510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD November 2021
DEVICE: BD Kiestra IdentifA
Becton, Dickinson and Company 510(k) NO: K191964(Traditional)
ATTN: Janine Spafford PHONE NO : 410 3164938
7 Loveton Circle, MC 964 SE DECISION MADE: 03-NOV-21
Sparks MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Capiox iCP Centrifugal Pump
Terumo Cardiovascular Systems Corp510(k) NO: K200091(Traditional)
ATTN: John Chesney PHONE NO : 734 7416410
6200 Jackson Road SE DECISION MADE: 18-NOV-21
Ann Arbor MI 48103 510(k) STATEMENT
DEVICE: LTV2 Series Ventilators
Vyaire Medical Inc 510(k) NO: K201082(Traditional)
ATTN: Colleen Watson PHONE NO : 872 7570070
26125 N. Riverwoods Blvd. SE DECISION MADE: 10-NOV-21
Mettawa IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor
Qura S.r.l. 510(k) NO: K201320(Traditional)
ATTN: Raffaella Tommasini PHONE NO : 39 0535 180305
Via di Mezzo 23 SE DECISION MADE: 03-NOV-21
Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARROW Short Stem Humeral System
FH Industrie 510(k) NO: K202024(Traditional)
ATTN: Patricia Donnard PHONE NO :
6 rue Nobel, Zi De Kernevez SE DECISION MADE: 30-NOV-21
Quimper FR 29000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIXI Medical Microdeep Micro-Macro Depth Electrodes
Dixi Medical 510(k) NO: K202087(Traditional)
ATTN: Lucie Petegnief PHONE NO : 033 3 81889890
2A Route de Pouligney SE DECISION MADE: 18-NOV-21
Chaudefontaine FR 25640 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MStim Drop Model: LGT-233
Guangzhou Longest Science & Techno510(k) NO: K202110(Traditional)
ATTN: Xiaobing Luo PHONE NO : 86 020 66353999
5&6F, Building B4, No.11, Kaiyuan SE DECISION MADE: 05-NOV-21
Guangzhou CN 510530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Finebeam
SNJ Co., Ltd. 510(k) NO: K202288(Traditional)
ATTN: Hyang-Kee Lee PHONE NO : 82 2 8669005
No. 604, Ace-Techno Tower 2, DigitSE DECISION MADE: 19-NOV-21
Seoul KR 08381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)
Tianjin Huahong Technology Co., Lt510(k) NO: K202319(Traditional)
ATTN: Yan Li PHONE NO : 86 22 58775333
A01, Plant B, No. 278, Hangkong RoSE DECISION MADE: 12-NOV-21
Tianjin CN 300308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BESPA Charcot System
Bespa Global, LLC 510(k) NO: K202326(Traditional)
ATTN: Lisa Viele PHONE NO :
9 Rand Road SE DECISION MADE: 09-NOV-21
Caoe Elizabeth ME 04107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Highspeed Airturbine Handpiece
Beijing Dongbo Dental Handpiece Co510(k) NO: K202371(Traditional)
ATTN: Chao Hao PHONE NO : 86 10 80479758
3F, Building 3, No. 17, First JinmSE DECISION MADE: 08-NOV-21
Beijing CN 101318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hystero-V Hysteroscope
Hysterovue, Inc. 510(k) NO: K202445(Traditional)
ATTN: Thomas Lawson PHONE NO : 650 3975174
5337 14th Place SE SE DECISION MADE: 23-NOV-21
Bellevue WA 98006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALTMS Magnetic Stimulation Therapy System
REMED Co., Ltd 510(k) NO: K202537(Traditional)
ATTN: Yonsoo Nam PHONE NO : 812 3457485
#301-#303 Migun Techno World II, 1SE DECISION MADE: 26-NOV-21
Daejeon KR 34025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)
Guangzhou Xinbo Electronic Co., Lt510(k) NO: K202671(Traditional)
ATTN: Sammy Li PHONE NO : 86 020 66393598
No.23 Building, The Second Phase, SE DECISION MADE: 12-NOV-21
Guangzhou CN 511450 510(k) STATEMENT
DEVICE: Disposable Medical Face Mask
Zhejiang Senhong Medical&Instrumen510(k) NO: K202676(Traditional)
ATTN: Eric Jian PHONE NO : 86 18 006712375
Floor 1-2, Building 2, No 889 NortSE DECISION MADE: 05-NOV-21
Huzhou CN 313200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOL-CARE IV Bag Safety Connector
Sol-Millennium Medical Group 510(k) NO: K202732(Traditional)
ATTN: Jim Barley PHONE NO : 949 4333058
315 Shawnee North Drive, Suite 100SE DECISION MADE: 03-NOV-21
Suwanne GA 30024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical surgical mask
Henan Huibo Medical Co.,Ltd. 510(k) NO: K202842(Traditional)
ATTN: Hui Lu PHONE NO : 86 400 6000067
Weishi Road Central, Nanyang New ESE DECISION MADE: 26-NOV-21
Nanyang CN 473000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F
Qura S.r.l. 510(k) NO: K203067(Traditional)
ATTN: Raffaella Tommasini PHONE NO : 39 0535 1803050
Via di Mezzo 23 SE DECISION MADE: 08-NOV-21
Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile)
PT. Universal Gloves 510(k) NO: K203074(Traditional)
ATTN: Li I-Feng PHONE NO : 62 61 7883055
Jl. Pertahanan No. 17 Patumbak SE DECISION MADE: 19-NOV-21
Medan ID 20361 510(k) STATEMENT
DEVICE: HYDRASHIFT 2/4 isatuximab
Sebia 510(k) NO: K203184(Traditional)
ATTN: Karen Anderson PHONE NO : 1 800 8356497 3704
1705 Corporate Drive Suite 400 SE DECISION MADE: 12-NOV-21
Norcross GA 30096 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Albumin BCG2
Abbott Ireland Diagnostics Divisio510(k) NO: K203248(Traditional)
ATTN: Suzanne Cheang PHONE NO : 972 5186617
Lisnamuck SE DECISION MADE: 23-NOV-21
Longford IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SyMRI
SyntheticMR AB 510(k) NO: K203372(Traditional)
ATTN: Lisa Warnroth PHONE NO : 46 73 3109915
Storgatan 11 SE DECISION MADE: 03-NOV-21
Linkoping SE 582 23 510(k) STATEMENT
DEVICE: Venen-trainer (Model: FM150, SFM90)
Shenzhen Pango Electronic CO., LTD510(k) NO: K203746(Traditional)
ATTN: Guojun Zeng PHONE NO : 86 136 32731945
No.25, 1st Industry Zone, FenghuanSE DECISION MADE: 10-NOV-21
Shenzhen CN 518115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SeptiCyte RAPID
Immunexpress, Inc 510(k) NO: K203748(Traditional)
ATTN: LaKesha Hunt-Dickens PHONE NO : 434 9419951
425 Pontius Avenue North, Suite 47SE DECISION MADE: 29-NOV-21
Seattle WA 98109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Guiding Catheter
CenterPoint Systems LLC 510(k) NO: K210009(Traditional)
ATTN: Marybeth Gamber PHONE NO : 774 2495250
3338 Parkway Blvd SE DECISION MADE: 24-NOV-21
West Valley City UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Mask
Suzhou Letian Protective Products 510(k) NO: K210042(Traditional)
ATTN: Huang Qizhi PHONE NO : 86 137 01567601
No. 12 Zhenfeng Road, Nanfeng TownSE DECISION MADE: 17-NOV-21
Suzhou CN 215600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Playboy Premium Silicone Lubricant
Thai Nippon Rubber Industry Public510(k) NO: K210095(Traditional)
ATTN: Ryosuke Takamiya PHONE NO : 66 38 317999
789/139 Pinthong Industrial EstateSE DECISION MADE: 23-NOV-21
Sriracha TH 20230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Paltop Narrow Implant
Paltop Advanced Dental Solutions, 510(k) NO: K210117(Traditional)
ATTN: Zina Gurgov PHONE NO : 972 4 627171
Hashita 5, Industrial Park SE DECISION MADE: 30-NOV-21
Caesarea IL 3088900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Mask
Guangdong Lide Medical Technology 510(k) NO: K210222(Traditional)
ATTN: Zhuang Shenglin PHONE NO : 186 645 14268
HFDB-05-2102 Ecological TechnologySE DECISION MADE: 02-NOV-21
Shanwei CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Best Glove-Latex Powder Free Examination Glove
Bestsafe Glove CO., LTD. 510(k) NO: K210253(Traditional)
ATTN: Piyawat Chirasakulkarun PHONE NO : 66 038 949880
52/43 Wat Khot Hin-Khao Phai Road,SE DECISION MADE: 05-NOV-21
Muang Rayong TH 21000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VS3 Iridium Sytem
Visionsense Ltd. 510(k) NO: K210265(Traditional)
ATTN: Nancy Sauer PHONE NO : 720 3615290
20 Hamagshimim St. SE DECISION MADE: 22-NOV-21
Petach Tikva, Hamerkaz IL 4934829510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: inVisionOS
PrecisionOS Technology Inc. 510(k) NO: K210344(Traditional)
ATTN: Danny Goel PHONE NO : 604 3450401
500-319 West Hastings Street SE DECISION MADE: 10-NOV-21
