510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD December 2020
DEVICE: Aidite PMMA
Aidite (Qinhuangdao) Technology Co510(k) NO: K190217(Traditional)
ATTN: Zhang Wei PHONE NO : 86 335 8587898
No.9 Dushan Road,Economic and TechSE DECISION MADE: 17-DEC-20
Qinhuangdao CN 066000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fever Garde
HuBDIC Co., Ltd. 510(k) NO: K191978(Traditional)
ATTN: Shin Jae-Ho PHONE NO : 82 31 3899077
301, 53 Jeonpa-ro, Mana-gu, AnyangSE DECISION MADE: 18-DEC-20
Anyang-si KR 14084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Helix Genetic Health Risk App for late-onset Alzheimer’s disease
Helix OpCo, LLC 510(k) NO: K192073(Traditional)
ATTN: Gloria Lee PHONE NO : 647 2482577
96 Colbeck Street SE DECISION MADE: 23-DEC-20
Toronto CA M6S1 V2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wu's Electrical Scooter
Wu's Tech Co., Ltd. 510(k) NO: K192308(Traditional)
ATTN: Jen Ke-Min PHONE NO : 886 32382 105
No. 225, Yuan Peir St. SE DECISION MADE: 21-DEC-20
Hsin-Chu City TW 30093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fixone All Suture Anchor
AJU Pharm Co.,Ltd. 510(k) NO: K192709(Traditional)
ATTN: Kim Jung Gil PHONE NO : 82 31 7654420
A-207, 697, Pangyo-ro SE DECISION MADE: 15-DEC-20
Seongnam-si KR 13511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S dispensing line
AEA srl 510(k) NO: K192770(Traditional)
ATTN: Michele Mengoni PHONE NO : 39 073 1816689
via Fiume 16 SE DECISION MADE: 17-DEC-20
Angeli di Rosora IT 60030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zimmer Segmental System
Zimmer, Inc. 510(k) NO: K192798(Traditional)
ATTN: Yoriko Kobayashi PHONE NO : 574 3724222
1800 W. Center Street SE DECISION MADE: 10-DEC-20
Warsaw IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVA Lite DAPI dsDNA Crithidia luciliae Kit
Inova Diagnostics, Inc. 510(k) NO: K192916(Traditional)
ATTN: Carolina Auza PHONE NO : 858 5869900
9900 Old Grove Rd SE DECISION MADE: 11-DEC-20
San Diego CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLIMUS
HIRONIC Co., Ltd 510(k) NO: K192970(Traditional)
ATTN: Duk Ho Kong PHONE NO : 82 31 5257000
19F, 767, Sinsu-Ro, Suji-Gu SE DECISION MADE: 01-DEC-20
Yongin-Si KR 16827 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tricoglam Home Use
Advihair S.R.L. 510(k) NO: K193008(Traditional)
ATTN: Angleo D’Andrea PHONE NO : 39 051 7554
Via Benini 11 SE DECISION MADE: 03-DEC-20
Zola Predosa IT 40069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeuroAmp II, NeuroAmp II.5s
Corscience gmbH & Co. KG 510(k) NO: K193159(Traditional)
ATTN: Stefan Bolleininger PHONE NO : 49 9131 97798650
Hartmannstrasse 65 SE DECISION MADE: 30-DEC-20
Erlangen DE 91052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MBT Sepsityper
Bruker Daltonik GmbH 510(k) NO: K193419(Traditional)
ATTN: Peter Trinder PHONE NO : 49 42122 054798
Fahrenheitstrasse 4 SE DECISION MADE: 27-DEC-20
Bremen DE 28359 510(k) STATEMENT
DEVICE: Vagisan MoistCream Cremolum
Dr. August Wolff GmbH & Co. KG Arz510(k) NO: K193444(Traditional)
ATTN: Thomas Flototto PHONE NO : 49 521 8808460
Sudbrackstrasse 56 SE DECISION MADE: 04-DEC-20
Bielefeld DE D-33611 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20
Oxoid Limited (Part of Thermo Fish510(k) NO: K193508(Traditional)
ATTN: Philip Brame PHONE NO : 44 01256 694279
Wade Road SE DECISION MADE: 04-DEC-20
Basingstoke GB RG24 8PW 510(k) STATEMENT
DEVICE: Dynamic Gas Scavenging System 2 (DGSS - 2)
Anesthetic Gas Reclamation, Inc. 510(k) NO: K193646(Special)
ATTN: James Berry PHONE NO : 972 7977321
10606 Shady Trail #22 SE DECISION MADE: 04-DEC-20
Dallas TX 75220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set
Quanta Dialysis Technologies Ltd. 510(k) NO: K193670(Traditional)
ATTN: Chris Rule PHONE NO : 44 1789400043
Tything Road SE DECISION MADE: 23-DEC-20
Alcester GB B49 6EU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Posterior Fusion Plate, HA Posterior Fusion Plate
Spinal Simplicity LLC 510(k) NO: K200066(Traditional)
ATTN: Adam Rogers PHONE NO : 913 4514414
6600 College Blvd, Ste 220 SE DECISION MADE: 10-DEC-20
Overland Park KS 66211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Taperloc® Complete Hip Stems
Biomet Orthopedics 510(k) NO: K200196(Traditional)
ATTN: Genoa Atwood PHONE NO : 864 5539153
56 East Bell Drive, PO Box 587 SE DECISION MADE: 08-DEC-20
Warsaw IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exofin High Viscosity Topical Skin Adhesive
Chemence Medical, Inc. 510(k) NO: K200264(Traditional)
ATTN: Charnelle Thomas PHONE NO : 678 6890760
200 Technology Drive SE DECISION MADE: 17-DEC-20
Alpharetta GA 30005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CREED™ Cannulated Screws
GLW Medical Inc 510(k) NO: K200291(Traditional)
ATTN: Arundhati Radhakrishnan PHONE NO : 201 2683281
300 Sylan Ave SE DECISION MADE: 16-DEC-20
Englewood Cliff NJ 07632 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Novaerus NV1050
Novaerus US Inc 510(k) NO: K200321(Traditional)
ATTN: Declan Kiely PHONE NO : 203 6620800
35 Melrose Place SE DECISION MADE: 28-DEC-20
Stamford CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L
Olympus Medical Systems Corp. 510(k) NO: K200342(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 17-DEC-20
Hachioji-shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wrist Type Blood Pressure Monitor
Avita Corporation 510(k) NO: K200346(Traditional)
ATTN: Amber Dong PHONE NO : 886 2 85121568
9F, No.78, Sec. 1, Kwang-Fu Road, SE DECISION MADE: 17-DEC-20
New Taipei City TW 24158 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Columbus Guidewire
Rapid-Medical Ltd. 510(k) NO: K200374(Traditional)
ATTN: Orit Yaniv PHONE NO : 972 72 2503331
Carmel Building, POB 337 SE DECISION MADE: 14-DEC-20
Yokneam IL 2069205 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration
Navbit Pty Ltd 510(k) NO: K200376(Traditional)
ATTN: David Thomson PHONE NO : 61 433 482325
Suite 1A, 136 Willoughby Road SE DECISION MADE: 10-DEC-20
Crows Nest AU 2065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORISE ProKnife
Boston Scientific Corporation 510(k) NO: K200404(Traditional)
ATTN: Jennifer Edouard PHONE NO : 508 6836134
300 Boston Scientific Way SE DECISION MADE: 03-DEC-20
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Image Quality Analyzer (IQA)
VisionQuest BioMedical, Inc. 510(k) NO: K200422(Traditional)
ATTN: Gilberto Zamora PHONE NO : 505 5081994
2501 Yale Blvd SE #301 SE DECISION MADE: 24-DEC-20
Albuquerque NM 87106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acute Dual Lumen Hemodialysis Catheter
Health Line International Corporat510(k) NO: K200426(Traditional)
ATTN: Aaron G. Faulkner PHONE NO : 801 7737798
5675 West 300 South SE DECISION MADE: 24-DEC-20
Salt Lake City UT 84104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InBody
InBody Co. Ltd. 510(k) NO: K200442(Abbreviated)
ATTN: Koeun Jung PHONE NO : 82 02 5013939
InBody Bldg., 625. Eonju-ro, GangnSE DECISION MADE: 04-DEC-20
Seoul KR 06106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tailored-C Cervical Interbody Fusion System
BeSpoke Technologies 510(k) NO: K200458(Traditional)
ATTN: Daniel Hoehn PHONE NO : 314 4940313
118 S. Cherry St, Suite E SE DECISION MADE: 28-DEC-20
Winston-Salemn NC 27101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SoloAsisst II, Voice Control
AKTORmed GmbH 510(k) NO: K200473(Traditional)
ATTN: Andreas Mohr PHONE NO : 49 9401 9320150
Borsigstraße 13 SE DECISION MADE: 22-DEC-20
Barbing DE 93092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lucero Medical Cervical Cage System
Lucero Medical, LLC 510(k) NO: K200549(Traditional)
ATTN: Lee Strnad PHONE NO : 330 6590855
6815 West Streetsboro SE DECISION MADE: 16-DEC-20
Richfield OH 44286 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Planmeca Romexis
Planmeca Oy 510(k) NO: K200572(Traditional)
ATTN: Lars Moring PHONE NO : 358 20 7795500
Asentajankatu 6 SE DECISION MADE: 02-DEC-20
Helsinki FI 00880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Customized Contour Implant
Implantech Associates Inc. 510(k) NO: K200610(Traditional)
ATTN: Craig Arthur PHONE NO : 805 3399415
6025 Nicolle St., Suite B SE DECISION MADE: 23-DEC-20
Ventura CA 93003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens
Visco Vision Inc 510(k) NO: K200618(Traditional)
ATTN: Evan Huang PHONE NO : 886 3359 6868
No. 1, Xingye St., Guishan Dist., SE DECISION MADE: 07-DEC-20
