510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD October 2021
DEVICE: MyoWorx TM20
MyoWorx Inc. 510(k) NO: K192746(Traditional)
ATTN: Bert Oucharek PHONE NO : 877 5036687
201-77 Westmount Road, Suite 201 SE DECISION MADE: 19-OCT-21
Guelph CA N1H 5J1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Allergen-Specific IgE Assay 12 Allergen Bundle
Hitachi Chemical Diagnostics, Inc.510(k) NO: K193613(Traditional)
ATTN: Christina Kong PHONE NO : 1 650 9615501
630 Clyde Court SE DECISION MADE: 18-OCT-21
Mountain View CA 94043 510(k) STATEMENT
DEVICE: E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS
Microport Orthopedics, Inc. 510(k) NO: K200011(Traditional)
ATTN: Kristen Russell PHONE NO : 901 4516510
5677 Airline Road SE DECISION MADE: 01-OCT-21
Arlington TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Legend Pro DMA
Pollogen, Ltd 510(k) NO: K200545(Traditional)
ATTN: Ayala Kamil PHONE NO : 972 3 5104110
6 Kaufman Street SE DECISION MADE: 21-OCT-21
Tel Aviv IL 6801298 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smart Neck Stimulator
GUANDONG SKG INTELLIGENT TECHNOLOG510(k) NO: K200558(Traditional)
ATTN: Mao Hui Zhang PHONE NO : 86 40 08220888
No.1, 7/F, Yingfeng Business CenteSE DECISION MADE: 04-OCT-21
Shunde District, Foshan City CN 5510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module
Clever Culture Systems 510(k) NO: K200839(Traditional)
ATTN: Julie Winson PHONE NO : 61 8 82271555
Seestrasse 204a SE DECISION MADE: 28-OCT-21
Bach CH CH-8806 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Piccolo Potassium Test System
Abaxis, Inc. 510(k) NO: K200865(Dual Track)
ATTN: Dennis M Bleile PHONE NO : 925 2161086
3240 Whipple Road SE DECISION MADE: 20-OCT-21
Union City CA 94587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit
GeneOhm Sciences Canada, Inc. (BD 510(k) NO: K201017(Traditional)
ATTN: Katie Edwards PHONE NO : 410 3164975
2555 Boul. Du Parc-Technologique SE DECISION MADE: 18-OCT-21
Quebec CA G1P4S5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Phoenix Digital Thermometer
Phoenix Innovative Healthcare Manu510(k) NO: K201032(Traditional)
ATTN: Ramshankar Ghosh PHONE NO : 91 22 61075524
EL-209 Shil Mahape Road ElectronicSE DECISION MADE: 29-OCT-21
Mahape, Navi Mumbai IN 400710 510(k) STATEMENT
DEVICE: The Micro Screw System, Micro Screw System Basic
Hager & Meisinger GmbH 510(k) NO: K201210(Traditional)
ATTN: Simon Göddeke PHONE NO : 0049 2131 2012292
Hansemannstrasse 10 SE DECISION MADE: 08-OCT-21
Neuss DE 41468 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack
Ortho Clinical Diagnostics 510(k) NO: K201312(Traditional)
ATTN: Leah Van De Water PHONE NO : 585 4533522
100 Indigo Creek Drive SE DECISION MADE: 04-OCT-21
Rochester NY 14626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System
i-SENS, Inc. 510(k) NO: K201394(Special)
ATTN: Joon Ho Jung PHONE NO : 82 2 9100453
43, Banpo-daero 28-gil, Seocho-gu SE DECISION MADE: 05-OCT-21
Seoul KR 06646 510(k) STATEMENT
DEVICE: Scan Monitor
Withings SA 510(k) NO: K201456(Traditional)
ATTN: Debreuil Xavier PHONE NO : 331 4146 0460
2 rue Maurice Hartmann SE DECISION MADE: 05-OCT-21
Issy-Les-Moulineaux FR 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N Latex FLC kappa, N Latex FLC lambda
Siemens Healthcare Diagnostics Pro510(k) NO: K201496(Traditional)
ATTN: Christine Perkins PHONE NO : 302 6354464
Emil-von-Behring-Str.- 76 SE DECISION MADE: 29-OCT-21
Marburg DE 35041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Child Face Mask
Shandong Shengquan New Material Co510(k) NO: K201514(Traditional)
ATTN: Xiumei Zhang PHONE NO : 86 138 64136816
Diaozhen Industrial Development ZoSE DECISION MADE: 10-OCT-21
Jinan CN 250204 510(k) STATEMENT
DEVICE: The Alma Opus System, Colibri Applicator and Tips
Alma Lasers Inc. 510(k) NO: K201520(Traditional)
ATTN: Jessica Rivera-Montejo PHONE NO : 224 3772000
485 Half Day Rd Ste 100 SE DECISION MADE: 27-OCT-21
Buffalo Grove IL 60089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICOHI
Hironic Co., Ltd. 510(k) NO: K201773(Traditional)
ATTN: Su Yeon Back PHONE NO : 82 31 5257000
19F,767,Sinsu-Ro, Suji-Gu SE DECISION MADE: 19-OCT-21
Yongin-Si KR 16827 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MultiSure GK Link Blood Glucose and Ketone Monitoring System
Apex Biotechnology Corp. 510(k) NO: K201880(Traditional)
ATTN: Lisu Liu PHONE NO : 011 886 35641952
No. 7, Li-Hsin Road V, Hsinchu SciSE DECISION MADE: 15-OCT-21
Hsinchu TW 30078 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)
Dixi Medical 510(k) NO: K201931(Traditional)
ATTN: Lucie Petegnief PHONE NO : 033 3 81889890
2A Route de Pouligney SE DECISION MADE: 02-OCT-21
Chaudefontaine FR 25640 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgimatix Absorbable Fixation System
Surgimatix, Inc. 510(k) NO: K201934(Traditional)
ATTN: Dorene Markwiese PHONE NO : 847 4002546
1539 Jarvis Ave SE DECISION MADE: 01-OCT-21
Elk Grove Village IL 60007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B4C System
Braincare Desenvolvimento e Inovac510(k) NO: K201989(Traditional)
ATTN: Arnaldo Betta PHONE NO : 55 11 940114055
Avenida Bruno Ruggiero Filho, 971 SE DECISION MADE: 08-OCT-21
Sao Carlos BR 13562-420 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TrusFIL Universal Composite Restorative
Rizhao HuGe Biomaterials Company, 510(k) NO: K202063(Traditional)
ATTN: Maggie Zheng PHONE NO : 86 633 2277268
No.2 North Zhaoyang Road, DistrictSE DECISION MADE: 06-OCT-21
Rizhao City CN 276800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P300 Attachment
Nakanishi Inc. 510(k) NO: K202120(Traditional)
ATTN: Masaaki Kikuchi PHONE NO : 81 289 647277
700 Shimohinata SE DECISION MADE: 22-OCT-21
Kanuma JP 322-8666 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aqueduct 200 Cervical Dilation Balloon Catheter
GTIMD LLC 510(k) NO: K202433(Traditional)
ATTN: Eran Levit PHONE NO : 603 8093089
6 Columbia Drive SE DECISION MADE: 15-OCT-21
Amherst NH 03031 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFS Medical Sterile Single-Use Access Port System
AFS Medical Co. Ltd. 510(k) NO: K202688(Traditional)
ATTN: Min Ah Kim PHONE NO : 82 10 53582661
Na-131, Ezen Mecha Zone, 117 HwangSE DECISION MADE: 14-OCT-21
Gyeonggi-do KR 10048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Brainance MD
Advantis Medical Imaging Single Me510(k) NO: K202808(Traditional)
ATTN: Paris Ziogkas PHONE NO : 30 210 9329558
Eleftheriou Venizelou Avenue 99 NeSE DECISION MADE: 14-OCT-21
Athens GR 17123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EYE-SYNC
SyncThink, Inc. 510(k) NO: K202927(Traditional)
ATTN: Dan Beeler PHONE NO : 650 7271819
2172 Staunton Court SE DECISION MADE: 02-OCT-21
Palo Alto CA 94306 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)
Winner Medical Co., Ltd. 510(k) NO: K202982(Traditional)
ATTN: Haoyuan He PHONE NO : 86 755 28138888
Winner Industrial Park, No. 660 BuSE DECISION MADE: 19-OCT-21
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vydence Zye and Vydence One
Vydence Medical Industria E Comerc510(k) NO: K202998(Traditional)
ATTN: Kathy Maynor PHONE NO : 352 5863113