Vancouver CA V6B 1H6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gemini 2 810+980 Soft Tissue Laser
Azena Medical, LLC 510(k) NO: K210350(Traditional)
ATTN: Lindsay Tilton PHONE NO : 925 6999091
3021 Citrus Circle Suite 180 SE DECISION MADE: 18-NOV-21
Walnut Creek CA 94598 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wrap Accessory Electrodes
Hi-Dow International Inc. 510(k) NO: K210383(Traditional)
ATTN: Eric Chen PHONE NO : 314 5692888
2555 Metro Blvd SE DECISION MADE: 12-NOV-21
Maryland Heights MO 63043 510(k) STATEMENT
DEVICE: CARESCAPE R860
Datex-Ohmeda, Inc. 510(k) NO: K210384(Traditional)
ATTN: Trishia Mercier PHONE NO : 608 6958319
3030 Ohmeda Drive, PO Box 7550 SE DECISION MADE: 04-NOV-21
Madison WI 53707-7550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LELTEK Ultrasound Imaging System (Model: LU700 Series)
Leltek Inc 510(k) NO: K210432(Traditional)
ATTN: Jessie Wang PHONE NO : 886 2 29137577
6F-3., No. 293, Sec. 1, Beixin Rd.SE DECISION MADE: 03-NOV-21
New Taipei City TW 23147 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)
Imicryl Dis Malzemeleri Sanayi Ve 510(k) NO: K210473(Traditional)
ATTN: Hüsamettin Sonmez PHONE NO : 0090 44 47130 144
Fetih Mahallesi Mahir Sokak No: 5/SE DECISION MADE: 02-NOV-21
Konya TR 42030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alpha Dent Implants Dental Implants System
Alpha Dent Implants GmbH 510(k) NO: K210499(Traditional)
ATTN: Simha Sibony PHONE NO : 972 52 6546625
Hanauer Street 8 SE DECISION MADE: 01-NOV-21
Pforzheim DE 75181 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IM007
Implicity, Inc. 510(k) NO: K210543(Traditional)
ATTN: David Perlmutter PHONE NO : 033 6 76731731
185 Alewife Brook Parkway Suite 21SE DECISION MADE: 03-NOV-21
Cambridge MA 02138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Velofix SA Cervical Cage
U&I Corporation 510(k) NO: K210573(Traditional)
ATTN: Jee-Ae Bang PHONE NO : 82 31 8606846
20, Sandan-ro 76beon-gil(Rd) SE DECISION MADE: 19-NOV-21
Uijeongbu-si KR 11781 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pediatric Nasogastric Feeding Tubes - Single ENFit Port
CAIR LGL 510(k) NO: K210598(Traditional)
ATTN: Irving L. Wiesen PHONE NO : 212 3818774
Parc Tertiaire De Bois Dieu, 1 AllSE DECISION MADE: 02-NOV-21
Lissieu FR 69380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-FLO Fluid Management System
Thermedx, LLC 510(k) NO: K210628(Traditional)
ATTN: Daniel Marijian PHONE NO : 440 5420883
31200 Solon Rd Unit 1 SE DECISION MADE: 04-NOV-21
Solon OH 44139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETEST Fosfomycin (FO) (0.032-512 µg/mL)
bioMerieux SA 510(k) NO: K210757(Traditional)
ATTN: Marine Taravant PHONE NO : 33 04 78872126
376, chemin de l’Orme SE DECISION MADE: 12-NOV-21
Marcy-l’Etoile FR 69280 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Patient Examination Gloves, Blue Color
Shandong Jieshi Medical Products C510(k) NO: K210777(Traditional)
ATTN: Li Biao PHONE NO : 86 530 2061157
North Road, Fumin Avenue, Qinghe SSE DECISION MADE: 02-NOV-21
Heze CN 274400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Patient Examination Gloves, Blue Color
Shandong Shangwei Medical Products510(k) NO: K210779(Traditional)
ATTN: Li Hua PHONE NO : 86 530 2069778
North Road, Fumin Avenue, Qinghe SSE DECISION MADE: 10-NOV-21
Heze CN 274400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tablo Cartridge
Outset Medical, Inc. 510(k) NO: K210782(Traditional)
ATTN: Jennifer Mascioli-Tudor PHONE NO : 699 2318200
3052 Orchard Drive SE DECISION MADE: 26-NOV-21
San Jose CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Gowns
Chongqing Litai Fashion Group Limi510(k) NO: K210785(Traditional)
ATTN: David Ni PHONE NO : 0086 15 678607429
Building D7-1, Chongqing China TexSE DECISION MADE: 13-NOV-21
Chongqing CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OnQ Neuro
CorTechs Labs, Inc 510(k) NO: K210831(Traditional)
ATTN: Kora Marinkovic PHONE NO : 1 858 4599703
5060 Shoreham Place, Suite 240 SE DECISION MADE: 19-NOV-21
San Diego CA 92122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula
Smiths Medical ASD, Inc. 510(k) NO: K210833(Traditional)
ATTN: Nancy DeAngelo PHONE NO : 1 763 3833059
6000 Nathan Lane North SE DECISION MADE: 26-NOV-21
Minneapolis MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InstruSafe Instrument Protection System
Summitt Medical LLC 510(k) NO: K210836(Traditional)
ATTN: Debra Kridner PHONE NO : 763 4434476
815 Vikings Pkwy, Suite 100 SE DECISION MADE: 30-NOV-21
St. Paul MN 55121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Enteral Feeding Set
KB Medical (Group) Inc. 510(k) NO: K210854(Traditional)
ATTN: Chunsheng Sheng PHONE NO : 1 949 4910797
9650 Research Dr STE#A SE DECISION MADE: 16-NOV-21
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NextAR™ Spine Platform
Medacta International, SA 510(k) NO: K210859(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 05-NOV-21
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TaiChiB
Our United Corporation 510(k) NO: K210921(Traditional)
ATTN: Qi Liu PHONE NO : 86 15 389012257
Room 10301, 3rd Floor, Unit 1, BloSE DECISION MADE: 02-NOV-21
Xi'an CN 710018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)
Johnson & Johnson Vision Care, Inc510(k) NO: K210930(Traditional)
ATTN: Jamie Frenz-Ross PHONE NO : 561 3737697
7500 Centurion Parkway, Suite 100 SE DECISION MADE: 29-NOV-21
Jacksonville FL 32256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
Abbott Diabetes Care Inc. 510(k) NO: K210943(Traditional)
ATTN: Ono Bacani PHONE NO : 510 2392622
1360 South Loop Rd. SE DECISION MADE: 22-NOV-21
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nulife
MRK Healthcare Pvt Ltd 510(k) NO: K210969(Abbreviated)
ATTN: Anil R Dave PHONE NO : 91 2766 297206
S.No.153/P&310,Panch, Pippal, HansSE DECISION MADE: 03-NOV-21
Patan IN 384265 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System
Brainlab AG 510(k) NO: K210989(Traditional)
ATTN: Chiara Cunico PHONE NO : 49 899 915680
Olof-Palme-Str. 9 SE DECISION MADE: 12-NOV-21
Munich DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-sterile Powder Free Nitrile Examination Gloves
Rubberex Alliance Sdn Bhd 510(k) NO: K210990(Traditional)
ATTN: Sabri Abd Hamid PHONE NO : 605 5482723
Lot 128201 Off 3/4 Mile, Jalan BerSE DECISION MADE: 22-NOV-21
Ipoh MY 314000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Urinary Catheter 12 Fr, Urinary Catheter 16 Fr
UroGen Pharma Ltd 510(k) NO: K211032(Traditional)
ATTN: James G. Otinger PHONE NO : 1 610 7451230
9 Ha'Ta'asiya Street SE DECISION MADE: 19-NOV-21
Ra'anana IL 4365405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Microcurrent device (Model: HBR2-1)
Shenzhen DJ Medical Equipment Co.,510(k) NO: K211055(Traditional)
ATTN: Jet Li PHONE NO : 86 755 85573525
Room 801, Building A, FirstFlag ScSE DECISION MADE: 05-NOV-21
Shenzhen CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HALYARD Flexaprene Green Powder-Free Exam Glove
O & M Halyard, Inc. 510(k) NO: K211063(Abbreviated)
ATTN: Steven Dowdley PHONE NO : 678 4518062
1 Edison Drive SE DECISION MADE: 19-NOV-21
Alpharetta GA 30005 510(k) STATEMENT
DEVICE: BioFire COVID-19 Test 2
BioFire Defense, LLC 510(k) NO: K211079(Traditional)
ATTN: Cynthia Phillips PHONE NO : 801 2623592 1370
79 W 4500 S, Suite 14 SE DECISION MADE: 01-NOV-21
Salt Lake City UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EkoSonic Endovascular Device
Boston Scientific 510(k) NO: K211080(Traditional)
ATTN: Joshua Kim PHONE NO : 530 9021194
Two Scimed Place SE DECISION MADE: 19-NOV-21
Maple Grove MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Vinyl Examination Gloves
Shanghai Shengda Medical Applicati510(k) NO: K211103(Traditional)
ATTN: Ying Su PHONE NO : 086 21 33517332
No. 608 Xingwen Road, North DeveloSE DECISION MADE: 04-NOV-21