Taoyuan City TW 33341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DeRoyal Temperature Monitoring Probe
DeRoyal Industries, Inc. 510(k) NO: K200631(Traditional)
ATTN: Sarah Bennett PHONE NO : 865 3626112
200 DeBusk Lane SE DECISION MADE: 23-DEC-20
Powell TN 37849 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TubeClear System
Actuated Medical, Inc. 510(k) NO: K200646(Traditional)
ATTN: Michael T. Britton PHONE NO : 814 3550003
310 Rolling Ridge Dr. SE DECISION MADE: 04-DEC-20
Bellefonte PA 16823 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)
AtriCure Inc. 510(k) NO: K200697(Traditional)
ATTN: Melissa Smallwood PHONE NO : 513 6444736
7555 Innovation Way SE DECISION MADE: 23-DEC-20
Mason OH 45040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electronic Blood Pressure Monitor
Shenzhen Pango Electronic Co., Ltd510(k) NO: K200716(Traditional)
ATTN: Xioyun Yang PHONE NO : 86 755 33825988
No.25, 1st Industrial Park, FenghuSE DECISION MADE: 04-DEC-20
Shenzhen CN 518115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive Navigation.S Instruments
NuVasive, Incorporated 510(k) NO: K200719(Traditional)
ATTN: Adan Alfaro PHONE NO : 858 7360370
7475 Lusk Blvd. SE DECISION MADE: 02-DEC-20
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: pjur WOMAN Nude pjur med SENSITIVE glide
pjur group Luxembourg SA 510(k) NO: K200730(Traditional)
ATTN: Andrea Giebel PHONE NO : 352 748989
87 esplanade de la Moselle SE DECISION MADE: 17-DEC-20
Wasserbillig LU L-6637 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Body Thermometer
HeiTaiDa Technology Co., Ltd. 510(k) NO: K200781(Traditional)
ATTN: Tom Chen PHONE NO : 86 769 82658050
4F, BaiShiDa High-Tech Park, XiangSE DECISION MADE: 09-DEC-20
DongGuan City CN 523820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System
L&K BIOMED Co., Ltd. 510(k) NO: K200789(Special)
ATTN: KiHyang Kim PHONE NO : 82 10 54770325
#201, #202 16-25, Dongbaekjungang-SE DECISION MADE: 04-DEC-20
Yongin-si KR 17015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electric wheelchair (Model: S7012)
Dongguan Prestige Sporting Goods C510(k) NO: K200857(Traditional)
ATTN: Zhang Zhao PHONE NO : 86 13763 128800
3rd Ind. District, Qiaotou Area, HSE DECISION MADE: 17-DEC-20
Dongguan CN 523950 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System
Dexcom, Inc. 510(k) NO: K200876(Traditional)
ATTN: Maryam Amini PHONE NO : 858 2036715
6310 Sequence Dr. SE DECISION MADE: 04-DEC-20
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B-Secur HeartKey Software Library
B-Secur Ltd. 510(k) NO: K200884(Traditional)
ATTN: David Brown PHONE NO : 44 2890737800
20 Queens Rd. SE DECISION MADE: 07-DEC-20
Belfast GB BT3 9DT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iSMILE
3D Diagnostix Inc. 510(k) NO: K200908(Traditional)
ATTN: Ehab Amin PHONE NO : 1 617 8205279
24 Denby Road SE DECISION MADE: 22-DEC-20
Allston MA 02134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BeamSite
DoseOptics LLC 510(k) NO: K200940(Traditional)
ATTN: Venkat Krishnaswamy PHONE NO : 256 4688173
16 Cavendish Ct SE DECISION MADE: 11-DEC-20
Lebanon NH 03766 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Accu-Joint Hemi Implant
Accufix Surgical, Inc. 510(k) NO: K200951(Traditional)
ATTN: Michael Parisi PHONE NO : 203 2587082
385 Main Street, Suite 10 SE DECISION MADE: 08-DEC-20
West Haven CT 06516 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XR-MX/1000
KARL STORZ Endoscopy America, Inc.510(k) NO: K200965(Traditional)
ATTN: Winkie Wong PHONE NO : 424 2188379
2151 E Grand Ave SE DECISION MADE: 29-DEC-20
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R
INSUNG MEDICAL CO., LTD. 510(k) NO: K200968(Traditional)
ATTN: Tae-il An PHONE NO : 82 33 8123800
168, Gieopdosi-Ro, Jijeong-Myeon, SE DECISION MADE: 28-DEC-20
Gangwon-Do KR 26354 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Self-Contained Biological Indicator
True Indicating LLC 510(k) NO: K200970(Traditional)
ATTN: Thomas Riha PHONE NO : 248 9826492
946 Kane St SE DECISION MADE: 28-DEC-20
Toledo OH 43612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 308nm Excimer System
Xuzhou Kernel Medical Equipment Co510(k) NO: K200971(Traditional)
ATTN: Jing Wang PHONE NO : 86 516 87732209
Kernel Mansion, Economic DevelopmeSE DECISION MADE: 15-DEC-20
Xuzhou CN 221004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M Attest Rapid Readout Biological Indicator
3M Company 510(k) NO: K200996(Traditional)
ATTN: Mary Fretland PHONE NO : 651 7372296
3M Center, Building 275-5W-06 SE DECISION MADE: 11-DEC-20
St.Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Callaly Tampliner
Calla Lily Personal Care, Ltd. 510(k) NO: K201003(Traditional)
ATTN: Shaun Knights PHONE NO : 44 759269 4078
10 Rose &Crown Yard SE DECISION MADE: 07-DEC-20
London GB SW1Y 6RE 510(k) STATEMENT
DEVICE: AcQMap High Resolution Imaging and Mapping System
Acutus Medical, Inc. 510(k) NO: K201015(Traditional)
ATTN: Serena Sanginthirath PHONE NO : 442 2326178
2210 Faraday Ave, Suite 100 SE DECISION MADE: 01-DEC-20
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NRFit® Caps, Male and Female Neuraxial Tip Caps
International Medical Industries, 510(k) NO: K201031(Traditional)
ATTN: David Melly PHONE NO : 954 9179570 283
2981 Gateway Drive SE DECISION MADE: 16-DEC-20
Pompano Beach FL 33069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PlaniMax Orthodontic Software
Choice Biotech Inc. 510(k) NO: K201036(Traditional)
ATTN: Tyler Kuo PHONE NO : 886 6 5057289
Rm. C, 4F, No.13, Nanke 3rd Rd., XSE DECISION MADE: 22-DEC-20
Tainan City TW 74147 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HepaFat-AI
Resonance Health Analysis Services510(k) NO: K201039(Traditional)
ATTN: Alison Laws PHONE NO : 61 89 2865300
141 Burswood Road SE DECISION MADE: 07-DEC-20
Burswood AU 6100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Automated ankle brachial pressure index measuring device, MESI mTABLET system
Mesi D.O.O.; Mesi, Development of 510(k) NO: K201046(Traditional)
ATTN: Jakob Susteric PHONE NO : 00386 1 6203487
Leskoskova cesta 11A SE DECISION MADE: 11-DEC-20
Ljubljana SI 1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161
Ensemble Orthopedics, LLC 510(k) NO: K201072(Traditional)
ATTN: Sandie Roth PHONE NO : 512 6660880
107 Redbud Trail, Suite 11 SE DECISION MADE: 02-DEC-20
Austin TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter
Becton, Dickinson and Company 510(k) NO: K201075(Traditional)
ATTN: Kimberly Geisler PHONE NO : 1 801 8341499
9450 South State Street SE DECISION MADE: 18-DEC-20
Sandy UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Strados Remote Electronic Stethoscope Platform (RESP)
Strados Labs 510(k) NO: K201077(Traditional)
ATTN: Nicholas Delmonico PHONE NO : 484 4523768
1315 Walnut Street, Suite 1101 SE DECISION MADE: 20-DEC-20
Philadelphia PA 19107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter
Philips Medical System Nederland B510(k) NO: K201081(Traditional)
ATTN: Gert De Vries PHONE NO : 31 618 206281
Veenpluis 4-6 SE DECISION MADE: 17-DEC-20
Best NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Physica system
LimaCorporate S.p.A. 510(k) NO: K201084(Traditional)
ATTN: Michela Zanotto PHONE NO : 39 043 2945511
Via Nazionale 52 SE DECISION MADE: 14-DEC-20
Villanova di San Daniele del Friul510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Resascope RS-01/B
Advanced Medical Systems Group SRL510(k) NO: K201113(Traditional)
ATTN: Francesco Sgarbi PHONE NO : 39 04 29719378
Via Europa 12 SE DECISION MADE: 21-DEC-20
San Pietro Viminario IT 35020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath
Coloplast Corp 510(k) NO: K201165(Traditional)
ATTN: Cori Ragan PHONE NO : 612 5975106
1601 West River Road North SE DECISION MADE: 17-DEC-20
Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AireHealth NebulizerTM
AireHealth Inc. 510(k) NO: K201167(Traditional)
ATTN: Rusty Kelly PHONE NO : 407 2520414
3251 Progess Dr., Suite F SE DECISION MADE: 03-DEC-20
Orlando FL 32826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vortex Radial Spray Catheter
CSA Medical, Inc. 510(k) NO: K201183(Traditional)
ATTN: Heather V Nigro PHONE NO : 781 5384793
91 Hartwell Ave SE DECISION MADE: 07-DEC-20
Lexington MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: microINR System
iLine Microsystems S.L. 510(k) NO: K201185(Traditional)
