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  1. 510(k) Clearances

February 2021 510(K) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD February 2021


DEVICE: Archworx
Utah Medical Products and Services510(k) NO: K173738(Traditional)
ATTN: Brandon  Farley             PHONE NO : 801 9042006 
DBA Cottonwood Laboratories 6526 SSE DECISION MADE: 26-FEB-21
Murray UT  84107                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solax Electric Scooter (Models: S3023, S3024, S3025, S3026)
Dongguan Prestige Sporting Goods C510(k) NO: K191897(Traditional)
ATTN: Zhang  Zhao                 PHONE NO : 86 1376 3128800 
3rd Ind. District, Qiaotou Area, HSE DECISION MADE: 10-FEB-21
Dongguan  CN 523950               510(k) STATEMENT
                                                    

DEVICE: Jaijian Self-Adhesive Electrode
Wuxi Jiajian Medical Instrument Co510(k) NO: K192568(Special)
ATTN: Caihong  Sun                PHONE NO : 86 510887 45788 
NO.35 Baiqiao Rd., Ehu Town, XishaSE DECISION MADE: 03-FEB-21
Wuxi  CN 214116                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann Variobase C
Institut Straumann AG             510(k) NO: K192742(Traditional)
ATTN: Gordon  Dodds               PHONE NO : 49 89 309075291 
Lochhamer Schlag 6                SE DECISION MADE: 12-FEB-21
Grafelfing  DE 82166              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DSP Implant System
D.S.P Industrial Eireli           510(k) NO: K192839(Traditional)
ATTN: Celio Gilson Netzel         PHONE NO : 55 41 32912200 
Rua Marechal Floriano Peixoto 303 SE DECISION MADE: 11-FEB-21
Campo Largo  BR 83606-290         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MedCAD® AccuPlate® Patient-Specific Plate
MedCAD                            510(k) NO: K193280(Traditional)
ATTN: Brian  Buss                 PHONE NO : 214 4538864 305
501 S 2nd Ave., Suite A-1000      SE DECISION MADE: 12-FEB-21
Dallas TX  75226                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clue Birth Control
BioWink GmbH                      510(k) NO: K193330(Abbreviated)
ATTN: Carrie  Walter              PHONE NO : 49 151 62780364 
Adalbertstrasse 7-8               SE DECISION MADE: 18-FEB-21
Berlin  DE 10999                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Easydrip Pen Needle, Easydrip Plus Pen Needle
Sandstone Medical (Suzhou) Inc.   510(k) NO: K193422(Traditional)
ATTN: Juanjuan  Sun               PHONE NO : 86 0512 65799368 
A601, Guangzhou International BusiSE DECISION MADE: 02-FEB-21
Suzhou  CN 215301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ezlymph, Ezlymph M
Eezcare Medical Corp              510(k) NO: K193662(Abbreviated)
ATTN: Michelle C Mitchell         PHONE NO : 757 2240177 
NO. 3-1, Minquan St               SE DECISION MADE: 11-FEB-21
New Taipei City 236, Taipei  TW 23510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Foot and Ankle System
Leith Medical LLC                 510(k) NO: K200062(Traditional)
ATTN: Tim  Leak                   PHONE NO : 512 4966786 
4705 Eagle Feather Dr             SE DECISION MADE: 22-FEB-21
Austin TX  78735                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 740 SafeSAT
Zoe Medical, Inc.                 510(k) NO: K200160(Traditional)
ATTN: Jim  Chickering             PHONE NO : 978 8871410 
460 Boston Street                 SE DECISION MADE: 15-FEB-21
Topsfield MA  01983               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPEAC System
Brain Sentinel, Inc.              510(k) NO: K200276(Traditional)
ATTN: Richard  Waite              PHONE NO : 214 6629277 
8023 Vantage Drive Suite 216      SE DECISION MADE: 06-FEB-21
San Antonio TX  78230             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UNiTi ACDF Implant System
Pressio, Inc.                     510(k) NO: K200301(Traditional)
ATTN: Joe  Ritz                   PHONE NO : 512 6952971 
14785 Omicron Drive, Suite 100    SE DECISION MADE: 03-FEB-21
San Antonio TX  78245             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload
M/s. Meril Endo Surgery Private Li510(k) NO: K200320(Traditional)
ATTN: Umesh  Sharma               PHONE NO : 91 260 3052100 
Third Floor, E1-E3, Meril Park, SuSE DECISION MADE: 05-FEB-21
Chala, Vapi  IN 396191            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LINK Embrace Shoulder System - Reverse Configuration
Waldemar Link GmbH & Co. KG       510(k) NO: K200368(Traditional)
ATTN: Stephanie  Fuchs            PHONE NO : 49 40 53995530 
Ostsraße 4-10                     SE DECISION MADE: 05-FEB-21
Norderstedt  DE 22844             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Velano ExT Extension Set
Velano Vascular                   510(k) NO: K200439(Traditional)
ATTN: Tiffini  Wittwer            PHONE NO : 707 7996732 
221 Pine St #200                  SE DECISION MADE: 23-FEB-21
San Francisco CA  94104           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Shofu Block HC Hard
Shofu Dental Corporation          510(k) NO: K200470(Traditional)
ATTN: Mauro  Malzyner             PHONE NO : 760 7363277 202
1225 Stone Drive                  SE DECISION MADE: 05-FEB-21
San Marcos CA  92078              510(k) STATEMENT
                                                    

DEVICE: pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur
pjur group Luxembourg SA          510(k) NO: K200527(Traditional)
ATTN: Andrea  Giebel              PHONE NO : 352 74 8989 
87 esplanade de la Moselle        SE DECISION MADE: 19-FEB-21
Wasserbillig  LU L-6637           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MectaLIF Transforaminal TiPEEK
Medacta Inernational SA           510(k) NO: K200551(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 12-FEB-21
Castel San Pietro  CH cH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ASI Plethysmogrpah Analyzer
Arterial Stiffness Inc.           510(k) NO: K200567(Traditional)
ATTN: Jospeh Henry Shaw           PHONE NO : 651 2089596 
1000 Westgate Drive Suite 101B    SE DECISION MADE: 26-FEB-21
Saint Paul MN  55114              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MyPAO Planning Report
Medacta International SA          510(k) NO: K200589(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91696 6060 
Strada Regina                     SE DECISION MADE: 19-FEB-21
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VesselIQ Xpress
GE Medical Systems SCS            510(k) NO: K200626(Traditional)
ATTN: Elizabeth  Mathew           PHONE NO : 262 4247774 
283 rue de la Miniere             SE DECISION MADE: 16-FEB-21
Buc  FR 78530                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AXUS ES-5 Electro-Acupuncture Device
Lhasa OMS, INC.                   510(k) NO: K200636(Traditional)
ATTN: Colleen  Pike               PHONE NO : 781 3401010 11
230 Libbey Parkway                SE DECISION MADE: 03-FEB-21
Weymouth MA  02189                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hi bebe super (Models BT-150S and BT-150L)
Bistos Co., Ltd.                  510(k) NO: K200675(Special)
ATTN: Hae Sun Jeong               PHONE NO : 82 31 7500340 
7th Fl. A Bldg., Woolim Lions VallSE DECISION MADE: 10-FEB-21
Seongnam-si  KR 13201             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
Sirius Medical Systems B.V.       510(k) NO: K200734(Traditional)
ATTN: Bram  Schermers             PHONE NO : 0031 6 20116299 
High Tech Campus 41               SE DECISION MADE: 24-FEB-21
Eindhoven  NL 5656AE              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AsoAligner
Aso International Manila, Inc.    510(k) NO: K201104(Traditional)
ATTN: Hiromichi  Takahashi        PHONE NO : 81 03 35470471 
Atlantica Bldg. 5, Block 12, PhaseSE DECISION MADE: 26-FEB-21
Cavite  PH 4106                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sphincterotome
Hangzhou AGS MedTech Co., Ltd.    510(k) NO: K201121(Traditional)
ATTN: Chunqi  Han                 PHONE NO : 86 571 87671223 
Building 5, Building 6, No.597 KanSE DECISION MADE: 05-FEB-21
Hangzhou  CN 311106               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set
Simplivia Healthcare Ltd.         510(k) NO: K201142(Traditional)
ATTN: Shay  Shaham                PHONE NO : 972 5283 13378 
North Industrial Zone             SE DECISION MADE: 25-FEB-21
Kiryat Shmona  IL 1011801         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iMask Disposable Surgical Face Mask
