| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K192554 |
12/13/2019 |
decimal3D |
.decimal, LLC. |
Kevin Erhart |
| K183676 |
12/19/2019 |
DentiqAir |
3D Industrial Imaging Co., Ltd. |
Bora Choi |
| K193254 |
12/23/2019 |
3M Attest Steam Chemical Integrator |
3M Company |
Mary Fretland |
| K183211 |
02/26/2019 |
3M Comply Hydrogen Peroxide Chemical Indicator |
3M Company |
Nadia Battah |
| K183209 |
02/15/2019 |
3M Comply Hydrogen Peroxide Indicator Tape |
3M Company |
Nadia Battah |
| K182440 |
02/26/2019 |
Body System |
A-1 Engineering |
Tony Picciano |
| K192267 |
12/17/2019 |
ILUMIEN System with AptiVue Software version D.3 |
Abbott Medical |
Anita Xavier |
| K193126 |
12/11/2019 |
HI-TORQUE InfilTrac Guide Wire Family |
Abbott Vascular |
Aniket Khakhadiya |
| K182259 |
02/07/2019 |
Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal |
ACell, Inc. |
Andrea Artman |
| K181577 |
02/07/2019 |
AcQMap High Resolution Imaging and Mapping System |
Acutus Medical, Inc. |
Greg Geissinger |
| K192471 |
12/20/2019 |
RHIN1 Stylus |
Aerin Medical Inc. |
Matthew M Hull |
| K183275 |
02/01/2019 |
DR 800 with Tomosynthesis |
Agfa N.V. |
Wim Govaerts |
| K192383 |
12/20/2019 |
BriefCase |
Aidoc Medical, Ltd. |
Nimrod Epstein |
| K193069 |
12/04/2019 |
AIROS 6 Sequential Compression Device |
AIROS Medical, Inc. |
Darren Behuniak |
| K193068 |
12/04/2019 |
AIROS 8 Sequential Compression Device |
AIROS Medical, Inc. |
Darren Behuniak |
| K190045 |
02/06/2019 |
DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives |
Alcon Laboratories, Inc. |
Heather Smith |
| K191379 |
12/04/2019 |
RELiZORB |
Alcresta Therapeutics, Inc. |
Eric First |
| DEN180014 |
12/02/2019 |
WOUNDCHEK Bacterial Status |
Alere Scarborough, Inc. |
Angela Drysdale |
| K190659 |
12/02/2019 |
Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Cl |
Allwin Medical Devices, Inc. |
Digish Mehta |
| K192938 |
12/12/2019 |
InvictusÖ Spinal Fixation System |
Alphatec Spine, Inc. |
Cynthia Adams |
| K182406 |
02/22/2019 |
Altus Spine Interbody Fusion System |
Altus Partners, LLC |
Mark Melton |
| K191836 |
12/20/2019 |
Ceramill A-Splint |
Amann Girrbach AG |
Debora Engel |
| K181070 |
02/01/2019 |
iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) |
Andon health Co., Ltd |
Yi Liu |
| K190537 |
12/12/2019 |
BIO-C Sealer Ion+ |
Angelus Industria de Produtos Odontologicos S/A |
Paulo Sergio Calixto De Oliveira |
| K182250 |
02/28/2019 |
Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm) |
AngioDynamics, Inc. |
Kasey Newcomb |
| K191643 |
12/19/2019 |
TK Sterile Hypodermic Needle |
Anhui Tiankang Medical Technology CO.,Ltd |
Bai Baodong |
| K191087 |
12/18/2019 |
IntraMarX Radiopaque Markers |
AnX Robotica Corp. |
Lin Wang |
| K192912 |
12/31/2019 |
AutoMIStar |
Apollo Medical Imaging Technology Pty. Ltd. |
Qing Yang |
| K192485 |
12/23/2019 |
BioCode Respiratory Pathogen Panel (RPP) |
Applied BioCode, Inc. |
Robert Di Tullio |
| K193292 |
12/20/2019 |
Voyant 5mm Fusion Device, Voyant Maryland Fusion Device |
Applied Medical Resources Corp. |
Blake Stacy |
| K191758 |
12/17/2019 |
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit |
Argon Medical Devices, Inc. |
Jo Huang |
| K190356 |
02/26/2019 |
ClariFix |
Arrinex, Inc |
Tracey Henry |
| K193157 |
12/12/2019 |
Arthrex 3.9mm Corkscrew Suture Anchor |
Arthrex Inc. |
Jessica L. Singelais |
| K191960 |
12/23/2019 |
Arthrex Univers Revers Modular Glenoid System |
Arthrex Inc. |
Ivette Galmez |
| K192027 |
12/20/2019 |
WEREWOLF COBLATION System, COBLATION HALO Wand |
Arthrocare Corporation |
Shruthi Bhat |
| K193116 |
12/20/2019 |
MRopen EVO |
ASG Superconductors S.p.A. |
DeBenedetti Luisella |
| K190151 |
02/25/2019 |
COBRA Fusion Ablation System |
AtriCure, Inc. |
Melissa Smallwood |
| K193162 |
12/13/2019 |
EPi-Sense Guided Coagulation System with VisiTrax |
AtriCure, Inc. |
Caitlin Wunderlin |
| K190929 |
12/20/2019 |
xvision Spine system (XVS) |
Augmedics Ltd. |
Tami Harel |
| K181528 |
02/28/2019 |
Austin Miller Large External Fixation System |
Austin Miller Trauma LLC |
Steve Miller |
| K191118 |
12/13/2019 |
Avanti Distal Radius and Forearm System |
Avanti Orthopaedics, Inc. |
J. Doug Patterson |
| K182768 |
02/17/2019 |
TMS-Cobot TS MV |
Axilum Robotics |
Romuald Ginhoux |
| K182705 |
02/14/2019 |
Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups |
b-ONE Ortho Corp. |
Allison Gecik |
| K192829 |
12/13/2019 |
Demetra BDEM-01 Dermatoscope |
Barco NV |
Julie Vandecandelaere |
| K183167 |
02/12/2019 |
Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens |
Bausch & Lomb, Incorporated |
Glenn A. Davies |
| K193028 |
12/05/2019 |
MEDRAD Mark 7 Arterion Injection System |
Bayer Medical Care Inc. |
Kelly Frank |
| K192370 |
12/13/2019 |
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation |
Bayer Medical Care, Inc. |
Alison Maloney |
| K183127 |
02/12/2019 |
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL) |
Beckman Coulter, Inc. |
Elaine Marie Duncan |
| K192516 |
12/10/2019 |
Diode Laser 808nm |
Beijing Superlaser Technology Co., Ltd. |
Shi Shuang |
| K181661 |
02/13/2019 |
QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System |
Bio-Rad Laboratories, Inc. |
Steve Lin |
| K191614 |
12/18/2019 |
BioSticker System |
BioIntelliSense Inc. |
Henry Leung |
| K192430 |
12/04/2019 |
Epic 980 |
Biolase, Inc. |
Alicia Mszyca |
| K183360 |
02/26/2019 |
VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 û >=64/8 ╡g/mL) |
bioMerieux, Inc |
Esther Hernandez |
| K183166 |
02/11/2019 |
BacT/ALERT FA Plus; BacT/ALERT PF Plus |
bioMerieux, Inc. |
Mary Beth Anheuser |
| K183415 |
02/20/2019 |
VITEK 2 AST-Gram Negative Imipenem (= 16 ug/mL) |
bioMerieux, Inc. |
Craig Buehler |
| K192522 |
12/09/2019 |
TSV BellaTek Express and BellaTek Flex Abutments |
Biomet 3i LLC |
Krupal Patel |
| K190035 |
02/07/2019 |
Biomet Headless Compression and Twist-Off Screws |
Biomet Inc |