ATTN: Miren Itaso Hormaeche PHONE NO : 34 94300 5651
Paseo Mikeletegi, 69 SE DECISION MADE: 18-DEC-20
San Sebastian-Donostia ES 20009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pasteur Pipette 3mL, Pasteur Pipette 1mL
HertART Aps 510(k) NO: K201213(Traditional)
ATTN: Per Svensson PHONE NO : 46 0 317218028
Gustaf Werners gata 2 SE DECISION MADE: 16-DEC-20
Vastra Frolunda SE SE-421 32 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuEra Tight Family, EMS Model
Bios s.r.l. 510(k) NO: K201239(Traditional)
ATTN: Maurizio Bianchi PHONE NO : 39 02273 04275 215
Via Guido Rossa 10/12 SE DECISION MADE: 31-DEC-20
Vimodrone IT 20090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SQuEEZ Software
Cardiowise, Inc. 510(k) NO: K201250(Traditional)
ATTN: John Coats PHONE NO : 479 5712592
535 W. Research Center Blvd., SuitSE DECISION MADE: 18-DEC-20
Fayetteville AR 72701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation
Smith & Nephew 510(k) NO: K201253(Traditional)
ATTN: Konrad Wolfmeyer PHONE NO : 901 2652909
7135 Goodlett Farms Parkway SE DECISION MADE: 08-DEC-20
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use
Set Medikal Sanayi Ve Ticaret Anon510(k) NO: K201284(Abbreviated)
ATTN: Mehice Ozturk PHONE NO : 90 212 6220400
Osmangazi Mahallesi Maresal Fevzi SE DECISION MADE: 14-DEC-20
Istanbul TR 34522 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Impulse Interbody Fusion System
DeGen Medical 510(k) NO: K201287(Traditional)
ATTN: Craig Black PHONE NO : 843 9924551
1321-C North Cashua Drive SE DECISION MADE: 22-DEC-20
Florence SC 29501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TTBIO EVOCLEAN Ultrasonic Scaler
TTBIO CORP. 510(k) NO: K201317(Traditional)
ATTN: Sheng-Chieh Su PHONE NO : 886 4 23595958
2F, NO.7, 6TH Road Industry Park SE DECISION MADE: 04-DEC-20
Taichung TW 40755 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HANAROSTENT Trachea/Bronchium (CCC)
M.I. Tech Co., Ltd. 510(k) NO: K201342(Traditional)
ATTN: Inae Kim PHONE NO : 82 704304 7450
174, Habuk 2-gil, Jinwi-myeon SE DECISION MADE: 31-DEC-20
Pyeongtaek-si KR 17706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENS & PMS
Hong Qiangxing (Shen Zhen) Electro510(k) NO: K201354(Traditional)
ATTN: Linda Liao PHONE NO : 86 75526 423665
4F, Jingcheng Building, Xicheng InSE DECISION MADE: 11-DEC-20
Shenzhen CN 518126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulse Oximeter
Shenzhen Raysintone Technology CO.510(k) NO: K201384(Traditional)
ATTN: Xingbao Yang PHONE NO : 86 0755 27407409
Zone C, 4th Floor, F Building, XinSE DECISION MADE: 07-DEC-20
Shenzhen CN 518106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Scrambler Therapy Technology (Model ST-5A)
Delta International Services & Log510(k) NO: K201458(Abbreviated)
ATTN: Mariella Giorgieri PHONE NO : 039 392 1603399
Piazza Adriana 4 SE DECISION MADE: 23-DEC-20
Rome IT 00193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mini Spike Plus 6/8R
B. Braun Medical Inc. 510(k) NO: K201469(Traditional)
ATTN: Angela J. Caravella PHONE NO : 610 5962966
901 Marcon Boulevard SE DECISION MADE: 09-DEC-20
Allentown PA 18109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Traveler38 0.038" Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set
Argon Medical Devices, Inc. 510(k) NO: K201489(Traditional)
ATTN: Amy Clendening-Wheeler PHONE NO : 903 6764276
1445 Flat Creek Road SE DECISION MADE: 22-DEC-20
Athens TX 75751 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neodent Implant System - Zirconia Implant System
JJGC Industria e Comercio de Mater510(k) NO: K201491(Traditional)
ATTN: Mariana Soares Hartmann PHONE NO : 55 41 21694000
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 22-DEC-20
Curitiba BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Maxxi Flow Sensor
Neurovirtual USA, INC. 510(k) NO: K201495(Traditional)
ATTN: Eduardo Faria PHONE NO : 786 6938200
3303 W Commercial Blvd #100 SE DECISION MADE: 14-DEC-20
Fort Lauderdale FL 33309 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Stone Extraction basket
Hangzhou AGS MedTech Co., Ltd. 510(k) NO: K201509(Traditional)
ATTN: Chunqi Han PHONE NO : 86 571876 71223
Building 5, Building 6, No.597 KanSE DECISION MADE: 16-DEC-20
Hangzhou CN 311106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROFEMUR® GLADIATOR® Cemented Classic Stem
MicroPort Orthopedics Inc. 510(k) NO: K201519(Traditional)
ATTN: Kristen Russell PHONE NO : 901 4516510
5677 Airline Road SE DECISION MADE: 10-DEC-20
Arlington TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlowTriever Retrieval/Aspiration System
Inari Medical 510(k) NO: K201541(Traditional)
ATTN: Eben Gordon PHONE NO : 949 6008433
9 Parker, Suite 100 SE DECISION MADE: 04-DEC-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EchoGo Pro
Ultromics Ltd 510(k) NO: K201555(Traditional)
ATTN: Melissa Clark PHONE NO : 203 9064644
4630 Kingsgate, Cascade Way, OxforSE DECISION MADE: 18-DEC-20
Oxford GB OX4 2SU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Primelase Excellence
High Technology Products SLU 510(k) NO: K201594(Traditional)
ATTN: Sergi Lozano PHONE NO : 934 588566
Pasaje Masoliver 24 SE DECISION MADE: 17-DEC-20
Barcelona ES 08005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Plasdent Disposable Barrier Sleeves and Barrier Film
Plasdent Corporation 510(k) NO: K201604(Traditional)
ATTN: Belen G Walayat PHONE NO : 909 6200289 106
969 Price Street SE DECISION MADE: 23-DEC-20
Pomona CA 91767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LacriJet®
FCI (France Chirurgie Instrumentat510(k) NO: K201606(Traditional)
ATTN: Thierry Fetick PHONE NO : 33 153 989898
20-22 rue Louis Armand SE DECISION MADE: 18-DEC-20
Paris FR 75015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Face Mask
Shandong Shengquan New Material Co510(k) NO: K201629(Traditional)
ATTN: Xiumei Zhang PHONE NO : 86 1386 4136816
Diaozhen Industrial Development ZoSE DECISION MADE: 14-DEC-20
Jinan CN 250204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ChoiceSpine Tiger Shark Cervical Spacer System
ChoiceSpine, LLC 510(k) NO: K201643(Traditional)
ATTN: Kim Finch PHONE NO : 865 2433969
400 Erin Drive SE DECISION MADE: 22-DEC-20
Knoxville TN 37919 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hamilton-C6
Hamilton Medical AG 510(k) NO: K201658(Traditional)
ATTN: Annemarie Weideli PHONE NO : 41 58 6101225
Via Crush 8 SE DECISION MADE: 11-DEC-20
Bonaduz CH 7402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ReVene Thrombectomy Catheter
Vetex Medical, Ltd. 510(k) NO: K201705(Traditional)
ATTN: Mark Bruzzi PHONE NO : 353 091 394795
Business Innovation Center, NUI GaSE DECISION MADE: 22-DEC-20
Galway IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Opallis, Opallis Flow
Dentscare LTDA 510(k) NO: K201707(Traditional)
ATTN: Roberta Uyara PHONE NO : 55 47344 16131
Av. Edgar Nelson Meister, 474 SE DECISION MADE: 22-DEC-20
Joinville BR 89219-501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARES Screw - Retained Bars and Bridges (SRBB)
Medentika GmbH 510(k) NO: K201711(Traditional)
ATTN: Alexandra Schulz PHONE NO : 49 07229 699120
Hammweg 8-10 SE DECISION MADE: 08-DEC-20
Hügelsheim DE 76549 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Z5-TL
Z-Systems AG 510(k) NO: K201712(Traditional)
ATTN: Rubino DiGirolamo PHONE NO : 41 62 3886969
Werkhofstrasse 5 SE DECISION MADE: 01-DEC-20
Oensingen CH CH-4702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Mask
Zhende Medical Co., Ltd 510(k) NO: K201729(Traditional)
ATTN: Chen Ming PHONE NO : 86 575 88770363
Gaobu Town SE DECISION MADE: 03-DEC-20
Shaoxing CN 312035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PlaDuo System
ShenB Co Ltd 510(k) NO: K201735(Traditional)
ATTN: Oskar Lee PHONE NO : 82 70 49122702
ShenB Bldg 148 Seongsui-ro SE DECISION MADE: 14-DEC-20
Seoul KR 04796 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Deep Learning Image Reconstruction for Gemstone Spectral Imaging
GE Medical Systems, LLC 510(k) NO: K201745(Traditional)
ATTN: Katelyn Rowley PHONE NO : 262 3095888
3000 N. Grandview Blvd. SE DECISION MADE: 10-DEC-20
Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 8-CH Electroencephalography Amplifier
HippoScreen Neurotech Corp. 510(k) NO: K201747(Traditional)
ATTN: William Lan PHONE NO : 886 2 87978060
2F., No. 578, Ruiguang Rd., Neihu SE DECISION MADE: 27-DEC-20