Pac-Dent, Inc.                    510(k) NO: K201182(Traditional)
ATTN: Jiahe  Li                   PHONE NO : 909 8390888 
670 Endeavor Circle               SE DECISION MADE: 19-FEB-21
Brea CA  92821                    510(k) STATEMENT
                                                    

DEVICE: Bio-C Repair Ion+
Angelus Industria de Produtos Odon510(k) NO: K201222(Traditional)
ATTN: Paulo Sergio Calixto de OlivPHONE NO : 55 43 21013205 
Rua Waldir Landgraf, 101          SE DECISION MADE: 11-FEB-21
Londrina  BR 86.031-218           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CTxx85 CT Scanner
Analogic Corporation              510(k) NO: K201231(Traditional)
ATTN: Laura  Green                PHONE NO : 216 7041442 
8 Centennial Drive                SE DECISION MADE: 02-FEB-21
Peabody MA  01960                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultrasonic Osteotomy Surgical System
SMTP Technology Co., Ltd          510(k) NO: K201274(Traditional)
ATTN: Songtao  Zhan               PHONE NO : 0086 0512 82508100 
 1F&4F, Building A, Emerging IndusSE DECISION MADE: 19-FEB-21
Zhangjiagang  CN 215634           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TRAUS SIP20
Saeshin Precision Co., Ltd.       510(k) NO: K201292(Traditional)
ATTN: GungSan  Nam                PHONE NO : 82 53 5872345 
52, Secheon-ro 1-gil, Dasa-eup, DaSE DECISION MADE: 11-FEB-21
Daegu  KR 42921                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HAMILTON-C3
Hamilton Medical AG               510(k) NO: K201306(Traditional)
ATTN: Simone  Haller              PHONE NO : 41 5861 02567 
Via Crusch 8                      SE DECISION MADE: 05-FEB-21
Bonaduz  CH 7402                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)
Suzhou Peaksonic Medical Technolog510(k) NO: K201316(Traditional)
ATTN: Calvin  Ma                  PHONE NO : 86 512 36693388 
2A, West Side of Building G4, KunsSE DECISION MADE: 26-FEB-21
Qiandeng, Kunshan, Suzhou  CN 2153510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Antibacterial Bandage
Jiangsu Excellence Medical Supplie510(k) NO: K201324(Traditional)
ATTN: Yanhua  Li                  PHONE NO : 86 519 83632311 
No.65 Huiling West Road, Zouqu TowSE DECISION MADE: 05-FEB-21
Changzhou  CN 203144              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Meditech ABPM-06 (BP6)
Meditech Ltd.                     510(k) NO: K201332(Traditional)
ATTN: Gabor  Kazi                 PHONE NO : 36 0203 3921 
24 Mikszath Kalman utca           SE DECISION MADE: 10-FEB-21
Budapest  HU 1184                 510(k) STATEMENT
                                                    

DEVICE: Plastic LOR Syringe
Jiangsu Caina Medical Co., Ltd    510(k) NO: K201356(Traditional)
ATTN: Jianwei  Pan                PHONE NO : 86 510868 666668027 
No.23,Huanxi Rd. Zhutang Town     SE DECISION MADE: 12-FEB-21
Jiangyin  CN 214415               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3D Accuitomo 150N
J. Morita USA, INC.               510(k) NO: K201378(Traditional)
ATTN: Fujio  Zushi                PHONE NO : 949 5819600 
9 Mason                           SE DECISION MADE: 18-FEB-21
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Artemis Proximal Femoral Nail System
GLW, Inc.                         510(k) NO: K201379(Traditional)
ATTN: Arundhati  Radhakrishnan    PHONE NO : 201 2683281 
300 Sylvan Avenue                 SE DECISION MADE: 19-FEB-21
Englewood Cliffs NJ  07632        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultrafast, Ultrafast Plus, Ultrafast Lite
DentLight Inc.                    510(k) NO: K201387(Traditional)
ATTN: Richard  Liu                PHONE NO : 972 8898857 
1825 Summit Ave. Ste 210          SE DECISION MADE: 26-FEB-21
Plano TX  75074                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Easytech® Anatomical Shoulder System
FX Shoulder USA, Inc.             510(k) NO: K201391(Traditional)
ATTN: Kathy  Trier                PHONE NO : 800 2800775 
13465 Midway Road, Suite 101      SE DECISION MADE: 16-FEB-21
Dallas TX  75244                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Demetra Analytics Toolkit
Barco NV                          510(k) NO: K201408(Traditional)
ATTN: Julie  Vandecandelaere      PHONE NO : 32 5626 2319 
President Kennedypark 35          SE DECISION MADE: 18-FEB-21
Kortrijk  BE 8500                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BEGO SEMADOS Tr 58350; BEGO SEMADOS RS/RSX-Line Tray Plus, BEGO Semados Tr 58349; BEGO Semados Tr 58348, BEGO Semados DSTr 58356; Drill Stop Tray Plus (RS/RSX-Line), BEGO SEMADOS PKTr 58357; Prosthetic Kit
BEGO Implant Systems GmbH & Co. KG510(k) NO: K201412(Traditional)
ATTN: Bertrand  Lecointe          PHONE NO : 49 0421 2028230 
Wilhelm-Herbst-Str. 1             SE DECISION MADE: 18-FEB-21
Bremen  DE 28359                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons
Dukal Corporation                 510(k) NO: K201421(Traditional)
ATTN: Megan  Quevedo              PHONE NO : 631 6563800 
2 Fleetwood Court                 SE DECISION MADE: 05-FEB-21
Ronkonkoma NY  11779              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Intraoperative Probe (DIOP8)
Huntleigh Healthcare Limited      510(k) NO: K201425(Traditional)
ATTN: Steve  Monks                PHONE NO : 44 2920 485885 
35 Portmanmoor Road               SE DECISION MADE: 19-FEB-21
Cardiff  GB CF24 5HN              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vortek Single Loop Ureteral Stent
Coloplast Corp                    510(k) NO: K201436(Traditional)
ATTN: Cori  Ragan                 PHONE NO : 612 5975106 
1601 West River Road North        SE DECISION MADE: 25-FEB-21
Minneapolis MN  55411             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DSG Connect Technology
SpineGuard, S.A.                  510(k) NO: K201454(Traditional)
ATTN: Stephane  Bette             PHONE NO : 33 01 45184519 
10 Cours Louis Lumiere            SE DECISION MADE: 10-FEB-21
Vincennes  FR 94300               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electro Flo 6 Airway Clearance System
Med Systems, Inc.                 510(k) NO: K201490(Traditional)
ATTN: Susan B Davis               PHONE NO : 858 4839671 
2631 Ariane Drive                 SE DECISION MADE: 12-FEB-21
San Diego CA  92117               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Veolity
MeVis Medical Solutions AG        510(k) NO: K201501(Traditional)
ATTN: Rolf  Rzodeczko             PHONE NO : 49 0421 22495120 
Caroline-Herschel-Strasse 1       SE DECISION MADE: 23-FEB-21
Bremen  DE 28359                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Forehead Thermometer
Hangzhou Qingyuan Medical Equipmen510(k) NO: K201536(Traditional)
ATTN: Jenny  Li                   PHONE NO : 86 0571 82623931 
No.688 Dong'an 1st Road, Xintang SSE DECISION MADE: 10-FEB-21
Hangzhou  CN 311200               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Face Mask
Amphastar Nanjing Pharmaceuticals,510(k) NO: K201545(Abbreviated)
ATTN: Bob  Bao                    PHONE NO : 86 025 85807880 211
No.5 Xinghe Road, Nanjing EconomicSE DECISION MADE: 12-FEB-21
Nanjing  CN 210038                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmartCT R1.0
Philips Medical Systems, Nederland510(k) NO: K201583(Abbreviated)
ATTN: Maria Silos Viu             PHONE NO : 31 61859 6430 
Veenpluis 4-6                     SE DECISION MADE: 09-FEB-21
Best  NL 5684 PC                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Panda iRes Warmer, Giraffe Warmer
GE Healthcare                     510(k) NO: K201628(Traditional)
ATTN: Michelle  Johnson           PHONE NO : 414 4299263 
9900 Innovation Drive             SE DECISION MADE: 12-FEB-21
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MouthLab Vital Signs Monitoring System
MultiSensor Diagnostics (dba Aidar510(k) NO: K201635(Traditional)
ATTN: Sathya  Elumalai            PHONE NO : 443 8756456 
3402 Birch Hollow Rd.             SE DECISION MADE: 06-FEB-21
Pikesville MD  21208              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QardioCore
Qardio Inc.                       510(k) NO: K201644(Traditional)
ATTN: Rosario  Iannella           PHONE NO : 415 6709613 
345 California Street, Suite 600 &SE DECISION MADE: 28-FEB-21
San Francisco CA  94104           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: COBRA-OS Kit