Rua Aldo Germano Klein, 359 CEP: 1SE DECISION MADE: 26-OCT-21
CEAT - Sao Carlos/SP Sao Paulo BR510(k) STATEMENT
DEVICE: SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System
Bonebridge AG 510(k) NO: K203002(Traditional)
ATTN: Christof Gerber PHONE NO : 41 79 4587276
Bahnhofstrasse 11 SE DECISION MADE: 05-OCT-21
Zug CH 6300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cala Trio
Cala Health, Inc. 510(k) NO: K203288(Traditional)
ATTN: Amanda Johnston PHONE NO : 763 6396951
875 Mahler Road, Suite 168 SE DECISION MADE: 05-OCT-21
Burlingame CA 94010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V.A.C.ULTA Negative Pressure Wound Therapy System
KCI, a part of 3M Health Care Busi510(k) NO: K203316(Traditional)
ATTN: Margaret Marsh PHONE NO : 210 2556481
6203 Farinon Drive SE DECISION MADE: 27-OCT-21
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer (Model K9)
Kangzhan Communication Electronics510(k) NO: K203497(Traditional)
ATTN: Su Baotong PHONE NO : 86 755 88377262
No. 1008, songbai road, yangguanSE DECISION MADE: 08-OCT-21
Shenzhen CN 518055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical 3D Mask
Inno Lifecare 510(k) NO: K203565(Traditional)
ATTN: Jae Ho Lee PHONE NO : 604 7772824
1615 Kebet Way SE DECISION MADE: 19-OCT-21
Port Coquitlam CA V3C 5W9 510(k) STATEMENT
DEVICE: Clear Aligner
Wuxi EA Medical Instruments Techno510(k) NO: K203688(Traditional)
ATTN: Yan He PHONE NO : 86 0510 83591717
No. 1619, Huishan Avenue, Huishan SE DECISION MADE: 08-OCT-21
Wuxi CN 214174 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann CARES P-Series CAD/CAM System
Institut Straumann AG 510(k) NO: K203750(Traditional)
ATTN: Gordon Dodds PHONE NO : 49 89 309075291
Peter Merien-Weg 12 SE DECISION MADE: 09-OCT-21
Basel CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Multi-unit Abutment, Multi-unit Angled Abutment
MegaGen Implant Co. Ltd. 510(k) NO: K203808(Traditional)
ATTN: You Jung Kim PHONE NO : 82 53 2222828
45, Secheon-ro, 7-gil SE DECISION MADE: 20-OCT-21
Daegu KR 42921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STELLA BIO
EGZOTech Sp. z o. o. 510(k) NO: K210002(Traditional)
ATTN: Michal Mikulski PHONE NO : 48 32 7504945
Romualda Traugutta 6H SE DECISION MADE: 01-OCT-21
Gliwice PL 44-100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeoMatriX Wound Matrix
NeXtGen Biologics, Inc. 510(k) NO: K210024(Traditional)
ATTN: Jonelle L. Toothman PHONE NO : 904 5993264
13709 Progress Blvd Box11 SE DECISION MADE: 07-OCT-21
Alachua FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Video Endoscopy System, 3D Video Endoscopy System
Surgnova Healthcare Technologies (510(k) NO: K210116(Traditional)
ATTN: Ma Guofang PHONE NO : 86 10 64116115
No.1 Xinxing Yilu Road, Emerging ISE DECISION MADE: 13-OCT-21
Cixi CN 315300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synergy Gold (SG) Portable (Models MM011450 and MM011460)
Uzinmedicare Co. 510(k) NO: K210124(Special)
ATTN: Nathan Ahn PHONE NO : 82 31 3751076
56, Dongtansandan 5-Gil,Dongtan-MySE DECISION MADE: 19-OCT-21
Hwaseong-Si KR 18487 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRA Wound Matrix (Macro-Channels)
Integra LifeSciences Corporation 510(k) NO: K210128(Traditional)
ATTN: Saakshi Arora-Tice PHONE NO : 609 3257374
1100 Campus Road SE DECISION MADE: 08-OCT-21
Princeton NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09
Edan Instruments, Inc. 510(k) NO: K210139(Traditional)
ATTN: Ying Dai PHONE NO : 86 152 21873029
#15 Jinhui Road, Jinsha Community,SE DECISION MADE: 01-OCT-21
Shenzhen CN 518122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: electrocardiograph: SE-1202
Edan Instruments, Inc 510(k) NO: K210140(Traditional)
ATTN: Ying Dai PHONE NO : 86 755 26856469
#15 Jinhui Road, Jinsha Community,SE DECISION MADE: 01-OCT-21
Shenzhen CN 518122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTAX Medical Video Upper GI Scopes EG17-J10
PENTAX of America, Inc. 510(k) NO: K210177(Traditional)
ATTN: William Goeller PHONE NO : 201 5712300 2318
3 Paragon Drive SE DECISION MADE: 20-OCT-21
Montvale NJ 07645-1782 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Capsule Vitals Plus Patient Monitoring System
Capsule Technologie SAS 510(k) NO: K210204(Traditional)
ATTN: Peter Kelley PHONE NO : 978___ 6974364
76 - 78 Avenue de France SE DECISION MADE: 19-OCT-21
Paris FR 75013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PuraStat-OM
3-D Matrix, Inc. 510(k) NO: K210211(Traditional)
ATTN: Lisa Spirio PHONE NO : 617 8756204
1234 Chestnut St., Suite 205 SE DECISION MADE: 08-OCT-21
Newton MA 02464 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vittra APS Unique
Dentscare Ltda 510(k) NO: K210231(Traditional)
ATTN: Roberta Uyara PHONE NO : 55 47 34416131
Av. Edgar Nelson Meister, 474 SE DECISION MADE: 14-OCT-21
Joinville BR 89219-501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Best Glove-Nitrile Powder Free Examination Glove
Bestsafe Glove CO., LTD 510(k) NO: K210249(Traditional)
ATTN: Piyawat Chirasakulkarun PHONE NO : 66 038 949880
52/43 Wat Khot Hin-Khao Phai Road,SE DECISION MADE: 25-OCT-21
Muang Rayong TH 21000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Endoscope Image Processing System
Jiangsu Jiyuan Medical Technology 510(k) NO: K210270(Traditional)
ATTN: Zong Yunfeng PHONE NO : 0086 523 86990001
No.48 CECEP (Taizhou) EnvironmentaSE DECISION MADE: 01-OCT-21
Jiangsu CN 225300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Enbio S
Enbio Group AG 510(k) NO: K210279(Traditional)
ATTN: Lukasz Rogowski PHONE NO : 48 60 5058629
Eichengasse 3 SE DECISION MADE: 29-OCT-21
Oensingen CH CH-4702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)
bioMerieux, Inc 510(k) NO: K210287(Traditional)
ATTN: Cherece L Jones PHONE NO : 314 7318684
595 Anglum Rd. SE DECISION MADE: 28-OCT-21
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit
Nuance Medical, LLC 510(k) NO: K210310(Traditional)
ATTN: Neal Hartman PHONE NO : 760 5859548
5931 Sea Lion Place, Suite 113 SE DECISION MADE: 22-OCT-21
Carlsbad CA 82010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XO Cross Support Catheter
Transit Scientific, LLC 510(k) NO: K210322(Traditional)
ATTN: Jenifer Arnold PHONE NO : 412 4963609
2757 South 300 West, Suite E SE DECISION MADE: 21-OCT-21
Salt Lake City UT 84115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Surgical Mask
Weihai Dishang Medical Technology 510(k) NO: K210348(Traditional)
ATTN: Ricky Xia PHONE NO : 86 186 63126766
Room 406-409, Block C, No.213 TorcSE DECISION MADE: 24-OCT-21
Weihai CN 264209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Superior Hair Remover
Guangzhou Haoxingwan Technology Co510(k) NO: K210376(Traditional)
ATTN: Chun Tao PHONE NO : 86 189 29315726
Room 718, No.9, Linhe West Road, TSE DECISION MADE: 07-OCT-21
Guangzhou CN 510000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bipolar Coagulation Foreceps
Hangzhou AGS MedTech Co., Ltd. 510(k) NO: K210406(Traditional)
ATTN: Yanping Fu PHONE NO : 86 571 87671223
Building 5, Building 6, No. 597 KaSE DECISION MADE: 05-OCT-21
Hangzhou CN 311106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantum Anterior Cervical Plate
