510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD July 2022
DEVICE: ROTEM sigma Thromboelastometry System
Tem Innovations GmbH 510(k) NO: K201440(Traditional)
ATTN: David Jacob PHONE NO : 49 89 45429523
Martin-Kollar-Strasse 15 SE DECISION MADE: 08-JUL-22
Munich DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DiviTum TKa
Biovica International AB 510(k) NO: K202852(Traditional)
ATTN: Wing Cheng PHONE NO : 46 073 1259245
Dag Hammarskjölds väg 54B SE DECISION MADE: 29-JUL-22
Uppsala SE 75237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AGNES
Agnes Medical CO., LTD 510(k) NO: K203013(Traditional)
ATTN: Chul Lee PHONE NO : 82 31 80209702
(Seohyeon-Dong, 5fCocoplaza), 20, SE DECISION MADE: 14-JUL-22
Seongnam-Si KR 13591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hanger Cranial Band 3D
Symbion Logistics, LLC 510(k) NO: K203134(Traditional)
ATTN: Roselle Abad PHONE NO : 480 8941755
1119 W Geneva Dr SE DECISION MADE: 01-JUL-22
Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Veuron-Brain-mN1
Heuron Co., Ltd. 510(k) NO: K203279(Traditional)
ATTN: Dong Hoon Shin PHONE NO : 82 32 4298508
10th Floor, 7, Mirae-ro, Namdong-gSE DECISION MADE: 12-JUL-22
Incheon KR 21558 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioFire JI Control Panel M420
Maine Molecular Quality Controls, 510(k) NO: K203680(Traditional)
ATTN: Joan Gordon PHONE NO : 207 8851072
23 Mill Brook Road SE DECISION MADE: 22-JUL-22
Saco ME 04072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Minuteful - kidney test
Healthy.io Ltd. 510(k) NO: K210069(Traditional)
ATTN: Ron Zohar PHONE NO : 972 54 4454514
2 Ibn Gabirol St. SE DECISION MADE: 06-JUL-22
Tel Aviv IL 6407702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLS Martin IPS Preprosthetic
KLS-Martin L.P. 510(k) NO: K210228(Traditional)
ATTN: Jennifer Damato PHONE NO : 904 6417746 8005
11201 Saint Johns Industrial ParkwSE DECISION MADE: 08-JUL-22
Jacksonville FL 32246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SNUCONE Bone Level Implant System
SNUCONE Co., LTD. 510(k) NO: K210354(Traditional)
ATTN: Ji Eun Song PHONE NO : 82 53 5927525
5, Seongseo-ro 75-gil SE DECISION MADE: 13-JUL-22
Dalseo-gu KR 42703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nerve Tape
BioCircuit Technologies, Incorpora510(k) NO: K210665(Traditional)
ATTN: Jack Griffis PHONE NO : 404 5836889
1819 Peachtree Road NE, STE 205 SE DECISION MADE: 15-JUL-22
Atlanta GA 30309 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLS Martin Individual Patient Solutions
KLS-Martin L.P. 510(k) NO: K210731(Traditional)
ATTN: Jennifer Damato PHONE NO : 800 6251557
11201 Saint Johns Industrial PKWY SE DECISION MADE: 18-JUL-22
Jacksonville FL 32246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIDAS NEPHROCHECK
bioMérieux SA 510(k) NO: K210793(Traditional)
ATTN: Julien Thao My PHONE NO : 33 4 78877064
376 Chemin de l’Orme SE DECISION MADE: 08-JUL-22
Marcy l’Etoile FR 69280 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DeepRhythmAI
Medicalgorithmics S.A. 510(k) NO: K210822(Traditional)
ATTN: Marek Dziubinski PHONE NO : 48 22 8251249
Aleje Jerozolimskie 81 SE DECISION MADE: 27-JUL-22
Warsaw PL 02-001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EliA Ro52, EliA Ro60
Phadia AB 510(k) NO: K210902(Traditional)
ATTN: Sheryl Skinner PHONE NO : 46 18 165000
Rapsgatan 7P SE DECISION MADE: 27-JUL-22
Uppsala SE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle
Becton, Dickinson and Company 510(k) NO: K211085(Traditional)
ATTN: Shan Lu PHONE NO : 801 2304317
1 Becton Drive SE DECISION MADE: 01-JUL-22
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental diode laser, SOGA Laser, ILaser II
Shenzhen Soga Technology Co., Ltd.510(k) NO: K211150(Abbreviated)
ATTN: Tse Adrian PHONE NO : 086 159 15873605
D906, Yinxing Technology Building SE DECISION MADE: 01-JUL-22
Shenzhen CN 518110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smith & Nephew Hip Systems
Smith & Nephew, Inc. 510(k) NO: K211176(Traditional)
ATTN: Crystal Higgenbottom-ShaffePHONE NO : 901 2811627
1450 East Brooks Rd SE DECISION MADE: 01-JUL-22
Memphis TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLUE 400
Carl Zeiss Meditec AG 510(k) NO: K211346(Traditional)
ATTN: Hans-Joachim Miesner PHONE NO : 49 364 1220362
Goeschwitzer Strasse 51-52 SE DECISION MADE: 22-JUL-22
Jena DE 07745 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tablo Hemodialysis System
Outset Medical, Inc. 510(k) NO: K211370(Traditional)
ATTN: Jennifer Mascioli-Tudor PHONE NO : 669 2318200
3052 Orchard Drive SE DECISION MADE: 29-JUL-22
San Jose CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KeriFlex® MCP and PIP Finger Joint Prostheses
Keri Medical SA 510(k) NO: K211385(Traditional)
ATTN: Bernard Prandi PHONE NO : 41 58 2550130
Route des Acacias, 45a SE DECISION MADE: 27-JUL-22
Geneva CH CH-1227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile & Non-Sterile Level 3 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Isolation Gown
Barco Tekstil Sanayi ve Ticaret A.510(k) NO: K211399(Traditional)
ATTN: Emre Gomruk PHONE NO : 90 850 3037441
Muratbey Mahallesi Karatoprak CaddSE DECISION MADE: 22-JUL-22
Istanbul TR TR 34540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TransLoc 3D
Foundation Fusion Solutions, LLC (510(k) NO: K211496(Traditional)
ATTN: Robert Compton PHONE NO : 888 7438736
11916 S. Oxford Ave., Suite 206 SE DECISION MADE: 27-JUL-22
Tulsa OK 74137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wei Nasal Jet Tube
Well Lead Medical Co., LTD. 510(k) NO: K211543(Traditional)
ATTN: Caroline Gong PHONE NO : 86 20 84758878
C-4 Jinhu Industrial Estate HualonSE DECISION MADE: 21-JUL-22
Guangzhou CN 511434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bodyport Cardiac Scale
Bodyport Inc. 510(k) NO: K211585(Third Party - Traditional)
ATTN: Mara Korsunsky PHONE NO : 650 2001557
970 Folsom Street SE DECISION MADE: 29-JUL-22
San Francisco CA 94107 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Planmed Clarity 2D, Planmed Clarify S
Planmed Oy 510(k) NO: K211720(Traditional)
ATTN: Niina Vuorikallas PHONE NO : 35 820 7795500
Sorvaajankatu 7 SE DECISION MADE: 18-JUL-22
Helsinki FI 00880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DM Converter - TiN coated
Medacta International S.A. 510(k) NO: K211891(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 22-JUL-22
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BTI Interna Narrow/Plus Dental Implant System UnicCa
B.T.I. Biotechnology Institute, SL510(k) NO: K211952(Traditional)
ATTN: Jose Ramon Rivero PHONE NO : 0034 945 297030
Leonardo Da Vinci 14, Parque TecnoSE DECISION MADE: 21-JUL-22
Minano ES 01510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alma Diode Tabletop Laser
Alma Lasers, Ltd. 510(k) NO: K212073(Traditional)
ATTN: Avi Hirshnzon PHONE NO : 972 54 3303402
18 Haharash Street, North IndustriSE DECISION MADE: 14-JUL-22
Caesarea IL 3079895 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MagXtract Collection Tube
MagBio Genomics, Inc. 510(k) NO: K212113(Traditional)
ATTN: Mothomang Mlalazi-Oyinloye PHONE NO : 301 3020144
944 Clopper Rd SE DECISION MADE: 28-JUL-22
Gaithersburg MD 20878 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Root Apex Locator
Foshan COXO Medical Instrument Co.510(k) NO: K212178(Traditional)
ATTN: Yongjian Zheng PHONE NO : 86 137 02544788
BLDG 4, District A, Guangdong New SE DECISION MADE: 20-JUL-22
Foshan CN 528226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tiche PTA Balloon Dilatation Catheter
BrosMed Medical Co., Ltd. 510(k) NO: K212215(Traditional)
ATTN: Crystal Lee PHONE NO : 86 769 22892018
2nd and 15th Buildings, SMEs VentuSE DECISION MADE: 19-JUL-22
Dongguan CN 523808 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gastric Lightguide (GLG)
Naser Dib Gabinet Lekarksi Nasmed 510(k) NO: K212407(Traditional)