Front Line Medical Technologies, I510(k) NO: K201652(Traditional)
ATTN: Asha  Parekh                PHONE NO : 519 7771577 
184 Paul Street, Unit 1           SE DECISION MADE: 22-FEB-21
London  CA n6hil2                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuFACE Mini Plus
Carole Cole Company               510(k) NO: K201680(Abbreviated)
ATTN: Danielle Barker Fernandes   PHONE NO : 760 5091236 
1325 Sycamore Ave, Suite A        SE DECISION MADE: 19-FEB-21
Vista CA  92081                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PROXEO Twist Cordless Polishing System PL-40 H
W&H Dentalwerk Buermoos GmbH      510(k) NO: K201703(Traditional)
ATTN: Johann Georg Scharl         PHONE NO : 0043 6274 6236297 
Ignaz Glaser Strasse 53           SE DECISION MADE: 24-FEB-21
Buermoos  AT AT - 5111            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LiPPS Analyzer, LiPPS Wire Pressure Guide Wire
Beijing Bywave Sensing Medical Tec510(k) NO: K201720(Traditional)
ATTN: Lizhe  Zhang                PHONE NO : 86 10 82890879 
Room 501, Buildinctg 22, No.12, JuSE DECISION MADE: 18-FEB-21
Beijing  CN 101399                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dukal Corporation Level 3 Surgical Face Masks (Ear loop), Dukal Corporation Level 3 Surgical Face Masks (Tie On)
Dukal Corporation                 510(k) NO: K201732(Traditional)
ATTN: Megan  Quevedo              PHONE NO : 631 6563800 
2 Fleetwood Court                 SE DECISION MADE: 16-FEB-21
Ronkonkoma NY  11779              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClarifEye R1.0, ClarifEye Needle
Philips Medical Systems Nederlands510(k) NO: K201743(Abbreviated)
ATTN: Owen  Callaghan             PHONE NO : 31 641 333263 
Veenpluis 6                       SE DECISION MADE: 23-FEB-21
Best  NL 5684PC                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CleaniCal
Maruchi                           510(k) NO: K201799(Traditional)
ATTN: Jang Sung Wook              PHONE NO : 82 33 7340330 
2-208, Medical Industry Complex BlSE DECISION MADE: 12-FEB-21
Wonju-si  KR 26311                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elos Accurate Hybrid Base
Elos Medtech Pinol A/S            510(k) NO: K201860(Traditional)
ATTN: Tina Friis Poulsen          PHONE NO : 0045 482 16400 
Engvej 33                         SE DECISION MADE: 19-FEB-21
Goerloese  DK dk-3330             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape
SOMATEX Medical Technologies GmbH 510(k) NO: K201863(Traditional)
ATTN: David  Vasmer               PHONE NO : 49 30 319822500 
Hohenzollerndamm 150/151          SE DECISION MADE: 18-FEB-21
Berlin  DE 14199                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Phyziofit Medical Surgical Mask
Wellpower Sporting Goods Co., Ltd 510(k) NO: K201868(Traditional)
ATTN: Carol  Tseng                PHONE NO : 86 138 29158242 
No. 12, Xinglong New Street, QuantSE DECISION MADE: 22-FEB-21
Dongguan  CN 523425               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trinity ELE Plus and Trinity ELE Plus Pro
Carol Cole Company dba NuFACE     510(k) NO: K201906(Traditional)
ATTN: Danielle Barker Fernandes   PHONE NO : 760 5091236 
1325 Sycamore Avenue, Suite A     SE DECISION MADE: 24-FEB-21
Vista CA  92081                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GenesisZr 4Y+ (ST1100) Zirconia
United Dental Resources Corporatio510(k) NO: K201915(Traditional)
ATTN: John Von Thaden             PHONE NO : 1 708 7465730 
70 Towncenter Drive               SE DECISION MADE: 23-FEB-21
University Park IL  60484         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KARL STORZ UDEL Sterilization Trays
Karl Storz EndoscopyAmerica Inc   510(k) NO: K201945(Traditional)
ATTN: Leigh  Spotten              PHONE NO : 424 2188376 
2151 E Grand Ave                  SE DECISION MADE: 25-FEB-21
El Segundo CA  90245-5017         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System
Chison Medical Technologies Co., L510(k) NO: K201967(Traditional)
ATTN: Qifei  Liu                  PHONE NO : 0086 510 85311707 
No.228, Changjiang East Road, BlocSE DECISION MADE: 26-FEB-21
Wuxi  CN 214142                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System
Chison Medical Technologies Co., L510(k) NO: K201968(Traditional)
ATTN: Qifei  Liu                  PHONE NO : 0086 510 85311707 
No.228, Changjiang East Road, BlocSE DECISION MADE: 26-FEB-21
Wuxi  CN 214142                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System
Chison Medical Technologies Co., L510(k) NO: K201969(Traditional)
ATTN: Qifei  Liu                  PHONE NO : 0086 510 85311707 
No.228, Changjiang East Road, BlocSE DECISION MADE: 25-FEB-21
Wuxi  CN 214142                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System
Chison Medical Technologies Co., L510(k) NO: K201971(Traditional)
ATTN: Qifei  Liu                  PHONE NO : 0086 510 85311707 
No.228, Changjiang East Road, BlocSE DECISION MADE: 25-FEB-21
Wuxi  CN 214142                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
GMP Medicare SDN BHD              510(k) NO: K202003(Traditional)
ATTN: Noraini  Binti              PHONE NO : 603 339 26317 
Lot/PT 64593, Jalan Dahlia/KU8, KaSE DECISION MADE: 24-FEB-21
Klang  MY 41050                   510(k) STATEMENT
                                                    

DEVICE: Balex bone Expander System
Taeyeon Medical Co., Ltd.         510(k) NO: K202027(Traditional)
ATTN: Sin-Ae  Kang                PHONE NO : 82 33 7427555 
132-1 Donghwagongdan-Ro, Munmak-euSE DECISION MADE: 03-FEB-21
Wonju-Si  KR 26365                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: imani i1
imani Co.                         510(k) NO: K202045(Traditional)
ATTN: Hyo-Soon  Hwang             PHONE NO : 82 31323 4435 
1F, Na Dong, 19, Wanjangcheon-ro 3SE DECISION MADE: 26-FEB-21
Yongin-si  KR 17117               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App
Cochlear Americas                 510(k) NO: K202048(Traditional)
ATTN: Krystal  Haley              PHONE NO : 303 2642527 
10350 Park Meadows Drive          SE DECISION MADE: 23-FEB-21
Lone Tree CO  80124               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On
EcoGuard Inc.                     510(k) NO: K202096(Traditional)
ATTN: Fang  Wang                  PHONE NO : 704 3223710 
700 S Battleground Ave., Suite 103SE DECISION MADE: 02-FEB-21
Grover NC  28073                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fundus Camera
Huvitz Co., Ltd.                  510(k) NO: K202097(Traditional)
ATTN: Hyung Min Heo               PHONE NO : 82 31 4289059 
38, 170 Beon-Gil, Dongan-Gu       SE DECISION MADE: 02-FEB-21
Anyang-Si  KR 14055               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical infrared forehead thermometer
Hunan Honggao Electronic Technolof510(k) NO: K202111(Traditional)
ATTN: Rongfang  Hu                PHONE NO : 86 0737 2762828 
Block 5, Tenghui Pioneer Park, NanSE DECISION MADE: 26-FEB-21
Yiyang  CN 413200                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece
Storz Medical AG                  510(k) NO: K202112(Traditional)
ATTN: Pavel  Novak                PHONE NO : 417 16 774513 
Lohstampfestrasse 8               SE DECISION MADE: 21-FEB-21
Tagerwilen  CH CH-8274            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smart SPACE Shoulder System
TechMah Medical LLC               510(k) NO: K202151(Traditional)
ATTN: Mohamed R. Mahfouz          PHONE NO : 1 877 7256920 104
2099 Thunderhead Rd. Suite 302    SE DECISION MADE: 03-FEB-21
Knoxville TN  37922               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Brite Tip Radianz Guiding Sheath
Cordis Corporation                510(k) NO: K202167(Traditional)
ATTN: Crystal  Placona            PHONE NO : 786 3138325 
14201 NW 60th Avenue              SE DECISION MADE: 26-FEB-21
Miami Lakes FL  33014             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital NeuroPort Biopotential Signal Processing System
Blackrock Microsystems            510(k) NO: K202174(Special)
ATTN: Rachelle  Frischknecht      PHONE NO : 801 9945668 
630 Komas Drive, Suite 200        SE DECISION MADE: 10-FEB-21
Salt Lake City UT  84108          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Practical Navigation Surgical Guidance System (PNSGS)
Practical Navigation, LLC         510(k) NO: K202184(Traditional)
ATTN: Brad  Clayton               PHONE NO : 303 5170506 
