System
SeaSpine Orthopedics Corporation 510(k) NO: K213359(Traditional)
ATTN: Hong Phan PHONE NO : 760 4212793
5770 Armada Drive SE DECISION MADE: 09-DEC-21
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Nitrile Examination Gloves (Model:XYS-001)
Anhui Xinyisheng Medical Technolog510(k) NO: K213371(Third Party - Traditional)
ATTN: Shyla Tang PHONE NO : 86 1801 2883846
No.999 North of the intersection oSE DECISION MADE: 09-DEC-21
Suzhou CN 234000 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Physica system
LimaCorporate S.p.A 510(k) NO: K213381(Traditional)
ATTN: Ilaria Giannuzzi PHONE NO :
Via Nazionale 52 SE DECISION MADE: 17-DEC-21
Villanova di San Daniele del Friul510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vy Spine™ VySpan™ PCT System
Vy Spine, LLC 510(k) NO: K213394(Traditional)
ATTN: Jordan Hendrickson PHONE NO : 866 4897746___
2236 Capital Circle NE, Suite 103-SE DECISION MADE: 10-DEC-21
Tallahassee FL 32308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InkSpace Imaging Pediatric Body Array
InkSpace Imaging, Inc. 510(k) NO: K213397(Traditional)
ATTN: Peter Fischer PHONE NO : 408 8345459
5635 West Las Positas Blvd Suite 4SE DECISION MADE: 17-DEC-21
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UltiCare Disposable Pen Needles
UltiMed Incorporated 510(k) NO: K213407(Third Party - Traditional)
ATTN: Paul Lewis PHONE NO : 651 2917909
350 Highway 7, Suite 100 SE DECISION MADE: 16-DEC-21
Excelsior MN 55331 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: iSR’obot Mona Lisa 2.0
Biobot Surgical Pte Ltd 510(k) NO: K213411(Traditional)
ATTN: Lim Yan Shin PHONE NO : 65 972 63992
79 Ayer Rajah Crescent, #04-05 SE DECISION MADE: 22-DEC-21
Singapore SG 139955 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EkoSonic Endovascular Device, EKOS+ Endovascular Device
Boston Scientific Corporation 510(k) NO: K213422(Traditional)
ATTN: Ambreen Athar PHONE NO : 763 9558171
Three Scimed Place SE DECISION MADE: 14-DEC-21
Maple Grove MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EdgePro
Biolase Inc. 510(k) NO: K213428(Special)
ATTN: Ed Balcos PHONE NO : 949 2268119
27042 Towne Centre Drive, Suite 27SE DECISION MADE: 22-DEC-21
Foothill Ranch CA 92610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Insignia™ Anterior Cervical Plate System
Alphatec Spine, Inc. 510(k) NO: K213443(Traditional)
ATTN: Sandy Gill PHONE NO : 760 4946633
1950 Camino Vida Roble SE DECISION MADE: 15-DEC-21
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xenco Medical Multilevel CerviKit
Xenco Medical, LLC 510(k) NO: K213456(Traditional)
ATTN: Jason Haider PHONE NO : 858 2021522 202
9930 Mesa Rim Rd SE DECISION MADE: 21-DEC-21
San Diego CA 92121-2910 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Invictus Spinal Fixation System
Alphatec Spine, Inc. 510(k) NO: K213460(Traditional)
ATTN: Sandy Gill PHONE NO : 760 4946633
1950 Camino Vida Roble SE DECISION MADE: 10-DEC-21
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NightOwl
Ectosense nv 510(k) NO: K213463(Special)
ATTN: Bart Van Pee PHONE NO : 32 2 5889044
Bosbessenlaan 19 A SE DECISION MADE: 16-DEC-21
Rotselaar BE 3110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D²RS and D²RS 9090
Stephanix 510(k) NO: K213479(Traditional)
ATTN: Sandie Perret PHONE NO : 334 77478160
10, rue Jean Moulin Z.I du Bayon SE DECISION MADE: 23-DEC-21
La Ricamarie FR 42150 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMABOND PRINEO Skin Closure System
Ethicon, Inc. 510(k) NO: K213512(Special)
ATTN: Noorhidayah Norizan PHONE NO : 908 8086624
1000 Rte. 202 South SE DECISION MADE: 07-DEC-21
Raritan NJ 08869 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nextra CH Cannulated Hammertoe System
Nextremity Solutions, Inc. 510(k) NO: K213530(Special)
ATTN: Elise Fox PHONE NO : 574 3762062
1195 Polk Drive SE DECISION MADE: 09-DEC-21
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TR BAND Radial Compression Device
Terumo Medical Corporation 510(k) NO: K213531(Traditional)
ATTN: Liang Lu PHONE NO : 410 3927321
950 Elkton Blvd SE DECISION MADE: 20-DEC-21
Elkton MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
Acuity Polymers, Inc. 510(k) NO: K213538(Traditional)
ATTN: James A Bonafini PHONE NO : 585 4588409
1667 Lake Ave. Suite 303 SE DECISION MADE: 30-DEC-21
Rochester NY 14615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
Neuronetics, Inc 510(k) NO: K213543(Special)
ATTN: Fred Cowdery PHONE NO : 610 9814138
3222 Phoenixville Pike SE DECISION MADE: 10-DEC-21
