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