720 E. Wiggins Street             SE DECISION MADE: 24-FEB-21
Superior CO  80027                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Safety Blood Collection Sets for Single Use
Anhui Hongyu Wuzhou Medical Manufa510(k) NO: K202188(Traditional)
ATTN: Gang  Yu                    PHONE NO : 86 0556 5129666 
No. 2 Guanyin Road, Economic DevelSE DECISION MADE: 19-FEB-21
Taihu, Anqing City  CN 246400     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TruPlan
Circle Cardiovascular Imaging Inc.510(k) NO: K202212(Traditional)
ATTN: Shirantha  Samarappuli      PHONE NO : 1 403 3381870 
Suite 1100-800 5th Ave SW         SE DECISION MADE: 19-FEB-21
Calgary  CA T2P 3T6               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VORTRAN GO2VENT with PEEP Valve
Vortran Medical Technology 1, Inc.510(k) NO: K202219(Traditional)
ATTN: Adam  Palumbo               PHONE NO : 800 4344034 
21 Goldenland Court, Suite 100    SE DECISION MADE: 11-FEB-21
Sacramento CA  95834              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Comprehensive Vault Reconstruction System
Biomet Manufacturing Corp.        510(k) NO: K202232(Traditional)
ATTN: Patricia Sandborn Beres     PHONE NO : 574 3733872 
56 E. Bell Drive                  SE DECISION MADE: 19-FEB-21
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Surgical Mask/Fluid Resistant Procedure Mask
LHM Medical Technology (Hong Kong)510(k) NO: K202240(Traditional)
ATTN: Frank  Cheng                PHONE NO : 86 0752 6611193 1169
Unit No. 2, 3/F., Block A, Ko Fai SE DECISION MADE: 25-FEB-21
HongKong  CN 999077               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EDS Bioceramic Sealer (Bioseal)
Essential Dental Systems          510(k) NO: K202281(Traditional)
ATTN: Jason  Guzman               PHONE NO : 201 4879090 119
89 Leuning Street                 SE DECISION MADE: 12-FEB-21
South Hackensack NJ  07606        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CORE E3 Suction/irrigator
ConMed Corporation                510(k) NO: K202303(Traditional)
ATTN: Tina  Mornak                PHONE NO : 303 6997600 135086
525 French Road                   SE DECISION MADE: 19-FEB-21
Utica NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Surgical Masks
Tianjin Teda Jinshan Easy Packing 510(k) NO: K202323(Traditional)
ATTN: Hui  Liu                    PHONE NO : 86 22 68228888 
No. 3 Wuhai Road, Jinhai Economic SE DECISION MADE: 02-FEB-21
Tianjin  CN 301600                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical Face Mask
Gemtier Medical (Shanghai) Inc    510(k) NO: K202331(Traditional)
ATTN: Li  Zhiqing                 PHONE NO : 86 189 17035908 
No.18 Jianding Road, Fengjing TownSE DECISION MADE: 02-FEB-21
Shanghai  CN 201502               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SpaceFlex Shoulder
G21 Srl                           510(k) NO: K202338(Traditional)
ATTN: Filippo  Foroni             PHONE NO : 39 053 530312 
Via Sandro Pertini, 8             SE DECISION MADE: 17-FEB-21
San Possidonio  IT 41039          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Molekule Air Mini, Molekule Air Mini +
Molekule, Inc.                    510(k) NO: K202339(Traditional)
ATTN: Frank  Bianco               PHONE NO : 925 4047724 
1301 Folsom St.                   SE DECISION MADE: 23-FEB-21
San Francisco CA  94103           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Surgical Mask
Shanghai Jianzhong Medical Packagi510(k) NO: K202341(Traditional)
ATTN: Nina  Huang                 PHONE NO : 86 21543 156665201 
Bldg. 16, 789# Puxing Rd, Minhang SE DECISION MADE: 12-FEB-21
Shanghai  CN 201114               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPiN Vision Video Bronchoscope System
Veran Medical Technologies, Inc.  510(k) NO: K202346(Traditional)
ATTN: B. Nathan Hunt              PHONE NO : 314 6598500 
1908 Innerbelt Business Center Dr SE DECISION MADE: 19-FEB-21
St. Louis MO  63114               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Thermometer
Shandong Bittel Intelligent Techno510(k) NO: K202368(Traditional)
ATTN: Cui  Shi                    PHONE NO : 86 633 2212103 
No.1 Rizhao North Road            SE DECISION MADE: 12-FEB-21
Rizhao  CN 276800                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Born PT-LIF Cage HA
SpineworxX AG                     510(k) NO: K202380(Traditional)
ATTN: Aouda  Ouzzaa               PHONE NO : 47 71 2424400 
Schuppisstrasse 10                SE DECISION MADE: 19-FEB-21
St. Gallen  CH 9016               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein
ECO Medi Glove Sdn. Bhd           510(k) NO: K202401(Traditional)
ATTN: Suresh  Kumar               PHONE NO : 605 8062315 
Lot 26910, Lorong Perusahaan 3/3, SE DECISION MADE: 17-FEB-21
Taiping  MY 34600                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Forehead Thermometer
Conmo Electronic Company Limited  510(k) NO: K202420(Traditional)
ATTN: Ying  Qi                    PHONE NO : 86 755 28397469 
Suiyi Town, Xincheng County       SE DECISION MADE: 25-FEB-21
Laibin City  CN                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MiniLoad Syringe
OcuJect, LLC                      510(k) NO: K202432(Traditional)
ATTN: Rebecca K Pine              PHONE NO : 760 8095178 
1441 Avocado Ave, Suite 204       SE DECISION MADE: 19-FEB-21
Newport Beach CA  92660           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical Face Mask
Gemtier Medical (Shanghai) Inc    510(k) NO: K202493(Traditional)
ATTN: Li  Zhiqing                 PHONE NO : 86 1891 7035908 
No.18 Jianding Road, Fengjing TownSE DECISION MADE: 04-FEB-21
Shanghai  CN 201502               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 4CIS SARA Spine System, 4CIS VERTU Spine System
Solco Biomedical Company India Pri510(k) NO: K202498(Traditional)
ATTN: Viral  Sheth                PHONE NO : 91 8511112597 
Survey No.1540, Beside Torrent PhaSE DECISION MADE: 18-FEB-21
Village-Rajpur  IN 382715         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Surgical Mask
Improve Medical (HuNan) Co., Ltd. 510(k) NO: K202511(Traditional)
ATTN: Wang  Jing                  PHONE NO : 86 159 89123029 
No. 6, Yizhang East Avenue, EconomSE DECISION MADE: 02-FEB-21
Yizhang  CN 424200                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EchoS Family
Echolight S.p.A.                  510(k) NO: K202514(Traditional)
ATTN: Giovanna  De Masi           PHONE NO : 39 0832 1592607 
Via Raffaello Sanzio, 18          SE DECISION MADE: 25-FEB-21
Lecce  IT 73100                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solax Electric Scooter (Model: S202261B)
Dongguan Prestige Sporting Goods C510(k) NO: K202549(Traditional)
ATTN: Zhang  Zhao                 PHONE NO : 86 137 63128800 
3rd Ind. District, Qiaotou Area, HSE DECISION MADE: 26-FEB-21
Dongguan  CN 523950               510(k) STATEMENT
                                                    

DEVICE: LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus
DiaSorin Inc.                     510(k) NO: K202573(Traditional)
ATTN: John C Walter               PHONE NO : 651 4399710 
1951 Northwestern Avenue          SE DECISION MADE: 18-FEB-21
Stillwater MN  55082              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus
DiaSorin Inc.                     510(k) NO: K202574(Traditional)
ATTN: John C Walter               PHONE NO : 651 4399710 
1951 Northwestern Avenue          SE DECISION MADE: 18-FEB-21
Stillwater MN  55082              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Standard Procedure Mask, Standard Surgical Mask
Jiangsu Medplus Non-woven Manufact510(k) NO: K202605(Traditional)
ATTN: Shuying  An                 PHONE NO : 86 527 80300123 
No.217 East Wencheng Road, EconomiSE DECISION MADE: 10-FEB-21
Siyang  CN 223700                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Catalyst OrthoScience R1 Reverse Shoulder System
Catalyst OrthoScience, Inc.       510(k) NO: K202611(Traditional)
ATTN: Dale  Davison               PHONE NO : 239 3259976 
14710 Tamiami Trail North         SE DECISION MADE: 12-FEB-21
Naples FL  34110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearCap Distal Attachment
Finemedix Co., Ltd.               510(k) NO: K202616(Traditional)
ATTN: Seok-Jun  Ma                PHONE NO : 82 53 7418388 
60, Maeyeo-ro, Dong-gu            SE DECISION MADE: 19-FEB-21