Nvision Biomedical Technologies, I510(k) NO: K210424(Traditional)
ATTN: Diana Langham PHONE NO : 210 5453713
4590 Lockhill Selma SE DECISION MADE: 22-OCT-21
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultrasonic Surgical & Electrosurgical Generator
Surgnova Healthcare Technologies (510(k) NO: K210488(Traditional)
ATTN: Guofang Ma PHONE NO : 86 10 64116115
No.1 XinXing Yilu Road, Emerging ISE DECISION MADE: 25-OCT-21
Cixi CN 315301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ChM 4.5mm Cortical screws
ChM sp. z o.o. 510(k) NO: K210490(Traditional)
ATTN: Andrzej Sobolewski PHONE NO : 48 85 8686100
Lewickie 3b SE DECISION MADE: 05-OCT-21
Juchnowiec Koscielny PL 16-061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InTray GC
Biomed Diagnostics Incorporated 510(k) NO: K210511(Traditional)
ATTN: John F Antiabong PHONE NO : 541 8303000 1040
1388 Antelope Road SE DECISION MADE: 20-OCT-21
White City OR 97503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HRSpheres Narrow-Size Embolic Microspheres
Suzhou Hengrui Hongyuan Medical Co510(k) NO: K210562(Traditional)
ATTN: Qianqian Zhang PHONE NO : 86 512 68356665
Building B9 Unit 201, No. 218 XingSE DECISION MADE: 01-OCT-21
Suzhou CN 215123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arm Blood Pressure Monitor
Alicn Medical Shenzhen,Inc 510(k) NO: K210563(Traditional)
ATTN: Fang Meisong PHONE NO :
Room 410, Building A, 3rd Sub-parkSE DECISION MADE: 15-OCT-21
Shenzhen CN 518118 510(k) STATEMENT
DEVICE: TraumaGuard Intra-abdominal Pressure Sensing System
Sentinel Medical Technologies, LLC510(k) NO: K210570(Traditional)
ATTN: Robert Mueller PHONE NO : 904 7049787
50 N Laura St, Suite 2500 SE DECISION MADE: 29-OCT-21
Jacksonville FL 32202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Black Nitrile Powder Free Patient Examination Glove, Non Sterile
Onetexx SDN BHD 510(k) NO: K210588(Traditional)
ATTN: Freddy Low PHONE NO : 605 8070666
No 73-86, Jalan Logam 5, PerindustSE DECISION MADE: 31-OCT-21
Kamunting MY 34600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series
Chongqing Jinshan Science & Techno510(k) NO: K210618(Traditional)
ATTN: Qing Xu PHONE NO : 0086 023 86098111
Yubei District No.18 Ningshang AveSE DECISION MADE: 20-OCT-21
Chongqing CN 400000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single-Use Medical Face Mask
Jiangxi Hongda Medical Equipment G510(k) NO: K210622(Traditional)
ATTN: Xiaohua Yang PHONE NO : 86 791 85660368
39 South Shengli Road, Jinxian CouSE DECISION MADE: 08-OCT-21
Nanchang CN 331700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Contour ProtegeAI
MIM Software Inc. 510(k) NO: K210632(Traditional)
ATTN: Lynn Hanigan PHONE NO : 216 4550600
25800 Science Park Drive - Suite 1SE DECISION MADE: 20-OCT-21
Cleveland OH 44122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Gloves
Niujian Technology Co., Ltd. 510(k) NO: K210706(Traditional)
ATTN: Xiuqiang Zhou PHONE NO : 86 182 10518920
Room 401 Building 1, Anfangcheng NSE DECISION MADE: 19-OCT-21
Shaoxing CN 312000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EQ-PEX
Meta Systems Co., Ltd. 510(k) NO: K210789(Traditional)
ATTN: Hyejin Park PHONE NO : 82 31 7317377
#1214-18, Sicox tower 12F, 484, DuSE DECISION MADE: 20-OCT-21
Seongnam-si KR 13229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlightPlan for Liver
GE Medical Systems SCS 510(k) NO: K210807(Traditional)
ATTN: Ning Wen PHONE NO : 33 6 20424417
283, rue de la Miniere SE DECISION MADE: 22-OCT-21
Buc FR 78530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Surgical Mask
Sichuan Pharmaceutical. Inc. 510(k) NO: K210813(Traditional)
ATTN: Yunrui Zhang PHONE NO : 86 136 78040510
Sichuan Pharmaceutical. Inc. No. 1SE DECISION MADE: 08-OCT-21
Sichuan CN 611731 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Mask (Model: YYKZ-01)
Jiaxing Amazing Travel-Ware CO.,LT510(k) NO: K210845(Traditional)
ATTN: Jiang Tao PHONE NO : 86 139 57376195
No.2196 Honggao Road, Xiuzhou InduSE DECISION MADE: 12-OCT-21
Jiaxing CN 314015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20
Oxoid Limited (part of Thermo Fish510(k) NO: K210873(Traditional)
ATTN: Philip Brame PHONE NO : 44 0 7884332059
Wade Road SE DECISION MADE: 27-OCT-21
Basingstoke GB RG24 8PW 510(k) STATEMENT
DEVICE: IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4
Philips Medizin Systeme Boeblingen510(k) NO: K210906(Traditional)
ATTN: Monica da Silva PHONE NO : 49 151 40903561
Hewlett-Packard-Strasse 2 SE DECISION MADE: 07-OCT-21
Boeblingen DE 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WOLF Thrombectomy System, 14F
DeVoro Medical, Inc. 510(k) NO: K210911(Traditional)
ATTN: Michael P Wallace PHONE NO : 925 7849985
46724 Lakeview Blvd SE DECISION MADE: 19-OCT-21
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTAX Medical Video Bronchoscope EB11-J10
PENTAX of America, Inc. 510(k) NO: K210928(Traditional)
ATTN: William Goeller PHONE NO : 201 5712300 2318
3 Paragon Drive SE DECISION MADE: 21-OCT-21
Montvale NJ 07645-1782 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SwiftMR
AIRS Medical Inc. 510(k) NO: K210999(Traditional)
ATTN: Jihyeon Seo PHONE NO : 82 10 34462636
8-9F, CS Tower, 1838, NambusunhwanSE DECISION MADE: 14-OCT-21
Seoul KR 08788 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Monopolar Laparoscopic Tips and Reusable Handles
Dannik LLC 510(k) NO: K211019(Traditional)
ATTN: Olga Haberland PHONE NO : 407 9271743
941 W. Morse Blvd Suite 100 SE DECISION MADE: 28-OCT-21
Winter Park FL 32789 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U9000 Plus Ultrafilter
Baxter Healthcare Corporation 510(k) NO: K211035(Traditional)
ATTN: Carina Pforr PHONE NO : 33 671 686357
25212 W. Illinois Route 120 SE DECISION MADE: 19-OCT-21
Round Lake IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: nView s1 with nav option
nView medical 510(k) NO: K211064(Traditional)
ATTN: Lisa Last PHONE NO : 617 2837053
2681 E Parleys Way STE 107 SE DECISION MADE: 29-OCT-21
Salt Lake City UT 84109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EndSnorZ Sleep Appliance
Prismatik Dentalcraft, Inc. 510(k) NO: K211069(Traditional)
ATTN: Herbert Schoenhoefer PHONE NO : 949 4402632
2144 Michelson Drive SE DECISION MADE: 26-OCT-21
Irvine CA 96212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Gown
Wujiang Tutaike Textiles & Finishi510(k) NO: K211077(Traditional)
ATTN: Zhang Yanwen PHONE NO : 86 151 62512333
No.1599, South 3rd Ring Road, ShenSE DECISION MADE: 07-OCT-21
Suzhou CN 317605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope
Shanghai Caremate Medical Device C510(k) NO: K211084(Traditional)
ATTN: Mark Chu PHONE NO : 86 21 57341588
Building 4, No. 281, Hong An Road,SE DECISION MADE: 19-OCT-21
Shanghai CN 201503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Deka Tiac II
EL.EN Electronic Engineering Spa 510(k) NO: K211091(Traditional)
ATTN: Paolo Peruzzi PHONE NO : 39 055 8826807
VIA Baldanzese 17 SE DECISION MADE: 15-OCT-21
Calenzano IT 50041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit
Intera Oncology, Inc. 510(k) NO: K211121(Traditional)