ATTN: Naser Dib PHONE NO : 48 721 000112
Ul Jana Nowaka Jezioranskiego 7/18SE DECISION MADE: 26-JUL-22
Warszawa PL 03-984 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AgeJet
Triworks Group SRL 510(k) NO: K212472(Traditional)
ATTN: Elio Piero Berchicci PHONE NO : 0039 0874 1896435
Via Don Giuseppe Mucciardi, 5 SE DECISION MADE: 07-JUL-22
Campochiaro IT 86020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSIX Breeze
Datum Dental Ltd. 510(k) NO: K212509(Traditional)
ATTN: Arie Goldlust PHONE NO : 972 8 6705400
1 Bat Sheva St., PO Box 6170 SE DECISION MADE: 18-JUL-22
Lod IL 7116003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultrasonic Scalpel System
Surgnova Healthcare Technologies (510(k) NO: K212614(Traditional)
ATTN: Guofang Ma PHONE NO : 86 10 64116115
No.1 XinXing Yilu Road, Emerging ISE DECISION MADE: 18-JUL-22
Cixi CN 315301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Adin Short Implants
Adin Dental Implants Systems Ltd. 510(k) NO: K212775(Traditional)
ATTN: Iris Yadin-Herling PHONE NO : 972 4 6426732
Alon Tavor Industrial Zone, P.O. BSE DECISION MADE: 08-JUL-22
Afula IL 1811101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)
Abbott Molecular, Inc. 510(k) NO: K212778(Traditional)
ATTN: Gina Sammarco PHONE NO : 224 3617627
1300 E. Touhy Ave SE DECISION MADE: 15-JUL-22
Des Plaines IL 60018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProstatID
ScanMed, LLC 510(k) NO: K212783(Traditional)
ATTN: Randall Jones PHONE NO : 402 9342650
9840 S 140 Street, Suite #8 SE DECISION MADE: 08-JUL-22
Omaha NE 68138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: My3D® Personalized Pelvic Reconstruction
Onkos Surgical 510(k) NO: K212815(Traditional)
ATTN: Matthew Vernak PHONE NO : 551 5791081
77 East Halsey Rd. SE DECISION MADE: 06-JUL-22
Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Biopsy Refill Needle
Suzhou Leapmed Healthcare Corporat510(k) NO: K212819(Traditional)
ATTN: Yu Zhu PHONE NO : 86 512 66554498 8043
Wuzhong Science Park, NO.2 & NO.3 SE DECISION MADE: 06-JUL-22
Suzhou CN 215100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Semi Automatic Biopsy Instrument
Suzhou Leapmed Healthcare Corporat510(k) NO: K212820(Traditional)
ATTN: Yu Zhu PHONE NO : 86 512 66554498 8043
Wuzhong Science Park, NO.2 & NO.3 SE DECISION MADE: 06-JUL-22
Suzhou CN 215100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Coaxial Biopsy Needle
Suzhou Leapmed Healthcare Corporat510(k) NO: K212822(Traditional)
ATTN: Yu Zhu PHONE NO : 86 512 66554498 8043
Wuzhong Science Park, NO.2 & NO.3 SE DECISION MADE: 06-JUL-22
Suzhou CN 215100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ers2 - ergoline Rehabilitation System
ergoline GmbH 510(k) NO: K212883(Traditional)
ATTN: Alexandra Lertz PHONE NO : 49 7431 9894138
Lindenstrasse 5 SE DECISION MADE: 15-JUL-22
Bitz DE 72475 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MedWand
MedWand Solutions, Inc. 510(k) NO: K212975(Traditional)
ATTN: Robert Rose PHONE NO : 844 6339263
23162 Arroyo Vista SE DECISION MADE: 22-JUL-22
Rancho Santa Margarita CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medispine - Spinal Needle, Glospine - Spinal Needle
Global Medikit Limited 510(k) NO: K212982(Traditional)
ATTN: Karun Narang PHONE NO : 91 112 7667889
Khasra No 323 MI, Camp Road, SelaqSE DECISION MADE: 29-JUL-22
Dehradun IN 248197 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cerebra Sleep System
Cerebra Medical Ltd. 510(k) NO: K213007(Traditional)
ATTN: Sharon Cholowsky PHONE NO : 1 431 8010332___
1470 Wilson Place Unit B SE DECISION MADE: 06-JUL-22
Winnipeg CA R3T2N9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Transcranial Doppler Ultrasound System
Shenzhen Delica Medical Equipment 510(k) NO: K213009(Traditional)
ATTN: Zhenhua Xiao PHONE NO : 86 755 86210116
18F, Building B, High-tech park, GSE DECISION MADE: 08-JUL-22
Shenzhen CN 518107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LED Facial Mask
Shenzhen OSTO Technology Company L510(k) NO: K213056(Traditional)
ATTN: Li Yang PHONE NO : 86 755 29769546
No.43 Longfeng Road, Xinsheng CommSE DECISION MADE: 07-JUL-22
Shenzhen CN 518100 510(k) STATEMENT
DEVICE: AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle
Micro-Tech (Nanjing) Co., Ltd. 510(k) NO: K213060(Traditional)
ATTN: Sally He PHONE NO : 86 25 58646395
No. 10 Gaoke Third Road, Nanjing NSE DECISION MADE: 20-JUL-22
Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Auxilock Titanium Screw-In Suture Anchor
Auxein Medical Private Limited 510(k) NO: K213104(Traditional)
ATTN: Rahul Luthra PHONE NO : 91 971 7586969
Plot No. 168, 169, 170 Phase-IV, SSE DECISION MADE: 29-JUL-22
Sonipat IN 131028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hemoclip
Hangzhou AGS MedTech Co., Ltd. 510(k) NO: K213143(Traditional)
ATTN: Yanping Fu PHONE NO : 86 571 87671223
Building 5, Building 6, No. 597 KaSE DECISION MADE: 12-JUL-22
Hangzhou CN 311106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Syringe with permanently attached needle, Safety Syringe with permanently attached needle
Berpu Medical Technology Co., Ltd.510(k) NO: K213158(Traditional)
ATTN: David Yu PHONE NO : 86 188 68131179
No. 14 Xingji Road, Yongxing StreeSE DECISION MADE: 21-JUL-22
Wenzhou CN 325000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NovaCore Semi-Automatic Biopsy Instrument
Argon Medical Devices 510(k) NO: K213232(Traditional)
ATTN: Daniel Lanois PHONE NO : 469 7311413
1445 Flat Creek Road SE DECISION MADE: 01-JUL-22
Athens TX 75751 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dornier Thulio
DornierMedTech America, Inc 510(k) NO: K213252(Traditional)
ATTN: John Hoffer PHONE NO : 770 5146163
1155 Roberts blvd, Suite 100 SE DECISION MADE: 27-JUL-22
Kennesaw GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CROSSLEAD Peripheral Guide Wire
Asahi Intecc Co., LTD. 510(k) NO: K213315(Traditional)
ATTN: Tomoya Eguchi PHONE NO : 81 561 561859
3-100 Akatsuki-Cho SE DECISION MADE: 01-JUL-22
Seto JP 489-0071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor
Verily Life Sciences LLC 510(k) NO: K213357(Traditional)
ATTN: Dinesh Puppala PHONE NO : 650 2671263
269 East Grand Avenue SE DECISION MADE: 19-JUL-22
South San Francisco CA 94080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SleepCheckRx
ResApp Health 510(k) NO: K213360(Traditional)
ATTN: Neroli Anderson PHONE NO : 61 416 220239
Level 12, 100 Creek Street SE DECISION MADE: 05-JUL-22
Brisbane AU 4000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEM
Obsidio, Inc. 510(k) NO: K213385(Traditional)
ATTN: Ehsan Jabbarzadeh PHONE NO : 267 2355951
1520 Main Street, Unit 4-C SE DECISION MADE: 01-JUL-22
Columbia SC 29201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AltiVate® Anatomic Shoulder AG e+™ with Markers
Encore Medical, L.P. 510(k) NO: K213387(Traditional)
ATTN: Michael Siano PHONE NO : 737 2074857
9800 Metric Boulevard SE DECISION MADE: 07-JUL-22
Austin TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINE ALNU (Model: Mine 2.1)
HDT Co., Ltd 510(k) NO: K213405(Traditional)
ATTN: Sung Hee Chun PHONE NO : 82 624 537752
# 202-ho, 29, Uchi-ro 880beon-gil,SE DECISION MADE: 10-JUL-22
Gwangju KR 61042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZEUS System (Zio Watch)
iRhythm Technologies, Inc. 510(k) NO: K213409(Traditional)
ATTN: Vishal Kanani PHONE NO : 213 4000963
699 8th Street, Suite 600 SE DECISION MADE: 19-JUL-22
San Francisco CA 94103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGIC Flow-Dependent Microcatheter
Balt USA, LLC 510(k) NO: K213435(Traditional)
ATTN: Ryan Kenney PHONE NO : 949 7881443
29 Parker SE DECISION MADE: 19-JUL-22
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bladder Scanner, Model Name:M5
Suzhou Peaksonic Medical Technolog510(k) NO: K213488(Traditional)
ATTN: Calvin Ma PHONE NO : 86 512 36693388
2A, West Side of Building G4, KunsSE DECISION MADE: 01-JUL-22