Daegu  KR 41065                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical Face Masks
Guilin HBM Sanitary Protections, I510(k) NO: K202627(Traditional)
ATTN: Liu  Xin                    PHONE NO : 86 0773 8569062 
No.1-2, Shuijing East Road, EconomSE DECISION MADE: 03-FEB-21
Guilin  CN 541805                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NOA Sleep Apnea and Snoring Device
Orthoapnea S.L.                   510(k) NO: K202651(Traditional)
ATTN: Jose  Repolles Llecha       PHONE NO : 34 9522 12174 154
C / Flauta Magica 22              SE DECISION MADE: 12-FEB-21
Malaga  ES 29006                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Parcus Titanium Interference Screws
Parcus Medical, LLC               510(k) NO: K202662(Traditional)
ATTN: Alejandra  Anderson         PHONE NO : 1 941 7557965 
6423 Parkland Drive               SE DECISION MADE: 22-FEB-21
Sarasota FL  34243                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60
Shenzhen LEPU Intelligent Medical 510(k) NO: K202687(Traditional)
ATTN: Aaron  Lin                  PHONE NO : 86 0755 86952278 
North side of floor 3, BLD 9 BaiWaSE DECISION MADE: 18-FEB-21
Shenzhen  CN 518055               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FLARE Single-Use Surgical Laser Fiber
Realton (Suzhou) Medical Technolog510(k) NO: K202702(Traditional)
ATTN: Mingzhu  Liu                PHONE NO : 086 0512 62868599 
601 Room, B8 Building, 218 Xinghu SE DECISION MADE: 26-FEB-21
Suzhou  CN 215123                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Monaco Rtp System
Elekta Solutions AB               510(k) NO: K202789(Traditional)
ATTN: Irina  Proutski             PHONE NO : 
Kungstensgatan 18, Box 7593       SE DECISION MADE: 23-FEB-21
Stockholm  SE SE-103 93           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Concerto Versa, Detachable Coil
Micro Therapeutics, Inc. d/b/a ev3510(k) NO: K202850(Traditional)
ATTN: Rita  De Rama               PHONE NO : 949 3084354 
9775 Toledo Way                   SE DECISION MADE: 09-FEB-21
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Prase PEEK Anterior Cervical Interbody Spacer
GBS Commonwealth Co., Ltd.        510(k) NO: K202872(Traditional)
ATTN: Jimmy  Kim                  PHONE NO : 82 2 69254469 
C-309, Woolim Lion's Valley, 168, SE DECISION MADE: 04-FEB-21
Geumcheon-gu  KR 08507            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann 4 mm Short Implants
Straumann USA, LLC                510(k) NO: K202942(Traditional)
ATTN: Chanrasmey N. White         PHONE NO : 978 7472500 
60 Minuteman Road                 SE DECISION MADE: 08-FEB-21
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StitchKit COMBO
Origami Surgical                  510(k) NO: K202950(Traditional)
ATTN: John  Gillespie             PHONE NO : 774 5670277 
79 Haven St.                      SE DECISION MADE: 23-FEB-21
Dover MA  02030                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Erisma LP Navigated Instruments
Clariance, SAS                    510(k) NO: K202956(Traditional)
ATTN: Fadwa  Bahr                 PHONE NO : 33 3 21161215 
18, Rue Robespierre               SE DECISION MADE: 26-FEB-21
Beaurains  FR 62217               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tixel System
Novoxel Ltd.                      510(k) NO: K202988(Traditional)
ATTN: Ronen  Shavit               PHONE NO : 972 52 2420798 
43 Hamelaha St.                   SE DECISION MADE: 25-FEB-21
Netanya  IL 4250573               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NinesMeasure
Nines, Inc.                       510(k) NO: K202990(Traditional)
ATTN: Russell  Stewart            PHONE NO : 650 9246159 
329 Alma St.                      SE DECISION MADE: 25-FEB-21
Palo Alto CA  94301               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: X-ray Flat Panel Detectors/CareView 3600RF
CareRay Digital Medical System Co.510(k) NO: K202995(Traditional)
ATTN: Leilei  Li                  PHONE NO : 86 512 86860288 
A2-201/B3-501, Biobay, 218 Xinghu SE DECISION MADE: 19-FEB-21
Suzhou  CN 215123                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spectral CT
Philips Medical Systems Nederland 510(k) NO: K203020(Traditional)
ATTN: Yaara  Oltchik              PHONE NO : 972 50 7119670 
Veenpluis 4-6                     SE DECISION MADE: 26-FEB-21
Best  NL 5684 PC                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker PEEK Customized Cranial Implant Kit
Stryker                           510(k) NO: K203055(Traditional)
ATTN: Zainab  Amini               PHONE NO : 269 2908072 
750 Trade Centre Way - Suite 200  SE DECISION MADE: 09-FEB-21
Portage MI  49002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HydroMID
Access Vascular Inc.              510(k) NO: K203069(Abbreviated)
ATTN: Brian  Hanley               PHONE NO : 781 5386594 101
175 Middlesex Turnpike Suite 1A   SE DECISION MADE: 08-FEB-21
Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MR Conditional Sticky Pad Electrode
Rhythmlink International, LLC     510(k) NO: K203079(Traditional)
ATTN: Gabriel  Orsinger           PHONE NO : 803 2521222 
1140 First Street South           SE DECISION MADE: 09-FEB-21
Columbia SC  29209                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MucoLock Oral Gel
PCCA, Inc.                        510(k) NO: K203091(Traditional)
ATTN: Gus  Bassani                PHONE NO : 832 2951218 
9901 S. Wilcrest Drive            SE DECISION MADE: 12-FEB-21
Houston TX  77099                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Synapse 3D, Synapse 3D Base Tools v6.1
Fujifilm Corporation              510(k) NO: K203103(Traditional)
ATTN: Randy  Vader                PHONE NO : 360 3566821 
26-30, Nishiazabu 2-Chome Minato-KSE DECISION MADE: 09-FEB-21
Tokyo  JP 106-8620                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SubtleMR
Subtle Medical, Inc.              510(k) NO: K203182(Traditional)
ATTN: Ajit  Shankaranarayanan     PHONE NO : 650 3978709 
883 Santa Cruz Ave Suite 205      SE DECISION MADE: 26-FEB-21
Menlo Park CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LYDUS Nitrile Examination Gloves, Powder Free
Nathan Trading Co., Ltd           510(k) NO: K203191(Third Party - Traditional)
ATTN: Chansamone  Saiyasak        PHONE NO : 66 81 8789953 
58 Moo 12 Palan Sub-District      SE DECISION MADE: 12-FEB-21
Nathan District  TH 34170         510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: iFuse-TORQ™ Implant System
SI-BONE, Inc.                     510(k) NO: K203247(Traditional)
ATTN: Susan  Noriega              PHONE NO : 650 7931966 
471 El Camino Real, Suite 101     SE DECISION MADE: 25-FEB-21
Santa Clara CA  95050             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 4K UHD Laparoscope
Scivita Medical Technology Co., Lt510(k) NO: K203255(Traditional)
ATTN: Ruqin  Wu                   PHONE NO : 86 512 81877788 
No. 8, Zhong Tian Xiang, Suzhou InSE DECISION MADE: 24-FEB-21
Suzhou  CN 215000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: nPro Surgical Mask
NP Medical Inc                    510(k) NO: K203265(Third Party - Abbreviated)
ATTN: Ruthann  Rapp               PHONE NO : 518 3310361 
101 Union Street                  SE DECISION MADE: 09-FEB-21
Clinton MA  01510                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers
Globus Medical Inc.               510(k) NO: K203278(Traditional)
ATTN: Kelly  Baker                PHONE NO : 610 9301800 
2560 General Armistead Ave.       SE DECISION MADE: 02-FEB-21
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bonelogic
Disior Ltd                        510(k) NO: K203290(Traditional)
ATTN: Markku  Laitinen            PHONE NO : 35 840 5430673 
Lapinlahdenkatu 16                SE DECISION MADE: 05-FEB-21
Helsinki  FI 00180                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Pilon Fusion System
Arthrex Inc.                      510(k) NO: K203294(Traditional)
ATTN: Samantha  Passman           PHONE NO : 239 6435553 71595
1370 Creekside Boulevard          SE DECISION MADE: 03-FEB-21
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CellFX System
Pulse Biosciences, Inc.           510(k) NO: K203299(Traditional)
ATTN: William  Knape              PHONE NO : 919 7572033 
3957 Point Eden Way               SE DECISION MADE: 02-FEB-21
Hayward CA  94545                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GentleWave X