ATTN: Michael Gaisford PHONE NO : 617 3314503
65 Williams Street, Suite 200 SE DECISION MADE: 14-OCT-21
Wellesley MA 02481 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALGO 7i
Path Medical GmbH 510(k) NO: K211147(Traditional)
ATTN: Ing. Johann Oswald PHONE NO : 49 89 80076502
Landsberger Strasse 65 SE DECISION MADE: 14-OCT-21
Germering DE 82110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EndoTool SubQ 2.1
Monarch Medical Technologies, LLC 510(k) NO: K211160(Traditional)
ATTN: Ann Marie Gaitan PHONE NO : 704 5620777
4400 Stuart Andrew Blvd., Suite N SE DECISION MADE: 28-OCT-21
Charlotte NC 28217 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Critical Care Suite with Endotracheal Tube Positing AI algorithm
GE Medical Systems, LLC 510(k) NO: K211161(Traditional)
ATTN: Chris Paulik PHONE NO : 262 8945415
3000 N. Grandview Blvd SE DECISION MADE: 29-OCT-21
Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single Use Irrigation bipolar cable
Modern Medical Equipment Manufactu510(k) NO: K211170(Traditional)
ATTN: Jerry Cheung PHONE NO : 852 2 4209068
Flat A, 11/F., Mai Wah Ind. Bldg.,SE DECISION MADE: 19-OCT-21
Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories
GE Healthcare Finland Oy 510(k) NO: K211171(Traditional)
ATTN: Joel Kent PHONE NO : 617 8510943
Kuortaneenkatu 2 SE DECISION MADE: 21-OCT-21
Helsinki FI FI-00510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Erchonia XLR8
Erchonia Corporation 510(k) NO: K211186(Traditional)
ATTN: Steven Shanks PHONE NO : 888 2420571
650 Atlantis Road SE DECISION MADE: 22-OCT-21
Melbourne FL 32904 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile syringes for single use with/without needle
Azur Medical Company Inc. 510(k) NO: K211211(Traditional)
ATTN: Di Zhao PHONE NO : 928 5922380
6710 Everglades Dr. SE DECISION MADE: 07-OCT-21
Richmond VA 23838 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Hypodermic Needles for Single Use
Azur Medical Company Inc. 510(k) NO: K211214(Traditional)
ATTN: Di Zhao PHONE NO : 928 5922380
6710 Everglades Dr. SE DECISION MADE: 14-OCT-21
Richmond VA 23838 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Porous Patella and Porous Tibia Baseplate
Smith & Nephew, Inc. 510(k) NO: K211221(Traditional)
ATTN: Brad Sheals PHONE NO : 901 2887141
7135 Goodlett Farms Parkway SE DECISION MADE: 01-OCT-21
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RM4 Control Unit
Institut Georges Lopez 510(k) NO: K211224(Traditional)
ATTN: Matthieu Prouteau PHONE NO : 33 437 646332
Parc Tertiaire Du Bois Dieu, 1 AllSE DECISION MADE: 15-OCT-21
Lissieu FR 69380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNI-CERA
Aon Co., Ltd 510(k) NO: K211308(Traditional)
ATTN: Julie Choi PHONE NO : 82 31 6895012
A-Dong 2508,2201, 17, Gosan-ro 148SE DECISION MADE: 04-OCT-21
Gunpo KR 15850 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D Camera Controller
Richard Wolf Medical Instruments C510(k) NO: K211332(Traditional)
ATTN: Michael Loiterman PHONE NO : 847 9131113
353 Corporate Woods Parkway SE DECISION MADE: 01-OCT-21
Vernon Hills IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Hair Remover, Model: G993, G996, G998 and G885
Shenzhen Mywin Technology Co., Ltd510(k) NO: K211368(Traditional)
ATTN: Meiyun Liu PHONE NO : 86 189 02842323
2nd Floor, Building B, New Age gonSE DECISION MADE: 04-OCT-21
Shenzhen CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Proclean - Nitrile Powder Free Examination Gloves
Dr.Boo Company Limited 510(k) NO: K211374(Traditional)
ATTN: Darunee Varabuntoonvit PHONE NO : 66 86 3419085
662/1-4 Moo 3 Phanomsarakarm-SattaSE DECISION MADE: 13-OCT-21
Sriracha TH 20110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HIVOX OTC Electrical Stimulator, FT610-B
Hivox Biotek Inc. 510(k) NO: K211403(Traditional)
ATTN: Ruby Lu PHONE NO : 886 2 85112668 510
SF., No. 123, Xingde Road, SanchonSE DECISION MADE: 15-OCT-21
New Taipei City TW 241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Prelude Guide Sheath
Merit Medical Systems, Inc. 510(k) NO: K211405(Traditional)
ATTN: David Thomas PHONE NO : 801 3164956
1600 West Merit Parkway SE DECISION MADE: 04-OCT-21
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OASIS MRI System
Hitachi Healthcare Americas 510(k) NO: K211406(Traditional)
ATTN: Aaron Pierce PHONE NO : 330 4251313
1959 Summit Commerce Park SE DECISION MADE: 07-OCT-21
Twinsburg OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Belun Ring BLR-100X
Belun Technology Company Limited 510(k) NO: K211407(Traditional)
ATTN: Leung Lap Wai Lydia PHONE NO : 852 37065640
Unit 218, 2/F, Core Building 2, NoSE DECISION MADE: 21-OCT-21
Sha Tin CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GR Splint Resin System
Pro3dure Medical GmbH 510(k) NO: K211415(Traditional)
ATTN: Frank Gischer PHONE NO : 49 02374 92005014
Am Burgberg 13 SE DECISION MADE: 21-OCT-21
Iserlohn DE 58642 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Private Stock Labs Surgical Face Mask
J.K. Private Stock Inc. 510(k) NO: K211425(Traditional)
ATTN: Jonathan Koon PHONE NO : 718 8863163
68-05 Fresh Meadow Lane SE DECISION MADE: 04-OCT-21
Fresh Meadows NY 11365 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIPLAN - CT Planning Software for Total Hip Replacement
Naviswiss AG 510(k) NO: K211429(Traditional)
ATTN: Jan Stifter PHONE NO : 41 61 7618537
Stahlrain 2 SE DECISION MADE: 05-OCT-21
Brugg CH 5200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Family of Venus RF Systems - Venus Freedom
Venus Concept USA Inc. 510(k) NO: K211461(Traditional)
ATTN: Yoni Iger PHONE NO : 972 54 9599215
1880 N Commerce Pkwy, Suite 2 SE DECISION MADE: 14-OCT-21
Weston FL 33326 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vital Signs Monitors
Shenzhen Mindray Bio-Medical Elect510(k) NO: K211475(Traditional)
ATTN: Yanhong Bai PHONE NO : 86 755 81887048
Mindray Building, Keji 12th Road SSE DECISION MADE: 05-OCT-21
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Steinmann Pins and Kirschner Wires
Stryker GmbH 510(k) NO: K211508(Traditional)
ATTN: Keith Neligan PHONE NO : 00 353 877995645
325 Corporate Drive SE DECISION MADE: 05-OCT-21
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Gown
Hubei Wanli Protective Products Co510(k) NO: K211509(Traditional)
ATTN: Andy Wen PHONE NO : 0086 185 51260980
Tangwan Street, Xiliuhe Town SE DECISION MADE: 24-OCT-21
XianTao CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Portable Scalp Cooling System
Cooler Heads Care, Inc. 510(k) NO: K211526(Traditional)
ATTN: Kate Dilligan PHONE NO : 858 3619355
2801 B Street, #209 SE DECISION MADE: 21-OCT-21
San Diego CA 92102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QuickAligners
Oral Image, Inc 510(k) NO: K211537(Traditional)
ATTN: Vinh Lam PHONE NO : 1 855 3525526
6440 Lusk Blvd, Suite D101 SE DECISION MADE: 26-OCT-21
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe
Anhui Hongyu Wuzhou Medical Manufa510(k) NO: K211555(Traditional)
ATTN: Bingyi Xiang PHONE NO : 86 556 5129666
No. 2 Guanyin Road, Economic DevelSE DECISION MADE: 18-OCT-21
Anqing City CN 246400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile High-pressure Angiographic Syringes for Single-use