Andrew Steward |
| K191700 |
12/09/2019 |
EyeStat |
Blinktbi Inc. |
Ryan Fiorini |
| K190824 |
12/18/2019 |
Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 2m/7ft, Airway Gas Sampling Set, disposable, Infant, TPE, 2m/7ft, Airway Adapter with Luer Connector, Adult/Pediatric |
Bluepoint Medical GmbH & Co. KG |
Bernd Lindner |
| K191996 |
12/05/2019 |
BC Reflex Uni Knee System |
Bodycad Laboratories, Inc. |
Guy Sevigny |
| K193279 |
12/23/2019 |
Comet II Pressure Guidewire |
Boston Scientific Corporation |
Kimberly Berg |
| K193202 |
12/13/2019 |
EXALT Model D Single-Use Duodenoscope, EXALT Controller |
Boston Scientific Corporation |
Carter Navarro |
| K183241 |
02/19/2019 |
BrainScope TBI (Model: Ahead 400) |
BrainScope Company Inc. |
Michael E Singer |
| K183240 |
02/22/2019 |
Empower RF Catheter |
Broncus Medical, Inc |
Aradhana Dhanabalan |
| K192224 |
12/05/2019 |
BTL-899 |
BTL |
David Chmel |
| K182796 |
02/06/2019 |
WavelinQ 4F EndoAVF System |
C. R. Bard, Inc. |
Kulveen Dhatt |
| K192313 |
12/19/2019 |
Halo One Thin-Walled Guiding Sheath |
C.R. Bard, Inc. |
Elizabeth Delahunty |
| K183452 |
02/01/2019 |
Vbeam Prima Laser System |
Candela Corp. |
Sharon Timberlake |
| K192374 |
12/02/2019 |
Cardinal HealthÖ Level 3 Surgical Mask with Anti-Fog Foam Strip |
Cardinal Health 200, LLC |
Dominic Tunzi |
| K181310 |
02/22/2019 |
HeartCheck Cardi Beat ECG Monitor with GEMS Mobile |
CardioComm Solutions, Inc. |
Jill Turcotte |
| K190241 |
12/30/2019 |
Sterile Latex Surgical Glove, Powder Free |
Careglove Global Sdn Bhd |
Lim Kwee Shyan |
| K193173 |
12/13/2019 |
CareView 1800Le |
CareRay Digital Medical System Co., Ltd. |
Leilei Li |
| K183245 |
02/08/2019 |
Carestream DRX-1 System with DRX Plus 2530 Detectors |
Carestream Health, Inc. |
Gina L Maiolo |
| K191879 |
12/20/2019 |
DRX-Evolution with Carestream Digital Tomosynthesis |
Carestream Health, Inc. |
Duane Gutowski |
| K181534 |
02/15/2019 |
CIRRUS HD-OCT |
Carl Zeiss Meditec, Inc. |
Mandy Ambrecht |
| K192442 |
12/09/2019 |
FFRangio |
CathWorks Ltd |
Asaf Azulay |
| K191823 |
12/20/2019 |
Clear-Aligners |
CDB Corporation |
Leah M. Lehman |
| K190074 |
02/14/2019 |
Presero 3D Scanning System |
Certis Health |
Richard Vogel Vogel |
| K192885 |
12/09/2019 |
C.T.M. Mobility Scooter HS-268 |
Chien Ti Enterprise Co., Ltd. |
Vivian Lo |
| K183588 |
02/22/2019 |
Choice Spine Hawkeye Vertebral Body Replacement (VBR) System |
Choice Spine |
Kim Finch |
| K191314 |
12/19/2019 |
Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q |
Chongqing Sunkingdom Medical Instrument Co., Ltd |
Shulin Guo |
| K193317 |
12/13/2019 |
CoreLite X-Ray Specimen Cabinet |
Cirdan Imaging Limited |
Jenna McGarry |
| K192939 |
12/27/2019 |
Volumetric Specimen Imager |
Clarix Imaging |
Xiao han |
| K191086 |
12/11/2019 |
Exciplex |
Clarteis |
Laurent Meilhac |
| K183255 |
02/21/2019 |
Coag-Sense Prothrombin Time (PT) / INR Monitoring Device |
CoaguSense, Inc. |
Robin Bush |
| K182040 |
02/08/2019 |
Coala Heart Monitor |
Coala Life AB |
Philip Siberg |
| K190382 |
12/06/2019 |
Intraocular Pressure Tonometer EASYTON |
Company Elamed |
Mikhail Kuzin |
| K181353 |
02/15/2019 |
Lunderquist« Fixed Core Wire Guide |
Cook Incorporated |
Jennifer L. Allman |
| K191696 |
12/27/2019 |
Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft |
Cook Biotech Incorporated |
Perry W. Guinn |
| K193133 |
12/12/2019 |
Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinm |
Cook Incorporated |
Irasema Rivera |
| K190903 |
12/16/2019 |
Lawson Retrograde Nephrostomy Wire Puncture Set |
Cook Incorporated |
Andrew Breidenbach |
| K191163 |
12/12/2019 |
Lumax Guiding Catheter |
Cook Incorporated |
David Lehr |
| K192040 |
12/20/2019 |
AVIEW Modeler |
Coreline Soft Co., Ltd |
Hyeyi Park |
| K182731 |
12/13/2019 |
Corelink Navigation Instruments |
Corelink LLC |
Steven D. Mounts |
| K192507 |
12/11/2019 |
LOSPA II Knee System |
Corentec Co., Ltd |
J.S. Daniel |
| K192038 |
12/02/2019 |
Emprint Visualization Application |
Covidien LLC. |
Janna Babson |
| K183072 |
02/15/2019 |
EndoFLIP System |
Crospon Ltd |
John O'Dea |
| K181872 |
02/19/2019 |
MIS Bunion System |
CrossRoads Extremity Systems, LLC |
Chad Hollis |
| K183637 |
02/12/2019 |
Cruxcan (CRX-1000) |
Cruxell Corp. |
Daeseok Hwang |
| K183635 |
02/14/2019 |
PhotoFix Decellularized Bovine Pericardium |
CryoLife, Inc. |
Heather Emerick |
| K191967 |
12/20/2019 |
Unyvero LRT BAL Application |
Curetis GmbH |
Karsten Mueller |
| K192711 |
12/20/2019 |
Dannik Titanium Ligation Clip |
Dannik |
Olga Haberlad |
| K190884 |
12/26/2019 |
TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool |
Datascope Corp. |
Mark Dinger |
| K192470 |
12/20/2019 |
DenMat Orthodontic Aligners |
DenMat Holdings, LLC |
Tom Juarez |
| K183569 |
02/14/2019 |
DD cube ONE ML |
Dental Direkt GmbH |
Uwe Greitens |
| K181142 |
02/05/2019 |
Absoanchor Microimplant |
Dentos Inc |
Kim Jin-Hyun |
| K183424 |
12/13/2019 |
Ambar, Ambar APS, Ambar Universal APS |
DentsCare LTDA |
Roberta Uyara |
| K191306 |
12/16/2019 |
Llis, Vittra APS |
Dentscare LTDA |
Roberta Uyara |
| K192149 |
12/11/2019 |
MIS Dental Implant System |
Dentsply Sirona Inc. |
Karl J. Nittinger |
| K182578 |
02/21/2019 |
Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device |
Devon Medical Products (Jiangsu) Ltd |
Neil Cheng |
| K183206 |
02/14/2019 |
Dexcom G6 Continuous Glucose Monitoring System |
Dexcom, Inc. |
Bryan Osborne |
| DEN180067 |
12/23/2019 |
Mucosal Integrity Conductivity (MI) Test System |
Diversatek Healthcare Inc. |
Laura L Boll |
| K180953 |
02/20/2019 |
AnyCheck IMT-100 |
DMS Co., Ltd. |
Guntae Kim |
| K190612 |
12/06/2019 |
EQUINOX Balloon Dilatation Catheter |
Dornier MedTech America Inc |
John Hoffer |
| K182859 |
02/22/2019 |
Babyleo TN500 |
Dragerwerk AG & Co. KGaA |
Dr. Bettina Mobius |
| K183388 |
02/05/2019 |
JADE Mobile X-Ray |
DRGEM Corporation |
Ki-Nam Yang |