Shanghai CN 201815 510(k) STATEMENT
DEVICE: CUBE Air Purifier
Samsung Electronics Co., Ltd. 510(k) NO: K211139(Traditional)
ATTN: Hana Jung PHONE NO : 82 10 83070822
129, Samsung-Ro, Yeongtong-Gu SE DECISION MADE: 26-NOV-21
Suwon-Si KR 16677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Face Masks, Model Name:MY020003
Huizhou Jie Bai Purification Co.,L510(k) NO: K211165(Traditional)
ATTN: Terrance Huang PHONE NO : 86 183 12418578
Dongjiang Road, Liangwu Village, YSE DECISION MADE: 09-NOV-21
Huizhou CN 516123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Philips Incisive CT on Trailer
Philips Healthcare (Suzhou) Co., L510(k) NO: K211168(Traditional)
ATTN: Shiguang An PHONE NO : 86 21 60902504
No. 258, ZhongYuan Road, Suzhou InSE DECISION MADE: 22-NOV-21
Suzhou CN 215024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bronchoscope System
Shanghai AnQing Medical Instrument510(k) NO: K211169(Traditional)
ATTN: Shuwen Fan PHONE NO : 86 021 61117375
3&4 Floor, No. 2 Building, 366 HuiSE DECISION MADE: 24-NOV-21
Shanghai CN 201201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ST AIA-PACK BNP Assay
Tosoh Bioscience, Inc. 510(k) NO: K211199(Special)
ATTN: Louise Musante PHONE NO : 650 2425563
6000 Shoreline Court, Suite 101 SE DECISION MADE: 08-NOV-21
South San Francisco CA 94080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FreedomEdge(R) Syringe Infusion System
Repro-Medical System, Inc., dba Ko510(k) NO: K211206(Traditional)
ATTN: Brian Schiller PHONE NO : 845 6105587
24 Carpenter Road SE DECISION MADE: 09-NOV-21
Chester NY 10918 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VSP® Orthopedics System
3D Systems 510(k) NO: K211244(Traditional)
ATTN: Ben Johnson PHONE NO : 720 6431001
5381 South Alkire Circle SE DECISION MADE: 10-NOV-21
Littleton CO 80127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger
Pall Corporation 510(k) NO: K211286(Traditional)
ATTN: Brian Goetz PHONE NO : 516 8019267
25 Harbor Park Drive SE DECISION MADE: 16-NOV-21
Port Washington NY 11050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B
Microlife Intellectual Property Gm510(k) NO: K211288(Traditional)
ATTN: Gerhard Firck PHONE NO : 41 71 7277000
Espenstrasse 139 SE DECISION MADE: 04-NOV-21
Widnau CH 9443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RMU-2000 Automated Chest Compression System
Defibtech, LLC 510(k) NO: K211289(Traditional)
ATTN: Allison Bohren PHONE NO : 203 4536652 159
741 Boston Post Road SE DECISION MADE: 09-NOV-21
Guilford CT 06437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Mask (sterile)
Nanjing 3H Medical Products Co., L510(k) NO: K211295(Traditional)
ATTN: Chun Yang PHONE NO : 86 25 57885555
No.5 Zhushan Road Gaochun County ESE DECISION MADE: 24-NOV-21
Nanjing CN 211300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Comby EEG Caps
Pamel d.o.o 510(k) NO: K211315(Traditional)
ATTN: Marko Pavic PHONE NO : 00385 1 3473134
Mesekov Put 16 SE DECISION MADE: 09-NOV-21
Zagreb HR 10090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EndoScreener
Chengdu Wision Medical Device Co.,510(k) NO: K211326(Traditional)
ATTN: JingJia Liu PHONE NO : 86 186 01037373
Unit 802, Floor 8, Building 17, YiSE DECISION MADE: 19-NOV-21
Chengdu CN 610041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle
Jiangsu Kangbao Medical Equipment 510(k) NO: K211329(Traditional)
ATTN: Rujun Tang PHONE NO : 86 514 88223540
78#, North Suzhong Road, Baoying SE DECISION MADE: 15-NOV-21
Yangzhou CN 225800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sofia 2 Campylobacter FIA
Quidel Corporation 510(k) NO: K211342(Traditional)
ATTN: Michelle Bodien PHONE NO : 210 7405756
10165 McKellar Court SE DECISION MADE: 23-NOV-21
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C-30 Crown Kit
Perfect Fit Crowns, LLC 510(k) NO: K211345(Traditional)
ATTN: Steve Ziskind PHONE NO : 954 4155639
1128 Royal Palm Beach Blvd, #166 SE DECISION MADE: 24-NOV-21
Royal Palm Beach FL 33411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Uretero1 Ureteroscope System
STERIS Corporation 510(k) NO: K211347(Traditional)
ATTN: Caroll Martin PHONE NO : 440 3586259
5976 Heisley Road SE DECISION MADE: 23-NOV-21
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GIQuant
Motilent Ltd 510(k) NO: K211356(Traditional)
ATTN: Ian Knott PHONE NO : 0044 0781 7476978
IDEALondon, 69 Wilson Street SE DECISION MADE: 08-NOV-21
London GB EC2A 2BB 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation
Tornier, Inc. 510(k) NO: K211359(Traditional)
ATTN: Lisa Stahl PHONE NO : 612 8499970
10801 Nesbitt Ave South SE DECISION MADE: 12-NOV-21
Bloomington MN 55437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Breathe Easy Mobile Respiratory Monitor (MRM)
Sound Life Sciences, Inc. 510(k) NO: K211387(Traditional)
ATTN: Kamal Shah PHONE NO : 206 4148667
Startup Hall, Box 354625, 1100 NE SE DECISION MADE: 23-NOV-21
Seattle WA 98195-4625 510(k) STATEMENT
DEVICE: Myomics Q
Phantomics Inc. 510(k) NO: K211432(Traditional)
ATTN: Sangmin Cho PHONE NO : 82 2 63472019
B-1224, 247, Gonghang-daero, GangsSE DECISION MADE: 23-NOV-21
Seoul KR 07803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Regulora
metaMe Health, Inc. 510(k) NO: K211463(Traditional)
ATTN: Tim Rudolphi PHONE NO : 224 6882057
222 W. Merchandise Mart Plaza - SuSE DECISION MADE: 24-NOV-21
Chicago IL 60654 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SofWave System
Sofwave Medical Ltd. 510(k) NO: K211483(Traditional)
ATTN: Ruthie Amir PHONE NO : 972 25 43003164
Beit Tavor 2 SE DECISION MADE: 15-NOV-21
Yokneam Ilit IL 2069202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories
Convergent Laser Technologies 510(k) NO: K211517(Traditional)
ATTN: Jennifer Mok PHONE NO : 510 8322130
1660 South Loop Road SE DECISION MADE: 09-NOV-21
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Protect X Level 3 Isolation Gown
AZAC Group 510(k) NO: K211538(Traditional)
ATTN: Yen Ping Shan PHONE NO : 937 8309632
17870 Castleton St. Suite 121 SE DECISION MADE: 17-NOV-21
City of Industry CA 91748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MammoScreen 2.0
Therapixel 510(k) NO: K211541(Traditional)
ATTN: Quentin De Snoeck PHONE NO : 0033 663 079607
455 Promenade des Anglais SE DECISION MADE: 26-NOV-21
Nice FR 06200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization
Brainlab AG 510(k) NO: K211544(Traditional)
ATTN: Chiara Cunico PHONE NO : 49 89 9915680
Olof-Palme-Str. 9 SE DECISION MADE: 03-NOV-21
Munich DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vektor Computational ECG Mapping System (vMap)
Vektor Medical, Inc. 510(k) NO: K211546(Traditional)
ATTN: Mike Monko PHONE NO : 858 4050094
7875 Sitio Abeto SE DECISION MADE: 09-NOV-21
Carlsbad CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Virtue RF
ShenB Co Ltd 510(k) NO: K211562(Traditional)
ATTN: Sunny Kang PHONE NO : 82 70 49122702
ShenB Bldg 148 Seongsui-ro SE DECISION MADE: 23-NOV-21
Seoul KR 04796 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SoftFix Balloon Trocar
Unimax Medical Systems Inc. 510(k) NO: K211577(Traditional)
ATTN: Monoj Mon Kalita PHONE NO : 886 2 89191698 202
8F-2, No. 127, Lane 235, Pao ChiaoSE DECISION MADE: 05-NOV-21
New Taipei TW 23145a 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Gloves (Blue, Violet)
Lyncmed Medical Technology (Beijin510(k) NO: K211586(Traditional)
ATTN: Jiali Zhou PHONE NO : 86 1511 7964608
Room 1601, Building No. 2, ZhubangSE DECISION MADE: 01-NOV-21
Beijing CN 100022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trevo Trak 21 Microcatheter
Stryker Neurovascular 510(k) NO: K211594(Special)
ATTN: Shivani H Patel PHONE NO : 949 4154982
47900 Bayside Parkway SE DECISION MADE: 26-NOV-21
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PCEA Syringe Set