Shenzhen Boon Medical Supply Co., 510(k) NO: K211564(Traditional)
ATTN: Baihan Feng PHONE NO : 86 755 28638515
No.18 Jirong Road, Shenkeng, HenggSE DECISION MADE: 19-OCT-21
Shenzhen CN 518173 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Examination Gloves (Powder free, Blue)
Leping Shengde Medical Technology 510(k) NO: K211581(Traditional)
ATTN: Sheng Jianchao PHONE NO : 86 189 25274085
No.17, Yubao Village, Lingang VillSE DECISION MADE: 28-OCT-21
Jingdezhen CN 333300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOQTEQ Proximal Humerus Plate 3.5 System
aap Implantate AG 510(k) NO: K211582(Traditional)
ATTN: Agnieszka Mierzejewska PHONE NO : 49 30 750190
Lorenzweg 5 SE DECISION MADE: 18-OCT-21
Berlin DE 12099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
Shanxi Hongjin Plastic Technology 510(k) NO: K211604(Traditional)
ATTN: Wu Zhigang PHONE NO : 86 311 66179653
Coal Bed Gas Industrial Zone, Qu'eSE DECISION MADE: 27-OCT-21
Lifen CN 042300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)
Careplus (M) SDN BHD 510(k) NO: K211621(Traditional)
ATTN: Lim Kwee Shyan PHONE NO : 606 6772781
Lot 120 & 121, Jalan Senawang 3, SSE DECISION MADE: 06-OCT-21
Seremban MY 70450 510(k) STATEMENT
DEVICE: MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL
Liofilchem S. R. L. 510(k) NO: K211672(Traditional)
ATTN: Fabio Brocco PHONE NO : 39 085 8930745
Via Scozia zona ind.le SE DECISION MADE: 20-OCT-21
Roseto degli Abruzzi IT 64026 510(k) STATEMENT
DEVICE: Streamline Surgical System
New World Medical, Inc. 510(k) NO: K211680(Traditional)
ATTN: Victor Arellano PHONE NO : 909 4664304 118
10763 Edison Court SE DECISION MADE: 08-OCT-21
Rancho Cucamonga CA 91730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vinyl Examination Gloves(Yellow)
Liuping Trading CO.,LTD. 510(k) NO: K211698(Traditional)
ATTN: Jing Li PHONE NO : 86 186 53343268
Xingtong Town, Linyi County SE DECISION MADE: 24-OCT-21
Dezhou CN 251500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Esophageal TTS Stent
Taewoong Medical Co., Ltd 510(k) NO: K211706(Traditional)
ATTN: Jennifer Moyer PHONE NO : 1 571 2795811
14 Gojeong-ro, Wolgot-myeon SE DECISION MADE: 08-OCT-21
Gimpo-si KR 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZinRom Nitrile examination gloves
Changzhou Xingrong Medical Technol510(k) NO: K211719(Traditional)
ATTN: Ray Lei PHONE NO : 86 137 75218805
No. 528, Daqiaotou, Chaoyang CunweSE DECISION MADE: 06-OCT-21
Changzhou CN 213118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile hypodermic syringes for single use
Jiangsu Kangyou Medical Instrument510(k) NO: K211728(Traditional)
ATTN: Xiang Yao PHONE NO : 138 13652889
Tangzhuang Yaotang Town SE DECISION MADE: 05-OCT-21
Jintan CN 213223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CO2 Laser Machine, Model: BW-203B
Zhengzhou Bestview St Co., Ltd. 510(k) NO: K211735(Traditional)
ATTN: Yangchun Jia PHONE NO : 86 158 03801506
Room 2004, 20F, Lande Center, HuaySE DECISION MADE: 22-OCT-21
Zhengzhou CN 450000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RecoveryAir PRO
Theragun, Inc. 510(k) NO: K211745(Traditional)
ATTN: Jaime Sanchez PHONE NO : 310 5708341
6100 Wilshire Blvd, Suite 200 SE DECISION MADE: 04-OCT-21
Los Angeles CA 90048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Syringe With Safety Needle
Jiangxi Hongda Medical Equipment G510(k) NO: K211753(Traditional)
ATTN: Xiaohua Yang PHONE NO : 86 791 85628918
No. 39 South Shengli Road SE DECISION MADE: 14-OCT-21
Nanchang CN 331700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cohitech Organic Cotton Non-Applicator Cottonlock Tampons
Cotton High Tech S.L. 510(k) NO: K211775(Traditional)
ATTN: Míriam Carrero PHONE NO : 34 93 8391628
Colònia La Rabeia, S/N SE DECISION MADE: 22-OCT-21
Balsareny ES 08660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EzDent-i/ E2/ Prora View/ Smart M Viewer
Ewoosoft Co., Ltd. 510(k) NO: K211795(Traditional)
ATTN: Young Seok Kim PHONE NO : 82 31 80156172
801-ho, Vatechnetworks Bldg., 13, SE DECISION MADE: 04-OCT-21
Hwaseong-si KR 18449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRACKER Plus Kyphoplasty System
GS Medical Co. Ltd. 510(k) NO: K211797(Traditional)
ATTN: Sam Camp PHONE NO : 352 327 4641
90, Osongsaengmyeong 4-ro Osong-euSE DECISION MADE: 28-OCT-21
Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPRINT PNS System
SPR Therapeutics, Inc. 510(k) NO: K211801(Traditional)
ATTN: Kathryn Stager PHONE NO : 216 3789067
22901 Millcreek Blvd. Suite 110 SE DECISION MADE: 13-OCT-21
Cleveland OH 44122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sapphire NC 24
OrbusNeich Medical (Shenzhen) Co.,510(k) NO: K211807(Traditional)
ATTN: Daniel Zhang PHONE NO : 86 755 83580181
No.1 Jinkui Road, Futian Free TradSE DECISION MADE: 14-OCT-21
Shenzhen CN 518038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Gown
Wuhan Dymex Healthcare Co., Ltd. 510(k) NO: K211809(Traditional)
ATTN: Lynn Wu PHONE NO : 86 27 85827780
Room 1701, Unit 2, Building 5, JinSE DECISION MADE: 18-OCT-21
Wuhan CN 430000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DiLumen C2 and Tool Mount
Lumendi, LLC 510(k) NO: K211819(Traditional)
ATTN: Dennis Daniels PHONE NO : 203 4632669
253 Post Road West SE DECISION MADE: 22-OCT-21
Westport CT 06880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask
Hubei YI-YA PROTECTIVE PRODUCTS CO510(k) NO: K211899(Traditional)
ATTN: Moody Shaw PHONE NO : 86 187 71150610
Miandong Road, Hefeng Village, XilSE DECISION MADE: 04-OCT-21
Xiantao CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UltraCal XS
Ultradent Products, Inc. 510(k) NO: K211905(Traditional)
ATTN: Adam Black PHONE NO : 801 5534425
505 West Ultradent Drive (10200 SoSE DECISION MADE: 13-OCT-21
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Patient Examination Gloves
Yingxiang Glove Products Co., Ltd.510(k) NO: K211914(Traditional)
ATTN: Liu Peng PHONE NO : 86 159 82348869
No. 1, Zhendong Industrial Park, HSE DECISION MADE: 14-OCT-21
Huanggang CN 435400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S.I.N. Dental Implant System
S.I.N. - Sistema de Implante Nacio510(k) NO: K211921(Traditional)
ATTN: Denise Domiciano PHONE NO : 55 11 21693000 3236
Avenida Vereador Abel Ferreira, 11SE DECISION MADE: 20-OCT-21
São Paulo BR 03340-000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile examination gloves
Fitone Latex Products Co., Ltd. Gu510(k) NO: K211927(Traditional)
ATTN: Christine Ou PHONE NO : 0 759 7905808
No.5 Huitong road, Lingbei IndustrSE DECISION MADE: 12-OCT-21
Zhanjiang CN 524338 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Diode Laser Systems
Wuhan Dimed Laser Technology Co., 510(k) NO: K211977(Traditional)
ATTN: Qiao Cheng PHONE NO : 0086 158 27482600
Room 311, 313, 315, Hubei Guozhi PSE DECISION MADE: 26-OCT-21
Wuhan CN 430223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATEC Alignment App
Alphatec Spine, Inc. 510(k) NO: K211987(Traditional)
ATTN: David Gramse PHONE NO : 760 4946711
1950 Camina Vida Roble SE DECISION MADE: 29-OCT-21