| K193149 |
12/27/2019 |
True 3D Viewer Software |
EchoPixel Inc. |
Michael Gabler |
| K192762 |
12/16/2019 |
Physio Flex Annuloplasty Ring |
Edwards Lifesciences LLC |
Milinda Mawley |
| K193179 |
12/17/2019 |
EV1000 Clinical Platform |
Edwards Lifesciences, LLC |
Jamie Byun |
| K192768 |
12/26/2019 |
Temporary Fixation Pins |
EiserTech, LLC |
Lukas Eisermann |
| K183447 |
02/04/2019 |
EIT Cellular Titanium Lumbar Cage - T/PLIF |
EIT Emerging Implant Technologies GmbH |
Barbara Wirth |
| K180509 |
02/16/2019 |
Quo-Test A1c System |
EKF-diagnostic GmbH |
Mick Fenton |
| K183371 |
12/03/2019 |
Deka Tiac 1 |
El..En. Electroic Engineering SpA |
Paolo Peruzzi |
| K192539 |
12/16/2019 |
Deka Luxea |
El..EN. Electronic Engineering SPA |
Paolo Peruzzi |
| K192482 |
12/05/2019 |
Elekta Unity |
Elekta Limited |
Nicholas Power |
| K183585 |
02/11/2019 |
Elitone Device |
Elidah, Inc. |
Gloria Kolb |
| K182976 |
02/25/2019 |
SpringTMS |
eNeura« Inc. |
David Rosen |
| K182915 |
02/13/2019 |
ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube |
ENvizion Medical Ltd. |
Doron Besser |
| K182991 |
02/13/2019 |
EPIC Extremity Fusion Plate System |
EPIC Extremity, LLC |
Dan Schwartzbauer |
| K191234 |
12/20/2019 |
APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets |
Erbe Elektromedizin GmbH |
Henry Kutz |
| K173937 |
02/15/2019 |
SpiroSphere |
eResearchTechnology GmbH |
Johannes Thalhammer |
| K183052 |
12/06/2019 |
ID-Cap System |
etectRx, Inc. |
Susan Baumgartner |
| K183435 |
02/06/2019 |
Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black |
Ethicon Endo-Surgery, LLC |
Sigfrido Delgado |
| K192580 |
12/18/2019 |
STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device |
Ethicon, Inc |
Eleanor Zhou |
| K190273 |
12/08/2019 |
T3 Platform software |
Etiometry, Inc. |
Tim Hanson |
| K183313 |
02/28/2019 |
EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) |
Euroimmun US, Inc. |
Daniel Castellanos |
| K182744 |
02/01/2019 |
HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High |
EUROTROL B.V. |
Mylene de Boer |
| K190860 |
12/23/2019 |
Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color |
Ever Growth (Vietnam) Co. Ltd. |
Ming Lee |
| K190736 |
12/23/2019 |
Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs |
Ever Growth (Vietnam) Co. Ltd. |
Ming Lee |
| K192589 |
12/19/2019 |
Everyway OTC TENS/EMS Combination |
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
Paul Hung |
| K190087 |
02/27/2019 |
EzDent-i / E2 / Prora View |
EWOO SOFT Co., Ltd. |
Young Seok Kim |
| K192473 |
12/03/2019 |
Exsomed Wrist Plating System |
Exsomed Corporation |
Michael Zwolinski |
| K181657 |
02/01/2019 |
easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use |
Ezisurg Medical Co., Ltd. |
Liang Xia |
| K183477 |
02/11/2019 |
easyPPHTM Hemorrhoidal Stapler for Single Use |
Ezisurg Medical Co., Ltd. |
Liang Xia |
| K190752 |
12/13/2019 |
Satisfaite |
FemmePharma Consumer Healthcare, LLC |
Gerianne DiPiano |
| K182476 |
12/18/2019 |
Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads |
Fengh Medical Co., Ltd. |
Jiao Liu |
| K190112 |
12/20/2019 |
Non-Sterile Zirconia Block |
Fine Advanced Compound Co., Ltd |
Jeong Kwang-Ho |
| K181900 |
12/09/2019 |
Dental high speed handpiece, Dental low speed handpiece |
Foshan CICADA Dental Instrument Co., Ltd. |
Juan Liu |
| K192766 |
12/05/2019 |
Digital Intraoral Imaging Plate System |
Fsusen Technology Co., Ltd |
Elsa Li |
| K193123 |
12/11/2019 |
FUJIFILM Distal Cap Models 33-40 |
FUJIFILM Corporation |
Randy Vader |
| K183683 |
02/27/2019 |
FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 |
FUJIFILM Corporation |
Randy Vader |
| K183686 |
02/28/2019 |
FUJIFILM Endoscope Model EG-530N |
Fujifilm Corporation |
Randy Vader |
| K182825 |
02/22/2019 |
FUJIFILM Ultrasonic Endoscope |
FUJIFILM Corporation |
Randy Vader |
| K183235 |
02/07/2019 |
SonoSite SII Ultrasound System |
FUJIFILM SonoSite, Inc. |
Aditi Chaubal |
| K193219 |
12/17/2019 |
G Surgical Marksman System |
G Surgical LLC |
Donald Grafton |
| K182819 |
12/02/2019 |
Decanting Device |
Gcmedica Enterprise Ltd., (WUXI) |
Mona Zhang |
| K190008 |
12/20/2019 |
Carescape One |
GE Healthcare |
Joel Kent |
| K193170 |
12/13/2019 |
Deep Learning Image Reconstruction |
GE Healthcare Japan Corporation |
Tomohiro Ito |
| K183161 |
02/13/2019 |
SnapShot Freeze 2 |
GE Medical Systems, LLC. |
Laura Turner |
| K182987 |
12/12/2019 |
Genesys Spine 3DP Lumbar Interbody System |
Genesys Spine |
William W. Sowers |
| K192744 |
12/16/2019 |
CORRIDOR Fixation System |
Globus Medical Inc. |
Kelly J. Baker |
| K183119 |
02/06/2019 |
SI-LOK« Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS« Instruments |
Globus Medical Inc. |
Lori Burns |
| K180626 |
02/01/2019 |
Pedimax II - Pedicular Screw Spinal System |
Gm Dos Reis Industria E Comerico Ltda |
Paula Oliveira |
| K182718 |
12/23/2019 |
Mini and Micro Fragments Reconstruction System û GMReis |
Gm Dos Reis Industria E Comerico Ltda. |
Paula Oliveira |
| K181930 |
02/14/2019 |
GMC Wrist Automatic Blood Pressure Monitor |
GMC Inc. |
Yolanda Li |
| K192335 |
12/04/2019 |
TRACKER Kyphoplasty System |
GS Medical Co., Ltd. |
Andrea Watt |
| K191239 |
12/06/2019 |
Smart Peak Flow Meter |
Guangzhou Homesun Medical Technology Co., Ltd |
Jinqun Li |
| K193132 |
12/11/2019 |
CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream |
Hangzhou Clongene Biotech Co.,Ltd. |
Zheng Shujian |
| K192700 |
12/27/2019 |
Xcam |
HDX WILL Corp. |
Myoung-Joon Lee |
| K192533 |
12/10/2019 |
Health Line CT CVC |
Health Line International Corporation |
Joel K. Faulkner |
| K191667 |
12/18/2019 |
Electronic Stethoscope |
Hefei Mintti Medical Technology Co., Ltd. China |
Shengsheng Cai |
| K181751 |
02/01/2019 |
HemoCue Hb 801 System |
HemoCue AB |
Maria Fagerberg |
| K191305 |
12/19/2019 |
Hereaeus Poseidon Microcatheter |
Heraeus Medical Components, LLC |
Chelsea Pioske |