Baxter Healthcare Corporation 510(k) NO: K211649(Traditional)
ATTN: Jeffrey E Thompson PHONE NO : 224 2703806
25212 West Illinois Route 120 SE DECISION MADE: 23-NOV-21
Round Lake IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Radian MIS Bunion System
Nvision Biomedical Technologies, I510(k) NO: K211650(Traditional)
ATTN: Diana Langham PHONE NO : 210 5453713
4590 Lockhill Selma SE DECISION MADE: 24-NOV-21
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eclipse PRO
Spacelabs Healthcare Ltd. 510(k) NO: K211651(Traditional)
ATTN: Roger Moldon PHONE NO : 011 44 1992507730
Unit B, Foxholes Centre, John TateSE DECISION MADE: 22-NOV-21
Hertford GB SG13 7DT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed IntellaMap Orion High Resolution Mapping Catheter
Innovative Health, LLC. 510(k) NO: K211662(Traditional)
ATTN: Rick Ferreira PHONE NO : 877 4003740
1435 North Hayden Road Suite 100 SE DECISION MADE: 18-NOV-21
Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KardiaMobile Card
AliveCor, Inc. 510(k) NO: K211668(Special)
ATTN: Saket Bhatt PHONE NO : 650 3968553
444 Castro Street, Suite 600 SE DECISION MADE: 30-NOV-21
Mountain View CA 94041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lunit INSIGHT MMG
Lunit Inc. 510(k) NO: K211678(Traditional)
ATTN: Joohee Lee PHONE NO : 82 10 89906329
15 Floor, 27 Teheran-ro-2-gil, GanSE DECISION MADE: 17-NOV-21
Seoul KR 06241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Face Mask
Anhui Cleanpro Pharmpack Co., Ltd.510(k) NO: K211696(Traditional)
ATTN: Chong Xiuming PHONE NO : 86 550 7981778
Yeshan Industrial Zone SE DECISION MADE: 30-NOV-21
Tianchang CN 239300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Esperance Aspiration Catheter System
Wallaby Medical 510(k) NO: K211697(Traditional)
ATTN: Nathaniel Knock PHONE NO : 949 4809466
22901 Mill Creek Drive SE DECISION MADE: 16-NOV-21
Laguna Hills CA 92653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acuson SC2000 Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K211726(Traditional)
ATTN: Christine Dunbar PHONE NO : 925 3742045
685 East Middlefield Road SE DECISION MADE: 05-NOV-21
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Blue Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs
Dong Tai City Huayi Gloves Co.,Ltd510(k) NO: K211727(Traditional)
ATTN: Wang Huamei PHONE NO : 86 137 05111918
No.36 Nanzhuang Road, Dongtai HighSE DECISION MADE: 15-NOV-21
Dongtai CN 224249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Comprehensive® Convertible Glenoid - Vivacit-E Liner
Biomet Manufacturing Corp. 510(k) NO: K211729(Traditional)
ATTN: Patricia Sandborn Beres PHONE NO : 574 2676639
56 East Bell Drive SE DECISION MADE: 04-NOV-21
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lunit INSIGHT CXR Triage
Lunit Inc. 510(k) NO: K211733(Traditional)
ATTN: Seulhee Jung PHONE NO : 82 10 71842481
15th Floor, 27 Teheran-ro 2-gil SE DECISION MADE: 10-NOV-21
Seoul KR 06241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pre-Formed Extra Support Guidewire
Lake Region Medical 510(k) NO: K211741(Traditional)
ATTN: Deko Hussein PHONE NO : 952 6428302
340 Lake Hazeltine Drive SE DECISION MADE: 22-NOV-21
Chaska MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-Contact Infrared Thermometer, model HL710H
Health & Life Co., Ltd 510(k) NO: K211744(Traditional)
ATTN: Simon Lee PHONE NO : 886 2 82271300 11205
9F, No. 186, Jian Yi Road Zhonghe SE DECISION MADE: 24-NOV-21
New Taipei TW 23553 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vital Signs Monitor
Beijing Choice Electronic Technolo510(k) NO: K211754(Traditional)
ATTN: Haiying Zhao PHONE NO : 86 10 88794631
No.9 Shuangyuan road, Badachu Hi-tSE DECISION MADE: 15-NOV-21
Beijing CN 100041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown
Cardinal Health LLC 510(k) NO: K211765(Traditional)
ATTN: Brenda Gerena PHONE NO : 312 2702148
3651 Birchwood Drive SE DECISION MADE: 23-NOV-21
Waukegan IL 60085 510(k) STATEMENT
DEVICE: Anterion
Heidelberg Engineering GmbH 510(k) NO: K211817(Traditional)
ATTN: Arianna Schoess Vargas PHONE NO : 49 6221 64630
Max-Jarecki-Strasse 8 SE DECISION MADE: 05-NOV-21
Heidelberg DE 69115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Deploy Expandable Interbody System
Southern Spine LLC 510(k) NO: K211845(Traditional)
ATTN: Calder Clay PHONE NO : 478 7450000
487 Cherry Street - Third Street TSE DECISION MADE: 16-NOV-21
Macon GA 31201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITA Akzent LC
VITA Zahnfabrik GmbH H Rauter & Co510(k) NO: K211854(Traditional)
ATTN: Bernd Walker PHONE NO : 49 7761 562384
Spitelgasse 3 SE DECISION MADE: 22-NOV-21
Bad Sackingen DE D-79713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FAICO Dental Implant System and CAD/CAM Abutments
Faico Medical LLC 510(k) NO: K211871(Traditional)
ATTN: Hernan Dario Fernandez PHONE NO : 561 3346123
2424 North Federal Highway, Suite SE DECISION MADE: 18-NOV-21
Boca Raton FL 33428 510(k) STATEMENT
DEVICE: Intellijoint VIEW
Intellijoint Surgical Inc. 510(k) NO: K211876(Traditional)
ATTN: Katarina Jugovic PHONE NO : 519 3423178 2231
809 Wellington Street North , UnitSE DECISION MADE: 12-NOV-21
Kitchener CA N2H 5L6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Promisemed Sharps container
Promisemed Hangzhou Meditech Co., 510(k) NO: K211890(Traditional)
ATTN: Zearou Yang PHONE NO : 86 571 88772985
No. 1388 Cangxing Street, CangqianSE DECISION MADE: 17-NOV-21
Hangzhou City CN 311121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trachealator
DISA Medintec 510(k) NO: K211894(Traditional)
ATTN: Michelle Nieuwoudt PHONE NO : 27 87 3302301
Stand 171, Northlands Business ParSE DECISION MADE: 24-NOV-21
Johannesburg ZA 2169 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System
Jiangsu Synecoun Medical Technolog510(k) NO: K211937(Traditional)
ATTN: Zhheng Li PHONE NO : 86 523 86511020
1/2F East Side,No. 50, G60, EastsiSE DECISION MADE: 18-NOV-21
Taizhou CN 225300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GlideScope BFlex 2.8 Single-Use Bronchoscope
Verathon Medical (Canada) ULC 510(k) NO: K211947(Traditional)
ATTN: Teresa Davidson PHONE NO : 425 6295516
2227 Douglas Road SE DECISION MADE: 03-NOV-21
Burnaby CA V5C 5A9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 039 Surgical Face Mask
AOK Tooling Limited 510(k) NO: K211956(Traditional)
ATTN: Francis Nithyananthan PHONE NO : 852 0 23101703
# 101 And 1Building, 2Building, 3BSE DECISION MADE: 23-NOV-21
Shenzhen CN 518122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Agile Esophageal OTW Stent System
Boston Scientific Corporation 510(k) NO: K211960(Traditional)
ATTN: Inderdeep Tiwana PHONE NO : 508 6834005
100 Boston Scientific Way SE DECISION MADE: 22-NOV-21
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sensual Massage, Ultra Pure
Dreambrands, Inc. 510(k) NO: K211967(Traditional)
ATTN: Cecile Kehoe PHONE NO : 602 3547640
11645 N. Cave Creek Road SE DECISION MADE: 09-NOV-21
Phoenix AZ 85020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Drug Relief v1
DyAnsys, Inc. 510(k) NO: K211971(Traditional)
ATTN: Srini Nageshwar PHONE NO : 408 4804700
300, North Bayshore Boulevard SE DECISION MADE: 05-NOV-21
San Mateo CA 94401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System
Caldera Medical, Inc. 510(k) NO: K211975(Special)
ATTN: Vicki Gail PHONE NO : 818 4837602
4360 Park Terrace drive SE DECISION MADE: 10-NOV-21
Westlake Village CA 91361 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMRA Profiler
AMRA Medical AB 510(k) NO: K211983(Traditional)
ATTN: Eric Converse PHONE NO : 46 13 162600
Badhusgatan 5 SE DECISION MADE: 24-NOV-21
Linkoping SE 582 22 510(k) STATEMENT
DEVICE: Desnuda Reflect
Good Clean Love, Inc. 510(k) NO: K211998(Traditional)
ATTN: Wendy Strgar PHONE NO : 541 3444483