Sonendo, Inc                      510(k) NO: K203302(Traditional)
ATTN: Lyle  VerPlanck             PHONE NO : 949 6677260 
26061 Merit Circle, Suite 102     SE DECISION MADE: 05-FEB-21
Laguna Hills CA  92653            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VIOLA
Vascular Graft Solutions, Ltd.    510(k) NO: K203307(Traditional)
ATTN: Orit  Yarden                PHONE NO : 972 54 3073050 
24 Raoul Wallenberg St            SE DECISION MADE: 17-FEB-21
Tel-Aviv  IL 6971921              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vitrea Software Package, VSTP-001A
Canon Medical Systems Corporation 510(k) NO: K203312(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 16-FEB-21
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SYMPHONY™ OCT System
Medos International Sarl          510(k) NO: K203319(Traditional)
ATTN: Eric  Zhu                   PHONE NO : 508 8283730 
Chemin Blanc 38                   SE DECISION MADE: 05-FEB-21
LeLocle  CH 2400                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C
HeiTaiDa Technology Co., Ltd.     510(k) NO: K203332(Special)
ATTN: Tom  Chen                   PHONE NO : 086 769 82658050 
4F, BaiShiDa High-Tech Park, XiangSE DECISION MADE: 25-FEB-21
DongGuan City  CN 523820          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The Citrefix Knotless Suture Anchor
Acuitive Technologies, Inc.       510(k) NO: K203334(Traditional)
ATTN: Matthew  Poggie             PHONE NO : 201 6612678 
50 Commerce Drive                 SE DECISION MADE: 05-FEB-21
Allendale NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann TLX Novaloc and Cementable Abutments
Institut Straumann AG             510(k) NO: K203355(Traditional)
ATTN: Laure Kuhner Borsenberger   PHONE NO : 41 61 9651111 
Peter Merian weg 12               SE DECISION MADE: 12-FEB-21
Basel  CH CH-4002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)
de Götzen S.r.l.                  510(k) NO: K203374(Abbreviated)
ATTN: Dario  Bandiera             PHONE NO : 39 0331 376760 
Via Roma, 45                      SE DECISION MADE: 05-FEB-21
Olgiate Olona  IT 21057           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TenoTac Soft Tissue Fixation System
Paragon 28, Inc                   510(k) NO: K203385(Traditional)
ATTN: Haylie  Hertz               PHONE NO : 303 7200017 
14445 Grasslands Dr.              SE DECISION MADE: 11-FEB-21
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FAST-FIX FLEX
Smith & Nephew, Inc.              510(k) NO: K203393(Traditional)
ATTN: Crystal  Morales            PHONE NO : 267 2665383 
7135 Goodlett Farms Parkway       SE DECISION MADE: 01-FEB-21
Cordova TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FITBONE(R) TAA
WITTENSTEIN intens GmbH           510(k) NO: K203399(Traditional)
ATTN: Hartmut  Kampa              PHONE NO : 49 7931 49310690 
Walter-Wittensstein-StraBe 1      SE DECISION MADE: 17-FEB-21
Igersheim  DE 97999               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lumify Diagnostic Ultrasound System
Philips Ultrasound, Inc.          510(k) NO: K203406(Traditional)
ATTN: Colin S. Jacob              PHONE NO : 425 9081209 
22100 Bothell Everett Highway     SE DECISION MADE: 23-FEB-21
Bothell WA  98021-8431            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Relivion
Neurolief Ltd.                    510(k) NO: K203419(Traditional)
ATTN: Michal  Kedar-Datel         PHONE NO : 972 9 3730288 
12 Giborei Israel St.             SE DECISION MADE: 16-FEB-21
Netanya  IL 4250412               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EcoFit® Hip System
Implantcast, GmbH                 510(k) NO: K203420(Traditional)
ATTN: Juliane  Hoppner            PHONE NO : 49 4161 7440 
Luneburger Schanze 26             SE DECISION MADE: 03-FEB-21
21614 Buxtehude  DE               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Face Mask (non-sterile)
Nantong Taiweishi Medical Technolo510(k) NO: K203426(Traditional)
ATTN: Zhang  Xuewen               PHONE NO : 86 187 61789767 
Taihangshan Road, New District, EcSE DECISION MADE: 18-FEB-21
Nan Tong  CN 226400               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Vinyl Examination Gloves
Shandong Zhushi Pharmaceutical Gro510(k) NO: K203439(Traditional)
ATTN: Junhui  Zhu                 PHONE NO : 86 157 64021131 
No.6 Shande Road, Shan County     SE DECISION MADE: 26-FEB-21
Heze  CN 274300                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Inbrace Orthodontic System
Swift Health Systems, Inc.        510(k) NO: K203442(Traditional)
ATTN: Alicia  Mszyca              PHONE NO : 949 7742239 
111 Academy, Suite 150            SE DECISION MADE: 19-FEB-21
Irvine CA  92617                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advanced Dental Appliance
DaSoft Partners                   510(k) NO: K203462(Abbreviated)
ATTN: Dante  Togliatti            PHONE NO : 619 4051530 
4079 Governor Drive #111          SE DECISION MADE: 19-FEB-21
San Diego CA  92122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LimaCorporate Kirschner Wire
Limacorporate S.p.A.              510(k) NO: K203475(Traditional)
ATTN: Ilaria  Giannuzzi           PHONE NO : 001817 385 0777 200
Via Nazionale, 52                 SE DECISION MADE: 05-FEB-21
Villanova di San Daniele  IT 33038510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Classic
Orthoapnea S.L.                   510(k) NO: K203477(Traditional)
ATTN: Jose Repolles Llecha        PHONE NO : 34 9522 12174 154
C / Flauta Magica 22              SE DECISION MADE: 25-FEB-21
Malaga  ES 29006                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ExtremiLOCK Lateral Ankle Fusion Plates
OsteoMed                          510(k) NO: K203479(Traditional)
ATTN: Andrew  Johnson             PHONE NO : 972 6774768 
3885 Arapaho Road                 SE DECISION MADE: 24-FEB-21
Addison TX  75001                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
Guilin HBM Health Protections, Inc510(k) NO: K203483(Traditional)
ATTN: Pu  Lei                     PHONE NO : 86 0773 8569061 
No.1-2, Shuijing East Road, EconomSE DECISION MADE: 01-FEB-21
Guilin  CN 541805                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: emField
Zimmer MedizinSysteme GmbH        510(k) NO: K203488(Traditional)
ATTN: Ute  Hauss                  PHONE NO : 49 731 9761216 
Junkersstrasse 9                  SE DECISION MADE: 19-FEB-21
Neu-Ulm  DE 89231                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FORE-SIGHT ELITE Absolute Tissue Oximeter
Edwards Lifesciences, LLC         510(k) NO: K203490(Traditional)
ATTN: Michelle  Ducca             PHONE NO : 949 2504113 
One Edwards Way                   SE DECISION MADE: 10-FEB-21
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MectaLock Extension
Medacta International SA          510(k) NO: K203493(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 22-FEB-21
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nissha Medical Technologies Neutral Electrodes
Nissha Medical Technologies LTD   510(k) NO: K203494(Traditional)
ATTN: Marcel  Salchner            PHONE NO : 43 512 219313 
Torbay Business Park, Woodview RoaSE DECISION MADE: 23-FEB-21
Paignton  GB TQ4 7HP              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IPL Hair removal
Shenzhen Weikai Technology CO.,LTD510(k) NO: K203510(Traditional)
ATTN: Jing  Li                    PHONE NO : 86 0755 83374619 
FL402, Building A, No.466 Jinbi RoSE DECISION MADE: 26-FEB-21
Shenzhen  CN 518118               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SLENDERTONE Evolve Abs, Type 735
Bio-Medical Research Ltd          510(k) NO: K203513(Special)
ATTN: Eoin  Keating               PHONE NO : 353 91 774300 
Parkmore Business Park West       SE DECISION MADE: 10-FEB-21
Galway  IE H91 NHT7               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surn5 Electrosurgical Argon Beam Generator and Accessories
Surnic Corporation                510(k) NO: K203522(Traditional)
ATTN: Helen  Xie                  PHONE NO : 1 909 8599055 
480 Apollo Street, Suite D.       SE DECISION MADE: 22-FEB-21
Brea CA  92821                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Masks
Bain Medical Equipment (Guangzhou)510(k) NO: K203524(Traditional)
ATTN: Mu  Fanzhen                 PHONE NO : 86 20 66856868 287
No.10 Juncheng Road, Eastern Area,SE DECISION MADE: 25-FEB-21