Suzhou CN 215341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PELNAC Meshed Bilayer Wound Matrix
Gunze Limited 510(k) NO: K213498(Traditional)
ATTN: Hidenori Nishioka PHONE NO : 81 773 428035
46 Natsumegaichi, Aono SE DECISION MADE: 14-JUL-22
Ayabe, Kyoto JP 623-8513 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AquaA
Fresenius Medical Care Rental Ther510(k) NO: K213507(Traditional)
ATTN: Denise Oppermann PHONE NO : 781 9969103
920 Winter Street SE DECISION MADE: 27-JUL-22
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nihon Kohden NKV-330 Ventilator System
Nihon Kohden OrangeMed, Inc. 510(k) NO: K213521(Traditional)
ATTN: Jacqueline Villanueva PHONE NO : 949 5026448 7045
1800 E. Wilshire Avenue SE DECISION MADE: 01-JUL-22
Santa Ana CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Vinyl Blend Powder Free Examination Gloves (Black)
Grand Work Plastic Products Co., L510(k) NO: K213574(Traditional)
ATTN: Wu Yuli PHONE NO : 86 311 66766067
Donggao Industrial Zone, Zanhuang SE DECISION MADE: 12-JUL-22
Shijiazhuang CN 050000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tatum Surgical Dental Implant System
Suncoast Dental, Inc. dba Tatum Su510(k) NO: K213576(Traditional)
ATTN: Tony Fiorello PHONE NO : 1 727 5364880
4500 140th Avenue North Suite 112 SE DECISION MADE: 15-JUL-22
Clearwater FL 33762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABMD Software
HeartLung Corporation 510(k) NO: K213760(Traditional)
ATTN: Morteza Naghavi PHONE NO : 650 4488089
1124 W Carson St SE DECISION MADE: 29-JUL-22
Torrance CA 90502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Joule diVa System
Sciton, Inc 510(k) NO: K213761(Traditional)
ATTN: Jay M Patel PHONE NO : 650 5438348
925 Commercial Street SE DECISION MADE: 19-JUL-22
Palo Alto CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Insufflation Retention Device
Bpendo, LLC 510(k) NO: K213773(Traditional)
ATTN: Robert Holbrook PHONE NO : 405 9740776
216 Foreman Circle SE DECISION MADE: 21-JUL-22
Norman OK 73069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single-Use Video Bronchoscopes, Digital Controller
Micro-Tech (Nanjing) Co., Lts 510(k) NO: K213782(Traditional)
ATTN: Sally He PHONE NO : 86 25 58646395
No.10 Gaoke Third Road, Nanjing NaSE DECISION MADE: 08-JUL-22
Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N Series Patient Monitors
Shenzhen Mindray Bio-medical Elect510(k) NO: K213799(Traditional)
ATTN: Li Lei PHONE NO : 86 755 81885953
Mindray Building, Keji 12th Road SSE DECISION MADE: 12-JUL-22
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DuraFuse Clip and Applier System
NeuraMedica Inc 510(k) NO: K213813(Traditional)
ATTN: Rachel Dreilinger PHONE NO : 503 9140723
402 Beavercreek Road, Suite 110 SE DECISION MADE: 22-JUL-22
Oregon City OR 97045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System
Roche Molecular Systems, Inc. 510(k) NO: K213822(Special)
ATTN: Kaitlyn Hameister PHONE NO : 925 3680589
4300 Hacienda Drive SE DECISION MADE: 06-JUL-22
Pleasanton CA 94588-2722 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus
DiaSorin Inc. 510(k) NO: K213858(Traditional)
ATTN: Christa Blaisdell PHONE NO : 651 4399710
1951 Northwestern Ave SE DECISION MADE: 26-JUL-22
Stillwater MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ennovate Cervical Spinal and Occiput System
Aesculap Implant Systems, LLC. 510(k) NO: K213871(Traditional)
ATTN: Paul Amudala PHONE NO : 610 4170839
3773 Corporate Parkway SE DECISION MADE: 01-JUL-22
Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ComPAS2
Morgan Scientific, Inc. 510(k) NO: K213872(Traditional)
ATTN: Deborah Cornish PHONE NO : 978 5214440
151 Essex Street STE 8 SE DECISION MADE: 15-JUL-22
Haverhill MA 01832 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SkyWalker Total Knee System
MicroPort NaviBot International LL510(k) NO: K213873(Traditional)
ATTN: Mike Manor PHONE NO : 508 5610097
300 Foxborough Blvd. SE DECISION MADE: 07-JUL-22
Foxborough MA 02035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Celerity Incubator
STERIS Corporation 510(k) NO: K213881(Traditional)
ATTN: Gregory Land PHONE NO : 440 3927424
5960 Heisley Road SE DECISION MADE: 21-JUL-22
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin
bioMerieux, Inc. 510(k) NO: K213899(Traditional)
ATTN: Esther Hernandez PHONE NO : 314 7318841
595 Anglum Road SE DECISION MADE: 12-JUL-22
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Microstream CO2 NanoPod
Covidien LLC 510(k) NO: K213911(Traditional)
ATTN: Andrew Berkeland PHONE NO : 720 5017884
6135 Gunbarrel Ave SE DECISION MADE: 29-JUL-22
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Injection Needle
Jiangsu Vedkang Medical Science an510(k) NO: K213914(Traditional)
ATTN: Ting Tang PHONE NO : 86 51969 8777918147
No. 52, Guoxiang Road, Wujin EconoSE DECISION MADE: 29-JUL-22
Changzhou CN 213149 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FX SPS
Pixee Medical 510(k) NO: K213922(Traditional)
ATTN: Agathe Joet PHONE NO : 33 4 58101365
18 rue Alain Savary SE DECISION MADE: 22-JUL-22
Besancon FR 25000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIAISON MeMed BV, LIAISON MeMed BV Control Set
DiaSorin Inc. 510(k) NO: K213936(Traditional)
ATTN: John C. Walter PHONE NO : 651 4399710
1951 Northwestern Avenue SE DECISION MADE: 14-JUL-22
Stillwater MN 55082-0285 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub
Becton, Dickinson and Company 510(k) NO: K213955(Traditional)
ATTN: Samhitha Mohan PHONE NO : 214 9710979
1 Becton Drive SE DECISION MADE: 16-JUL-22
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TruAbutment DS, TruBase
TruAbutment Inc. 510(k) NO: K213961(Traditional)
ATTN: Hyeonhwa An PHONE NO : 714 9561488
17666 Fitch SE DECISION MADE: 14-JUL-22
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kontact Dental Implant System
Biotech Dental, SAS 510(k) NO: K213997(Traditional)
ATTN: Delphine Mercier PHONE NO : 33 049 0446060
305, Allées de Craponne SE DECISION MADE: 15-JUL-22
Salon de Provence FR 13300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: cvi42 Auto Imaging Software Application
Circle Cardiovascular Imaging Inc 510(k) NO: K213998(Traditional)
ATTN: Sydney Toutant PHONE NO : 1 403 2007706
Suite 1100 - 800 5th Ave SW SE DECISION MADE: 28-JUL-22
Calgary CA T2P 3T6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap
Owens & Minor (O&M) Halyard, Inc. 510(k) NO: K214007(Traditional)
ATTN: Anureet Singh PHONE NO : 470 4134225
9120 Lockwood Blvd SE DECISION MADE: 27-JUL-22
Mechanicsville VA 23116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Examination gloves-Type A(Latex gloves)
Jiangxi Kemei Medical Apparatus & 510(k) NO: K214017(Traditional)
ATTN: Jenny Huang PHONE NO : 86 177 02094798
No. 316 National road, Xinju, ChanSE DECISION MADE: 14-JUL-22
Nanchang CN 331724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oscar Peripheral Multifunctional Catheter system
BIOTRONIK, Inc. 510(k) NO: K214038(Traditional)
ATTN: Jon Brumbaugh PHONE NO : 888 3450374
6024 Jean Road SE DECISION MADE: 06-JUL-22
Lake Oswego OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENT Nasopharyngoscope and Accessories
Medimaging Integrated Solution Inc510(k) NO: K214050(Traditional)
ATTN: Jung-Yi Yen PHONE NO : 886 357 98860 1706
3F., No.24-2, Industry E. Rd. IV, SE DECISION MADE: 01-JUL-22
Hsinchu TW 30077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pentaflush
PENTAFERTE ITALIA S.R.L. 510(k) NO: K214080(Traditional)
ATTN: Rosa Di Gioia PHONE NO : 390 86 1560201
Viale Piane Nocella, 23 SE DECISION MADE: 20-JUL-22
Campli Teramo IT 64012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Invia Ease Negative Pressure Wound Therapy (NPWT) System
Medela AG 510(k) NO: K214112(Traditional)
ATTN: Mike McAndrew PHONE NO : 1 815 5782376
Lattichstrasse 4b SE DECISION MADE: 26-JUL-22
Baar CH 6340 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel
Becton, Dickinson and Company 510(k) NO: K214122(Traditional)
ATTN: Joseph Basore PHONE NO : 616 3014068
7 Loveton Circle SE DECISION MADE: 28-JUL-22
Sparks MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ChoiceSpine Navigation System
ChoiceSpine, LLC 510(k) NO: K220024(Traditional)
ATTN: Kim Finch PHONE NO : 865 2433969
400 Erin Drive SE DECISION MADE: 06-JUL-22
Knoxville TN 37919 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AutoSeg
AI Medic Inc. 510(k) NO: K220039(Traditional)
ATTN: Jeong Soon Song PHONE NO : 82 256 82667
2F, 437, Bongeunsa-ro, Gangnam-gu SE DECISION MADE: 20-JUL-22
Seoul KR KS013/06097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems
Medos International, SARL 510(k) NO: K220040(Traditional)
ATTN: Michael Liao PHONE NO : 925 9998646
Chemin-Blanc 38 SE DECISION MADE: 14-JUL-22
Le Locle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NobelProcera Zirconia N1 Base
Nobel Biocare Services AG 510(k) NO: K220048(Traditional)
ATTN: Bernice Jim PHONE NO : 41 779 8550073
Balz Zimmermann-Str. 7 SE DECISION MADE: 29-JUL-22
Kloten CH 8302 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single Use Cytology Brush
Zhejiang Chuangxiang Medical Techn510(k) NO: K220063(Traditional)
ATTN: Lucius Long PHONE NO : 86 571 89167088
Room 101, 201, 301, 401, 501, BuilSE DECISION MADE: 28-JUL-22
Hangzhou CN 311100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synergy Marble (Model: Opasm)
YRS Group Inc 510(k) NO: K220064(Traditional)
ATTN: Raphael Arvili PHONE NO : 1 702 4268921
5151 S Procyon St Suite 105 SE DECISION MADE: 22-JUL-22
Las Vegas NV 89118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANNE Sleep
Sibel Inc. 510(k) NO: K220095(Traditional)
ATTN: Peter Xu PHONE NO : 224 25188590
6650 W. Touhy Ave. SE DECISION MADE: 11-JUL-22
Niles IL 60714 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: K220127(Traditional)
ATTN: Cory Anderson PHONE NO : 404 4356781
3222 Phoenixville Pike SE DECISION MADE: 15-JUL-22
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biofeedback Nerve and Muscle Stimulator
Shenzhen Konmed Technology Co.,Ltd510(k) NO: K220161(Traditional)
ATTN: ShuiShan Yin PHONE NO : 86 136 03046428
601, Building B4, Shenchengtou CreSE DECISION MADE: 20-JUL-22
Shenzhen CN 518118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter
Northeast Scientific, Inc. 510(k) NO: K220171(Traditional)
ATTN: Matthew Farley PHONE NO : 203 7562111
2142 Thomaston Ave. SE DECISION MADE: 01-JUL-22
Waterbury CT 06704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Safety Syringes for Single Use (Retractable)
Shanghai Kindly Enterprise Develop510(k) NO: K220183(Traditional)
ATTN: Liu Hualong PHONE NO : 86 691 182328125
No. 658 Gaochao Road SE DECISION MADE: 21-JUL-22
Shanghai CN 201803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pump Alignment Syringe
Jiangsu Caina Medical Co., Ltd. 510(k) NO: K220184(Traditional)
ATTN: Jianwei Pan PHONE NO : 86 510 86205183
No.23, Huanxi Road, Zhutang Town SE DECISION MADE: 21-JUL-22
Jiangyin CN 214415 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Safety Insulin Syringes for Single Use
Shanghai Kindly Enterprise Develop510(k) NO: K220185(Traditional)
ATTN: Liu Hualong PHONE NO : 86 691 182328125
No. 658 Gaochao Road SE DECISION MADE: 11-JUL-22
Shanghai CN 201803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle
Anhui Tiankang Medical Technology 510(k) NO: K220204(Traditional)
ATTN: Zhang Yong PHONE NO : 86 137 05505106
No.228,Weiyi Road, Economic DeveloSE DECISION MADE: 14-JUL-22
Tianchang CN 239300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C-Stem AMT LE Prosthesis
DePuy Ireland UC 510(k) NO: K220216(Traditional)
ATTN: Sarah Matamisa PHONE NO :
Loughbeg, Ringaskiddy SE DECISION MADE: 22-JUL-22
Cork IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Home use hair removal device
Shenzhen Mareal Tech Co., Ltd 510(k) NO: K220248(Traditional)
ATTN: Liu Libin PHONE NO : 86 755 29980779
301,Building 1,No.2,Xiashiwei RoadSE DECISION MADE: 01-JUL-22
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)
AVIA Vascular 510(k) NO: K220258(Traditional)
ATTN: Kevin Cook PHONE NO : 801 8245375
6030 W Harold Gatty Dr. SE DECISION MADE: 14-JUL-22
Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Gloves (Blue)
KGM Gloves Sdn. Bhd. 510(k) NO: K220284(Traditional)
ATTN: Ooi Loon Seng PHONE NO : 60 12 4612918
Lot 18893 & 18894, Jalan PerusahaaSE DECISION MADE: 08-JUL-22
Kamunting MY 34600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CerroZone Mobile
CerroZone 510(k) NO: K220298(Traditional)
ATTN: Marlon E. Robinson PHONE NO :
P.O.Box 66800 SE DECISION MADE: 01-JUL-22
St. Louis MO 63166 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PuraPly Micronized Wound Matrix (PuraPly MZ)
Organogenesis Inc. 510(k) NO: K220317(Traditional)
ATTN: Kurdea Lyon PHONE NO : 781 4011063
150 Dan Road SE DECISION MADE: 01-JUL-22
Canton MA 02021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 091 Balloon Guide Catheter
InNeuroCo Inc. 510(k) NO: K220331(Traditional)
ATTN: Marc Litzenberg PHONE NO : 954 4725988
19700 Stirling Road, Suite 1 SE DECISION MADE: 29-JUL-22
Pembroke Pines FL 33332 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V
Remex Medical Corporation 510(k) NO: K220348(Traditional)
ATTN: Chuang Shih-Chang PHONE NO : 886 4 23595336
4F., No. 9, Jingke Road, Nantun DiSE DECISION MADE: 14-JUL-22
Taichung TW 408224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Protrieve Sheath
Inari Medical, Inc. 510(k) NO: K220415(Traditional)
ATTN: Kaitlyn Weinkauf PHONE NO : 949 4184116
6001 Oak Canyon, Suite 100 SE DECISION MADE: 12-JUL-22
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Through the Scope Tracheal Stent System
Micro-Tech (Nanjing) Co., Ltd. 510(k) NO: K220424(Traditional)
ATTN: Sally He PHONE NO : 86 25 58646395
No.10 Gaoke Third Road, Nanjing NaSE DECISION MADE: 08-JUL-22
Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Viz SDH
Viz.ai, Inc. 510(k) NO: K220439(Traditional)
ATTN: Vi Ma PHONE NO : 626 2363138
201 Mission St, 12th Floor SE DECISION MADE: 25-JUL-22
San Francisco CA 94105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)
Tianjin Huahong Technology Co., Lt510(k) NO: K220475(Traditional)
ATTN: Yuan Ying PHONE NO : 1 530 2127671
A01, Plant B, No. 278, Hangkong RoSE DECISION MADE: 06-JUL-22
Tianjian CN 300308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Revogene
Meridian Bioscience, Inc 510(k) NO: K220480(Traditional)
ATTN: Jack Rogers PHONE NO : 513 2713700 638
3471 River Hills Drive SE DECISION MADE: 11-JUL-22
Cincinnati OH 45244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kentrospine PSS Pedicle Screw System
Rivarp Medical Private Limited 510(k) NO: K220486(Traditional)
ATTN: Sushma N.R PHONE NO : 080 23391136
No.34, Azeez Sait Industrial Town,SE DECISION MADE: 22-JUL-22
Bangalore IN 560039 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by Ergoline
JK-Holding GmbH 510(k) NO: K220500(Traditional)
ATTN: Juergen Gerstenmeier PHONE NO : 49 0 2224818330
Koehlershohner Strasse 60 SE DECISION MADE: 01-JUL-22
Windhagen DE 53578 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wet Essential95 Personal Lubricant
Trigg Laboratories, Inc. 510(k) NO: K220534(Traditional)
ATTN: Marla Bolden PHONE NO : 702 9574400
4220 W. Windmill Ln. Suite 140 SE DECISION MADE: 07-JUL-22
Las Vegas NV 89139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DolorClast Radial
EMS Electro Medical Systems SA 510(k) NO: K220538(Traditional)
ATTN: Timothée Deblock PHONE NO : 41 22 9948516
Ch. de la Vuarpilliere 31 SE DECISION MADE: 11-JUL-22
Nyon CH 1260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dermatac Drape
3M 510(k) NO: K220560(Traditional)
ATTN: Melanie Avila PHONE NO : 210 2755038
6203 Farinon Drive SE DECISION MADE: 14-JUL-22
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vascette HP (hemostatic pad)