207 W 5th Avenue SE DECISION MADE: 18-NOV-21
Eugene OR 97401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medley
Good Clean Love, Inc. 510(k) NO: K212000(Traditional)
ATTN: Wendy Strgar PHONE NO : 541 3444483
207 W 5th Avenue SE DECISION MADE: 18-NOV-21
Eugene OR 97401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESSENZ Patient Monitor
LivaNova Deutschland GmbH 510(k) NO: K212003(Special)
ATTN: Florian Goetz PHONE NO :
Lindberghstr. 25 SE DECISION MADE: 10-NOV-21
Munich DE 80939 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: eKuore Pro 4T - REF EP0098
Chip Ideas Electronics S.L. 510(k) NO: K212013(Special)
ATTN: Bernardo Plaza Trillo PHONE NO : 0034 961 156738
C/ Alfareria 3 B SE DECISION MADE: 10-NOV-21
Burjasot ES 46100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Nano 2nd Gen Pen Needle
Becton Dickinson and Company 510(k) NO: K212015(Traditional)
ATTN: Charlton Foo PHONE NO : 857 2701395
1 Becton Drive SE DECISION MADE: 19-NOV-21
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single
Jiangsu Micsafe Medical Technology510(k) NO: K212019(Traditional)
ATTN: Tony Yang PHONE NO : 086 136 51929266
Xituan Industrial Park, Dafeng DisSE DECISION MADE: 04-NOV-21
Yancheng CN 224125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Nitrile Examination Gloves (non-sterile)
Taizhou Kangjian Medical Equipment510(k) NO: K212029(Traditional)
ATTN: Hua Cong PHONE NO : 86 576 87299799
The Machine Electricity Zone (HangSE DECISION MADE: 16-NOV-21
Taizhou CN 317600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TrueLok Evo
Orthofix SRL 510(k) NO: K212044(Traditional)
ATTN: Gianluca Ricadona PHONE NO : 39 045 6719000
Via delle Nazioni, 9 SE DECISION MADE: 05-NOV-21
Bussolengo IT 37012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Impertech Surgical Face Mask
Impertech Industries Ltd. 510(k) NO: K212046(Traditional)
ATTN: Mohamad Khweis PHONE NO : 972 3 9367682
20 Derech Barkan St. SE DECISION MADE: 18-NOV-21
Barkan IL 4482000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pantheris System
Avinger, Inc. 510(k) NO: K212047(Traditional)
ATTN: Thomas Lawson PHONE NO : 650 2417004
400 Chesapeake Drive SE DECISION MADE: 16-NOV-21
Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biotech Dental Kits
Biotech Dental, SAS 510(k) NO: K212068(Traditional)
ATTN: Delphine Mercier PHONE NO : 33 490 446060
305 Allées De Craponne SE DECISION MADE: 08-NOV-21
Salon de Provence FR 13300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fetal Doppler
Shenzhen Mericonn Technology Co., 510(k) NO: K212084(Traditional)
ATTN: Jiang Chuanyuan PHONE NO : 0086 139 28416535__
Room 20203, Building 6, DonglongxiSE DECISION MADE: 03-NOV-21
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci SP Firefly Imaging System
Intuitive Surgical, Inc. 510(k) NO: K212101(Traditional)
ATTN: Connor McCarty PHONE NO : 805 7984205
1266 Kifer Road SE DECISION MADE: 23-NOV-21
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Water-soluble Personal Lubricant
Foshan PingChuang Medical Technolo510(k) NO: K212104(Traditional)
ATTN: Huang Zhiyue PHONE NO : 86 757 29269896
Room 301, No. 3, Huaye Road, LingaSE DECISION MADE: 18-NOV-21
Foshan CN 528312 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reverso
Intelis Instruments Ltd. 510(k) NO: K212107(Traditional)
ATTN: Amit Goren PHONE NO : 972 528 701672
HaOman 12 SE DECISION MADE: 10-NOV-21
Hadera IL 3850172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spin Care Disposable Protective Mask Level 3
SpinTech LLC 510(k) NO: K212109(Traditional)
ATTN: Jim Jean PHONE NO : 704 9293596
1920 Flintstone Drive SE DECISION MADE: 14-NOV-21
Statesville NC 28677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cardiologs Holter Platform
Cardiologs Technologies 510(k) NO: K212112(Traditional)
ATTN: Arezou Azar PHONE NO : 1 650 8040285
136 Rue Saint Denis SE DECISION MADE: 18-NOV-21
Paris FR 75002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exablate Prostate System
Insightec, Inc 510(k) NO: K212150(Traditional)
ATTN: Nadir Alikacem PHONE NO : 214 6302000
4851 LBJ Freeway, Suite 400 SE DECISION MADE: 23-NOV-21
Dallas TX 75244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLUME catheter
The Flume Catheter Company, Ltd. 510(k) NO: K212151(Traditional)
ATTN: Roger Holmes PHONE NO : 44 0207 8089125
The Granary, Millhouse SE DECISION MADE: 03-NOV-21
Frensham GB GU10 3EE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Air compression therapy system FO3002
Foshan Hongfeng Co., Ltd. 510(k) NO: K212169(Traditional)
ATTN: Dongfeng Cheng PHONE NO : 86 0757 8392028
No.4-2 Leqiang Road, Leping SanshuSE DECISION MADE: 23-NOV-21
Foshan CN 528000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electronic Blood Pressure Monitor
Dongguan Kangweile Electronic Tech510(k) NO: K212171(Traditional)
ATTN: Zhixin Gao PHONE NO : 86 769 82677482
4th Floor, Building D, Yizhong SciSE DECISION MADE: 01-NOV-21
Dongguan CN 523770 510(k) STATEMENT
DEVICE: ASAP Aspiration Catheter, ASAPLP Aspiration Catheter
Merit Medical Systems, Inc. 510(k) NO: K212199(Special)
ATTN: Kirk McIntosh PHONE NO : 801 3163695
1600 West Merit Parkway SE DECISION MADE: 03-NOV-21
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Atellica CH Enzymatic Creatinine_3 (ECre3)
Siemens Healthcare Diagnostics Inc510(k) NO: K212223(Traditional)
ATTN: Ian Thompson PHONE NO :
511 Benedict Avenue SE DECISION MADE: 24-NOV-21
Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3D-Cut
3D-Side SA 510(k) NO: K212237(Traditional)
ATTN: Laurent Paul PHONE NO : 32 0 10813548
Rue André Dumont 5 SE DECISION MADE: 29-NOV-21
Mont-Saint-Guibert BE 1435 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Zirdent New Material Co., Ltd 510(k) NO: K212259(Traditional)
ATTN: Jia Li PHONE NO : 86 731 85529297
No.101,3rd building of Hai Ping InSE DECISION MADE: 12-NOV-21
Changsha CN 410205 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face mask
Nantong Taiweishi Medical Technolo510(k) NO: K212264(Traditional)
ATTN: Zhang Xuewen PHONE NO : 0086 187 61789767
Taihangshan Road, New District, EcSE DECISION MADE: 13-NOV-21
Nantong CN 226400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K212265(Traditional)
ATTN: Hao Yixuan PHONE NO : 86 755 81886129
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 16-NOV-21
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dermalux Flex MD
Aesthetic Technology Ltd. 510(k) NO: K212275(Traditional)
ATTN: Dale Needham PHONE NO : 44 0845 6891789
Unit 211 Europa Blvd. SE DECISION MADE: 18-NOV-21
Warrington GB WA5 7TN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Automatic Core Biopsy Instrument
Suzhou Leapmed Healthcare Corporat510(k) NO: K212284(Traditional)
ATTN: Yu Zhu PHONE NO : 86 512 66554498 8043
Wuzhong Science Park, NO.2 & NO.3 SE DECISION MADE: 10-NOV-21
Suzhou CN 215100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device
Covidien, LLC 510(k) NO: K212301(Traditional)
ATTN: Celso Duran PHONE NO : 303 5306445
5920 Longbow Dr. SE DECISION MADE: 15-NOV-21
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tapestry Biointegrative Implant
Embody, Inc. 510(k) NO: K212306(Traditional)
ATTN: Brianna Schehr PHONE NO : 236 9947912
4211 Monarch Way, Suite 500 SE DECISION MADE: 02-NOV-21
Norfolk VA 23508 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BodySculp
Rohrer Aesthetics, LLC 510(k) NO: K212331(Traditional)
ATTN: Mark Rohrer PHONE NO : 205 3561172
105 Citation Court SE DECISION MADE: 09-NOV-21
Birmingham AL 35209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Soteria.AI
Omega Medical Imaging, LLC 510(k) NO: K212336(Traditional)
ATTN: John Newman PHONE NO : 407 3239400 203
3400 St. Johns Parkway, Suite 1020SE DECISION MADE: 17-NOV-21
Sanford FL 32771 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SterileRight sterilization pouch and roll