Taipei City TW 11492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JianYu Surgical Mask
Jiangsu JianYu Health Medical Co.,510(k) NO: K201754(Traditional)
ATTN: Andy Shu PHONE NO : 86 519 82445588
No. 88 Longxi Avenue, Zhulin Town,SE DECISION MADE: 30-DEC-20
Changzhou CN 213241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System
SeaSpine Orthopedics Corporation 510(k) NO: K201755(Traditional)
ATTN: Aly Alvarez PHONE NO : 619 8844342
5770 Armada Drive SE DECISION MADE: 15-DEC-20
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Foley Balloon Catheter for Urology
Apollon co., Ltd. 510(k) NO: K201776(Traditional)
ATTN: Donghyuk Shin PHONE NO : 82 70 42249790
M-1804/3203, 32, Songdogwahak-ro, SE DECISION MADE: 30-DEC-20
Incheon KR 21984 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Uni-FuZe-P Bone Putty
Zavation Medical Products, LLC 510(k) NO: K201781(Traditional)
ATTN: Steve Gordon PHONE NO : 601 9191119
220 Lakeland Parkway SE DECISION MADE: 28-DEC-20
Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)
NANORAY Co., Ltd. 510(k) NO: K201800(Traditional)
ATTN: Won Hyun Sung PHONE NO : 82 53 9604900
#401, #402, #403, #408, #409, 76, SE DECISION MADE: 28-DEC-20
Daegu KR 41061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-Tack Endoscopic HeliX Tacking System
Apollo Endosurgery, Inc. 510(k) NO: K201808(Traditional)
ATTN: Natalie Allen PHONE NO : 956 5015049
1120 S. Capital of Texas Hwy SE DECISION MADE: 15-DEC-20
Austin TX 78749 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YUWELL Infrared Thermometer
Jiangsu Yuyue Medical Equipment & 510(k) NO: K201864(Traditional)
ATTN: Caixia Yang PHONE NO : 0511 869 00827
Yunyang Industrial Park, Danyang, SE DECISION MADE: 07-DEC-20
Danyang CN 212300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biomonitor III, Biomonitor IIIm
Biotronik, Inc. 510(k) NO: K201865(Traditional)
ATTN: Jon Brumbaugh PHONE NO : 888 3450374
6024 Jean Road SE DECISION MADE: 08-DEC-20
Lake Oswego OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Mask
Xiamen Probtain Medical Techology 510(k) NO: K201893(Traditional)
ATTN: MR./MRS. Kangjianli PHONE NO : 86 592 7557106
4th Floor, No.1 Building, No.6 Ji'SE DECISION MADE: 09-DEC-20
Xiamen CN 361100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMR 140° Reverse Humeral Body
LimaCorporate S.p.A. 510(k) NO: K201905(Traditional)
ATTN: Giuseppe Valenti PHONE NO : 39 04329 45511
Via Nazionale 52 SE DECISION MADE: 17-DEC-20
Villanova di San Daniele del Friul510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZTrack
Neurologic LLC 510(k) NO: K201910(Traditional)
ATTN: Sridevi Sarma PHONE NO : 617 8759380
6500 Tucker Avenue SE DECISION MADE: 22-DEC-20
McLean VA 22101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blue Sky Bio TAD
Blue Sky Bio, LLC. 510(k) NO: K201919(Traditional)
ATTN: Sharon Nichols PHONE NO : 718 3760422
800 Liberty Drive SE DECISION MADE: 17-DEC-20
Libertyville IL 60048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Braces on Demand Bracket
Braces on Demand, Inc 510(k) NO: K201940(Traditional)
ATTN: Colin Corey PHONE NO : 925 8997066
422 South Broadway, Suite 223 SE DECISION MADE: 03-DEC-20
Hicksville NY 11801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TempTraq
Blue Spark Technologies Inc. 510(k) NO: K201977(Traditional)
ATTN: John Gannon PHONE NO : 440 2495421
806 Sharon Drive, Suite G SE DECISION MADE: 03-DEC-20
Westlake OH 44145 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer
Contec Medical Systems Co., Ltd. 510(k) NO: K201980(Traditional)
ATTN: Xueyong Li PHONE NO : 86 355 8015490
No.112 Qinhuang West Street, EconoSE DECISION MADE: 18-DEC-20
Qinhuangdao CN 066004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Monocryl Plus Antibacterial Suture
Ethicon Inc. 510(k) NO: K201996(Traditional)
ATTN: Joice Pappan PHONE NO : 718 4191838
Route 22 West, P.O. Box 151 SE DECISION MADE: 21-DEC-20
Somerville NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NovoFine Plus 32G Tip x 4 mm
Novo Nordisk Inc. 510(k) NO: K202005(Traditional)
ATTN: Hiral Palkhiwala Shah PHONE NO : 609 7877603
P.O Box 846 SE DECISION MADE: 19-DEC-20
Plainsboro NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System
ArthroCare Corporation 510(k) NO: K202006(Traditional)
ATTN: Jean Asquith PHONE NO : 512 6805802
7000 West William Cannon Drive, BuSE DECISION MADE: 18-DEC-20
Austin TX 78749 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blue Sky Bio CAD-CAM Abutments
Blue Sky Bio, LLC 510(k) NO: K202026(Traditional)
ATTN: Michele Kupcso PHONE NO : 718 3760422
800 Liberty Drive SE DECISION MADE: 18-DEC-20
Libertyville IL 60048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: dermalux Flex MD
Aesthetic Technology Ltd 510(k) NO: K202028(Traditional)
ATTN: Dale Needham PHONE NO : 44 0845 6891789
Unit 211 Europa Blvd SE DECISION MADE: 16-DEC-20
Warrington GB WA5 7TN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Surgical Mask
Beijing Biosis Healing Biological 510(k) NO: K202029(Traditional)
ATTN: Ting Jiang PHONE NO : 86 10 61252660 816
No.6 plant west, Valley No.1 Bio-mSE DECISION MADE: 16-DEC-20
Beijing CN 102600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: aprevo Intervertebral Body Fusion Device
Carlsmed, Inc. 510(k) NO: K202034(Traditional)
ATTN: Mike Cordonnier PHONE NO : 760 2051195
4250 Executive Sq. Ste. 200 SE DECISION MADE: 03-DEC-20
La Jolla CA 92037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CryoTreQ
VitreQ B.V. 510(k) NO: K202038(Traditional)
ATTN: Christian Neele PHONE NO : 31 0181 745090
Segglant-Noord 2 SE DECISION MADE: 30-DEC-20
Vierpolders NL 3237MG 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Face mask
Jiangsu Province Jianerkang Medica510(k) NO: K202061(Traditional)
ATTN: Hongfang Tang PHONE NO : 86 135 85416869
No.1 Jianerkang Road, Zhixi IndustSE DECISION MADE: 23-DEC-20
Changzhou CN 213251 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BASE4 Disposable Medical Mask
Base4 Group, Inc. 510(k) NO: K202069(Abbreviated)
ATTN: Jon Filipski PHONE NO : 972 3316619
4393 Sunbelt Drive SE DECISION MADE: 01-DEC-20
Addison TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CreoDent Solidex Customized Abutment and Screw
CreoDent Prosthetics, Ltd. 510(k) NO: K202095(Traditional)
ATTN: Calvin Shim PHONE NO : 212 3023860
29 West 30th Street, 11th Floor SE DECISION MADE: 16-DEC-20
New York NY 10001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: actiTENS
Sublimed 510(k) NO: K202159(Traditional)
ATTN: Corinne Bulteau PHONE NO : 33 04 76933715
137 Rue De Mayoussard SE DECISION MADE: 22-DEC-20
Moirans FR 38430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulse Oximeter
Shenzhen AOJ Medical Technology Co510(k) NO: K202173(Traditional)
ATTN: Wendy Lin PHONE NO : 86 13 631601525
601, 6th floor, B2 Building, An'leSE DECISION MADE: 07-DEC-20
Shenzhen CN 518126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Graffiti
GE Medical Systems Information Tec510(k) NO: K202189(Traditional)
ATTN: Camille Vidal PHONE NO : 240 2805356
9900 W Innovation Dr. SE DECISION MADE: 08-DEC-20
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Surgical Face Masks
Guangdong Kaidi Garments Co.,Ltd 510(k) NO: K202211(Traditional)
ATTN: MR./MRS. Vicky PHONE NO : 86 754 83718111
Shenxiyang Industrial Zone, FengshSE DECISION MADE: 22-DEC-20
Shantou CN 515000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Irrisept Wound Debridement and Cleansing System
Irrimax Corporation 510(k) NO: K202222(Traditional)
ATTN: Christy Coleman PHONE NO :
1665 Lakes Parkway - Suite 102 SE DECISION MADE: 14-DEC-20
Lawrenceville GA 30043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lim Precision Steerable TS, Steerable Sheath, Dilator
Keystone Heart, Ltd. 510(k) NO: K202226(Traditional)
ATTN: Jaime Sarabia PHONE NO : 972 4 6158000
15 Halamish Street, PO Box 3170 SE DECISION MADE: 15-DEC-20
Caesaria IL 3088900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AI Metrics
AI Metrics, LLC 510(k) NO: K202229(Traditional)
ATTN: Andrew D. Smith PHONE NO : 769 6106235
432 Renaissance Dr. SE DECISION MADE: 22-DEC-20
Hoover AL 35226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXXT MATRIXX Stand Alone ALIF System
Nexxt Spine LLC 510(k) NO: K202230(Traditional)
ATTN: Andy Elsbury PHONE NO : 317 4367801
14425 Bergen Blvd, Suite B SE DECISION MADE: 15-DEC-20
Noblesville IN 46060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JADE