KOAG LLC 510(k) NO: K220566(Traditional)
ATTN: David Lang PHONE NO : 470 7559291
790 Rarity Bay Pkwy SE DECISION MADE: 29-JUL-22
Vonore TN 37885 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Noodle
Pourang Bral, DDS, LLC 510(k) NO: K220573(Traditional)
ATTN: Pourang Bral PHONE NO : 201 2644862
155 Albion Street SE DECISION MADE: 09-JUL-22
Passaic NJ 07055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental Handpiece, Model CA160, CA160L, and CA500L
Micro-NX Co., Ltd. 510(k) NO: K220577(Traditional)
ATTN: Sojeong Park PHONE NO : 82 05 36501000
22 Maeyeo-ro 1 gil SE DECISION MADE: 29-JUL-22
Dong-gu KR 41059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2
Ambu A/S 510(k) NO: K220606(Traditional)
ATTN: Gurpreet Kaur Rehal PHONE NO : 45 266 08888
Baltorpbakken 13 SE DECISION MADE: 25-JUL-22
Ballerup DK 2750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vivid S60N, Vivid S70N
GE Medical Systems Ultrasound and 510(k) NO: K220619(Traditional)
ATTN: Tracey Ortiz PHONE NO : 262 4701003
LLC 9900 W. Innovation Drive SE DECISION MADE: 15-JUL-22
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hailie Sensor NF0106
Adherium (NZ) Ltd 510(k) NO: K220622(Traditional)
ATTN: Geoff Feakes PHONE NO : 64 9 3072771
Level 11, 16 Kingston Street SE DECISION MADE: 15-JUL-22
Auckland NZ 1010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AI4CMR v1.0
AI4MedImaging Medical Solutions S.510(k) NO: K220624(Traditional)
ATTN: Carla Almeida PHONE NO : 93 507 7566
Rua do Parque Poente, Lote 35 SE DECISION MADE: 22-JUL-22
Braga PT 4705-002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NomadAir PMU810
Neurotronics, Inc. 510(k) NO: K220631(Traditional)
ATTN: James "Cody" Smith PHONE NO : 352 3729955
4500 NW 27th Ave STE C2 SE DECISION MADE: 15-JUL-22
Gainesville FL 32606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets
HTL-Strefa S.A. 510(k) NO: K220643(Traditional)
ATTN: Justyna Zemigala PHONE NO : 48 42 2700010
Adamowek 7 SE DECISION MADE: 08-JUL-22
Ozorkow PL 95-035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Prevena Restor Adapti-Form Dressing
3M Health Care Business Group 510(k) NO: K220660(Traditional)
ATTN: Teri Feeley PHONE NO : 210 4591952
6203 Farinon Dr. SE DECISION MADE: 01-JUL-22
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Manual Wheelchair
Hebei Ruilangde Medical Equipment 510(k) NO: K220671(Traditional)
ATTN: Liu Zhihao PHONE NO : 86 134 75165790
Zhongkuang S. Rd., High-tech DevelSE DECISION MADE: 21-JUL-22
Hengshui CN 053599 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pediatric Nailing Platform | Femur
OrthoPediatrics Corp. 510(k) NO: K220679(Traditional)
ATTN: Yan Li PHONE NO : 574 2670864
2850 Frontier Drive SE DECISION MADE: 20-JUL-22
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OptiVu ROSA MxR
Orthosoft, Inc. (d/b/a Zimmer CAS)510(k) NO: K220733(Traditional)
ATTN: Paul Hardy PHONE NO : 574 4536739
75 Queen St., Suite 3300 SE DECISION MADE: 29-JUL-22
Montreal CA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NxtGen Infant Transport Incubator
International Biomedical 510(k) NO: K220742(Traditional)
ATTN: Amy Pieper PHONE NO : 512 8730033
8206 Cross Park Drive SE DECISION MADE: 15-JUL-22
Austin TX 78754 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CediTEC
VOCO GmbH 510(k) NO: K220743(Traditional)
ATTN: M. Th. Plaumann PHONE NO : 49 4721 7190
Anton-Flettner-Str. 1-3 SE DECISION MADE: 05-JUL-22
Cuxhaven DE 27472 510(k) STATEMENT
DEVICE: Stratasys TrueDent
Stratasys Ltd 510(k) NO: K220771(Traditional)
ATTN: Melanie Glennon PHONE NO : 972 74 7454000
1 Holtzman St. Science Park P.O. BSE DECISION MADE: 07-JUL-22
Rehovot IL 7612401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical face mask
Hubei Qianjiang Kingphar Medical M510(k) NO: K220777(Traditional)
ATTN: Zhao Fusong PHONE NO : 86 133 49716939
Yuanguang Road SE DECISION MADE: 19-JUL-22
Qianjiang CN 433100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcQMap High Resolution Imaging and Mapping System
Acutus Medical, Inc. 510(k) NO: K220784(Traditional)
ATTN: Sindhu Sridhar PHONE NO : 1 442 9997630___
2210 Faraday Ave, Suite 100 SE DECISION MADE: 01-JUL-22
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tigertriever 13 Revascularization Device
Rapid Medical Ltd. 510(k) NO: K220808(Traditional)
ATTN: Orit Yaniv PHONE NO : 972 72 2503331___
Carmel Building, POB 337 SE DECISION MADE: 25-JUL-22
Yokneam IL 2069205 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAEOTOM Alpha, Scan&GO Software
Siemens Medical Solutions USA, Inc510(k) NO: K220814(Traditional)
ATTN: Tabitha Estes PHONE NO : 865 8044553
810 Innovation Drive SE DECISION MADE: 12-JUL-22
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BrainInsight
Hyperfine, Inc. 510(k) NO: K220815(Traditional)
ATTN: Christine Kupchick PHONE NO : 203 3433404
351 New Whitfield St SE DECISION MADE: 19-JUL-22
Guilford CT 06437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves
American Nitrile Operations LLC 510(k) NO: K220825(Abbreviated)
ATTN: Stephen Perrin PHONE NO : 937 9645559
3500 Southwest Blvd SE DECISION MADE: 08-JUL-22
Grove City OH 43123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electric Wheelchair
Foshan Dahao Medical Technology C510(k) NO: K220827(Traditional)
ATTN: Bao Yi Xie PHONE NO : 86 137 60674304
Building 1, 2nd Floor of Building SE DECISION MADE: 05-JUL-22
Foshan CN 528137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-GPS Navigated Instruments
Precision Spine, Inc. 510(k) NO: K220862(Traditional)
ATTN: Michael Dawson PHONE NO : 601 4204244
2050 Executive Dr. SE DECISION MADE: 14-JUL-22
Pearl MS 39208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AOK 95A Medical Mask (20200049)
AOK Tooling Limited 510(k) NO: K220876(Traditional)
ATTN: Francis Nithyananthan PHONE NO : 852 0 23101703
Flat 2009, 20/F, Kowloon Plaza, NoSE DECISION MADE: 27-JUL-22
Cheung Sha Wan, Kowloon CN 518122510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems
Lumenis Be, Inc. 510(k) NO: K220877(Traditional)
ATTN: Shlomit Segman PHONE NO : 972 4 9599230
1870 South Milestone Drive SE DECISION MADE: 15-JUL-22
Salt Lake City UT 84104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vivid E80, Vivid E90, Vivid E95
GE Medical Systems Ultrasound and 510(k) NO: K220882(Traditional)
ATTN: Tracey Ortiz PHONE NO : 262 4701003
Primary Care Diagnostics, LLC 9900SE DECISION MADE: 22-JUL-22
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Upper Arm Type Blood Pressure Monitor
Shenzhen Jamr Technology Co.,Ltd 510(k) NO: K220886(Traditional)
ATTN: Luo Fusheng PHONE NO : 86 755 85292057
A101-301,D101-201, Jamr Science & SE DECISION MADE: 27-JUL-22
Shenzhen CN 518100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S-Core Implant System
Subchondral Solutions, Inc. 510(k) NO: K220901(Traditional)
ATTN: Michael Kolber PHONE NO : 408 5056626
7146 Edinger Ave. Suite A SE DECISION MADE: 29-JUL-22
Huntington Beach CA 92647 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SECURE-LOCK
Xiros Ltd 510(k) NO: K220906(Traditional)
ATTN: Steve Curran PHONE NO : 44 113 2387200
Springfield House Lane, WhitehouseSE DECISION MADE: 22-JUL-22
Leeds GB LS17 7UE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit
Cochlear Americas 510(k) NO: K220922(Traditional)
ATTN: Samata Veluvolu PHONE NO : 302 5426468
10350 Park Meadows Drive SE DECISION MADE: 27-JUL-22
Lone Tree CO 80124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EchoPAC Software Only, EchoPAC Plug-in
GE Medical Systems Ultrasound and 510(k) NO: K220940(Traditional)
ATTN: Tracey Ortiz PHONE NO : 262 4701003
LLC 9900 W. Innovation Drive SE DECISION MADE: 22-JUL-22
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim
ECO Medi Glove Sdn.Bhd. 510(k) NO: K220943(Traditional)
ATTN: Suresh Kumar PHONE NO : 605 8062316
Lot 23826, Jalan Tembaga Kuning, KSE DECISION MADE: 19-JUL-22
Taiping MY 34600 510(k) STATEMENT