| K191751 |
12/16/2019 |
EM Provisional |
Hiossen, Inc. |
Peter Lee |
| K183291 |
02/01/2019 |
Supria True64 Whole-Body X-Ray CT System |
Hitachi Healthcare Americas |
Doug Thistlethwaite |
| K193148 |
12/13/2019 |
VaPro Plus Pocket, VaPro Plus |
Hollister Incorporated |
Michelle Schiltz-Taing |
| K182052 |
02/26/2019 |
Omni Instrument Tray |
Hologic, Inc |
Rachelle D. Fitzgerald |
| K190009 |
12/02/2019 |
Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) |
Hong Qiangxing (Shen Zhen) Electronics Limited |
Xu Jianhua |
| K183375 |
02/12/2019 |
Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode |
Horiba, Ltd |
Naoyuki Nomura |
| K181916 |
02/04/2019 |
d-Nav System |
Hygieia, Inc |
Kimberly Chaperon |
| K192220 |
12/13/2019 |
ReliOn Premier Classic Blood Glucose Monitoring System |
i-SENS, Inc. |
Joon Ho Jung |
| K183213 |
12/20/2019 |
IceSense 3, ProSense, MultiSense |
IceCure Medical LTD. |
Elisabeth Sadka |
| K192130 |
12/13/2019 |
Icobrain |
Icometrix NV |
Dirk Smeets |
| K192178 |
12/20/2019 |
R&D Series Nova Compo N |
Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. |
Husamettin Sonmez |
| K183571 |
02/04/2019 |
Capture-CMV |
Immucor, Inc. |
Howard Yorek |
| K191350 |
12/20/2019 |
ACTIVE« Free Testosterone RIA |
Immunotech s.r.o. |
Vit Oburka |
| K192249 |
12/17/2019 |
InMode System with Tone Applicator |
InMode Ltd. |
Amit Goren |
| K192695 |
12/27/2019 |
InMode System with the Morpheus8 (Fractora) Applicators |
Inmode MD Ltd. |
Amit Goren |
| K193020 |
12/04/2019 |
VenaPro Vascular Therapy System |
Innovamed Health, LLC |
Luke Zeutzius |
| K191880 |
12/11/2019 |
Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter |
Innovative Health, LLC. |
Amanda Babcock |
| K182488 |
02/22/2019 |
Reprocessed Response Diagnostic Electrophysiology Catheter |
Innovative Health, LLC. |
Amanda Babcock |
| K191256 |
12/27/2019 |
Straumann BLX ╪3.5 mm Implants |
Institut Straumann AG |
Ana C. M. Vianna |
| K191895 |
12/09/2019 |
Straumann Mini Implants |
Institut Straumann AG |
Viviana Horhoiu |
| K191522 |
12/03/2019 |
Straumann Modular Cassette |
Institut Straumann AG |
Jenni Vescovo |
| K183546 |
02/16/2019 |
GEM Premier ChemSTAT |
Instrumentation Laboratory Co. |
Gabriella Erdosy |
| K183555 |
02/16/2019 |
GEM Premier ChemSTAT |
Instrumentation Laboratory Co. |
Gabriella Erdosy |
| K183549 |
02/16/2019 |
GEM Premier ChemSTAT |
Instrumentation Laboratory Co. |
Gabriella Erdosy |
| K190588 |
12/02/2019 |
Integra TITAN Reverse Shoulder System |
Integra LifeSciences Corporation |
Blesson Abraham |
| K190715 |
12/13/2019 |
EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand |
Interscope, Inc. |
Jeffery Ryan |
| K182188 |
02/14/2019 |
Ion Endoluminal System ; Flexision Biopsy Needle |
Intuitive Surgical |
Sarah Rizk |
| K182643 |
02/22/2019 |
IRIS 1.0 System |
Intuitive Surgical |
Crystal Ong |
| K183139 |
02/01/2019 |
Endoscope Sterilization Tray |
Intuitive Surgical, Inc. |
Brandon Hansen |
| K193403 |
12/27/2019 |
UroNav System |
Invivo Corporation |
Kym Rupp |
| K190552 |
12/06/2019 |
JJ Implant System |
JJ Implants |
Jiju John |
| K191191 |
12/05/2019 |
Neodent Implant System - Temporary Abutments |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Mariana Soares Hartmann |
| K192229 |
12/19/2019 |
Neodent Implant System- GM Titanium Base for Bridge |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Mariana Soares Hartmann |
| K190665 |
12/23/2019 |
Neodent Instrument Kit Cases |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Luiza Vaccari Toppel |
| K192670 |
12/18/2019 |
Neodent Instrument Kit Cases |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Luiza Vaccari Toppel |
| K192680 |
12/18/2019 |
Percusys« Plus Pedicle Screw System |
Joimax GmbH |
Gary Mocnik |
| K182629 |
02/28/2019 |
Digital Thermometer |
Joytech Healthcare Co., Ltd. |
Ren Yunhua |
| K192487 |
12/23/2019 |
EZ-TRAX Containment Device |
K1 Medical LLC |
Joseph Azary |
| K193235 |
12/20/2019 |
Telepack + |
Karl Storz Endoscopy America, Inc. |
Winkie Wong |
| K181507 |
02/15/2019 |
PREVENA RESTOR(TM) Incision Management System |
KCI USA, Inc. |
Kimberly McCoy |
| K181143 |
02/08/2019 |
Keeler TonoCare Tonometer |
Keeler Instruments Inc. |
Eugene VanArsdale |
| K193174 |
12/16/2019 |
Keos Lumbar IBFD |
Keos |
Scott Peterson |
| K190056 |
02/12/2019 |
KOWA VK-2s |
KOWA Co. Ltd. CHOFU |
Rinji Kondo |
| K192196 |
12/27/2019 |
Medical Radiation Dosimetry System microSTARii |
Landauer |
Matt Ennis |
| K182494 |
02/27/2019 |
FlowMet-R |
Laser Associated Sciences, Inc. |
Sean White |
| K183118 |
02/07/2019 |
dpl SpotLite |
LED Technologies, Inc. |
Lloyd Nelson |
| K183622 |
12/02/2019 |
NasalCEASE and BleedCEASE |
Les Laboratoires Brothier S.A. |
Christian Girardiere |
| K191864 |
12/05/2019 |
21HK512D |
LG Electronics Inc. |
Jinhwan Jun |
| K191834 |
12/16/2019 |
Stand-Alone ALIF Titanium System |
Life Spine Inc. |
Angela Batker |
| K193381 |
12/31/2019 |
RadCalc Software |
LifeLine Software, Inc. |
Craig Laughton |
| K181362 |
02/16/2019 |
TEMA Elbow System |
Limacorporate S.p.A. |
Roberto Gabetta |
| K182224 |
02/07/2019 |
SafeAir Smoke Evacuator compact |
LiNA Medical APS |
Natalia Szychulska |
| K190935 |
12/19/2019 |
EZER, Portable X-ray System |
Livermoretech Inc. |
Jae Hong Kim |
| K193167 |
12/11/2019 |
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software |
Luminex Molecular Diagnostics, Inc. |
Jennifer Grimes |
| K183396 |
02/11/2019 |
HANAROSTENT FASTTM Biliary (NNN) |
M.I.Tech Co., Ltd. |
Inae Kim |
| K182267 |
02/27/2019 |
PAT (Pain Alleviation Technologies) |
Marchan Medical, LLC |
Mark Chandler |
| K191059 |
12/27/2019 |
Masimo Rad-97 and Accessories |
Masimo Corporation |
Linus Park |
| K183640 |
02/22/2019 |
Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes |
Mauna Kea Technologies |
Veronique Dentan |
| K183365 |
02/22/2019 |
Libertas Acetabular Hooded Liner |
Maxx Orthopedics, Inc. |