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ortho MI System
Osteonic Co., Ltd. 510(k) NO: K211992(Traditional)
ATTN: Lee Jisun PHONE NO : 82 2 69028411
303Ho, 405Ho, 505-2Ho, 505-3Ho, 90SE DECISION MADE: 15-OCT-21
Guro-gu KR 08381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Nitrile Examination Gloves
Jiangxi Ronglai Medical Technology510(k) NO: K212014(Traditional)
ATTN: Hailin Shu PHONE NO : 86 138 70683591
No.666 Baixu Street, Baixu town, jSE DECISION MADE: 13-OCT-21
Nanchang CN 331701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs
Jiangsu Yanfang Medical Technology510(k) NO: K212036(Traditional)
ATTN: Kaijian Wei PHONE NO : 86 138 12992152
No.16, Kaiyuan Road, Changjing TowSE DECISION MADE: 05-OCT-21
Wuxi CN 214411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EnSite X EP System
Abbott 510(k) NO: K212061(Traditional)
ATTN: Jamie Glaser PHONE NO : 651 7565091
One St. Jude Medical Drive SE DECISION MADE: 22-OCT-21
St. Paul MN 55117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger
Remington Medical, Inc. 510(k) NO: K212065(Traditional)
ATTN: Caitlin Senter PHONE NO : 770 8888520
6830 Meadowridge Court SE DECISION MADE: 07-OCT-21
Alpharetta GA 30005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Examination Gloves
Guangdong Gymda Medical Technology510(k) NO: K212078(Traditional)
ATTN: Olivia Chen PHONE NO : 86 20 37738661
No.13, Quan'an Third Road, Phase 2SE DECISION MADE: 08-OCT-21
Nanxiong CN 512400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Picore
Bio-Med USA Inc 510(k) NO: K212082(Special)
ATTN: Young Chi PHONE NO : 973 2785222
27 New England Dr SE DECISION MADE: 06-OCT-21
Ramsey NJ 07446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elekta Unity
Elekta Solutions AB 510(k) NO: K212114(Traditional)
ATTN: Melinda Smith PHONE NO : 678 2317791
Kungstensgatan 18 Box 7593 SE DECISION MADE: 01-OCT-21
Stockholm SE SE10393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VBrain-OAR
Vysioneer Inc. 510(k) NO: K212116(Traditional)
ATTN: Vicki Lin PHONE NO : 609___ 8658659
33 Rogers. St., # 308 SE DECISION MADE: 12-OCT-21
Cambridge MA 02142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dry DBM- A Putty
SeaSpine Corporation 510(k) NO: K212135(Traditional)
ATTN: Caryn Sailor PHONE NO : 949 8557174
2 Goodyear SE DECISION MADE: 04-OCT-21
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex LoopLoc Knotless Suture
Arthrex, Inc. 510(k) NO: K212146(Traditional)
ATTN: Lai Saeteurn PHONE NO : 239 5984302
1370 Creekside Boulevard SE DECISION MADE: 25-OCT-21
Naples FL 34108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABCcolla Bone Matrix
ACRO Biomedical Co., Ltd. 510(k) NO: K212156(Traditional)
ATTN: Dar-Jen Hsieh PHONE NO : 886 7 6955069
3rd Fl., No.57, Luke 2nd Rd., LujhSE DECISION MADE: 08-OCT-21
Kaohsiung TW 82151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERRAD 100NX Sterilizer with ALLClear Technology
Advanced Sterilization Products, I510(k) NO: K212174(Traditional)
ATTN: Summer Bowman PHONE NO : 949 5619540
33 Technology Drive SE DECISION MADE: 09-OCT-21
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Adhesive Electrodes
Voncare Medical Device Co., Ltd 510(k) NO: K212191(Traditional)
ATTN: Jimmy Zhai PHONE NO : 86 752 6730765
Shiwan Science and Technology InduSE DECISION MADE: 06-OCT-21
Boluo County, Huizhou CN 516127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
Plasmapp Co., Ltd. 510(k) NO: K212193(Traditional)
ATTN: Seung Hun Lee PHONE NO : 82 042 7162115
BVC-111, 125, Gwahak-ro, Yuseong-gSE DECISION MADE: 22-OCT-21
Daejeon KR 34141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tyvek(R) Roll with CI for STERLINKTM Sterilizer
Plasmapp Co,.Ltd. 510(k) NO: K212198(Traditional)
ATTN: Lee Seung Hun PHONE NO : 82 042 7162115
BVC-111, 125, Gwahak-ro, Yuseong-gSE DECISION MADE: 22-OCT-21
Daejeon KR 34141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette
Plasmapp Co,.Ltd 510(k) NO: K212200(Traditional)
ATTN: LEE Seung Hun PHONE NO : 82 042 7162116
BVC-111, 125, Gwahak-ro, Yuseong-gSE DECISION MADE: 22-OCT-21
Daejeon KR 34141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTAX Medical Auto Leakage Tester SHA-P6
PENTAX of America, Inc. 510(k) NO: K212201(Traditional)
ATTN: William Goeller PHONE NO : 201 5712300 2318
3 Paragon Drive SE DECISION MADE: 01-OCT-21
Montvale NJ 07645-1782 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Protective Masks
Qinhuangdao Taizhi Medical Technol510(k) NO: K212205(Traditional)
ATTN: Fan Xifan PHONE NO : 86 133 83659307
No.5, Small and Medium EnterprisesSE DECISION MADE: 14-OCT-21
Qinhuangdao CN 066000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advanced Algorithms for Treatment Management Applications (AATMA)
Elekta Solutions AB 510(k) NO: K212218(Traditional)
ATTN: Melinda Smith PHONE NO : 678 2317791
Kungstensgatan 18 Box 7593 SE DECISION MADE: 25-OCT-21
Stockholm SE SE10393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RTHawk, HeartVista Cardiac Package
HeartVista, Inc. 510(k) NO: K212233(Traditional)
ATTN: James J Rogers PHONE NO : 724 7132298
2625 Middlefield Rd, #710 SE DECISION MADE: 05-OCT-21
Palo Alto CA 94306 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)
HDX Will Corp. 510(k) NO: K212254(Traditional)
ATTN: Kaon Kim PHONE NO : 82 43 7107318
#105, 106, 201, 202, 203, 204, 38,SE DECISION MADE: 19-OCT-21
Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StrokeSENS LVO
Circle Neurovascular Imaging, Inc 510(k) NO: K212261(Traditional)
ATTN: Kyle Mayr PHONE NO : 403 9936297
Suite 1100 - 800 5th Avenue SW SE DECISION MADE: 14-OCT-21
Calgary CA T2P 3T6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEKA LipoAI
EL.EN Electronic Engineering Spa 510(k) NO: K212270(Traditional)
ATTN: Paolo Peruzzi PHONE NO : 39 055 8826807
VIA Baldanzese 17 SE DECISION MADE: 21-OCT-21
Calenzano IT 50041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Intraoral X-ray Imaging System
iRay Technology Taicang Ltd. 510(k) NO: K212279(Traditional)
ATTN: Guo Wu PHONE NO : 86 0512 53690872
No. 33 Xinggang Rd. Taicang Port ESE DECISION MADE: 07-OCT-21
Taicang CN 215434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Examination gloves -Type C (Nitrile gloves)
Jiangxi Kemei Medical Apparatus & 510(k) NO: K212290(Traditional)
ATTN: Jenny Huang PHONE NO : 86 177 02094798
316 National Road, Xinju, ChangshaSE DECISION MADE: 28-OCT-21
Nanchang CN 331724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)
Jiangmen Ningrui Medical Supplies 510(k) NO: K212293(Traditional)
ATTN: Guorong Tan PHONE NO : 86 750 5522088
F/4 & F/6, 2nd Building, No. 84, XSE DECISION MADE: 25-OCT-21
Taishan CN 529200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BC Reflex Uni Knee System
Bodycad Laboratories, Inc. 510(k) NO: K212307(Traditional)
ATTN: Nadine Adia PHONE NO : 418 5271388
2035, rue du Haut-Bord SE DECISION MADE: 12-OCT-21
Quebec City CA G1N 4R7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free
Srirungruang Global Co., LTD. 510(k) NO: K212308(Traditional)
ATTN: Suttichai Sripradub PHONE NO : 66 038 151671
51/7 Moo1, Mabphai SE DECISION MADE: 29-OCT-21