OrbusNeich Medical (Shenzhen) Co.,510(k) NO: K202231(Traditional)
ATTN: Daniel Zhang PHONE NO : 86 755 83580181
No.1 Jinkui Road, Futian Free TradSE DECISION MADE: 10-DEC-20
Shenzhen CN 518038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Locking device
Hangzhou AGS MedTech Co., Ltd. 510(k) NO: K202237(Traditional)
ATTN: Yanping Fu PHONE NO : 86 571 87671223
Building 5, Building 6, No.597 KanSE DECISION MADE: 23-DEC-20
Hangzhou CN 311106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V30 system, V20 system, V10 system, V-VR Hand piece
Viora Ltd. 510(k) NO: K202247(Traditional)
ATTN: Simona F Krant PHONE NO : 972 9 9551344
6 Hagavish Street SE DECISION MADE: 09-DEC-20
Netanya IL 4250706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Attune Revision Sleeve LPS Femoral Adaptors
DePuy Ireland UC 510(k) NO: K202248(Traditional)
ATTN: Erin Combs PHONE NO : 574 3727211
Loughbeg Ringaskiddy SE DECISION MADE: 28-DEC-20
Co. Cork IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neocis Guidance System (NGS) with Yomi Plan v2.0
Neocis Inc. 510(k) NO: K202264(Traditional)
ATTN: Thomas E. Claiborne PHONE NO : 631 7938945
2800 Biscayne Blvd Suite 600 SE DECISION MADE: 04-DEC-20
Miami FL 33137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles
Isoray Medical, Inc. 510(k) NO: K202267(Traditional)
ATTN: Leslie White PHONE NO : 509 3751202
350 Hills St, Suite 106 SE DECISION MADE: 31-DEC-20
Richland WA 99354 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CrossRoads Tray System
CrossRoads Extremity Systems, LLC 510(k) NO: K202268(Traditional)
ATTN: Kim Strohkirch PHONE NO : 901___ 2218406
6055 Primacy Pkwy, Suite 140 SE DECISION MADE: 30-DEC-20
Memphis TN 38119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device
K1 Medical LLC 510(k) NO: K202270(Traditional)
ATTN: Jospeh Azary PHONE NO : 203 2426670
56 Newton Road SE DECISION MADE: 02-DEC-20
Woodbridge CT 06525 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CorPath GRX System
Corindus, Inc. 510(k) NO: K202275(Traditional)
ATTN: Dana Hartlein PHONE NO : 508 6533335 215
309 Waverley Oaks Road, Suite 105 SE DECISION MADE: 11-DEC-20
Waltham MA 02452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
Stryker GmbH 510(k) NO: K202289(Traditional)
ATTN: Jonathan Schell PHONE NO : 484 8895804
325 Corporate Drive SE DECISION MADE: 16-DEC-20
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lucent XP, Lucent XP Curved
Spinal Elements, Inc. 510(k) NO: K202298(Traditional)
ATTN: Julie Lamothe PHONE NO : 760 6070125
3115 Melrose Dr. Suite 200 SE DECISION MADE: 22-DEC-20
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System
Brainlab AG 510(k) NO: K202320(Traditional)
ATTN: Cunico Chiara PHONE NO : 49 89 9915680
Olof-Palme-Str. 9 SE DECISION MADE: 23-DEC-20
Munich DE 80809 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sim&Size
Sim&Cure 510(k) NO: K202322(Traditional)
ATTN: Caroline Oziel PHONE NO : 33 95 3438809
95 rue Pierre Flourens Batiment H SE DECISION MADE: 31-DEC-20
Montpellier FR 34090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fingertip Pulse Oximeter
Shenzhen BSX Technology Electronic510(k) NO: K202324(Traditional)
ATTN: Fang Kai PHONE NO : 86 755 28719103
Rm301.3F 8th Building, LiHao IndusSE DECISION MADE: 14-DEC-20
Shenzhen CN 518116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Impella XR Sheath Set
Abiomed Inc. 510(k) NO: K202330(Traditional)
ATTN: J. Kenneth Ryder PHONE NO : 978 6461400
22 Cherry Hill Drive SE DECISION MADE: 07-DEC-20
Danvers MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neuronaute
Bioserenity SAS 510(k) NO: K202334(Traditional)
ATTN: Julien Dupont PHONE NO : 33 683 970625
ICM-iPEPS, 47 Boulevard de l'HopitSE DECISION MADE: 10-DEC-20
Paris FR 75013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulsed electromagnetic field wrap
Hi-Dow International Inc. 510(k) NO: K202337(Traditional)
ATTN: Eric Chen PHONE NO : 314 5692888
2555 Metro Blvd SE DECISION MADE: 15-DEC-20
Maryland Heights MO 63043 510(k) STATEMENT
DEVICE: FlowTriever Retrieval/Aspiration System
Inari Medical 510(k) NO: K202345(Traditional)
ATTN: Eben Gordon PHONE NO : 949 6008433
9 Parker, Suite 100 SE DECISION MADE: 18-DEC-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: External Remote Controller ERC 4P
NuVasive Specialized Orthopedics, 510(k) NO: K202348(Traditional)
ATTN: Miriam Cervantes PHONE NO : 909 2297836
101 Enterprise, Suite 100 SE DECISION MADE: 22-DEC-20
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System
Shantou Institute of Ultrasonic In510(k) NO: K202353(Traditional)
ATTN: Flower Cai PHONE NO : 86 754 88250150
77 Jinsha Road SE DECISION MADE: 23-DEC-20
Shantou CN 515041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UltraSlim Digital, UltraSmooth Digital
Ward Photonics LLC 510(k) NO: K202361(Traditional)
ATTN: Terry Ward PHONE NO : 800 3925950
1980 N Atlantic Avenue SE DECISION MADE: 18-DEC-20
Cocoa Beach FL 32931 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Upper Arm Electronic Blood Pressure Monitor
Conmo Electronic Company Limited 510(k) NO: K202372(Traditional)
ATTN: Alice Qi PHONE NO : 86 755 28397469
Room 1402, Building No.10,ShenzhenSE DECISION MADE: 30-DEC-20
Shenzhen City CN 518126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Palm Care Latex Examination Powder Free Gloves
Hi-Care Thai Gloves Co. Ltd. 510(k) NO: K202377(Abbreviated)
ATTN: Daniel John PHONE NO : 66 92 2258472
199Moo.11, T. Banpru SE DECISION MADE: 01-DEC-20
Hat Yai TH 90250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Palm Care Blue Nitrile Examination Gloves Powder Free
Hi-Care Thai Gloves Co. Ltd. 510(k) NO: K202384(Abbreviated)
ATTN: Daniel John PHONE NO : 66 92 2258472
199Moo.11, T.Banpru SE DECISION MADE: 02-DEC-20
Hat Yai TH 90250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Apolo D / Apolo S
VMI Tecnologias LTDA 510(k) NO: K202388(Abbreviated)
ATTN: Siele Santos PHONE NO : 55 31 33703750
Rua Prefeito Elizeu Alves Da SilvaSE DECISION MADE: 01-DEC-20
Aparecido De Oliveira, Lagoa Santa510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClearRT Helical kVCT for the Radixact Treatment Delivery System
Accuray Incorporated 510(k) NO: K202412(Traditional)
ATTN: Keith Picker PHONE NO : 608 8243069
1240 Deming Way SE DECISION MADE: 18-DEC-20
Madison WI 53717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Magic UCLA Abutment System
InnoBioSurg Co., Ltd. 510(k) NO: K202418(Special)
ATTN: Sun-Mi Park PHONE NO : 82 42 9332879
44-19, Techno 10-ro, Yuseong-gu SE DECISION MADE: 03-DEC-20
Daejeon KR 34027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ControlRad Select Model Z
ControlRad, Inc 510(k) NO: K202431(Traditional)
ATTN: Chris Fair PHONE NO : 800 5225148
275 Scientific Drive NW #1100 SE DECISION MADE: 23-DEC-20
Norcross GA 30092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NobelProcera Zirconia Implant Bridge
Nobel Biocare AB 510(k) NO: K202452(Traditional)
ATTN: Bernice Jim PHONE NO : 41 79 8550073
Vastra Hamngatan 1 SE DECISION MADE: 03-DEC-20
Goteborg Gotlands Lan SE 411 17 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smart SPACE Shoulder System
TechMah Medical LLC 510(k) NO: K202454(Traditional)
ATTN: Mohamed R. Mahfouz PHONE NO : 1 877 7256920 104
2099 Thunderhead Rd., Suite 302 SE DECISION MADE: 28-DEC-20
Knoxville TN 37922 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems
Supersonic Imagine 510(k) NO: K202455(Special)
ATTN: Jacques Souquet PHONE NO : 33 442 992424
Les Jardins de la Duranne - Bat E&SE DECISION MADE: 29-DEC-20
Aix-en-Provence FR 13857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M5 Recorder
Global Instrumentation LLC 510(k) NO: K202456(Third Party - Abbreviated)
ATTN: Jason DeMaso PHONE NO : 315 6820272
8104 Cazenovia Road SE DECISION MADE: 29-DEC-20
Manlius NY 13104 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads
Fengh Medical Co., Ltd. 510(k) NO: K202467(Special)
ATTN: Jiao Liu PHONE NO : 0086 138 15132106
D3 No. 6 Dongsheng West Road, JianSE DECISION MADE: 14-DEC-20
Jiangyin CN 214437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft
PECA Labs 510(k) NO: K202471(Traditional)
ATTN: Doug Bernstein PHONE NO : 877 8422873
4424 Penn Ave, Suite 201 SE DECISION MADE: 11-DEC-20
Pittsburgh PA 15224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ImPACT Version 4
ImPACT Applications, Inc. 510(k) NO: K202485(Traditional)