Guangzhou  CN 510760              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems
SEDECAL SA                        510(k) NO: K203537(Abbreviated)
ATTN: Ma Luisa  Gomez de Aguero   PHONE NO : 34 91 6280544 
C/ Pelaya, 9-13 Pol. Ind. Rio de JSE DECISION MADE: 01-FEB-21
Algete  ES 28110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: gammaCore Sapphire
Electrocore, Inc.                 510(k) NO: K203546(Traditional)
ATTN: Mike  Romaniw               PHONE NO : 973 2900097 
150 Allen Road, Suite 201         SE DECISION MADE: 12-FEB-21
Basking Ridge NJ  07920           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation 510(k) NO: K203553(Traditional)
ATTN: Janine F Reyes              PHONE NO : 714 6697853 
1385 Shimoshigami                 SE DECISION MADE: 02-FEB-21
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing
Encore Medical, L.P.              510(k) NO: K203557(Traditional)
ATTN: Teffany  Hutto              PHONE NO : 512 8346255 
9800 Metric Blvd.                 SE DECISION MADE: 10-FEB-21
Austin TX  78758                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hoffmann LRF System
Stryker GmbH                      510(k) NO: K203568(Traditional)
ATTN: Sanja  Jahr                 PHONE NO : 201 8316797 
325 Corporate Drive               SE DECISION MADE: 01-FEB-21
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RESPONSE Navigation Instruments
OrthoPediatrics, Corp.            510(k) NO: K203573(Traditional)
ATTN: Yan  Li                     PHONE NO : 574 2670868 
2850 Frontier Drive               SE DECISION MADE: 04-FEB-21
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System
Perimeter Medical Imaging AI, Inc.510(k) NO: K203578(Special)
ATTN: Elizabeth  Munro            PHONE NO : 416 8568124 
359 Eastern Avenue, Suite 110     SE DECISION MADE: 25-FEB-21
Toronto  CA M4M 1B7               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QUIBIM Precision Prostate (qp-Prostate)
QUIBIM S.L.                       510(k) NO: K203582(Traditional)
ATTN: Angel  Alberich Bayarri     PHONE NO : 34 961 243225 
Avenida Aragón 30, 12th floor, OffSE DECISION MADE: 04-FEB-21
Valencia  ES 46021                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ELEOS™ Limb Salvage System
Onkos Surgical                    510(k) NO: K203588(Traditional)
ATTN: Matthew  Vernak             PHONE NO : 551 5791081 
77 East Halsey Rd                 SE DECISION MADE: 05-FEB-21
Parsippany NJ  07054              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Omnichroma Flow Bulk
Tokuyama Dental Corporation       510(k) NO: K203598(Traditional)
ATTN: Keith A. Baritt             PHONE NO : 202 7835070 
38-9 Taitou 1-chome               SE DECISION MADE: 03-FEB-21
Taitou-ku  JP 110-0016            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Monopolar Hook
Human Xtensions Ltd.              510(k) NO: K203603(Traditional)
ATTN: Maija  Wallenstein          PHONE NO : 972 77 3630300 
Meir Ariel 4                      SE DECISION MADE: 01-FEB-21
Netanya  IL 4250574               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments
Intuitive Surgical, Inc.          510(k) NO: K203632(Traditional)
ATTN: Kunal  Gunjal               PHONE NO : 909 5252027 
1266 Kifer Road, Building 101     SE DECISION MADE: 10-FEB-21
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioPoly Great Toe Hemiarthroplasty Implant
BioPoly, LLC                      510(k) NO: K203634(Traditional)
ATTN: Herb  Schwartz              PHONE NO : 260 9996135 
7136 Gettysburg Pike              SE DECISION MADE: 02-FEB-21
Fort Wayne IN  46804              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Patient Monitoring Cables
JKH USA, LLC                      510(k) NO: K203635(Traditional)
ATTN: Bill Quanqin Dai            PHONE NO : 909 9299896 
20505 Valley Blvd. Suite 108      SE DECISION MADE: 05-FEB-21
Walnut CA  91789                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cuptimize
Cuptimize, Inc.                   510(k) NO: K203651(Traditional)
ATTN: Noah  Wollowick             PHONE NO : 617 6696794 
2840 West Bay Drive, Unit #163    SE DECISION MADE: 26-FEB-21
Belleair Bluffs FL  33770         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STOP U Model UXV Device
Pollogen Ltd.                     510(k) NO: K203665(Special)
ATTN: Ayala  Kamil                PHONE NO : 972 3 5104110 
6 kaufman St.                     SE DECISION MADE: 25-FEB-21
Tel Aviv  IL 6801298              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EzRay M (Model: VMX-P300)
Vatech Co., Ltd                   510(k) NO: K203667(Traditional)
ATTN: Daniel  Kim                 PHONE NO : 82 31 3799492 
13, Samsung 1-ro 2-gil            SE DECISION MADE: 02-FEB-21
Hwaseong-si  KR 18449             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Extra Large Check-Flo Introducer
Cook Incorporated                 510(k) NO: K203670(Traditional)
ATTN: Reuben  Lidster             PHONE NO : 812 3353575 104866
P.O. Box 489, 750 Daniels Way     SE DECISION MADE: 16-FEB-21
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vinyl Examination Gloves (Yellow)
Xinying Trading CO., LTD.         510(k) NO: K203702(Traditional)
ATTN: Tongguang  Liu              PHONE NO : 86 177 53110186 
Garden Street                     SE DECISION MADE: 12-FEB-21
Dezhou  CN 253000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JuggerKnot Soft Anchor
Riverpoint Medical                510(k) NO: K203740(Traditional)
ATTN: Amanda  Cole                PHONE NO : 503 5178001 
825 NE 25th Ave.                  SE DECISION MADE: 12-FEB-21
Portland OR  97232                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Eustachi Ear Pressure Relief Device
Exercore, LLC                     510(k) NO: K203754(Traditional)
ATTN: Kevin  Connelly             PHONE NO : 888 4060668 
8170 Old Carriage Court N, Suite 2SE DECISION MADE: 19-FEB-21
Shakopee MN  55379                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 4D Integrated Treatment Console
Varian Medical Systems, Inc.      510(k) NO: K203766(Special)
ATTN: Peter J. Coronado           PHONE NO : 650 4246320 
3100 Hansen Way                   SE DECISION MADE: 12-FEB-21
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PreXion3D Explorer PRO
PreXion Corporation               510(k) NO: K203784(Traditional)
ATTN: Hiroaki  Takahashi          PHONE NO : 81 3 52977551 
1-14-1 Kandasuda-cho              SE DECISION MADE: 23-FEB-21
Chiyoda-ku  JP 101-0041           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture
Medos International Sarl          510(k) NO: K203794(Special)
ATTN: Elizabeth  Messana          PHONE NO : 508 8283150 
Chemin-Blanc 38, Case Postale     SE DECISION MADE: 01-FEB-21
Le Locle  CH CH 2400              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Global Med Systems Milesman Compact Laser
Global Med Systems SL             510(k) NO: K203804(Traditional)
ATTN: Fernando  Diez              PHONE NO : 34 654 897087 
Av/ Padre Isla 127                SE DECISION MADE: 23-FEB-21
Leon  ES 24008                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System
Stryker GmbH                      510(k) NO: K203819(Traditional)
ATTN: Jemin  Dedania              PHONE NO : 201 8316461 
325 Corporate Drive               SE DECISION MADE: 26-FEB-21
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Laser Treatment System, Model: NYX and Grace
Canadian Pioneer Medical Technolog510(k) NO: K210033(Traditional)
ATTN: Rashid Reza Mirsayah        PHONE NO : 
Unit 2 -210 Drumlin Circle, ConcorSE DECISION MADE: 26-FEB-21
Vaughan  CA L4K 3E3               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System
Aegis Spine                       510(k) NO: K210035(Traditional)
ATTN: Kay  Kwon                   PHONE NO : 
9781 S. Meridian Blvd, Ste 300    SE DECISION MADE: 16-FEB-21
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Carnation Ambulatory Monitor (CAM)
Bardy Diagnostics, Inc.           510(k) NO: K210036(Special)
ATTN: Jocelyn  Kersten            PHONE NO : 425 7615912 
316 Occidental Avenue South Suite SE DECISION MADE: 05-FEB-21
Seattle WA  98104                 510(k) STATEMENT
                                                    

DEVICE: LVivo Software Application
DiA Imaging Analysis Ltd          510(k) NO: K210053(Special)
ATTN: Michal  Yaacobi             PHONE NO : 972 77 7648318 
77 Haenergia Street               SE DECISION MADE: 05-FEB-21