Priscilla Herpai |
| K182758 |
12/05/2019 |
MCI - CMF System |
MCI Medical Concept Innovation Inc. |
Carlos Lacerda |
| K183693 |
02/22/2019 |
Doctor Tecar |
Mectronic Medicale S.r.l. |
Gloria Aloisini |
| K193083 |
12/03/2019 |
M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System |
Medacta International SA |
Stefano Baj |
| K190738 |
12/13/2019 |
MyShoulder Placement Guides |
Medacta International SA |
Stefano Baj |
| K182191 |
02/01/2019 |
Invia Abdominal Dressing Kit |
Medela AG |
Judith Bernardo |
| K181955 |
02/12/2019 |
WiEMSpro |
Medical Cables, S.L. |
Jose Fuertes Pena |
| K192100 |
12/19/2019 |
Aveta Disposable Hysteroscope |
Meditrina, Inc. |
Csaba Truckai |
| K191759 |
12/04/2019 |
Medline Quick Switch Valve with ENFit Connector |
Medline Industries, Inc. |
Dinah Rincones |
| K192104 |
12/23/2019 |
Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test for Use with Chemotherapy Drugs) |
Medline Industries, Inc. |
Claire Pigman |
| K190284 |
12/20/2019 |
Bengal Stackable Cage System |
Medos International SARL |
Linda Bernier |
| K183506 |
02/14/2019 |
HEALIX ADVANCE Anchor with DYNACORD Suture |
Medos International SARL |
Tatyana Korsunsky |
| K182941 |
02/26/2019 |
HEALIX ADVANCE SP PEEK Anchor |
Medos International SARL |
Elizabeth Messana |
| K183279 |
02/21/2019 |
HEALIX Ti ANCHOR with DYNACORD |
Medos International SARL |
N/A N/A |
| K182677 |
02/14/2019 |
DynaNail Mini |
Medshape, Inc. |
Akhilesh Gokhale |
| K182417 |
02/07/2019 |
ROSA ONE Brain Application |
MEDTECH S.A. |
Serge Tabet |
| K190012 |
12/18/2019 |
OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid |
Medtrade Product Ltd |
Mina Patel |
| K182885 |
02/06/2019 |
AtlantisÖ Anterior Cervical Plate, DivergenceÖ Anterior Cervical Fusion System, PremierÖ Anterior Cervical Plate, VentureÖ Anterior Cervical Plate, ZephirÖ Anterior Cervical Plate System and ZevoÖ Anterior Cervical Plate System |
Medtronic Sofamor Danek USA, Inc. |
Kanesha Hines |
| K183409 |
02/11/2019 |
Athena II Cervical Plate System |
Medyssey USA, Inc. |
Shawn Kim |
| K182003 |
02/27/2019 |
Lympha Press Optimal Plus |
Mego Afek AC Ltd. |
Reuven Yunger |
| K192444 |
12/31/2019 |
mCare« Powder Free Nitrile Black Examination Glove |
Mercator Medical (Thailand) LTD. |
Praneet Inthajak |
| K190876 |
12/02/2019 |
mCare«Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed |
Mercator Medical (Thailand) LTD. |
Dariusz Jan Krezymon |
| K192584 |
12/18/2019 |
BEACON Caresystem Model 00002144 |
Mermaid Care A/S |
Claus Lindholt |
| K191618 |
12/11/2019 |
SleepTight Mouthpiece STZ |
Michael D Williams DDS PA |
Michael Williams |
| K190968 |
12/09/2019 |
CEDIA Benzodiazepine Assay |
Microgenics Corporation |
Minoti Patel |
| K192943 |
12/16/2019 |
CEDIA Heroin Metabolite (6-AM) assay |
Microgenics Corporation |
Sharron Penn |
| K192135 |
12/24/2019 |
VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33) |
MicroVention, Inc. |
Sapna Singh |
| K192572 |
12/17/2019 |
CNS Envision |
Moberg Research, Inc. |
Anna Rodriguez |
| K191898 |
12/18/2019 |
Sterile Latex Powder-Free Surgical Gloves |
Modern Healthcare Corp. |
Ke-Min Jen |
| K191371 |
12/04/2019 |
MolecuLight i:X |
MolecuLight Inc. |
Anil Amlani |
| K183163 |
02/05/2019 |
Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix |
Motiva USA, LLC |
ALberto Quesada Rivera |
| K182756 |
02/14/2019 |
MyoStrain 5.1 |
Myocardial Solutions |
Linda Horne |
| K183499 |
02/04/2019 |
JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor |
Nanjing Jusha Display Technology Co., Ltd |
Zilong Liang |
| K183498 |
02/05/2019 |
JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor |
Nanjing Jusha Display Technology Co., Ltd. |
Zilong Liang |
| K190633 |
12/20/2019 |
NanoOrtho NanoKnee« System |
NanoOrtho, LLC |
Austin Ferro |
| K191793 |
12/09/2019 |
Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System |
Nebula Surgical Private Limited |
Rajat Kumar Khant |
| K191796 |
12/13/2019 |
Neo Cage System |
Neo Medical S.A. |
Jonas Larsson |
| K190742 |
12/13/2019 |
EPIFLO-28 |
Neogenix, LLC dba Ogenix |
Srinivasan Sarangapani |
| K193269 |
12/20/2019 |
UroLift System (UL400) |
Neotract, Inc. |
Brian Gall |
| K183594 |
02/19/2019 |
Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode |
New Deantronics Taiwan Ltd |
Jane Liu |
| K193004 |
12/19/2019 |
Monopolar Cord |
New Deantronics Taiwan Ltd |
Jane Liu |
| K192578 |
12/31/2019 |
InCore TMT System |
Nextremity Solutions, Inc. |
Elise Fox |
| K173418 |
02/21/2019 |
NobelParallel Conical Connection |
Nobel Biocare AB |
Charlemagne Chua |
| K191403 |
12/20/2019 |
Pulse Oximeter |
Nonin Medical, Inc. |
Walter Holbein |
| K192356 |
12/14/2019 |
Airlock Centrolock Osteosynthesis Implant System |
NOVASTEP |
Gilles Audic |
| K192773 |
12/06/2019 |
ALLIVE |
Nu Eyne Co., Ltd |
Dong Seong Lee |
| K182170 |
02/05/2019 |
PRECICE« BONE TRANSPORTÖ System |
NuVasive Specialized Orthopedics, Inc. |
Vidhi Bhatt |
| K182974 |
02/13/2019 |
NuVasive Reline System |
NuVasive, Incorporated |
Joseph De La Rosa |
| K192645 |
12/23/2019 |
TrigonÖ Ti Stand-Alone Wedge Fixation System |
Nvision Biomedical Technologies, Inc. |
Diana Langham |
| K183055 |
02/19/2019 |
Vector Hammertoe Correction System |
Nvision Biomedical Technologies, LLC |
Diana Langham |
| K183132 |
02/05/2019 |
Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs |
O & M Halyard, Inc. |
Angela L. Bunn |
| K192362 |
12/13/2019 |
Aero Blue Performance Surgical Gowns |
O&M Halyard, Inc. |
Kimberly Lewis |
| K182102 |
02/06/2019 |
RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4 |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K190239 |
12/10/2019 |
Single Use Aspiration Needle |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K193039 |
12/17/2019 |
Single Use Balloon Dilator V (with knife) |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K183659 |
02/06/2019 |
Omnia Medical Rotary PLIF System |