Banbung TH 20170 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Examination Gloves
Guangzhou Junda Gloves Co., Ltd 510(k) NO: K212311(Traditional)
ATTN: Olivia Chen PHONE NO : 86 20 37738661
No.38 Heting Fengwei Industrial ZoSE DECISION MADE: 21-OCT-21
Guangzhou CN 510470 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Hair Removal Device
Zhongshan Bisen Plastic Electronic510(k) NO: K212314(Traditional)
ATTN: Rao Guanhua PHONE NO : 86 760 88297142
Second Floor, A Building, No.32 JiSE DECISION MADE: 21-OCT-21
Zhongshan CN 528437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Nitrile Examination Gloves
Lanhuo Medical Technology (Jiangsu510(k) NO: K212363(Traditional)
ATTN: Liu Ying PHONE NO : 86 139 17265389
Industrial Park, Liuzhuang Town, DSE DECISION MADE: 26-OCT-21
Yancheng CN 224100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask
Anhui Tiankang Medical Technology 510(k) NO: K212368(Traditional)
ATTN: Zhang Yong PHONE NO : 86 137 05505106
No. 228 Weiyi Road, Economic DevelSE DECISION MADE: 24-OCT-21
Tianchang CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF
Intelivation LLC 510(k) NO: K212389(Traditional)
ATTN: Amit Sinha PHONE NO : 484 3433075
70 Gruber Lane SE DECISION MADE: 29-OCT-21
Saint Simons Island GA 31522 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UroLift System Rigid Retrieval Kit Sterilization Tray
NeoTract, Inc. 510(k) NO: K212396(Special)
ATTN: Brian Gall PHONE NO : 1 925 3296547
4155 Hopyard Road SE DECISION MADE: 22-OCT-21
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aveli
NC8, Inc. 510(k) NO: K212399(Traditional)
ATTN: Mellissa Viotti PHONE NO : 650 3365985
2570W. El Camino Real, Suite 310 SE DECISION MADE: 22-OCT-21
Mountain View CA 94040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Examination Glove
Inner Mongolia Cureguard Medical T510(k) NO: K212401(Traditional)
ATTN: Guo Hua PHONE NO : 86 134 85097856
Room 326, Management Committee of SE DECISION MADE: 25-OCT-21
Baotou CN 014100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tracheal Stent System (Y-Shaped)
Micro-Tech (Nanjing) Co., Ltd. 510(k) NO: K212403(Traditional)
ATTN: Sally He PHONE NO : 86 25 58646395
No.10 Gaoke Third Road, Nanjing NaSE DECISION MADE: 30-OCT-21
Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSDSIGN Cranial PSI
OssDsign AB 510(k) NO: K212414(Traditional)
ATTN: Ulrik Birgersson PHONE NO : 46 018 553993
Rapsgatan 23A SE DECISION MADE: 01-OCT-21
Uppsala SE SE 754 50 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers
STERIS Corporation 510(k) NO: K212424(Special)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437
5960 Heisley Rd SE DECISION MADE: 28-OCT-21
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: cobas Cdiff nucleic acid test for use on the cobas Liat System
Roche Molecular Systems, Inc. 510(k) NO: K212427(Special)
ATTN: Kaitlyn Hameister PHONE NO : 925 3680589
4300 Hacienda Drive SE DECISION MADE: 20-OCT-21
Pleasanton CA 94588-2722 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anthem Fracture System
Globus Medical Inc. 510(k) NO: K212433(Traditional)
ATTN: Jennifer Antonacci PHONE NO : 610 9301800
2560 General Armistead Ave. SE DECISION MADE: 01-OCT-21
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iRAD
Claritas HealthTech Pte Ltd 510(k) NO: K212470(Traditional)
ATTN: Devika Dutt PHONE NO : 65 979 51921
20A Tanjong Pagar Road SE DECISION MADE: 20-OCT-21
Singapore SG 088443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cohitech Reusable Tampon Applicator
Cotton High Tech S.L. 510(k) NO: K212479(Traditional)
ATTN: Anna Garcia PHONE NO : 34 93 8391628
Colònia La Rabeia S/N SE DECISION MADE: 08-OCT-21
Balsareny ES 08660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BonOs Inject Bone Cement; NEO Pedicle Screw System
Neo Medical SA 510(k) NO: K212489(Traditional)
ATTN: Jonas Larsson PHONE NO : 41 79 4440443
Route de Lausanne 157 A SE DECISION MADE: 28-OCT-21
Villette (Lavaux) CH 1096 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVVIGO Guidance System II
Boston Scientific Corporation 510(k) NO: K212490(Special)
ATTN: Margaret Batchelder PHONE NO : 763 4941423
Three Scimed Place SE DECISION MADE: 20-OCT-21
Maple Grove MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IRNF App
Apple Inc. 510(k) NO: K212516(Traditional)
ATTN: Dachan Kwon PHONE NO :
1 Apple Park Way SE DECISION MADE: 22-OCT-21
Cupertino CA 95014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Magicore System
InnoBioSurg Co., Ltd. 510(k) NO: K212517(Special)
ATTN: JongHyuk Seo PHONE NO : 82 42 9332879
44-19, Techno 10-ro, Yuseong-gu SE DECISION MADE: 15-OCT-21
Daejeon KR 34027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProLift Micro Expandable Spacer System
Life Spine, Inc. 510(k) NO: K212520(Traditional)
ATTN: Angela Batker PHONE NO : 847 8846117
13951 S. Quality Drive SE DECISION MADE: 08-OCT-21
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Change Healthcare Cardiology
Change Healthcare Israel Ltd. 510(k) NO: K212528(Traditional)
ATTN: Chester McCoy PHONE NO : 574 3025855
26 Harokmim St. SE DECISION MADE: 18-OCT-21
Holon IL 5885849 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MiniLoad Syringe
OcuJect, LLC 510(k) NO: K212544(Special)
ATTN: Rebecca K Pine PHONE NO : 760 8095178
1441 Avocado Ave, Suite 204 SE DECISION MADE: 13-OCT-21
Newport Beach CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Correx Software
Vilex LLC 510(k) NO: K212552(Traditional)
ATTN: Louis Monaco PHONE NO : 435 6591880
111 Moffitt Street SE DECISION MADE: 12-OCT-21
McMinnville TN 37110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Signature™ ONE System
Orthosoft Inc. (d/b/a Zimmer CAS) 510(k) NO: K212560(Traditional)
ATTN: Sankalp Dere PHONE NO : 1 514 8614074
75 Queen Street Suite 3300 SE DECISION MADE: 12-OCT-21
Montreal CA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Idys-C ZP 3DTi
Clariance, SA 510(k) NO: K212562(Traditional)
ATTN: Mélody La Porte PHONE NO : 33 2 21161215
18, rue Robespierre SE DECISION MADE: 12-OCT-21
Beaurains FR 62217 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ViaCath, AcQRate Dx Steerable Catheter
Biotronick, Inc. 510(k) NO: K212593(Traditional)
ATTN: Jon Brumbaugh PHONE NO : 888 3450374
6024 Jean Road SE DECISION MADE: 15-OCT-21
Lake Oswego OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClotTriever Thrombectomy System
Inari Medical, Inc. 510(k) NO: K212632(Special)
ATTN: Larry Boucher PHONE NO : 949 6008433
9 Parker, Suite 100 SE DECISION MADE: 18-OCT-21
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORUS Spinal System-X
Providence Medical Technology, Inc510(k) NO: K212636(Traditional)
ATTN: Edward Liou PHONE NO : 415 9239376
4234 Hacienda Dr., Suite 150 SE DECISION MADE: 15-OCT-21
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neuromark System
Neurent Medical 510(k) NO: K212666(Traditional)
ATTN: Kenny Walsh PHONE NO : 353 87 9471202
1 Oran Point, Main Street, OranmorSE DECISION MADE: 22-OCT-21
Galway IE H91D7X2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcuPulse CO2 Laser System, Delivery Devices and Accessories
Lumenis, Ltd. 510(k) NO: K212703(Traditional)