SterileRight Packaging Mfg., Inc. 510(k) NO: K212338(Traditional)
ATTN: Thomas Chou PHONE NO : 886 2 24555498
1F, No.33-7, Dahua 2nd Rd., Qidu DSE DECISION MADE: 01-NOV-21
Keelung City TW 206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Mask
Xiantao Dingcheng Non-woven Produc510(k) NO: K212344(Traditional)
ATTN: Cheng Qin PHONE NO : 86 1800 7229722
Liukou Industrial Park SE DECISION MADE: 16-NOV-21
Xiantao CN 433099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S.I.N. Instrument Kits
S.I.N. - Sistema de Implante Nacio510(k) NO: K212404(Traditional)
ATTN: Denise Domiciano PHONE NO : 55 11 21693000 3236
Avenida Vereador Abel Ferreira, 11SE DECISION MADE: 03-NOV-21
São Paulo BR 03340-000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Modular Glenoid System-Titanium Glenosphere
Arthrex Inc. 510(k) NO: K212415(Traditional)
ATTN: David L. Rogers PHONE NO : 1 239 6435553
1370 Creekside Boulevard SE DECISION MADE: 17-NOV-21
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Qora Stool Management Kit
CM Technologies, Inc. 510(k) NO: K212444(Special)
ATTN: Nishith Chasmawala PHONE NO : 800 5204714___
2165 San Diego Avenue SE DECISION MADE: 17-NOV-21
San Diego CA 92110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive Anterior Cervical Plate Systems
NuVasive, Incorporated 510(k) NO: K212446(Traditional)
ATTN: Priscila Saraiva PHONE NO : 858 9091807
7475 Lusk Blvd. SE DECISION MADE: 03-NOV-21
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NightGuard Flex
SprintRay Inc 510(k) NO: K212448(Traditional)
ATTN: Sara Moghtadernejad PHONE NO : 917 9123858
2705 Media Center Drive, Suite 100SE DECISION MADE: 12-NOV-21
Los Angeles CA 90065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InZone Detachment System
Stryker Neurovascular 510(k) NO: K212455(Traditional)
ATTN: Breskella Halteh PHONE NO : 650 8143781
47900 Bayside Parkway SE DECISION MADE: 16-NOV-21
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
Hyperfine, Inc. 510(k) NO: K212456(Traditional)
ATTN: Christine Kupchick PHONE NO : 203 3433404
530 Old Whitfield Street SE DECISION MADE: 17-NOV-21
Guilford CT 06437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))
Guangzhou ZhengKang Medical Equipm510(k) NO: K212460(Traditional)
ATTN: Mike Wu PHONE NO : 86 136 00073056
Room101,No.9Nanling Zhongxin KuangSE DECISION MADE: 05-NOV-21
GuangZhou CN 510540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Examination Glove
Inner Mongolia Boming Medical Supp510(k) NO: K212467(Traditional)
ATTN: Guo Hua PHONE NO : 86 134 85097856
Room 326, New Industrial Park ManaSE DECISION MADE: 04-NOV-21
Baotou CN 014017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Face Mask
Haian Medigauze Co., Ltd 510(k) NO: K212471(Traditional)
ATTN: Weihua Xu PHONE NO : 13 90 1478762
Jiaoxie Industry Park, Haian SE DECISION MADE: 04-NOV-21
Nantong CN 226633 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Examination gloves
Fujian Yuanxin Safety Protection T510(k) NO: K212485(Traditional)
ATTN: Alan Wu PHONE NO : 86 593 8311666
Xiacun Medical Industry Zone, ZherSE DECISION MADE: 05-NOV-21
Ningde CN 355300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoLink Vallux Plating System
In2Bones USA, LLC 510(k) NO: K212487(Traditional)
ATTN: Christine Scifert PHONE NO :
6000 Poplar Ave, Suite 115 SE DECISION MADE: 18-NOV-21
Memphis TN 38119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synthetic Nitrile Examination Gloves
Shandong Hongxin Chemicals Co., Lt510(k) NO: K212488(Traditional)
ATTN: Ping Wang PHONE NO : 86 155 50323002
No. 10161, Xinhua Road, Zhoucun DiSE DECISION MADE: 26-NOV-21
Zibo CN 255399 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ortho Aligner System
Ortho Lab Services, LLC 510(k) NO: K212496(Traditional)
ATTN: Zuzana Huelsbusch PHONE NO : 0049 1573 0655886
251 Little Falls SE DECISION MADE: 04-NOV-21
Wilmington DE 19808 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Glove (Powder free, Blue)
Jiangsu Jinlian Medical Technology510(k) NO: K212497(Traditional)
ATTN: Wu Min PHONE NO : 86 186 41219728
No. 14 Factory Building, 1st FloorSE DECISION MADE: 11-NOV-21
Suqian CN 223800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Resonic Rapid Acoustic Pulse Device
Soliton Inc. 510(k) NO: K212502(Traditional)
ATTN: Leslie Honda PHONE NO : 206 3758586
5304 Ashbrook Drive SE DECISION MADE: 05-NOV-21
Houston TX 77081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Isolation Gown AAMI Level 3
Kenpax International Limited 510(k) NO: K212504(Traditional)
ATTN: Solomon Chen PHONE NO : 909 4387898
Flat 5, 5/F, Wing On Plaza, 62 ModSE DECISION MADE: 07-NOV-21
Hong Kong CN 999077 510(k) STATEMENT
DEVICE: Medical Examination Gloves (Tested for Use with Chemotherapy)
GUANGDONG GYMDA MEDICAL TECHNOLOGY510(k) NO: K212506(Traditional)
ATTN: Olivia Chen PHONE NO : 86 20 37738661
No.13, Quan'an Third Road, Phase 2SE DECISION MADE: 07-NOV-21
Shaoguan City CN 512400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 7 Series Phototherapy Device
Daavlin Distributing Co. 510(k) NO: K212510(Traditional)
ATTN: Michele Thiel PHONE NO : 419 6366304 207
205 W. Bement Street SE DECISION MADE: 04-NOV-21
Bryan OH 43506 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110)
Stryker 510(k) NO: K212511(Traditional)
ATTN: Marlene Fraga PHONE NO : 928 2949043
5900 Optical Court SE DECISION MADE: 04-NOV-21
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOVIX DReamy
Stephanix 510(k) NO: K212515(Abbreviated)
ATTN: Sandie Perret PHONE NO : 33 477 478160
10, rue Jean Moulin Z.I du Bayon SE DECISION MADE: 03-NOV-21
La Ricamarie FR 42150 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VFSS Pro Mobile Digital Imaging System
IMAGExRAY, LLC 510(k) NO: K212523(Traditional)
ATTN: Gary Korkola PHONE NO : 973 2350606
160 Park Avenue SE DECISION MADE: 05-NOV-21
Nutley NJ 07110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask
Suzhou JaneE Medical Technology Co510(k) NO: K212526(Traditional)
ATTN: Chen Ke PHONE NO : 86 139 14506197
No.339 HuaFeng Road, New District SE DECISION MADE: 09-NOV-21
Suzhou CN 215129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hypotension Decision Assist Model HDA-OR2
Directed Systems Ltd 510(k) NO: K212529(Special)
ATTN: Mark S. Leaning PHONE NO : 011 44 7552747389
47-51 Norfolk Street SE DECISION MADE: 23-NOV-21
Cambridge GB CB1 2LD 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)
CRDLight Optoelectronic Technology510(k) NO: K212532(Traditional)
ATTN: Fishy Liang PHONE NO : 86 13924 689685
Floor 1-5 Building No.7 & Floor 1-SE DECISION MADE: 11-NOV-21
Jiangmen CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REAL INTELLIGENCE CORI (CORI)
Blue Belt Technologies, Inc. 510(k) NO: K212537(Traditional)
ATTN: Sarah Plittman PHONE NO : 423 8384454
2905 Northwest Blvd., Ste. 40 SE DECISION MADE: 03-NOV-21
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hura CTP v1.0
Hura Imaging, Inc. 510(k) NO: K212550(Traditional)
ATTN: Danny Wang PHONE NO : 310 9483390
23120 Park Sorrento SE DECISION MADE: 08-NOV-21
Calabasas CA 91302 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Gloves
Anhui Fine Glove Medical Technolog510(k) NO: K212551(Traditional)
ATTN: Guanghao Liu PHONE NO : 86 135 88829369
Intersection of Feng Xiang Avenue SE DECISION MADE: 05-NOV-21
Chuzhou CN 233100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MicroPen EVO
Eclipse Medcorp LLC 510(k) NO: K212558(Traditional)
ATTN: Julie Summerville PHONE NO : 972 3802911 2405
5916 Stone Creek Drive SE DECISION MADE: 24-NOV-21
The Colony TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask
Hubei Huanfu Plastic Products Co.,510(k) NO: K212575(Traditional)
ATTN: Yan Zhao PHONE NO : 86 137 07291713
No.188 Wanfu Street, Chenhu Town SE DECISION MADE: 14-NOV-21