Omnia Medical, LLC |
Troy Schifano |
| K191666 |
12/20/2019 |
Unscented W long plastic and cardboard applicator tampons |
ONTEX BVBA |
Henri Lesage |
| K192340 |
12/12/2019 |
OptoMonitor |
Opsens Inc |
Marc Chaunet |
| K192629 |
12/21/2019 |
Spinalytics |
Optima Health Solutions International Corp. |
Farhad Ghani |
| K181467 |
02/08/2019 |
Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line |
Oridion Medical 1987 Ltd. |
Dalia Givony |
| K182332 |
02/15/2019 |
PhantomMSK |
OrthoGrid Systems Inc. |
Sebastian Edin |
| K192279 |
12/07/2019 |
PhantomMSK Trauma |
OrthoGrid Systems Inc. |
Sebastian Edin |
| K192394 |
12/02/2019 |
Hi-Fatigue Bone Cement |
OSARTIS GmbH |
Volker Stirnal |
| K190793 |
12/12/2019 |
Tablo Hemodialysis System, Tablo Cartridge |
Outset Medical, Inc. |
Jennifer Mascioli-Tudor |
| K181548 |
12/16/2019 |
Pantheon Spinal Pontus Interbody Fusion Device |
Pantheon Spinal |
Bob Schultz |
| K191440 |
12/20/2019 |
Paragonix SherpaPak Pancreas Transport System |
Paragonix Technologies |
Lisa M. Anderson |
| K183331 |
02/07/2019 |
Parcus GFS BTB |
Parcus Medical, LLC |
Paul Vagts |
| K190805 |
12/20/2019 |
PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL |
PENTAX of America, Inc. |
William Goeller |
| K192833 |
12/20/2019 |
Indigo Aspiration System |
Penumbra, Inc. |
Teri Nguyen |
| DEN180056 |
12/12/2019 |
GSP Neonatal Creatine Kinase - MM kit |
PerkinElmer Inc. |
Brian Ciccariello |
| K191647 |
12/20/2019 |
QLAB Advanced Quantification Software |
Philips Healthcare |
Eri Gremi |
| K183063 |
02/14/2019 |
Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems |
Philips Medical Systems Nederland B.V. |
Jan van de Kerkhof |
| K191804 |
12/05/2019 |
TOMi Scope |
PhotoniCare, Inc. |
Ryan Shelton |
| K192718 |
12/20/2019 |
Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology |
Pioneer Surgical Technology, Inc., DBA RTI Surgical, Inc. |
Linda Busklein |
| K183374 |
02/26/2019 |
GrayDuck Stent |
POLL Medical LLC |
Adrian Polliack |
| K192450 |
12/17/2019 |
Precision Casting Solutions Total Hip System |
Precision Casting Solution, LLC |
Jim Moore |
| K180682 |
02/27/2019 |
AeroPro Cordless Prophy System |
Premier Dental Company Products |
Noel Hetrick |
| K192666 |
12/02/2019 |
Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K193009 |
12/03/2019 |
Promisemed Heel Blood Lancet |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K192990 |
12/20/2019 |
Litho Evo |
Quanta System spa |
Francesco Dell'Antonio |
| K191962 |
12/05/2019 |
Vitra 2 |
Quantel Medical |
Bruno Pages |
| K192531 |
12/13/2019 |
QyScore Software |
Qynapse |
Olivier Courreges |
| K190075 |
02/12/2019 |
Aurora Evacuator |
Rebound Therapeutics |
Donald Atienza |
| K191861 |
12/06/2019 |
Aurora Surgiscope System |
Rebound Therapeutics |
Naomi Gong |
| K183049 |
02/15/2019 |
Reliance Lumbar IBF System |
Reliance Medical Systems LLC |
Bret Berry |
| K192595 |
12/17/2019 |
ExSpiron 2Xi |
Respiratory Motion |
Susan K. Hamann |
| K191551 |
12/23/2019 |
RIST Cath Radial Access Long Sheath |
RIST Neurovascular, Inc. |
Marianne Grumwaldt |
| K190725 |
12/17/2019 |
Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White |
Riverstone Resources SDN BHD |
Suresh Kumar |
| K183517 |
02/08/2019 |
Ammonia II |
Roche Diagnostics Operations (RDO) |
Noel B. Mencias |
| DEN190016 |
12/05/2019 |
cobas vivoDx MRSA |
Roche Molecular Systems, Inc. |
Nobuko Nakajima |
| K181551 |
02/22/2019 |
DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette |
Runbio BioTech Co.,Ltd |
Lyn Chen |
| K182542 |
02/22/2019 |
The EPAD 2 System |
SafeOp Surgical, Inc. |
Richard O'Brien |
| K192319 |
12/10/2019 |
HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Ji Yea Lee |
| K192505 |
12/12/2019 |
HS50/HS60 Diagnostics Ultrasound System |
Samsung Medison CO., LTD. |
Scully Kim |
| K182932 |
02/15/2019 |
RS85 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Ji Yea Lee |
| K192569 |
12/13/2019 |
Diode Laser Therapy System |
San He Lefis Electronics Co., Ltd. |
Ning Li |
| K183073 |
02/11/2019 |
SMG Anterior Cervical Plate System |
Sapphire Medical Group |
Anthony Ruggiero |
| K193194 |
12/13/2019 |
CrossTorq 14 Guidewire |
Scientia Cardio Access LLC |
Amy McManus |
| K192287 |
12/10/2019 |
Transpara |
Screenpoint Medical B.V. |
Umar Waqas |
| K191656 |
12/02/2019 |
Zipbond |
SDI Limited |
Ray Cahill |
| K192132 |
12/03/2019 |
SeaSpine Beachside System |
SeaSpine Orthopedics Corporation |
Aly Alvarez |
| K183083 |
02/14/2019 |
Shoreline Cervical Interbody RT System |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K180835 |
02/08/2019 |
SEKURE Acetaminophen L3K Assay |
Sekisui Diagnostics PEI Inc. |
Penny White |
| K180479 |
02/28/2019 |
ReDS System |
Sensible Medical Innovations Ltd. |
Inbal Ben-Tzvi |
| K190255 |
02/21/2019 |
Sensus Healthcare TVM Balloon Applicator |
Sensus Healthcare, Inc |
Nicolas Soro |
| K182641 |
02/21/2019 |
Sensus IORT System |
Sensus Healthcare, Inc. |
Nicolas Soro |
| K182665 |
02/21/2019 |
Sensus TPS Workstation |
Sensus Healthcare, Inc. |
Nicolas Soro |
| K193001 |
12/19/2019 |
Albumin BCP |
Sentinel CH. SpA |
Patricia Dupe |
| K192627 |
12/13/2019 |
Laser Hair Growth Cap |
Shang Fa Biotechnology Co. |
Chung Ju Zhi |
| K192528 |
12/03/2019 |
CO2 Laser Therapy System |
Shangdong Huamei Technology Co., Ltd. |
Xu QingHua |
| K192521 |
12/06/2019 |
Intense Pulsed Light Treatment System |
Shangdong Huamei Technology Co., Ltd. |
Xu QingHua |
| K183186 |
02/08/2019 |
Head Coil û 12, Head Coil û 32, Carotid Coil û 8, Temporomandibular Joint Coil û 4, Infant Coil û 24, Cardiac Coil û 24, Foot & Ankle Coil - 24 |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin Gao |
| K183014 |
02/27/2019 |
uPMR 790 |
Shanghai United Imaging Healthcare Co., Ltd. |
Shumei Wang |
| K183144 |
12/19/2019 |
uMC 560i |
Shanghai United Imaging Healthcare Co.,Ltd. |
Shumei Wang |
| K182388 |
12/19/2019 |
Krystal Klear Aligners |