ATTN: Michael Zagorski PHONE NO : 412 5678400
2140 Norcor Ave., Suite 115 SE DECISION MADE: 25-DEC-20
Coralville IA 52241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HealthJOINT
Zebra Medical Vision Ltd. 510(k) NO: K202487(Traditional)
ATTN: Flair Bar PHONE NO : 972 9 8827795
Shefayim Commercial Center PO Box SE DECISION MADE: 04-DEC-20
Shefayim IL 6099000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OmniTom Elite
NeuroLogica Corporation, a subsidi510(k) NO: K202526(Traditional)
ATTN: Ninad Gujar PHONE NO : 978 5648632
14 Electronics Avenue SE DECISION MADE: 23-DEC-20
Danvers MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AquaPulse Irrigation Tubing
GA Health Company Limited 510(k) NO: K202560(Traditional)
ATTN: Cindy Ye PHONE NO : 85 2 28339010
Unit 18, 21/F, Metropole Square, 2SE DECISION MADE: 10-DEC-20
Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAVICIDE-OPA MEC Indicator
Serim Research Corporation 510(k) NO: K202565(Traditional)
ATTN: Jackie Nelson PHONE NO : 574 2643440
3506 Reedy Drive SE DECISION MADE: 02-DEC-20
Elkhart IN 46514 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BNA Platform
elminda, Ltd 510(k) NO: K202588(Traditional)
ATTN: Keren Elghouzzi-KazachinskyPHONE NO : 972 53____ 7739780
1 Arie Skenkar Street SE DECISION MADE: 07-DEC-20
Herzliya IL 4672501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Transtek Wrist Blood Pressure Monitor
Guangdong Transtek Medical Electro510(k) NO: K202599(Traditional)
ATTN: Nicole Hu PHONE NO : 86 188 14069923
Zone B, No.105, Dongli Road, TorchSE DECISION MADE: 06-DEC-20
Zhongshan CN 528437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single-use Sterile medical laser fiber
Realton (Suzhou) Medical Technolog510(k) NO: K202601(Traditional)
ATTN: Mingzhu Liu PHONE NO : 086 0512 62868599
601 Room, B8 Building, 218 Xinghu SE DECISION MADE: 15-DEC-20
Suzhou CN 215123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ventrax Delivery System
Merit Medical Systems, Inc. 510(k) NO: K202610(Traditional)
ATTN: Elizabeth Lazaro PHONE NO : 610 6515093
1600 West Merit Parkway SE DECISION MADE: 14-DEC-20
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nordiwell Medical Face Mask
Changzhou Combat Protective Equipm510(k) NO: K202615(Traditional)
ATTN: Yanmei Song PHONE NO : 86 519 85190068
QingSiTang village, Henglin Town, SE DECISION MADE: 31-DEC-20
Changzhou CN 213101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Novapak Nasal Sinus Packing and Stent
Medtronic Xomed 510(k) NO: K202623(Traditional)
ATTN: Matthew Harmon PHONE NO : 513 4044495
6743 Southpoint Drive North SE DECISION MADE: 08-DEC-20
Jacksonville FL 32256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iHelmet Laser Comb
Slinph Technologies Co., Ltd 510(k) NO: K202631(Traditional)
ATTN: Jian Zou PHONE NO : 86 0755 83461353
Room 211, Building B, 1970 CulturaSE DECISION MADE: 08-DEC-20
Longhua, Shenzhen CN 518110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MY01 Continuous Compartmental Pressure Monitor
MY01, Inc. 510(k) NO: K202635(Traditional)
ATTN: Charles Allan PHONE NO : 855 7996901
400 De Maisonneuve Boulevard West,SE DECISION MADE: 10-DEC-20
Montreal CA H3A 1L4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: F3D Corpectomy System
CoreLink, LLC 510(k) NO: K202637(Traditional)
ATTN: Steven Mounts PHONE NO : 888 3497808
2072 Fenton Logistics Park Blvd. SE DECISION MADE: 23-DEC-20
St.Louis MO 63026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DNA/RNA Shield Collection Tube
Zymo Research 510(k) NO: K202641(Traditional)
ATTN: Julie Ogi PHONE NO : 949 6791190
17062 Murphy Ave. SE DECISION MADE: 14-DEC-20
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biofeedback Nerve and Muscle Stimulator
Shenzhen Konmed Technology Co., Lt510(k) NO: K202648(Traditional)
ATTN: Tony No Last Name Provided PHONE NO : 86 755 86704556
601, Building B4, Shenchengtou CreSE DECISION MADE: 08-DEC-20
Shenzhen CN 518118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Javelin Tailor's Bunion Fixation System
Nvision Biomedical Technologies, I510(k) NO: K202657(Traditional)
ATTN: Diana Langham PHONE NO : 210 5453713
4590 Lockhill Selma SE DECISION MADE: 14-DEC-20
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker Arthroscope
Stryker 510(k) NO: K202659(Special)
ATTN: Christie Samsa PHONE NO : 978 5001303
5900 Optical Court SE DECISION MADE: 01-DEC-20
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Evis Exera III Duodenovideoscope Olympus TJF-Q190V
Olympus Medical Systems Corp. 510(k) NO: K202661(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 08-DEC-20
Hachioji-shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable Protein
Medline Industries, Inc. 510(k) NO: K202668(Traditional)
ATTN: Jennifer Mason PHONE NO : 847 6433652
Three Lakes Drive SE DECISION MADE: 19-DEC-20
Northfield IL 60093 510(k) STATEMENT
DEVICE: X-cera Pre-shaded Zirconia Blanks
Dongguan Xiangtong Co., Ltd. 510(k) NO: K202673(Traditional)
ATTN: Charles Shen PHONE NO : 1 608 2179358
No.4, Tech 9th Rd, Hi-Tech IndustrSE DECISION MADE: 10-DEC-20
Dongguan CN 523808 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Promisemed Covered Safety Pen Needle
Promisemed Hangzhou Meditech Co., 510(k) NO: K202681(Special)
ATTN: Zearou Yang PHONE NO : 86 571 88772985
No. 1388 Cangxing Street, CangqianSE DECISION MADE: 31-DEC-20
Hangzhou City CN 311121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GMK Total Knee System - TiNbN Coating
Medacta International SA 510(k) NO: K202684(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91____ 6966060
Strada Regina SE DECISION MADE: 11-DEC-20
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Remunity Pump for Remodulin (treprostinil) Injection
DEKA Research and Development 510(k) NO: K202690(Traditional)
ATTN: Paul Smolenski PHONE NO : 603 2060371
340 Commercial Street SE DECISION MADE: 30-DEC-20
Manchester NH 03101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Prefilled Syringe
Hangzhou Primecare Medical Co., Lt510(k) NO: K202698(Traditional)
ATTN: Xueqing Yan PHONE NO : 86 133 57148752
Room 408-409, Zancheng Center WestSE DECISION MADE: 15-DEC-20
Hangzhou CN 310008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-Cath STIM acc. Tsui
PAJUNK GmbH Medizintechnologie 510(k) NO: K202699(Special)
ATTN: Christian G.H. Quass PHONE NO : 49 07704 9291586
Karl-Hall-Str 1 SE DECISION MADE: 29-DEC-20
Geisingen DE 78187 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GIA Stapler with Tri-Staple Technology
Covidien 510(k) NO: K202701(Special)
ATTN: Leo Chen PHONE NO : 86 21 33230182
Rooms 501, 502, 601, 602, No.3 buiSE DECISION MADE: 07-DEC-20
Min Hang District, Shanghai CN 20510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Gown (Sterile), Surgical Gown (Non-sterile)
B.J.ZH.F.Panther Medical Equipment510(k) NO: K202706(Traditional)
ATTN: Wenyue Han PHONE NO : 86 10 80789058
Floor 3, Building1, 28 Huoju StreeSE DECISION MADE: 31-DEC-20
Beijing CN 102200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quadra-P
Medacta International SA 510(k) NO: K202730(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 28-DEC-20
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADAPT for Gamma3
Stryker GmbH 510(k) NO: K202749(Traditional)
ATTN: Ugochi Okereke PHONE NO : 201 8315083
325 Corporate Drive SE DECISION MADE: 18-DEC-20
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: num Vapocoolant
623 Medical, LLC 510(k) NO: K202782(Traditional)
ATTN: Ty Schlander PHONE NO : 602 6143762
623 Davis Drive, Suite 100 SE DECISION MADE: 21-DEC-20
Morrisville NC 27522 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IdentiTi Cervical Standalone Interbody System
Alphatec Spine, Inc. 510(k) NO: K202812(Traditional)
ATTN: Ruby Zheng PHONE NO : 760 4946884
5818 El Camino Real SE DECISION MADE: 18-DEC-20
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Australis Anterior Lumbar Cage System
Prism Surgical Designs Pty Ltd 510(k) NO: K202820(Traditional)
ATTN: Emma May Young PHONE NO : 61 7 37208882
15/43 Lang Parade SE DECISION MADE: 22-DEC-20
Milton AU 4064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 308nm Excimer UV-light Skin Therapy System
Shenzhen GSD Tech Co., Ltd. 510(k) NO: K202827(Traditional)
ATTN: Zoe Yao PHONE NO : 86 15 018526594
Building A, JUNSD Hi-Tech Park, WeSE DECISION MADE: 15-DEC-20