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla
TTK Healthcare Limited 510(k) NO: K213547(Special)
ATTN: Daniel J S PHONE NO : 91 413 2261401
12, K P Natham Road, Thiruvandar KSE DECISION MADE: 23-DEC-21
Puducherry IN 605102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length
Total Joint Othopedics, Inc. 510(k) NO: K213580(Special)
ATTN: Chris Weaber PHONE NO : 801 4866070
1567 E. Stratford Avenue SE DECISION MADE: 03-DEC-21
Salt Lake City UT 84106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSIOfiber Compression Screw, 3.5mm
OSSIO Ltd. 510(k) NO: K213596(Traditional)
ATTN: Taly Lindner PHONE NO : 972 4 9986600
8 HaTochen St. SE DECISION MADE: 21-DEC-21
Caesarea IL 3079861 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RF Vapor System
Aqua Medical, Inc. 510(k) NO: K213627(Special)
ATTN: Scott McGill PHONE NO : 916 4021619
191 West Second St. SE DECISION MADE: 17-DEC-21
Santa Ana CA 92701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VBrain
Vysioneer Inc. 510(k) NO: K213628(Special)
ATTN: Vicki Lin PHONE NO : 609 8658659
33 Rogers. St., # 308 SE DECISION MADE: 16-DEC-21
Cambridge MA 02142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Chocolate PTA Balloon Catheter
Medtronic, Inc. 510(k) NO: K213631(Special)
ATTN: Laura Hanson PHONE NO : 763 5913024
2300 Berkshire Lane North, Suite 5SE DECISION MADE: 15-DEC-21
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JAZZ Solo sensor
Jazz Imaging LLC dba JAZZ Imaging 510(k) NO: K213637(Special)
ATTN: Todd C Miller PHONE NO : 567 2345299
SE DECISION MADE: 10-DEC-21
San Jose CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Traveler 0.038" Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003)
Argon Medical Devices 510(k) NO: K213638(Special)
ATTN: Ana Jimenez-Hughes PHONE NO : 903 6764276
1445 Flat Creek Road SE DECISION MADE: 10-DEC-21
Athens TX 75751 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Knotless Mini TightRopes
Arthrex Inc. 510(k) NO: K213644(Special)
ATTN: Rebecca R Homan PHONE NO : 239 643553 73429
1370 Creekside Boulevard SE DECISION MADE: 17-DEC-21
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solas OR
Cirdan Imaging Ltd 510(k) NO: K213691(Third Party - Traditional)
ATTN: Paul Matthews PHONE NO : 011 4428 92660880
The Green, Tullynacross Rd, LambegSE DECISION MADE: 22-DEC-21
Lisburn GB BT27 5SR 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MULTIX Impact, MULTIX Impact C
Siemens Medical Solutions USA, Inc510(k) NO: K213700(Special)
ATTN: Denise Adams PHONE NO : 610 9442184
40 Liberty Boulevard SE DECISION MADE: 13-DEC-21
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRSplus
CenterVue SpA 510(k) NO: K213705(Special)
ATTN: Luca Scienza PHONE NO : 39 049 5018399
Via S. Marco 9H SE DECISION MADE: 21-DEC-21
Padova IT 35129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition
GE Medical Systems,LLC 510(k) NO: K213715(Special)
ATTN: Katelyn Rowley PHONE NO : 262 3095888
3000 N Grandview Blvd. SE DECISION MADE: 17-DEC-21
Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Serranator PTA Serration Balloon Catheter
Cagent Vascular, LLC 510(k) NO: K213728(Special)
ATTN: Carol Burns PHONE NO : 610 6882006
150 Strafford Avenue #315 SE DECISION MADE: 15-DEC-21
Wayne PA 19087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ponto 5 SuperPower
Oticon Medical AB 510(k) NO: K213733(Special)
ATTN: Anja Ravn PHONE NO : 45 26 774422
Datavagen 37B SE DECISION MADE: 16-DEC-21
Askim SE SE-436 32 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sonosite PX Ultrasound System
FUJIFILM Sonosite, Inc. 510(k) NO: K213763(Third Party - Traditional)
ATTN: Anoush Frankian PHONE NO : 425 9516824
21919 30th Drive SE SE DECISION MADE: 27-DEC-21
Bothell WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T
Invivo Corporation 510(k) NO: K213766(Third Party - Traditional)
ATTN: Ann Lebar PHONE NO : 414 2176244
3545 SW 47th Ave SE DECISION MADE: 23-DEC-21
Gainesville FL 32608 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LiverSmart
Resonance Health Analysis Services510(k) NO: K213776(Special)
ATTN: Mitchell Wells PHONE NO : 61 8 92865300
141 Burswood Road SE DECISION MADE: 29-DEC-21
Perth AU 6100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ArchForm Orthodontic Software System
ArchForm, Inc 510(k) NO: K213916(Third Party - Traditional)
ATTN: Andrew S. Martz PHONE NO : 661 3048575
8421 Blue Heron Drive SE DECISION MADE: 16-DEC-21
Bakersfield CA 93312 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 308
TOTAL WITH SUMMARIES 295
TOTAL WITH STATEMENTS 13