Shatkin F.I.R.S.T. LLC |
Kimberly Wiesmore |
| K191279 |
12/06/2019 |
Disposable SpO2 Sensor |
Shenzhen Caremed Medical Technology Co., Ltd. |
Alan Xie |
| K191106 |
12/13/2019 |
C50 and C80 Multi-parameter Patient Monitor |
Shenzhen Comen Medical Instruments Co.,Ltd. |
Hongbo Yan |
| K192343 |
12/31/2019 |
Patient Monitor |
Shenzhen Creative Industry Co., Ltd. |
Jia Wang |
| K190775 |
12/19/2019 |
The RHEA Vital Sign Vigilance System |
Shenzhen Fiber Medical Technology Co. Ltd. |
Luo Li |
| K182839 |
02/28/2019 |
Lifetech Cardio Model 8301 Temporary Pacemaker |
Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. |
Stephy Pan |
| K192152 |
12/13/2019 |
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., LTD |
Zhang Wei |
| K192410 |
12/19/2019 |
ZS3 and z.one pro Ultrasound Systems |
ShenZhen Mindray Bio-Medical Electronics Co., Ltd |
Jiang Haosen |
| K190673 |
12/12/2019 |
Health Expert Electronic Stimulator |
Shenzhen OSTO Technology Company Limited |
Li Yang |
| K190717 |
12/13/2019 |
Infrared Thermometer, model: PC808 |
Shenzhen Pacom Medical Instruments Co., Ltd. |
Xuewen Chen |
| K191088 |
12/02/2019 |
Checkme O2 Pulse Oximeter |
Shenzhen Viatom Technology Co., Ltd. |
Zhou Saixin |
| K192348 |
12/04/2019 |
SICAT Implant V2.0 |
SICAT GmbH & Co. KG |
Manfred Breuer |
| K183222 |
02/15/2019 |
MAGNETOM Terra |
Siemens Medical Solutions USA Inc. |
Milind Dhamankar |
| K183272 |
02/01/2019 |
AI Rad Companion (Engine) |
Siemens Medical Solutions USA, Inc. |
Kimberly Mangum |
| K190138 |
02/15/2019 |
MAGNETOM Aera |
Siemens Medical Solutions USA, Inc. |
Cordell L. Fields |
| K183221 |
02/14/2019 |
MAGNETOM Amira, MAGNETOM Sempra |
Siemens Medical Solutions USA, Inc. |
Martin Rajchel |
| K192763 |
12/17/2019 |
syngo.CT CaScoring |
Siemens Medical Solutions USA, Inc. |
Tabitha Estes |
| K183317 |
02/14/2019 |
AdvantageRib System |
SIG Medical Corporation |
Andrew Davison |
| K181340 |
02/11/2019 |
Cemented TSI Hip Stem |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K192755 |
12/20/2019 |
Soli-Lite LG4 Galileo |
Silhouet-Tone Corporation |
Eric Ghedin |
| K182661 |
02/13/2019 |
Kava and Kava with Herbst |
Sketchpad Innovations LLC |
Phillip "Sonnie" Bocala |
| K190467 |
12/26/2019 |
iHelmet Hair Growth System |
Slinph Technologies Co., LTD |
Zou Jian |
| K190085 |
02/11/2019 |
Journey II Unicompartmental Knee System |
Smith & Nephew Inc |
Amy Winegarden |
| K191760 |
12/05/2019 |
PICO 14 Single Use Negative Pressure Wound Therapy System |
Smith & Nephew Medical Limited |
Sam Greenhalgh |
| K190756 |
12/20/2019 |
IODOFLEX |
Smith & Nephew Medical Ltd. |
Meenakshi Gupta |
| K190730 |
12/20/2019 |
IODOSORB |
Smith & Nephew Medical Ltd. |
Meenakshi Gupta |
| K192443 |
12/06/2019 |
Dextile Anatomical Mesh |
Sofradim Production |
Benjamin Rochette |
| K192571 |
12/11/2019 |
NemoScan |
Software Nemotec S.L. |
Carlos Arias |
| K192044 |
12/19/2019 |
4CIS Marlin PEEK ACIF Cage |
Solco Biomedical Co., Ltd. |
Hwi-geun Yu |
| K192873 |
12/20/2019 |
SX-One MicroKnife |
Sonex Health, Inc. |
Aaron Keenan |
| K191054 |
12/09/2019 |
Southern Implants MAX Implant System |
Southern Implants (Pty) Ltd |
Lauranda G. Breytenbach |
| K191250 |
12/05/2019 |
Southern Implants PEEK Abutments |
Southern Implants (Pty) Ltd |
Lauranda Breytenbach |
| K190881 |
12/19/2019 |
Spinal Elements Navigated Instruments |
Spinal Elements Inc |
Julie Lamothe |
| K190071 |
02/25/2019 |
Perla« Posterior Cervico-Thoracic Fixation System |
SPINEART |
Franck Pennesi |
| K182874 |
02/13/2019 |
Fenom Pro Nitric Oxide Test |
Spirosure, Inc. |
Ryan Leard |
| K183099 |
02/28/2019 |
QUANTIEN Measurement System |
St. Jude Medical (now Abbott Medical) |
Ka Zoua Xiong |
| K183225 |
02/15/2019 |
Stabil Orthopaedic Solutions Total Knee System |
Stabil Orthopaedic Solutions, LLC |
Jim Moore |
| K192929 |
12/10/2019 |
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 |
STERIS Corporation |
Jennifer Nalepka |
| K180346 |
02/19/2019 |
Byte Aligner System |
Straight Smile, LLC |
Sepi Abbasi |
| K183196 |
02/14/2019 |
Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker |
Stryker Corporation |
Andrea Wallen-Gerding |
| K183039 |
02/15/2019 |
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) |
Stryker GmbH |
Tina Mornak |
| K190833 |
12/15/2019 |
AXS Vecta Aspiration Catheter |
Stryker Neurovascular |
Shazia Hakim |
| K190394 |
12/16/2019 |
SunClear Aligner system |
Sun Dental Laboratories, LLC |
Derek Diasti |
| K193018 |
12/20/2019 |
Surgical Direct Hand-held Laparoscopic Instruments |
Surgical Direct, Inc. |
David Murray |
| K182293 |
02/15/2019 |
OsseOne Dental Implant System |
Synoross DBA OsseOne |
Gennady Shapiro |
| K192615 |
12/17/2019 |
Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) |
Synovis Life Technologies, Inc. (Baxter International Inc.) |
Megan Sajjad |
| K192655 |
12/30/2019 |
Depuy Synthes Maxillofacial Portfolio - MR Conditional |
Synthes (USA) Products LLC |
Satapa Dhamankar |
| K182934 |
02/12/2019 |
FORA P100 Blood Pressure Monitoring System |
TaiDoc Technology Corporation |
Diana Sung |
| K190105 |
02/21/2019 |
ZOOM Aspiration Pump |
Taiwan Biomaterial Co., Ltd. |
Monoj Mon Kalita |
| K183556 |
02/15/2019 |
oCare Wrist Pulse Oximeter |
Taiwan Biophotonic Corporation |
JC Chen |
| DEN190034 |
12/13/2019 |
Control-IQ Technology |
Tandem Diabetes Care, Inc. |
Michael Sarrasin |
| DEN180058 |
02/14/2019 |
t:slim X2 insulin pump with interoperable technology |
Tandem Diabetes Care, Inc. |
Michael Sarrasin |
| K192324 |
12/06/2019 |
Sheridan Spiral-Flex Endotracheal Tubes |
TeleflexMedical, Inc |
Lori Pfohl |
| K183081 |
02/05/2019 |
Spectra Optia Apheresis System |
Terumo BCT, Inc. |
Nicholas Wong |
| K193160 |
12/03/2019 |
Glidesheath Slender Tibial Pedal Kit |
Terumo Medical Coporation |
Liang Lu |
| K182833 |
02/08/2019 |
ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer |
The Argen Corporation |