ATTN: Shlomit Segman PHONE NO : 972 4 9599230
6 Hakidma Street PO Box 240 SE DECISION MADE: 19-OCT-21
Yokneam IL 2069204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ActiFlip
Parcus Medical LLC. 510(k) NO: K212739(Traditional)
ATTN: Calen Souther PHONE NO : 770 6161389
6423 Parkland Drive SE DECISION MADE: 06-OCT-21
Sarasota FL 34243 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 0909FCB, 1212FCA
Rayence Co., Ltd 510(k) NO: K212753(Special)
ATTN: Kevin Kim PHONE NO : 82 31 80156459
14, Samsung 1-ro, 1-gil SE DECISION MADE: 18-OCT-21
Hwaseong-si KR 445-170 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Laser Treatment System, Model: Hera, Armo
Canadian Pioneer Medical Technolog510(k) NO: K212793(Traditional)
ATTN: Rashid Reza Mir Sayah PHONE NO : 1 437 7727788
unit 2, 210 Drumlin Circle, ConcorSE DECISION MADE: 25-OCT-21
Vaughan CA L4k 3E3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zenition 70
Philips Medical Systems Nederland 510(k) NO: K212813(Special)
ATTN: Swapnil Sharadkumar Jain PHONE NO : 91 878 8984943
Veenpluis 4-6 SE DECISION MADE: 01-OCT-21
Best NL 5684PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoreLink Navigation Instruments
CoreLink, LLC 510(k) NO: K212825(Traditional)
ATTN: Steven Mounts PHONE NO : 888 3497808
2072 Fenton Logistics Park SE DECISION MADE: 13-OCT-21
St. Louis MO 63026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRIUS Planner Software
BRIUS Technologies Inc 510(k) NO: K212828(Special)
ATTN: Mehdi Roein-Peiker PHONE NO : 312 4791449
2611 Westgrove Dr SE DECISION MADE: 01-OCT-21
Carrollton TX 75006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MectaLIF Extension
Medacta International S .A. 510(k) NO: K212831(Traditional)
ATTN: Stefano Baj PHONE NO : 4 191 6966060
Strada Regina SE DECISION MADE: 29-OCT-21
Castrel San Pietro CH 6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AquaBeam Robotic System
PROCEPT BioRobotics Corporation 510(k) NO: K212835(Special)
ATTN: Sara Muddell PHONE NO : 650 2327217
900 Island Drive, Suite 101 SE DECISION MADE: 06-OCT-21
Redwood City CA 94065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)
Steris Corporation 510(k) NO: K212860(Special)
ATTN: Carroll Martin PHONE NO : 400 3586259
5976 Heisley Road SE DECISION MADE: 07-OCT-21
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Carescape SpO2 - Masimo
Masimo Corporation 510(k) NO: K212876(Special)
ATTN: Kertana Shankar PHONE NO : 949 2977260
52 Discovery SE DECISION MADE: 08-OCT-21
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device
Neuravi Ltd. 510(k) NO: K212908(Special)
ATTN: Niall Fox PHONE NO : 353 86 1730678
Block 3, Ballybrit Business Park SE DECISION MADE: 13-OCT-21
Galway IE H91 K5YD 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter
Siemens Medical Solutions USA, Inc510(k) NO: K212959(Special)
ATTN: HyunJung Lee PHONE NO : 425 2815061
22010 S.E. 51st Street SE DECISION MADE: 15-OCT-21
Issaquah WA 98029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AxTiHA Stand-Alone ALIF System
Innovasis, Inc. 510(k) NO: K212967(Special)
ATTN: Marshall McCarty PHONE NO : 801 2612236
614 East 3900 South SE DECISION MADE: 15-OCT-21
Salt Lake City UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCORPION Portal Vein Access Set
Argon Medical Devices 510(k) NO: K213002(Special)
ATTN: Scott Bishop PHONE NO : 469 4300546
1445 Flat Creek Road SE DECISION MADE: 14-OCT-21
Athens TX 75751 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tenax Laser Resistant Endotracheal Tube
Bryan Medical , Inc. 510(k) NO: K213028(Special)
ATTN: Andrew J Georgilis PHONE NO : 513 2721600
5725 Dragon Way, Suite 300 SE DECISION MADE: 21-OCT-21
Cincinnati OH 45227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Treace Medical Concepts (TMC) Screw Fixation System
Treace Medical Concepts, Inc. 510(k) NO: K213036(Special)
ATTN: Kristina Hall PHONE NO : 904 3735940
203 Fort Wade Rd., Suite 150 SE DECISION MADE: 21-OCT-21
Ponte Vedra FL 32081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLISIS SYSTEMS, Discovery RF180
General Medical Merate S.P.A 510(k) NO: K213081(Traditional)
ATTN: Luca Bianchessi PHONE NO : 39 035 4525396
Via Partigiani, 25 SE DECISION MADE: 26-OCT-21
Seriate IT 24068 510(k) STATEMENT
DEVICE: Introcan Safety 3 Closed IV Catheter
B.Braun Medical Inc. 510(k) NO: K213085(Special)
ATTN: Tracy Larish PHONE NO : 610 5965941
901 Marcon Blvd SE DECISION MADE: 25-OCT-21
Allentown PA 18109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Orthoscan Tau Mini C-Arm
Orthoscan, Inc. 510(k) NO: K213113(Special)
ATTN: Kevin Bridgman PHONE NO : 480 5038010
14555 N. 82nd St. SE DECISION MADE: 21-OCT-21
Scottsdale AZ 85260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tomier Perform™ Reversed Glenoid Cannulated Glenospheres
Tornier, Inc. 510(k) NO: K213124(Special)
ATTN: Lisa Stahl PHONE NO : 612 8499970
10801 Nesbitt Ave. South SE DECISION MADE: 26-OCT-21
Bloomington MN 55437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology
Synovis Life Technologies. Inc. (A510(k) NO: K213125(Special)
ATTN: Megan Sajjad PHONE NO : 414 2181464
International Inc.) 2575 UniversitSE DECISION MADE: 27-OCT-21
St. Paul MN 55114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIWay Endonasal Access Guide
SPIWay, LLC 510(k) NO: K213153(Special)
ATTN: Eugene Chen PHONE NO : 844 5651226
3600 Corte Castillo SE DECISION MADE: 27-OCT-21
Carlsbad CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VersaWrap
Alafair Biosciences Inc 510(k) NO: K213163(Special)
ATTN: Angela Mallery PHONE NO : 651 2104766
6101 W Courtyard Drive Suite 2-225SE DECISION MADE: 29-OCT-21
Austin TX 78730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avaira Vitality
CooperVision. Inc. 510(k) NO: K213164(Special)
ATTN: Ahanitha Ashok PHONE NO : 925 6604482
6101 Bollinger Canyon Road, Suite SE DECISION MADE: 26-OCT-21
San Ramon CA 94583 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Thrombuster II Aspiration Catheter
Kaneka Medical America LLC 510(k) NO: K213166(Special)
ATTN: Audra Bogucki PHONE NO : 917 6289870
623 Fifth Avenue SE DECISION MADE: 26-OCT-21
New York NY 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Balloon BS-3
FUJIFILM Corporation 510(k) NO: K213195(Special)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 29-OCT-21
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARTO 3 EP Navigation System Version 7.2
Biosense Webster, Inc. 510(k) NO: K213264(Special)
ATTN: Khaled Hamad PHONE NO : 949 4536350
31 Technology Drive, Suite 200 SE DECISION MADE: 29-OCT-21
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ds Head 32ch 3.0T
Invivo Corporation (Business Trade510(k) NO: K213351(Third Party - Traditional)
ATTN: Sarah Pleaugh PHONE NO : 906 4588054
3545 SW 47th Ave SE DECISION MADE: 29-OCT-21
Gainesville FL 32608 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Titan Manufacturing Bipolar Forceps
Titan Manufacturing, Inc. 510(k) NO: K213386(Third Party - Special)
ATTN: Donald Seavey PHONE NO : 610 9358203
1 Rapps Run SE DECISION MADE: 25-OCT-21
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 230
TOTAL WITH SUMMARIES 219
TOTAL WITH STATEMENTS 11