Shenzhen CN 518106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
Intuitive Surgical, Inc. 510(k) NO: K202834(Traditional)
ATTN: Brandon Hansen PHONE NO : 408 5232100
1266 Kifer Road SE DECISION MADE: 10-DEC-20
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Auryon Atherectomy System
Eximo Medical Ltd. 510(k) NO: K202835(Special)
ATTN: Yoel Zabar PHONE NO : 972 8 6307639
Pekeris St 3 SE DECISION MADE: 02-DEC-20
Rehovot IL 7670203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GoSpiro
Monitored Therapeutics, Inc. 510(k) NO: K202837(Special)
ATTN: Michael Taylor PHONE NO : 614 7613555
5995 Shier Rings Road, Ste A SE DECISION MADE: 04-DEC-20
Dublin OH 43016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Everyway Analog OTC TENS, model N103A/N302
Everyway Medical Instruments Co., 510(k) NO: K202849(Traditional)
ATTN: Paul Hung PHONE NO : 886 2 26620038
3FL., No.5, Lane 155, Section 3, PSE DECISION MADE: 22-DEC-20
Shenkeng District, New Taipei City510(k) STATEMENT
DEVICE: Confirm Rx Insertable Cardiac Monitor
Abbott (St. Jude Medical) 510(k) NO: K202876(Special)
ATTN: Juni Sarkar PHONE NO : 818 2943429
15900 Valley View Ct. SE DECISION MADE: 01-DEC-20
Sylmar CA 91342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Affinity
Hermes Medical Solutions AB 510(k) NO: K202882(Traditional)
ATTN: Joakim Arwidson PHONE NO : 46 8 190325
Strandbergsgatan 16 SE DECISION MADE: 23-DEC-20
Stockholm SE 11251 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KARL STORZ ICG Imaging System
KARL STORZ Endoscopy_America, Inc.510(k) NO: K202925(Traditional)
ATTN: Alita McElroy PHONE NO : 424 2188376
2151 E. Grand Avenue SE DECISION MADE: 17-DEC-20
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: First Relief v1
DyAnsys, Inc 510(k) NO: K202940(Traditional)
ATTN: Srini Nageshwar PHONE NO : 408 4804700
300, North Bayshore Boulevard SE DECISION MADE: 29-DEC-20
San Mateo CA 94401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Da Vinci SP Surgical System
Intuitive Surgical, Inc. 510(k) NO: K202968(Traditional)
ATTN: Connor McCarty PHONE NO : 805 7984205
1266 Kifer Road SE DECISION MADE: 22-DEC-20
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DenTek Fresh Protect Dental Guard
Medtech Products, Inc. 510(k) NO: K202974(Traditional)
ATTN: Vincent Argiro PHONE NO : 914 5248721
660 White Plains Rd. SE DECISION MADE: 22-DEC-20
Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra
Lode B.V. 510(k) NO: K202979(Abbreviated)
ATTN: J.R. Fransens PHONE NO : 31 50 5712811
Zernikepark 16 SE DECISION MADE: 21-DEC-20
Groningen NL 9747 AN 510(k) STATEMENT
DEVICE: easy Hairfull
Y&J BIO Co., Ltd. 510(k) NO: K202983(Traditional)
ATTN: Kwang Sic Kim PHONE NO : 82 31 51803491
B-916, 947, Hanam-daero SE DECISION MADE: 08-DEC-20
Hanam-si KR 12982 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
ACIST Medical Systems, Inc. 510(k) NO: K203004(Special)
ATTN: Jeff Koll PHONE NO : 952 6562409
7905 Fuller Rd SE DECISION MADE: 17-DEC-20
Eden Prairie MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DVT-2600
Daesung Maref Co., LTD 510(k) NO: K203016(Special)
ATTN: Su Hyeon So PHONE NO : 82 314597211
298-24, Gongdan-Ro SE DECISION MADE: 05-DEC-20
Gunpo-si KR 15809 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AltiVate® Anatomic Pegged Glenoid with Markers
Encore Medical, L.P. 510(k) NO: K203026(Traditional)
ATTN: Teffany Hutto PHONE NO : 512 8346255
9800 Metric Blvd. SE DECISION MADE: 23-DEC-20
Austin TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMS Cementless Stem
Medacta International SA 510(k) NO: K203041(Special)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 02-DEC-20
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I
Canon Medical Systems Corporation 510(k) NO: K203042(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 10-DEC-20
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation 510(k) NO: K203053(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 02-DEC-20
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optiflux Series of Dialyzers F160NR, F180NR, F200NR
Fresenius Medical Care Renal Thera510(k) NO: K203062(Traditional)
ATTN: Denise Oppermann PHONE NO : 781 9969103
920 Winter Street SE DECISION MADE: 28-DEC-20
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOLIEF Cooled Radiofrequency Kit Advanced
Avanos Medical, Inc. 510(k) NO: K203066(Third Party - Traditional)
ATTN: Christian Supina PHONE NO : 844 4282667
5405 Windward Parkway, Suite 100 SE DECISION MADE: 22-DEC-20
Alpharetta GA 30004 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CombiDiagnost R90
Philips Medical Systems DMC GmbH 510(k) NO: K203087(Third Party - Traditional)
ATTN: Supriya Dalvi PHONE NO : 49 40 50782425
Roentgenstrasse 24-26 SE DECISION MADE: 03-DEC-20
Hamburg DE 22335 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ELEOS Limb Salvage System featuring BIOGRIP
Onkos Surgical 510(k) NO: K203090(Traditional)
ATTN: Matthew (Matt) Vernak PHONE NO : 551 5791081
77 East Halsey Rd SE DECISION MADE: 11-DEC-20
Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HydroMARK Breast Biopsy Site Markers
Devicor Medical Products, Inc 510(k) NO: K203097(Traditional)
ATTN: Rhonda M. Kops PHONE NO : 513 8649272
300 E-Business Way, Fifth Floor SE DECISION MADE: 16-DEC-20
Cincinnati OH 45241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClearPetra Suction-Evacuation Sheath
Well Lead Medical Co., LTD. 510(k) NO: K203119(Special)
ATTN: Jenny Zhu PHONE NO : 86 20 84758878
C-4# Jinhu Industrial Estate, HualSE DECISION MADE: 09-DEC-20
Guangzhou CN 511434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Invictus™ OCT Spinal Fixation System
Alphatec Spine, Inc. 510(k) NO: K203125(Traditional)
ATTN: Ruby Zheng PHONE NO : 760 4946884
5818 El Camino Real SE DECISION MADE: 18-DEC-20
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S10 Kirra
ResMed Pty Ltd 510(k) NO: K203126(Traditional)
ATTN: Peter Jennings PHONE NO : 612 88841000
1 Elizabeth Macarthur Drive SE DECISION MADE: 18-DEC-20
Bella Vista AU 2053 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ophthalmic Yag Laser System YC-200
Nidek Co., Ltd. 510(k) NO: K203130(Traditional)
ATTN: Tsutomu Sunada PHONE NO : 81 533 678901
34-14 Machama, Hiroishicho SE DECISION MADE: 07-DEC-20
Gamagori JP 443-0038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Venue Fit
GE Medical Systems Ultrasound and 510(k) NO: K203137(Traditional)
ATTN: Tracey Ortiz PHONE NO : 262 4701003
LLC 9900 W. Innovation Drive SE DECISION MADE: 29-DEC-20
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lux 35 Detector
Carestream Health 510(k) NO: K203159(Special)
ATTN: Gina Maiolo PHONE NO : 585 6276543
150 Verona St SE DECISION MADE: 02-DEC-20
Rochester NY 14608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advanix Biliary Stent with NaviFlex RX Delivery System
Boston Scientific Corporation 510(k) NO: K203162(Traditional)
ATTN: Elena Hennessey PHONE NO : 508 6834347
100 Boston Scientific Way SE DECISION MADE: 18-DEC-20
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARx Illiac Spinal Screw System
Life Spine, Inc. 510(k) NO: K203163(Traditional)
ATTN: Angela Batker PHONE NO : 847 8846117
13951 S. Quality Drive SE DECISION MADE: 17-DEC-20
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
PENTAX of America, Inc. 510(k) NO: K203166(Special)
ATTN: William Goeller PHONE NO : 201 5722300 2318
3 Paragon Drive SE DECISION MADE: 30-DEC-20
Montvale NJ 07645-1782 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOSAIQ Oncology Information System
Elekta Solutions AB 510(k) NO: K203172(Traditional)
ATTN: Melinda Smith PHONE NO : 1 678 2317791
Kungstensgatan 18, Box 7593 SE DECISION MADE: 18-DEC-20
Stockholm SE SE-10393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flexitouch Plus System
Tactile Systems Technology, Inc. (510(k) NO: K203178(Traditional)
ATTN: Brett Demchuk PHONE NO : 612 3555135
151 5th Ave NW Suite 100 SE DECISION MADE: 20-DEC-20
New Brighton MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex DynaNite Nitinol Staples
Arthrex Inc. 510(k) NO: K203180(Traditional)
ATTN: Rebecca R Homan PHONE NO : 239 6435553 73429
1370 Creekside Boulevard SE DECISION MADE: 16-DEC-20
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector
STERIS Corporation 510(k) NO: K203199(Special)
ATTN: Jennifer Nalepka PHONE NO : 440 3927458
5960 Heisley Road SE DECISION MADE: 01-DEC-20
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Omnia Medical TiBrid-SA