Craig Jolicoeur |
| K183324 |
02/15/2019 |
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL |
Thermo Fisher Scientific |
Cynthia Knapp |
| K193135 |
12/11/2019 |
TSolution One Total Knee Application |
Think Surgical, Inc. |
Meliha Mulalic |
| K183290 |
02/25/2019 |
Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 |
Thrombolex, Inc. |
Amy Katsikis |
| K193071 |
12/17/2019 |
Bashir Plus Endovascular Catheter |
Thrombolex, Inc. |
Amy Katsikis |
| K183621 |
02/22/2019 |
EMMA 1.5T MRI System |
Time Medical Limited |
Nick Tse |
| K183557 |
02/11/2019 |
Endoskeleton« TA Interbody Fusion Device, Endoskeleton« TAS Interbody Fusion Device, Endoskeleton« TO Interbody Fusion Device, Endoskeleton« TT Interbody Fusion Device, Endoskeleton« TC Interbody Fusion Device, Endoskeleton« TCS Interbody Fusion Device, E |
Titan Spine, Inc |
Jane Rodd |
| K183217 |
02/15/2019 |
IPL Hair Removal Device |
Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. |
Aaron Zhai |
| K193107 |
12/03/2019 |
TriSalus Infusion System |
TriSalus Life Sciences |
Patrick McCain |
| K181194 |
02/15/2019 |
SmartMouth DryMouth Oral Rinse |
Triumph Pharmaceuticals, Inc. |
Andrew Burch |
| K180691 |
02/11/2019 |
TrueDorsal Devices |
True Function Laboratory, Inc. |
Frank Madrigal |
| K192023 |
12/23/2019 |
Arm Blood Pressure Monitor |
Truly Instrument Limited |
Su HaiSen |
| K190508 |
12/11/2019 |
EVO 450 series High Speed Handpieces |
TTBIO CORP. |
Sheng-Chieh Su |
| K183454 |
02/26/2019 |
Tyece OTC EMS System |
Tyece Ltd. |
Parshid Falahati |
| K181981 |
02/06/2019 |
CO2 Sampling Line |
Tylenol Medical Instruments Co., Ltd |
Kavin Huang |
| K190053 |
02/01/2019 |
SECULOKÖ ACP System |
U&i Corporation |
Kwang-Eun Song |
| K190067 |
02/04/2019 |
Velofix Interbody Fusion System |
U&i Corporation |
Jee-Ae Bang |
| K181508 |
02/13/2019 |
U&U Blood Collection Sets |
U&U Medical Technology Co.,Ltd |
Nick Wang |
| K192733 |
12/23/2019 |
RelieforMe TENS/EMS Device Model UPK-GE01 |
Umeheal Ltd. |
Rui Lin |
| K192647 |
12/13/2019 |
neria guard Infusion Set |
Unomedical a/s |
Mette Busk Henningsen |
| K183134 |
02/07/2019 |
ArcTV Transvaginal Sling System |
UroCure LLC |
John Nealon |
| K190987 |
12/02/2019 |
Uroject12 Syringe Lever |
UroGen Pharma Ltd. |
Liz Schindel |
| K181393 |
02/15/2019 |
Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP |
VALMED SRL |
Parravicini Christian |
| K193238 |
12/20/2019 |
Nexus DR Digital X-Ray Imaging System (with vSharp) |
Varex Imaging Corporation |
Michael Van Ryn |
| K183179 |
02/25/2019 |
CAPERE Thrombectomy System |
Vascular Medcure, Inc. |
Jeffrey P. DuMontelle |
| K182094 |
02/01/2019 |
Family of Venus RF Systems - Heal |
Venus Concept USA Inc. |
Yoni Iger |
| K192607 |
12/19/2019 |
LiteWalk |
Viasonix Ltd. |
Shlomi Deler |
| K181989 |
02/20/2019 |
MRIdian Linac System |
ViewRay, Incorporated |
Sean Delaney |
| K190155 |
02/27/2019 |
FibermarX Radiopaque Tissue Marker |
Viscus Biologics, LLC |
Justin Baker |
| K183704 |
02/16/2019 |
RX-1 Rhythm Express Remote Cardiac Monitoring System |
VivaQuant Inc. |
Brian Brockway |
| K192225 |
12/09/2019 |
Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses |
VizionFocus, Inc. |
Angus Shih |
| K190078 |
02/11/2019 |
IntraSight |
Volcano Corporation |
Kimberly Simon |
| K191846 |
12/23/2019 |
MAXReach Laser Probe |
Vortex Surgical Inc. |
Bob Neu |
| K192559 |
12/21/2019 |
Acetabular Bone Screws (for MobileLink Acetabular Cup System) |
Waldemar Link GmbH & Co. KG |
Karen Sonnenberger |
| K183141 |
02/08/2019 |
LINK MP Monoblock Hip Prosthesis |
Waldemar Link GmbH & Co. KG |
Andre von Malotki |
| K192439 |
12/09/2019 |
JETi Peripheral Thrombectomy System |
Walk Vascular, LLC |
David Look |
| K182739 |
12/11/2019 |
Endotracheal Tube with Evacuation Lumen |
WELL LEAD MEDICAL CO., LTD. |
Huang Kaigen |
| K193344 |
12/13/2019 |
Tri-Ex Extraction Balloon with Multiple Sizing |
Wilson-Cook Medical Inc. |
Theresa de Prat |
| K181317 |
02/08/2019 |
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush |
Wilson-Cook Medical, Inc. |
Sierra Lowe |
| K182319 |
02/01/2019 |
Glo-Tip Spray Catheter |
Wilson-Cook Medical, Inc. |
Paula Joyce |
| K190829 |
12/19/2019 |
Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) |
Wilson-Cook Medical, Inc. / Cook Endoscopy |
Tiffanny A Thomas |
| K181315 |
02/14/2019 |
Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing |
Winner Medical Co., Ltd |
Dan Wang |
| K181163 |
02/16/2019 |
Wu's Powered Wheelchair |
Wu's Tech Co., Ltd. |
Jen Ke-Min |
| K181870 |
02/26/2019 |
Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use |
Wuhan W.E.O Science & Technology Development Co., Ltd. |
Chengling Fu |
| K190990 |
12/31/2019 |
Digital Thermometer |
Xiamen Ants Bro Technology Co., Ltd. |
Jane Xu |
| K181409 |
02/19/2019 |
Pressure Therapy System PT1003 |
Xiamen Senyang Co., Ltd. |
Nina Cai |
| K183698 |
02/25/2019 |
Zap-X Radiosurgery System |
Zap Surgical Systems |
Jim Talbot |
| K192258 |
12/30/2019 |
Disposable Valve Sets |
Zhejiang Chuangxiang Medical Technology Co., LTD. |
Lucius Long |
| K193230 |
12/20/2019 |
Ziehm Vision FD |
Ziehm Imaging GmbH |
Steve Seeman |
| K191722 |
12/02/2019 |
Vital Navigation System |
Zimmer Biomet Spine, Inc. |
Alex Pawlowski |
| K193050 |
12/26/2019 |
Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem |
Zimmer GmbH |
Roberto Tommasini |
| K193030 |
12/06/2019 |
Avenir Muller Stem, Avenir Cemented Hip Stem |
Zimmer GmbH |
Roberto Tommasini |
| K190656 |
12/06/2019 |
Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings |
Zimmer Inc. |
Charles Neitzel |
| K192189 |
12/18/2019 |
Avenir Complete Hip System, Size 0 Coxa Vara |
Zimmer, Inc. |
Rebecca D Noftz |
| K190660 |
12/05/2019 |
G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene |
Zimmer, Inc. |
Mary Wentorf |
| K190939 |
12/19/2019 |
ZOLL Arrhythmia Management Sysyem |
ZOLL Manufacturing Corporation |
Zachary Nelson |