Hanchuan CN 431608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AlignRT Plus
Vision RT Ltd 510(k) NO: K212583(Traditional)
ATTN: Jade Dunphy PHONE NO : 44 208 3464300
Dove House, Arcadia Avenue SE DECISION MADE: 10-NOV-21
London GB N3 2JU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Erchonia FX-405
Erchonia Corporation 510(k) NO: K212595(Traditional)
ATTN: Steven Shanks PHONE NO : 888 2420571
650 Atlantis Road SE DECISION MADE: 12-NOV-21
Melbourne FL 32904 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Nitrile Examination Gloves (Non-sterile)
Suqian Linglian Medical Technology510(k) NO: K212600(Traditional)
ATTN: Eric Li PHONE NO : 86 137 61053383
No 1 Rd Wanpi Industrial Park, XinSE DECISION MADE: 18-NOV-21
Suqian CN 223699 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Darwin
Luvo Medical Technologies, Inc 510(k) NO: K212607(Traditional)
ATTN: Gregory Berzak PHONE NO : 519 6203900
125 Fleming Drive SE DECISION MADE: 15-NOV-21
Cambridge CA N1T 2B8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAMMOVISTA B.smart
Siemens Medical Solutions USA, Inc510(k) NO: K212621(Traditional)
ATTN: Martin Rajchel PHONE NO : 484 4734209
40 Liberty Boulevard SE DECISION MADE: 12-NOV-21
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue
String King Lacrosse, LLC 510(k) NO: K212633(Traditional)
ATTN: Thomas Frasca PHONE NO : 1 508 6541988
19100 S Vermont Ave. SE DECISION MADE: 24-NOV-21
Gardena CA 90248 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stratum® Ankle Fusion Plating System
Nextremity Solutions, Inc. 510(k) NO: K212640(Traditional)
ATTN: Elise Fox PHONE NO : 574 3762062
1195 Polk Drive SE DECISION MADE: 18-NOV-21
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Catalyft LS Expandable Interbody System
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K212653(Traditional)
ATTN: Madhuvanthi Soundirarajan PHONE NO : 901 3963133
1800 Pyramid Place SE DECISION MADE: 19-NOV-21
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: More-Cell-System
Agency for Medical Innovations Gmb510(k) NO: K212659(Traditional)
ATTN: Martin Hohlrieder PHONE NO : 43 5522 90505
Im Letten 1 SE DECISION MADE: 10-NOV-21
Feldkirch AT 6800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Examination Glove
Inner Mongolia Cureguard Medical T510(k) NO: K212661(Traditional)
ATTN: Guo Hua PHONE NO : 86 134 85097856
Room 326, Management Committee of SE DECISION MADE: 19-NOV-21
Baotou CN 014100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sherlock
Open Implants, LLC 510(k) NO: K212664(Traditional)
ATTN: Gregg Gellman PHONE NO : 1 781 5873242
800 West Cummngs Ave, Suite 4900 SE DECISION MADE: 30-NOV-21
Woburn MA 01801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MR 5300
Philips Medical Systems Nederland 510(k) NO: K212673(Abbreviated)
ATTN: Jan van de Kerkhof PHONE NO : 31 613 300542
Veenpluis 4-6 SE DECISION MADE: 19-NOV-21
Best NL 5684PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KARL STORZ ICG Imaging System
KARL STORZ Endoscopy America 510(k) NO: K212695(Traditional)
ATTN: Mario Trujillo PHONE NO : 424 2188184
2151 E. Grand Avenue SE DECISION MADE: 15-NOV-21
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Leaf Smooth
Shenzhen Leaflife Technology Co., 510(k) NO: K212697(Traditional)
ATTN: Cheng Qiang PHONE NO : 086 178 75910506
4 F,Bldg. C, JMD Industrial Park, SE DECISION MADE: 19-NOV-21
Shenzhen CN 518116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoolSculpting Elite System
Zeltiq Aesthetics, Inc. 510(k) NO: K212707(Special)
ATTN: Vicky Chai PHONE NO : 919 5648811
4410 Rosewood Drive SE DECISION MADE: 05-NOV-21
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Gloves
Wuhan Huirui Technology Co., Ltd 510(k) NO: K212722(Traditional)
ATTN: Jing Li PHONE NO : 86 181 86661114
Building 29-1 and 29-2, wuhan DianSE DECISION MADE: 26-NOV-21
Wuhan CN 430075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Circul8 Pro
Ortho8 Inc. 510(k) NO: K212731(Special)
ATTN: Nordeen Taylor PHONE NO : 916 2894002
2217 Plaza Drive SE DECISION MADE: 15-NOV-21
Rocklin CA 95765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: geko W-2
Firstkind Limited 510(k) NO: K212762(Traditional)
ATTN: Neil Buckley PHONE NO : 44 845 2222921
Hawk House, Peregrine Business ParSE DECISION MADE: 29-NOV-21
High Wycombe GB HP13 7DL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Bloomden Bioceramics (HuNan) Co., 510(k) NO: K212765(Traditional)
ATTN: Shengyong Liao PHONE NO : 86 158 74253042
No.301, 5th Building, Hi-tech Int'SE DECISION MADE: 15-NOV-21
Changsha CN 410000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GT5 conductive & abrasive gel
Wuhan Greentek Pty Ltd. 510(k) NO: K212787(Traditional)
ATTN: Yarong Liu PHONE NO : 86 27 88185488
Room 03-2, Floor 3, Dingye BuildinSE DECISION MADE: 08-NOV-21
Wuhan CN 430074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C2 CryoBalloon Ablation System
PENTAX of America, Inc. 510(k) NO: K212814(Traditional)
ATTN: William Goeller PHONE NO : 201 5712300 2318
303 Convention Way, Suite 1 SE DECISION MADE: 29-NOV-21
Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy CONDUIT LLIF Angled Inserters
Enztec Limited 510(k) NO: K212823(Traditional)
ATTN: Claire Mai PHONE NO : 6 427 8292440
3/17 Print Place SE DECISION MADE: 01-NOV-21
Middleton NZ 8024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Opulent TiNbN Coated Knee
Meril Healthcare Pvt. Ltd. 510(k) NO: K212839(Traditional)
ATTN: Neelam Desai PHONE NO : 91 905 4623695
Survey No. 135/2/B & 174/2, H1-H3,SE DECISION MADE: 16-NOV-21
Vapi IN 396191 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cervical Stand-Alone System
Eminent Spine, LLC 510(k) NO: K212853(Traditional)
ATTN: Stephen Courtney PHONE NO : 972 499 3593
2004 Ventura Drive, Suite 100 SE DECISION MADE: 05-NOV-21
Plano TX 75093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RTapp
SegAna, Inc. 510(k) NO: K212887(Traditional)
ATTN: Jennifer Bosley PHONE NO : 410___ 2273124
3259 Progress Drive SE DECISION MADE: 10-NOV-21
Orlando FL 32826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Paragon 28 External Ring Fixation System
Paragon 28, Inc 510(k) NO: K212895(Traditional)
ATTN: Haylie Hertz PHONE NO : 303 7200017
14445 Grasslands Dr. SE DECISION MADE: 08-NOV-21
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Visible Patient Suite
Visible Patient, SAS 510(k) NO: K212896(Traditional)
ATTN: Emeline Degivry PHONE NO : 33 03 68668181
8 rue Gustave Adolphe HIRN SE DECISION MADE: 05-NOV-21
Strasbourg FR 67000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Hair Removal Device, model: AI01
Shenzhen Century Dongyuan Technolo510(k) NO: K212897(Traditional)
ATTN: He Wang PHONE NO : 86 137 98450554
Floor 2, Building B1, Gonghe FourtSE DECISION MADE: 04-NOV-21
Shenzhen CN 518104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K212900(Traditional)
ATTN: Shi Jufang PHONE NO : 86 755 81886293
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 05-NOV-21
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System
b-ONE ORTHO, Corp 510(k) NO: K212912(Traditional)
ATTN: Allison Gecik PHONE NO : 973 9658940
3 Wing Drive Suite #259 SE DECISION MADE: 04-NOV-21
Cedar Knolls NJ 07927 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dakota ALIF Plate System
Precision Spine, Inc. 510(k) NO: K212937(Traditional)
ATTN: Michael Dawson PHONE NO : 601 4204244
2050 Executive Dr. SE DECISION MADE: 04-NOV-21
Pearl MS 39208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I)
Guangzhou Xinbo Electronic Co., Lt510(k) NO: K212948(Traditional)
ATTN: Sammy Li PHONE NO : 86 20 66393598
No.23 Building, The Second Phase, SE DECISION MADE: 01-NOV-21
Guangzhou CN 511450 510(k) STATEMENT
DEVICE: FDR Cross (DR-XD 3000)