Omnia Medical, LLC 510(k) NO: K203207(Traditional)
ATTN: Troy Schifano PHONE NO : 304 4134851
6 Canyon Rd, Suite 300 SE DECISION MADE: 23-DEC-20
Morgantown WV 26508 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever
Stryker Neurovascular 510(k) NO: K203219(Traditional)
ATTN: Kathy Nguyen PHONE NO : 510 4132633
47900 Bayside Parkway SE DECISION MADE: 29-DEC-20
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERLA TL Posterior Osteosynthesis System
SPINEART 510(k) NO: K203222(Traditional)
ATTN: Franck Pennesi PHONE NO : 41 22 5701200
3 Chemin du Pré Fleuri SE DECISION MADE: 17-DEC-20
Plan Les Ouates CH 1228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Low Profile Screws
Arthrex Inc. 510(k) NO: K203239(Traditional)
ATTN: Samantha Passman PHONE NO : 1 239 6435553 71595
1370 Creekside Boulevard SE DECISION MADE: 30-DEC-20
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nucleus.io
NucleusHealth, LLC 510(k) NO: K203249(Third Party - Traditional)
ATTN: Zachary Wright PHONE NO : 858 5463400
13280 Evening Creek Dr. Ste 110 SE DECISION MADE: 04-DEC-20
San Diego CA 92128 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NuVasive ACP System
NuVasive, Incorporated 510(k) NO: K203253(Special)
ATTN: Jessica LeBlanc PHONE NO : 951 8160973
7475 Lusk Blvd. SE DECISION MADE: 03-DEC-20
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUBi Water Based Personal Lubricant
Boya Biotechnology Co., Ltd. 510(k) NO: K203257(Traditional)
ATTN: Jason Lau PHONE NO : 86 769 82881368
Floor3,#7, Changfu Rd., Ludong ComSE DECISION MADE: 23-DEC-20
Dongguan CN 523935 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X
medPhoton GmbH 510(k) NO: K203281(Traditional)
ATTN: Daniel Schaffarzick PHONE NO : 0043 699 16105406
Karolingerstraße 16 SE DECISION MADE: 22-DEC-20
Salzburg AT 5020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator
3M Company 510(k) NO: K203284(Special)
ATTN: Andrew Wingen PHONE NO : 651 7339209
2510 Conway Ave, Bldg 275-5W-06 SE DECISION MADE: 07-DEC-20
St. Paul MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M Comply Hydrogen Peroxide Indicator Tape 1228
3M Company 510(k) NO: K203285(Special)
ATTN: Mary Fretland PHONE NO : 651 7372296
3M Center, Building 275-5W-06 SE DECISION MADE: 10-DEC-20
St. Pauk MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD Horizon Spinal System Instruments
Medtronic Sofamor Danek USA, INC. 510(k) NO: K203291(Special)
ATTN: Erikka Edwardsen PHONE NO : 901 3992485
1800 Pyramid Place SE DECISION MADE: 08-DEC-20
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Emprint SX Ablation Platform with Thermosphere Technology
Covidien, LLC 510(k) NO: K203303(Special)
ATTN: Liron Bar-Yaakov PHONE NO : 303 5816668
5920 Longbow Dr SE DECISION MADE: 17-DEC-20
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cystoject Syringe Lever
UroGen Pharma Ltd 510(k) NO: K203321(Special)
ATTN: James G. Ottinger PHONE NO : 1 610 7451230
9 Ha'Ta'asiya Street SE DECISION MADE: 09-DEC-20
Ra'anana IL 4365405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Triever20 Curve Catheter
Inari Medical, Inc. 510(k) NO: K203333(Special)
ATTN: Ellen Nguyen PHONE NO : 949 6008433
9 Parker, Suite 100 SE DECISION MADE: 10-DEC-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Longeviti ClearFit Cranial Implant
Longeviti Neuro Solutions, LLC 510(k) NO: K203349(Special)
ATTN: Jesse Christopher PHONE NO : 410 5271803
303 International Circle Suite 190SE DECISION MADE: 16-DEC-20
Hunt Valley MD 21030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LineSider™ Spinal System
Integrity Implants Inc. 510(k) NO: K203367(Special)
ATTN: Lauren Kamer PHONE NO : 561 5293861
354 Hiatt Drive SE DECISION MADE: 03-DEC-20
Palm Beach Gardens FL 33418 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62
Philips Consumer Lifestyle - Innov510(k) NO: K203383(Special)
ATTN: Aurore Millet PHONE NO : 0031 6 18191888
High Tech Campus 37 SE DECISION MADE: 15-DEC-20
Eindhoven NL 5656 AE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neocis Guidance System (NGS) with Patient Splints (EPS)
Neocis Inc. 510(k) NO: K203401(Special)
ATTN: Thomas E. Claiborne PHONE NO : 631 7938945
2800 Biscayne Blvd Suite 600 SE DECISION MADE: 15-DEC-20
Miami FL 33317 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System
DePuy Synthes 510(k) NO: K203414(Special)
ATTN: Stacey Bonnell PHONE NO : 484 2387519
1301 Goshen Parkway SE DECISION MADE: 16-DEC-20
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Serranator PTA Serration Balloon Catheter
Cagent Vascular, LLC 510(k) NO: K203437(Special)
ATTN: Carol Burns PHONE NO : 610 6882006
150 Strafford Avenue #315 SE DECISION MADE: 22-DEC-20
Wayne PA 19087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trigon HA Stand-Alone Wedge Fixation System
Nvision Biomedical Technologies, I510(k) NO: K203445(Special)
ATTN: Diana Langham PHONE NO : 210 5453713
4590 Lockhill Selma SE DECISION MADE: 21-DEC-20
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement
Conformis Inc. 510(k) NO: K203447(Special)
ATTN: Mary Kruitwagen PHONE NO : 781 3459038
600 Technology Park Drive, 4th FloSE DECISION MADE: 22-DEC-20
Billerica MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nano FortiFix® System
Nanovis LLC 510(k) NO: K203452(Special)
ATTN: Matthew Hedrick PHONE NO : 877 9076266
5865 East State Rd. 14 SE DECISION MADE: 22-DEC-20
Columbia City IN 46725 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M Comply Hydrogen Peroxide Chemical Indicator 1248
3M Company 510(k) NO: K203458(Special)
ATTN: Yumi Wackerfuss PHONE NO : 651 7365286
3M Center, Building 275-5W-06 SE DECISION MADE: 11-DEC-20
St. Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aesculap Caiman 12 Seal and Cut Technology System
Aesculap Inc. 510(k) NO: K203461(Special)
ATTN: Omunique Luke PHONE NO : 484 5236868
3773 Corporate Parkway SE DECISION MADE: 18-DEC-20
Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WishBone Medical Plate and Screw System
WishBone Medical, Inc. 510(k) NO: K203467(Special)
ATTN: Mary Wentorf PHONE NO : 574 5279517
100 Capital Drive SE DECISION MADE: 23-DEC-20
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPERE Thrombectomy System
Vascular Medcure, INC. 510(k) NO: K203476(Special)
ATTN: Jeffrey P. DuMontelle PHONE NO : 714 9150886
1500 S. Sunkist ST. Suite H SE DECISION MADE: 22-DEC-20
Anaheim CA 92806 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Drakon and Sequre Microcatheters
Accurate Medical Therapeutics Ltd 510(k) NO: K203487(Special)
ATTN: Osnat Harbater PHONE NO : 972 543 386871
19 Eli Hurvitz Street SE DECISION MADE: 11-DEC-20
Rehovot IL 7608802 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cios Flow
Siemens Medical Solutions USA, Inc510(k) NO: K203504(Special)
ATTN: Cordell Fields PHONE NO : 610 3063167
40 Liberty Boulevard 65-1A SE DECISION MADE: 22-DEC-20
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BriefCase
Aidoc Medical, Ltd. 510(k) NO: K203508(Special)
ATTN: Nimrod Epstein PHONE NO : 972 73 7946870
3 Aminaday St. SE DECISION MADE: 29-DEC-20
Tel-Aviv IL 6706703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Baby Gorilla/Gorilla Plating System
Paragon 28, Inc. 510(k) NO: K203511(Special)
ATTN: Haylie Hertz PHONE NO : 888 7281888
14445 Grasslands Dr. SE DECISION MADE: 29-DEC-20
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bridge Occlusion Balloon
Spectranetics, Inc. 510(k) NO: K203540(Special)
ATTN: Sondra Chandler PHONE NO : 719 4825909
9965 Federal Drive SE DECISION MADE: 23-DEC-20
Colorado Springs CO 80921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories
Lumenis Ltd. 510(k) NO: K203544(Special)
ATTN: Shlomit Segman PHONE NO : 972 4 9599230
6 Hakidma Street PO Box 240 SE DECISION MADE: 24-DEC-20
Yokneam IL 2069204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alphenix, INFX-8000V/B, /S, V9.1
Canon Medical Systems Corporation 510(k) NO: K203551(Special)
ATTN: Paul Biggins PHONE NO : 714 7305000
1385 Shimoishigami SE DECISION MADE: 18-DEC-20
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rapid Reboot
Rapid Reboot Recovery Products, LL510(k) NO: K203552(Third Party - Traditional)
ATTN: David Johnson PHONE NO : 1 801 4714968
1396 W 200 S, Building 2, Unit A SE DECISION MADE: 22-DEC-20
Lindon UT 84042 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 276
TOTAL WITH SUMMARIES 269
TOTAL WITH STATEMENTS 7