DEVICE: Libby Echo:Prio
Dyad Medical, Inc 510(k) NO: K220956(Traditional)
ATTN: Ronny Shalev PHONE NO : 617 4809569
215 Brighton Avenue, Suite 203 SE DECISION MADE: 20-JUL-22
Boston MA 02134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Real Intelligence Cori
Blue Belt Technologies, Inc. 510(k) NO: K220958(Traditional)
ATTN: Unnati Bhuptani PHONE NO : 412 8536682
2905 Northwest Blvd., Ste. 40 SE DECISION MADE: 27-JUL-22
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Deep Learning Image Reconstruction
GE Healthcare Japan Corporation 510(k) NO: K220961(Special)
ATTN: Wang Xing PHONE NO : 86 10 57388271
7-127, 4-Chome, Asahigaoka SE DECISION MADE: 29-JUL-22
Hino JP 191-8503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Renuvion APR Handpiece
Apyx Medical Corporation(formerly 510(k) NO: K220970(Traditional)
ATTN: Priscilla Herpai PHONE NO : 610 5337984
5115 Ulmerton Road SE DECISION MADE: 15-JUL-22
Clearwater FL 33760-4004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Life Scope PT BSM-1700 Series Bedside Monitor
Nihon Kohden Corporation 510(k) NO: K220976(Special)
ATTN: Sandra Gadeyne PHONE NO : 949 3563401
1-31-4 Nishiochiai, Shinjuki-Ku SE DECISION MADE: 21-JUL-22
Tokyo JP 161-8560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Next Generation NetKonnect
Nihon Kohden Digital Health Soluti510(k) NO: K220989(Special)
ATTN: Maria Pronina PHONE NO : 949 5919596
14 Bunsen SE DECISION MADE: 29-JUL-22
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Osteon Precision Milled Suprastructure
Implant Solutions PTY LTD (aka Ost510(k) NO: K221019(Traditional)
ATTN: Andrea Del Ciotto PHONE NO : 61 408 583222
759-767 Springvale Road SE DECISION MADE: 05-JUL-22
Mulgrave AU 3170 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: i_ Field 1.5T Superconducting Magnetic Resonance Imaging System
MRI Division,Beijing Wandong Medic510(k) NO: K221025(Traditional)
ATTN: Wang Huan PHONE NO : 86 10 65794660
No.38, Chaoyang Road, Chaoyang DisSE DECISION MADE: 01-JUL-22
Beijing CN 100024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Power Wheelchair
Zhejiang Innuovo Rehabilitation De510(k) NO: K221026(Traditional)
ATTN: Leo Zheng PHONE NO : 86 183 58936043
No.196 Industry Road, Hengdian MovSE DECISION MADE: 01-JUL-22
Dongyang CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGIVISIO Device
Ecential Robotics 510(k) NO: K221028(Traditional)
ATTN: Sarah Lefevre-Billard PHONE NO : 0033 4 58005721
Zone Mayencin II, Parc Equation - SE DECISION MADE: 06-JUL-22
Gieres FR 38610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Model 9100 PFT/DICO
Vitalograph Ireland Ltd. 510(k) NO: K221030(Traditional)
ATTN: Tony O'Hanlon PHONE NO : 353 65 6864100
Gort Road Business Park SE DECISION MADE: 15-JUL-22
Ennis Co Clare IE V95 HFT4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UniPrime A, UniPrime E, UniPrime E/C
S&C Polymer Silicon- und Composite510(k) NO: K221033(Traditional)
ATTN: Christian Böttcher PHONE NO : 49 4121 4830
Robert-Bosch-Str. 2 SE DECISION MADE: 06-JUL-22
Elmshorn DE 25335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Astroglide Warming
BioFilm Inc. 510(k) NO: K221036(Traditional)
ATTN: Kevin Jamil PHONE NO : 760 7279030
3225 Executive Ridge SE DECISION MADE: 01-JUL-22
Vista CA 92081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TruDi Shaver Blade
Acclarent, Inc. 510(k) NO: K221037(Traditional)
ATTN: Leena Zalavadia PHONE NO : 1 949 9234118
31 Technology Drive, Suite 200 SE DECISION MADE: 20-JUL-22
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Changsha Honchon Technology Co., L510(k) NO: K221051(Traditional)
ATTN: Ling Li PHONE NO : 86 731 85529297
Room 627-628, Building 3th, JinqiaSE DECISION MADE: 08-JUL-22
Changsha CN 410200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smartlux Mini
MEDMIX Co., Ltd. 510(k) NO: K221083(Traditional)
ATTN: Yunseok Yu PHONE NO : 82 10 94878160
B-707 Smartvalley, 30, SongdomiraeSE DECISION MADE: 12-JUL-22
Incheon KR 21990 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmileSeries
Ordont Orthodontic Laboratories, I510(k) NO: K221097(Traditional)
ATTN: Paul Rudzicka PHONE NO : 800 3253698
1755 Smizer Station Road SE DECISION MADE: 14-JUL-22
Fenton MO 63026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
Stryker Corporation 510(k) NO: K221098(Traditional)
ATTN: Maya Schiel PHONE NO : 49 30 31199189
Boetzinger Strasse 41 SE DECISION MADE: 12-JUL-22
Freiburg DE D-79111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Medical Examination Gloves
Anhui Fulewei Electronic Technolog510(k) NO: K221108(Traditional)
ATTN: Beina Gong PHONE NO : 86 1505 5553699
South Of Binheroad, West Of GangkoSE DECISION MADE: 12-JUL-22
Fuyang CN 236000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vivid T8, Vivid T9
GE Medical Systems Ultrasound and 510(k) NO: K221147(Traditional)
ATTN: Lee Bush PHONE NO : 262 3099429
LLC 9900 W. Innovation Drive SE DECISION MADE: 18-JUL-22
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vivid iq
GE Medical Systems Ultrasound & Pr510(k) NO: K221148(Traditional)
ATTN: Lee Bush PHONE NO : 262 3099429
9900 W. Innovation Drive SE DECISION MADE: 18-JUL-22
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Beauty LED Mask, Model: KFB265
Hunan Guangye Biotechnology Co., L510(k) NO: K221151(Traditional)
ATTN: Eileen Li PHONE NO : 86 0755 89373426
Room 701, Jinhong Park Incubation SE DECISION MADE: 19-JUL-22
Changsha City CN 410006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Mask (Model: 0868F, 0866F)
Jiangxi SanHao Medical Instruments510(k) NO: K221173(Traditional)
ATTN: Jiali Chen PHONE NO : 86 151 79660192
Chengxi Industrial Park, Jishui CoSE DECISION MADE: 06-JUL-22
Ji'an CN 331699 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Insulin Pen Needle
Tianjin Huahong Technology Co., Lt510(k) NO: K221176(Special)
ATTN: Yuan Ying PHONE NO : 1 530 2127671
A01, Plant B, No. 278, Hangkong RoSE DECISION MADE: 01-JUL-22
Tianjin CN 300308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Face Mask (ear loop)
Xiantao Topmed Nonwoven Protective510(k) NO: K221196(Traditional)
ATTN: Vivian Zhu PHONE NO : 86 2787 861070
North of the National Road 318, ToSE DECISION MADE: 22-JUL-22
Xiantao CN 433000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AHI System
Fifth Eye Inc. 510(k) NO: K221203(Special)
ATTN: Jennifer Baird PHONE NO : 734 2604800
110 Miller Avenue, Suite 300 SE DECISION MADE: 14-JUL-22
Ann Arbor MI 48104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves
Zibo Blue Sail Health Technology C510(k) NO: K221229(Traditional)
ATTN: Xu Shulong PHONE NO : 0086 533 7859085
No.1888 Honghua Road, High TechnicSE DECISION MADE: 16-JUL-22
Zibo CN 255400 510(k) STATEMENT
DEVICE: TRON
Xoran Technologies LLC 510(k) NO: K221230(Traditional)
ATTN: Mark McGarrow PHONE NO : 734 4185125
5210 S. State Rd. SE DECISION MADE: 28-JUL-22
Ann Arbor MI 48108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TargetCool
RecensMedical Inc. 510(k) NO: K221234(Traditional)
ATTN: Yeonui Lee PHONE NO : 82 31 80433064__
908, SK V1 center, 830 DongtansunhSE DECISION MADE: 22-JUL-22
Hwaseong-si KR 18468 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: neXus Ultrasonic Surgical Aspirator System
Misonix Inc. 510(k) NO: K221235(Traditional)
ATTN: John Salerno PHONE NO : 1 631 6949555
1938 New Highway SE DECISION MADE: 28-JUL-22
Farmingdale NY 11735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Hunan Vsmile Biotechnology Co., Lt510(k) NO: K221242(Traditional)
ATTN: Xiaomi Tang PHONE NO : 86 731 85682958
Juxing 501-5,501-6, Lujing Road NoSE DECISION MADE: 29-JUL-22
Changsha CN 410000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)
Shenzhen Semlamp Intelligent Techn510(k) NO: K221246(Traditional)
ATTN: Qi Wenjun PHONE NO : 86 1342 8733261
Room 915, Lankun Building, MinkangSE DECISION MADE: 07-JUL-22
Shenzhen CN 518131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)