Beer-Sheva  IL 8470912            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cios Spin
Siemens Medical Systems USA, Inc. 510(k) NO: K210054(Special)
ATTN: Cordell  Fields             PHONE NO : 610 3063167 
40 Liberty Boulevard, 65-1A       SE DECISION MADE: 05-FEB-21
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cios Alpha
Siemens Medical Solutions USA, Inc510(k) NO: K210055(Special)
ATTN: Cordell  Fields             PHONE NO : 610 3063167 
40 Liberty Boulevard 65-1A        SE DECISION MADE: 05-FEB-21
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Freudenberg Surgical Mask
Freudenberg Performance Materials 510(k) NO: K210063(Third Party - Traditional)
ATTN: Eberhard  Link              PHONE NO : 919 3498389 
3500 Industrial Drive             SE DECISION MADE: 05-FEB-21
Durham NC  27704                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7
Penumbra, Inc.                    510(k) NO: K210083(Special)
ATTN: Teri  Nguyen                PHONE NO : 510 9952012 
One Penumbra Place                SE DECISION MADE: 09-FEB-21
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CATSmart, Automated Blood Processing Autotransfusion System
Fresenius Kabi AG                 510(k) NO: K210089(Special)
ATTN: Deepak  Mehta               PHONE NO : 847 5502666 
                                  SE DECISION MADE: 11-FEB-21
Bad Homburg  DE 61346             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rebar Micro Catheter
Micro Therapeuatics, Inc. d/b/a ev510(k) NO: K210114(Special)
ATTN: Catherine  Chiou            PHONE NO : 562 2863057 
9775 Toledo Way                   SE DECISION MADE: 16-FEB-21
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: s-Clean SQ-SL Implant System Regular
Dentis Co., Ltd.                  510(k) NO: K210132(Special)
ATTN: Gyu Ri Kim                  PHONE NO : 82 53 5893541 
99, Seongseoseo-ro, Dalseo-gu     SE DECISION MADE: 17-FEB-21
Daegu  KR 42718                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PhantomMSK Hip
OrthoGrid Systems, Inc            510(k) NO: K210136(Special)
ATTN: Trevor  Hafer               PHONE NO : 801 7937015 
3865 Wasatch Boulevard Suite 301  SE DECISION MADE: 18-FEB-21
Salt Lake City UT  84109          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EsoCheck Cell Collection Device
Lucid Diagnostics, Inc.           510(k) NO: K210137(Special)
ATTN: Lishan  Aklog               PHONE NO : 212 9494319 
One Grand Central Place, Suite 460SE DECISION MADE: 18-FEB-21
New York NY  10165                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Duo Expandable Interbody Fusion System
Spineology Inc.                   510(k) NO: K210155(Special)
ATTN: Andrew  Adams               PHONE NO : 651 2568534 
7800 3rd Street North Suite 600   SE DECISION MADE: 19-FEB-21
Saint Paul MN  55128              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DELTA XTEND Reverse Shoulder System
DePuy Orthopaedics Inc.           510(k) NO: K210167(Special)
ATTN: Megan  Bernier              PHONE NO : 651 3251178 
700 Orthopaedic Drive             SE DECISION MADE: 19-FEB-21
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set
Bemer INT. AG                     510(k) NO: K210174(Third Party - Traditional)
ATTN: Sandra  Schwarzenberger     PHONE NO : 423 3993999 
Austrasse 15                      SE DECISION MADE: 04-FEB-21
Triesen  LI 9495                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ClotTriever Thrombectomy System
Irani Medical, Inc.               510(k) NO: K210190(Special)
ATTN: Larry  Boucher              PHONE NO : 949 6008433 
9 Parker, Suite 100               SE DECISION MADE: 23-FEB-21
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: A.L.P.S. Clavicle Plating System
Biomet Inc.                       510(k) NO: K210192(Special)
ATTN: Kyle  Ponce                 PHONE NO : 908 8399069 
56 East Bell Drive                SE DECISION MADE: 19-FEB-21
Warsaw IN  46581                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Triever Catheters
Inari Medical                     510(k) NO: K210195(Special)
ATTN: Ellen  Nguyen               PHONE NO : 949 6008433 
9 Parker, Suite 100               SE DECISION MADE: 24-FEB-21
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioWaveGO  RX
BioWave Corporation               510(k) NO: K210202(Special)
ATTN: Bradford  Siff              PHONE NO : 203 2479020 
8 Knight Street, Suite 201        SE DECISION MADE: 24-FEB-21
Norwalk CT  06851                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Phenom Catheters
Micro Therapeutics, lnc. d/b/a ev3510(k) NO: K210230(Special)
ATTN: Prerana  Gurubasavaraj      PHONE NO : 949 2975804 
9775 Toledo Way                   SE DECISION MADE: 25-FEB-21
lrvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System
Roche Molecular Systems, Inc.     510(k) NO: K210234(Special)
ATTN: Kaitlyn  Hameister          PHONE NO : 
4300 Hacienda Drive               SE DECISION MADE: 16-FEB-21
Pleasanton CA  94588-2722         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CITRESPLINE and CITRELOCK ACL Implants
Acuitive Technologies, Inc.       510(k) NO: K210239(Special)
ATTN: Matthew  Poggie             PHONE NO : 201 6612678 
50 Commerce Drive                 SE DECISION MADE: 24-FEB-21
Allendale NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Air Compression Therapy Device, model HW6007
Konliking Tech & Dev. Limited     510(k) NO: K210240(Traditional)
ATTN: Jane  Chen                  PHONE NO : 86 13 713821827 
The 2nd Floor, Building D, No 168,SE DECISION MADE: 22-FEB-21
Shenzhen  CN 518115               510(k) STATEMENT
                                                    

DEVICE: iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System
Conformis Inc.                    510(k) NO: K210252(Special)
ATTN: Mary  Kruitwagen            PHONE NO : 781 3459038 
600 Technology Park Drive, 4th FloSE DECISION MADE: 17-FEB-21
Billerica MA  01821               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LTJ Screws and Washer
AzurMeds Inc.                     510(k) NO: K210268(Special)
ATTN: Jean-Marie  Berger          PHONE NO : 612 8107221 
4809 N Ravenswood Avenue Suite 119SE DECISION MADE: 26-FEB-21
Chicago IL  60604                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PowerDot PD-01MT2 Muscle Stimulator
Smartmissimo Technologies Pte Ltd 510(k) NO: K210269(Special)
ATTN: Alexey  Pisarev             PHONE NO : 65 83216256 
#28-01, SGX Centre II, 4 Shenton WSE DECISION MADE: 23-FEB-21
Singapore  SG 068807              510(k) STATEMENT
                                                    

DEVICE: LIAISON Anti-HAV
DiaSorin Inc.                     510(k) NO: K210272(Special)
ATTN: John C. Walker              PHONE NO : 651 4399710 
1951 Northwestern Ave             SE DECISION MADE: 09-FEB-21
Stillwater MN  55082              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Indigo Aspiration System - Lightning Aspiration Tubing
Penumbra, Inc.                    510(k) NO: K210323(Special)
ATTN: Micaela  Victoria           PHONE NO : 510 5897363 
One Penumbra Place                SE DECISION MADE: 26-FEB-21
Alameda CA  94501                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Green X 18(Model : PHT-75CHS)
Vatech Co., Ltd                   510(k) NO: K210329(Special)
ATTN: Daniel  Kim                 PHONE NO : 82 31 3799492 
13, Samsung 1-ro 2-gil            SE DECISION MADE: 18-FEB-21
Hwaseong-si  KR 18449             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PLPT LDV (Low Dead Volume) Sterile Syringe
Poonglim Pharmatech Inc.          510(k) NO: K210443(Traditional)
ATTN: Cho Hee Min                 PHONE NO : 82 63 4518141 
21, Jayumuyeok 1-gil              SE DECISION MADE: 16-FEB-21
Gunsan  KR                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EZ-Injec LDV Sterile Safety Needle
Poonglim Pharmatech Inc.          510(k) NO: K210444(Traditional)
ATTN: Cho Hee Min                 PHONE NO : 82 63 4518141 
21, Jayumuyeok 1-gil              SE DECISION MADE: 16-FEB-21
Gunsan  KR                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
              TOTAL 510(k)s THIS PERIOD   230                                     
              TOTAL WITH SUMMARIES        221                                     
              TOTAL WITH STATEMENTS        9
                                       
 
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