FUJIFILM Corporation 510(k) NO: K212956(Traditional)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 08-NOV-21
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diode laser therapy system
BEIJING UNT Technology Co., Ltd 510(k) NO: K212978(Traditional)
ATTN: Qianwen Sheng PHONE NO : 86 106 1960002
M2-1 Area, Xinggu Development ZoneSE DECISION MADE: 10-NOV-21
Beijing CN 101200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MiPACS HTML5 Web Viewer
LEAD Technologies Inc. 510(k) NO: K212984(Traditional)
ATTN: William Little PHONE NO : 704 2740243
1927 S. Tryon Street, Suite 200 SE DECISION MADE: 12-NOV-21
Charlotte NC 28203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Low-frequency Stimulator (Model: AST-645, AST-646)
Shenzhen OSTO Technology Co., Ltd.510(k) NO: K212989(Traditional)
ATTN: Li Yang PHONE NO : 86 755 29769546
No.43 Longfeng Road, Xinsheng CommSE DECISION MADE: 22-NOV-21
Shenzhen CN 518116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINK® Embrace Shoulder System - Reverse Configuration
Waldemar Link GmbH & Co. KG 510(k) NO: K212992(Traditional)
ATTN: Stefanie Fuchs PHONE NO : 49 405 3995530
Ostsraße 4-10 SE DECISION MADE: 18-NOV-21
Norderstedt DE 22844 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile PHALINX Hammertoe System
Wright Medical Technology, Inc. 510(k) NO: K212996(Traditional)
ATTN: Michael Mullins PHONE NO : 901 8674142
1023 Cherry Road SE DECISION MADE: 16-NOV-21
Memphis TN 37117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Air Compression Massager (Model LF-FT003)
Wenzhou Lingfeng Electronic Techno510(k) NO: K213000(Traditional)
ATTN: Xiaoqun Ye PHONE NO : 86 577 65436666
No.9,Jintang Road,Jielu Industry DSE DECISION MADE: 15-NOV-21
Ruian CN 325200 510(k) STATEMENT
DEVICE: IPL Hair Removal, Model: OBT-02
Glan Electronics Co., Ltd. 510(k) NO: K213041(Traditional)
ATTN: Lisa Pan PHONE NO : 0086 755 28910840
A4 Building, Huafa Industrial ZoneSE DECISION MADE: 18-NOV-21
Shenzhen CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MD-320W Ultrasound Biomicroscope
Meda Co., LTD 510(k) NO: K213070(Traditional)
ATTN: Linda Zhang PHONE NO : 86 22 83713808 812
F2C,F3D,F4C,F5, F6C, Building C2, SE DECISION MADE: 18-NOV-21
Tianjin CN 300384 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOTOTM Partial Knee & MOTO PFJ Systems Extension
Medacta International S.A. 510(k) NO: K213071(Traditional)
ATTN: Stefano Baj PHONE NO : 41 916 966060
Strada Regina SE DECISION MADE: 16-NOV-21
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector
Ivenix, Inc. 510(k) NO: K213089(Special)
ATTN: John Sokolowski PHONE NO : 978 7758030
50 High St SE DECISION MADE: 10-NOV-21
North Andover MA 01845 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Frontier Series Power Wheelchairs
Magic Mobility 510(k) NO: K213090(Traditional)
ATTN: Jill Mckechnie PHONE NO : 61 387 915600
3 International Court SE DECISION MADE: 19-NOV-21
Scoreby AU 3179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MZ Skin LightMAX Supercharged LED Mask 2.0
Mz Skin 510(k) NO: K213184(Traditional)
ATTN: Maryam Zamani PHONE NO : 44 020 34091479
110-112 Kings Road, First floor SE DECISION MADE: 23-NOV-21
London GB SW3 4TX 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Vortex Threaded Bone Marrow Recovery Needle
Arthrex Inc. 510(k) NO: K213213(Traditional)
ATTN: Nick Moore PHONE NO : 1 239 6435553 71883
1370 Creekside Boulevard SE DECISION MADE: 19-NOV-21
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xpert Wrist
Newclip Technics 510(k) NO: K213214(Traditional)
ATTN: Gregoire Larche PHONE NO : 33 2 28213712
P.A. de la Lande Saint Martin - 45SE DECISION MADE: 24-NOV-21
Haute-Goulaine FR F-44115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RCT700
RAY Co., Ltd 510(k) NO: K213226(Traditional)
ATTN: Youna Im PHONE NO : 82 31 6051000
332-7, Samsung 1-ro SE DECISION MADE: 29-NOV-21
Hwaseong-si KR 18380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HANAROSTENT Esophagus Asymmetric (CCC)
M.I.Tech Co., Ltd. 510(k) NO: K213251(Special)
ATTN: Sunyoung Jo PHONE NO : 82 10 43047429
174, Habuk 2-gil, Jinwi-myeon SE DECISION MADE: 18-NOV-21
Pyeongtaek-si KR 17706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Axialis Ophthalmic Ultrasound System
Quantel Medical 510(k) NO: K213254(Traditional)
ATTN: Bruno Pages PHONE NO :
11 Rue du Bois Joli-CS40015 SE DECISION MADE: 15-NOV-21
Cournon D'Auvergne-Cedex FR 63808510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VisionX 3.0
Durr Dental SE 510(k) NO: K213326(Special)
ATTN: Oliver Lange PHONE NO : 49 0 7142705190
Hopfigheimer Str. 17 SE DECISION MADE: 02-NOV-21
Bietigheim-Bissingen DE 74321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EnSite X EP System
Abbott Medical 510(k) NO: K213364(Special)
ATTN: Tabitha Payne PHONE NO : 612 2688558
5050 Nathan Ln N SE DECISION MADE: 11-NOV-21
Plymouth MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WHILL Model C2
Whill, Inc. 510(k) NO: K213383(Third Party - Traditional)
ATTN: Tsuyoshi Iriyama PHONE NO : 81 90 25672984
2-1-11 Higashi-Shinagawa; Harbor PSE DECISION MADE: 09-NOV-21
Shinagawa-ku JP 140-0002 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System
Conformis Inc. 510(k) NO: K213389(Special)
ATTN: Kara Johnson PHONE NO : 781 3459122
600 Technology Park Drive, 4th FloSE DECISION MADE: 10-NOV-21
Billerica MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Savvy Mask - Level 3 Surgical Face Mask
Texas MedPlast LLC 510(k) NO: K213406(Third Party - Traditional)
ATTN: Diego Olmos PHONE NO : 832 2882106
6630 Roxburgh Drive #171 SE DECISION MADE: 18-NOV-21
Houston TX 77041 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Vector® Hammertoe Correction System
Nvision Biomedical Technologies, I510(k) NO: K213421(Special)
ATTN: Diana Langham PHONE NO : 210 5453713
4590 Lockhill Selma SE DECISION MADE: 19-NOV-21
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BruxZir Esthetic
Prismatik Dentalcraft, Inc. 510(k) NO: K213425(Special)
ATTN: So Hyun Park PHONE NO : 949 8635479
2144 Michelson Drive SE DECISION MADE: 17-NOV-21
Irvine CA 96212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clarius Ultrasound Scanner
Clarius Mobile Health Corp. 510(k) NO: K213436(Special)
ATTN: Agatha Szeliga PHONE NO : 416 7071707
130-2985 Virtual Way SE DECISION MADE: 15-NOV-21
Vancouver CA V5M 4X7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DS Implants abutments provided with the EV connection
Dentsply Sirona 510(k) NO: K213449(Special)
ATTN: Courtney Clark PHONE NO : 248 8954379
221 West Philadelphia Street, SuitSE DECISION MADE: 15-NOV-21
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spartan MC 0165
Spartan Micro 510(k) NO: K213451(Traditional)
ATTN: Gary Avedovech PHONE NO : 415 6024279
3167 Skyway Ct SE DECISION MADE: 22-NOV-21
Fremont CA 94539 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm
Medtronic Powered Surgical Solutio510(k) NO: K213454(Special)
ATTN: Carrie Eddings PHONE NO : 214 3840606
4620 North Beach Street SE DECISION MADE: 23-NOV-21
Fort Worth TX 76137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ControlRad Select Model Z
ControlRad, Inc. 510(k) NO: K213455(Special)
ATTN: Chris Fair PHONE NO : 1 800 5225148
275 Scientific Drive NW #1100 SE DECISION MADE: 24-NOV-21
Norcross GA 30092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALORY
Agfa N.V. 510(k) NO: K213469(Traditional)
ATTN: Wim Govaerts PHONE NO : 32 34446246
Septestraat 27 SE DECISION MADE: 18-NOV-21
Mortsel BE B-2640 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)
H&abyz Co., Ltd. 510(k) NO: K213497(Special)
ATTN: Hyunook (David) Han PHONE NO : 82 70 46589300
IF, 2-Dong, 41-16 Cheoinseong-Ro NSE DECISION MADE: 15-NOV-21
Yongin-Si KR 17118 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 256
TOTAL WITH SUMMARIES 241
TOTAL WITH STATEMENTS 15