Guangzhou Hua Kai Electronic Techn510(k) NO: K221251(Traditional)
ATTN: Cao Ke PHONE NO : 86 020 82061985
4th Floor, Building 8, No.39 Bi GaSE DECISION MADE: 29-JUL-22
Guangzhou CN 510730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hummingbird Tympanostomy Tube System
Preceptis Medical, Inc. 510(k) NO: K221254(Traditional)
ATTN: Steve Anderson PHONE NO : 763 5687809
10900 89th Avenue North, Suite 4 SE DECISION MADE: 27-JUL-22
Maple Grove MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System
Dexcom, Inc. 510(k) NO: K221259(Special)
ATTN: Rachel Ellena PHONE NO : 858 2036046
6340 Sequence Dr. SE DECISION MADE: 29-JUL-22
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Better Care Plastic Technology Co.510(k) NO: K221269(Traditional)
ATTN: Zhu Chunyan PHONE NO : 86 311 66766067
Fuqian Xi Road, West district of SSE DECISION MADE: 27-JUL-22
Shenze County CN 050000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)
Shandong Maida Medical Technology 510(k) NO: K221271(Traditional)
ATTN: Kitty Xu PHONE NO : 86 1385 3370291
Room 102, Eastern building, No.166SE DECISION MADE: 27-JUL-22
Dongying CN 257000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-Brik Visualization Assistant
JDI Surgical, Inc. 510(k) NO: K221293(Traditional)
ATTN: Dwight Lenox PHONE NO : 720 3713071
9925 Silver Maple Way SE DECISION MADE: 07-JUL-22
Highlands Ranch CO 80129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OsteoCentric Spine MIS Pedicle Fastener System
OsteoCentric Technologies 510(k) NO: K221332(Traditional)
ATTN: Todd Evans PHONE NO : 435 7572253
75 West 300 N, Suite 150 SE DECISION MADE: 28-JUL-22
Logan UT 84321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Materialise TKA Guide System
Materialise NV 510(k) NO: K221337(Traditional)
ATTN: Jenny Jones PHONE NO : 32 16 396611
Technologielaan 15 SE DECISION MADE: 05-JUL-22
Leuven BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker VariAx 2 MIS Calcaneus
Stryker GmbH 510(k) NO: K221346(Traditional)
ATTN: Jonathan Schell PHONE NO : 484 8895804
325 Corporate Drive SE DECISION MADE: 08-JUL-22
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AF Laser
ShenB Co Ltd 510(k) NO: K221363(Traditional)
ATTN: Sunny Kang PHONE NO : 82 70 49122702
ShenB Bldg 148 Seongsui-ro SE DECISION MADE: 20-JUL-22
Seoul KR 04796 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mitek TIGHT-N Anchor
Medos International SARL 510(k) NO: K221364(Traditional)
ATTN: Ashley Aromando (Goncalo) PHONE NO : 508 9773907
Chemin-Blanc 38, Case Postale SE DECISION MADE: 11-JUL-22
Le Locle CH CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 14HQ701G-B
LG Electronics Inc. 510(k) NO: K221394(Traditional)
ATTN: Jinhwan Jun PHONE NO : 82 31 80665641
77, Sanho-daero SE DECISION MADE: 22-JUL-22
Gumi-si KR 39381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Footmotion Plating System
Newclip Technics 510(k) NO: K221395(Traditional)
ATTN: Gaëlle Lussori PHONE NO : 33 228 213712
P.A. de la Lande Saint Martin - 45SE DECISION MADE: 01-JUL-22
Haute-Goulaine FR 44 115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIP™ MIS Interspinous Fusion System
Aurora Spine, Inc. 510(k) NO: K221399(Traditional)
ATTN: Laszlo Garamszegi PHONE NO : 760 4242004
1930 Palomar Point Way, Suite #103SE DECISION MADE: 08-JUL-22
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)
Conformis Inc. 510(k) NO: K221404(Traditional)
ATTN: Mary Kruitwagen PHONE NO : 781 3459038
600 Technology Park Drive, 4th FloSE DECISION MADE: 26-JUL-22
Billerica MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: truSculpt iD
Cutera Inc. 510(k) NO: K221407(Traditional)
ATTN: Amogh Kothare PHONE NO : 415 6906796
3240 Bayshore Blvd. SE DECISION MADE: 13-JUL-22
Brisbane CA 94005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Paneffort 3-ply Surgical and Procedural Masks
Paneffort, LLC 510(k) NO: K221409(Traditional)
ATTN: Harry No Last Name ProvidedPHONE NO : 855 12284810
700 Elmridge Center Drive SE DECISION MADE: 25-JUL-22
Rochester NY 14626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Functional MR V1.0
Olea Medical SAS 510(k) NO: K221426(Traditional)
ATTN: Nathalie Palumbo PHONE NO : 33 4 42712420
93 Avenue des Sorbiersm ZI ATHELIASE DECISION MADE: 06-JUL-22
La Ciotat FR 13600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KDF Zirconia Disc
DENKEN-HIGHDENTAL Co., Ltd. 510(k) NO: K221429(Traditional)
ATTN: Daijiro Goto PHONE NO : 81 75 6722124
24-3 SE DECISION MADE: 14-JUL-22
Kisshoin Ishiharakyomichi-cho, Min510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: reVive Light Therapy LED Cleansing System
LED Technologies, Inc. 510(k) NO: K221430(Special)
ATTN: Jelena Barbaric PHONE NO : 303 8450028
12821 Starkey Rd., Suite 4900 SE DECISION MADE: 27-JUL-22
Largo FL 33773 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant
Church & Dwight Co., Inc. 510(k) NO: K221431(Traditional)
ATTN: Supreet Sahota-Bhatti PHONE NO : 609 8067893
500 Charles Ewing Blvd. SE DECISION MADE: 14-JUL-22
Ewing NJ 08628 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Facet 28G Universal Lancet
Facet Technologies LLC 510(k) NO: K221433(Traditional)
ATTN: James Bonds PHONE NO : 770 5906462
3900 N. Commerce Dr. SE DECISION MADE: 15-JUL-22
Atlanta GA 30344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 17HQ701G-B
LG Electronics Inc. 510(k) NO: K221434(Traditional)
ATTN: Jinhwan Jun PHONE NO : 82 31 80665641
77, Sanho-daero SE DECISION MADE: 13-JUL-22
Gumi-si KR 39381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Nitrile Examination Gloves - Non Sterile
Guangzhou Kangling Biotechnology C510(k) NO: K221454(Traditional)
ATTN: Yan Wang PHONE NO : 86 208 7866619
Baiyun Avenue,Yongping Street,BaiySE DECISION MADE: 12-JUL-22
Guangzhou CN 510440 510(k) STATEMENT
DEVICE: BioFire COVID-19 Test 2
BioFire Defense, LLC 510(k) NO: K221460(Special)
ATTN: Cynthia Phillips PHONE NO : 801 2623592 1370
79 W 4500 S, Suite 14 SE DECISION MADE: 25-JUL-22
Salt Lake City UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 10HQ701G-B
LG Electronics Inc. 510(k) NO: K221461(Traditional)
ATTN: Jinhwan Jun PHONE NO : 82 31 80665641
77, Sanho-daero SE DECISION MADE: 22-JUL-22
Gumi-si KR 39381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CorPath GRX System
Corindus, Inc. 510(k) NO: K221464(Special)
ATTN: Robert Lavado PHONE NO : 978 7607727
309 Waverley Oaks Road, Suite 105 SE DECISION MADE: 27-JUL-22
Waltham MA 02452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Parcus Synd-EZ SS
Parcus Medical, LLC 510(k) NO: K221502(Traditional)
ATTN: Vasavi Vora PHONE NO :
6423 Parkland Drive SE DECISION MADE: 26-JUL-22
Sarasota FL 34243 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)
Vieworks Co., Ltd. 510(k) NO: K221512(Traditional)
ATTN: Kevin Oh PHONE NO : 82 70 44663220
41-3, Burim-ro 170beon-gil, DonganSE DECISION MADE: 20-JUL-22
Anyang-si KR 14055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTIS icono (Ceiling Configuration)
Siemens Medical Solutions USA, Inc510(k) NO: K221516(Traditional)
ATTN: Patricia D. Jones PHONE NO : 678 5758832
40 Liberty Boulevard SE DECISION MADE: 19-JUL-22
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PreXion3D Explorer PRO
PreXion Corporation 510(k) NO: K221525(Traditional)
ATTN: Hiroaki Takahashi PHONE NO : 81 3 52977551
1-14-1, Kandasuda-cho SE DECISION MADE: 22-JUL-22
Chiyoda-ku JP 101-0041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Align Lumbar Interbody Fusion System
Acuity Surgical Devices, LLC 510(k) NO: K221535(Traditional)
ATTN: Bryan Cowan PHONE NO : 844 2284890
8710 N. Royal Lane SE DECISION MADE: 22-JUL-22
Irving TX 75063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)
Qingdao Hisense Medical Equipment 510(k) NO: K221567(Traditional)
ATTN: Li Mingcheng PHONE NO : 86 532 83091111
No. 399 Songling Road, Laoshan DisSE DECISION MADE: 26-JUL-22
Qingdao CN 266100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VyPlate Anterior Cervical Plate System
Vy Spine, LLC 510(k) NO: K221572(Traditional)
ATTN: Jordan Hendrickson PHONE NO : 866 4897746
2236 Capital Circle NE, Suite 103-SE DECISION MADE: 26-JUL-22
Tallahassee FL 32308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2-Way 100% Silicone ClearTract Catheter
Silq Technologies Corporation 510(k) NO: K221625(Special)
ATTN: Sigi Caron PHONE NO : 831 3466970
323 Sunny Isles Blvd SE DECISION MADE: 01-JUL-22
Sunny Isles Beach FL 33160 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: medi pneumatic compression system (pcs)-genius (Model 652)
medi USA, L.P. 510(k) NO: K221654(Third Party - Traditional)
ATTN: Moses Lipshaw PHONE NO : 336 4494440 229
6481 Franz Warner Parkway SE DECISION MADE: 07-JUL-22
Whitsett NC 27377-9214 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Normatec Go
NormaTec Industries, LP 510(k) NO: K221666(Third Party - Traditional)
ATTN: Steve Henderson PHONE NO : 800 3350906
480 Pleasant Street, Suite A200 SE DECISION MADE: 14-JUL-22
Watertown MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: IPL Hair Remover, Model: G993, G996, G998 and G885
Shenzhen Mywin Technology Co., Ltd510(k) NO: K221679(Special)
ATTN: Meiyun Liu PHONE NO : 86 18902 842323
2nd Floor, Building B, New Age gonSE DECISION MADE: 07-JUL-22
Shenzhen CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pegasus-X Expandable PLIF System
GS Medical Co. Ltd. 510(k) NO: K221687(Traditional)
ATTN: Sam Camp PHONE NO : 352 3274641
90, Osongsaengmyeong 4-ro Osong-euSE DECISION MADE: 27-JUL-22
Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.CT Extended Functionality
Siemens Medical Solutions USA, Inc510(k) NO: K221727(Special)
ATTN: Monsuru Bello PHONE NO : 202 8566099
810 innovation Drive SE DECISION MADE: 13-JUL-22
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUSA Clarity Ultrasonic Surgical Aspirator System
Integra LifeSciences Corporation 510(k) NO: K221763(Special)
ATTN: Alexandra Wells PHONE NO : 609 9036300
1100 Campus Rd SE DECISION MADE: 15-JUL-22
Princeton NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid
ONETEXX SDN BHD 510(k) NO: K221773(Traditional)
ATTN: Freddy Low PHONE NO : 605 8070666
No 73-86, JLN Logam 5, PerindustriSE DECISION MADE: 30-JUL-22
Kamunting MY 34600 510(k) STATEMENT
DEVICE: Vario-Cup System
Waldemar Link GmbH & Co. KG 510(k) NO: K221794(Special)
ATTN: Pia Mueller PHONE NO : 49 40 53575530
Oststraße 4-10 SE DECISION MADE: 20-JUL-22
Norderstedt DE 22844 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.
SEDECAL SA 510(k) NO: K221803(Special)
ATTN: Ma Luisa Gomez de Aguero PHONE NO : 34 91 6280544
C/ Pelaya, 9 – 13 Pol. Ind. Río deSE DECISION MADE: 18-JUL-22
Algete ES 28110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OK Handpiece
Jaintek Co.,Ltd 510(k) NO: K221814(Third Party - Traditional)
ATTN: Jung Gun Lee PHONE NO : 82 31 4959091
#302, 419, Byeolmang-ro, Danwon-guSE DECISION MADE: 15-JUL-22
Ansan-si KR 15605 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Cionic Neural Sleeve NS-100
CIONIC 510(k) NO: K221823(Special)
ATTN: Mihai Ionescu PHONE NO : 1 831 8244051
1606 Stockton St, Suite #1 SE DECISION MADE: 21-JUL-22
San Francisco CA 94133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Artix Ballon Guiding Sheath
Inari Medical 510(k) NO: K221846(Third Party - Traditional)
ATTN: Elllen Nguyen PHONE NO : 949 4184127
6001 Oak Canyon Suite 100 SE DECISION MADE: 11-JUL-22
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: OTC DDR
Konica Minolta Healthcare Americas510(k) NO: K221853(Special)
ATTN: Jan Maniscalco PHONE NO : 973 6331500
2217 US Highway 70 East SE DECISION MADE: 27-JUL-22
Garner NC 27529 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMONITOR IIIm, BIOMONITOR III
BIOTRONIK, Inc. 510(k) NO: K221856(Special)
ATTN: Jon Brumbaugh PHONE NO : 888 3450374
6024 Jean Road SE DECISION MADE: 27-JUL-22
Lake Oswego OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Radiography CXDI-Pro, Digital Radiography D1
Canon Inc. 510(k) NO: K221876(Special)
ATTN: Akira Hirai PHONE NO : 81 33 7582111
9-1 Imaikami-cho, Nakahara-ku, SE DECISION MADE: 15-JUL-22
Kawasaki JP 211-8501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder-Free Nitrile Examination Glove, Non-Sterile
GoodGloves Industries Sdn Bhd 510(k) NO: K221877(Third Party - Traditional)
ATTN: Yee Kam Lin PHONE NO :
PT 12678, Jalan Techvalley 2, SendSE DECISION MADE: 23-JUL-22
Seremban MY 71950 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Gastrointestinal Boundary Identifier (GIBI HD)
ReShape Lifesciences 510(k) NO: K221898(Special)
ATTN: Michelle Ravert PHONE NO : 949 4817851
1001 Calle Amanecer SE DECISION MADE: 28-JUL-22
San Clemente CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EleGARD
AdvancedCPR Solutions LLC 510(k) NO: K221901(Special)
ATTN: Philip Faris PHONE NO : 210 5086647
5201 Eden Avenue Suite 300 SE DECISION MADE: 29-JUL-22
Edina MN 55436 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INERTIA CONNEXX Modular Pedicle Screw System
Nexxt Spine LLC 510(k) NO: K221905(Special)
ATTN: Andy Elsbury PHONE NO : 317 4367801
14425 Bergen Blvd Suite B SE DECISION MADE: 28-JUL-22
Noblesville IN 46060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RhinAer® Stylus (FG1393)
Aerin Medical Inc. 510(k) NO: K221907(Special)
ATTN: Shannon Scott PHONE NO : 512 2219956
2565 Leghorn St. SE DECISION MADE: 29-JUL-22
Mountain View CA 91043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: J-Temp
Ultradent Products, Inc. 510(k) NO: K221909(Third Party - Traditional)
ATTN: Matthew Buck PHONE NO : 801 5534339
505 W Ultradent Drive (10200 SouthSE DECISION MADE: 01-JUL-22
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Catapult Guide Sheath
Contract Medical International Gmb510(k) NO: K221914(Special)
ATTN: Juliana Vaz Nuernberger PHONE NO : 49 351 21074719
Lauensteiner Strasse 37 SE DECISION MADE: 29-JUL-22
Dresden DE 01277 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trinias
Shimadzu Corporation Medical Syste510(k) NO: K221922(Special)
ATTN: Koichi Kataoka PHONE NO : 81 75 8231305
1, Nishinokyo-Kuwabaracho, NakagyoSE DECISION MADE: 28-JUL-22
Kyoto JP 604-8511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Swoop Portable MR Imaging System
Hyperfine, Inc. 510(k) NO: K221923(Special)
ATTN: Christine Kupchick PHONE NO : 203 3433404
351 New Whitfield Street SE DECISION MADE: 28-JUL-22
Guilford CT 06437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cemented Round Patella with JRNY Pegs
Smith & Nephew, Inc. 510(k) NO: K221939(Special)
ATTN: Madison Padgett PHONE NO : 901 4568789
7135 Goodlett Farms Parkway SE DECISION MADE: 26-JUL-22
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 mm X 320 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm X 230 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm x 320 cm, Beamer AVEO FILTER INTEGRATED ARGON SIDEFIRE PROBE 2.3 mm x 230 cm
Conmed Corporation 510(k) NO: K221945(Special)
ATTN: Kavita Amin PHONE NO : 508 9482084
11311 Concept Blvd SE DECISION MADE: 28-JUL-22
Largo FL 33773 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXALT Model B Single-Use Bronchoscope
Boston Scientific Corporation 510(k) NO: K222014(Special)
ATTN: Carter Navarro PHONE NO : 508 3820356
100 Boston Scientific Way SE DECISION MADE: 28-JUL-22
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biotres
Biotricity 510(k) NO: K222017(Special)
ATTN: Spencer LaDow PHONE NO : 585 4147407
203 Redwood Shores Pkwy Suite 600 SE DECISION MADE: 28-JUL-22
Redwood City CA 94065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Selectra Lead Implantation System
Biotronik, Inc. 510(k) NO: K222037(Special)
ATTN: Jon Brumbaugh PHONE NO : 888 3450374
6024 Jean Road SE DECISION MADE: 19-JUL-22
Lake Oswego OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 257
TOTAL WITH SUMMARIES 251
TOTAL WITH STATEMENTS 6
