| 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 |
| 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 |
| K192471 |
12/20/2019 |
RHIN1 Stylus |
Aerin Medical Inc. |
Matthew M Hull |
| 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 |
| 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 |
| K191836 |
12/20/2019 |
Ceramill A-Splint |
Amann Girrbach AG |
Debora Engel |
| K190537 |
12/12/2019 |
BIO-C Sealer Ion+ |
Angelus Industria de Produtos Odontologicos S/A |
Paulo Sergio Calixto De Oliveira |
| 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 |
| 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 |
| 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 |
| K191118 |
12/13/2019 |
Avanti Distal Radius and Forearm System |
Avanti Orthopaedics, Inc. |
J. Doug Patterson |
| K192829 |
12/13/2019 |
Demetra BDEM-01 Dermatoscope |
Barco NV |
Julie Vandecandelaere |
| 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 |
| K192516 |
12/10/2019 |
Diode Laser 808nm |
Beijing Superlaser Technology Co., Ltd. |
Shi Shuang |
| K191614 |
12/18/2019 |
BioSticker System |
BioIntelliSense Inc. |
Henry Leung |
| K192430 |
12/04/2019 |
Epic 980 |
Biolase, Inc. |
Alicia Mszyca |
| K192522 |
12/09/2019 |
TSV BellaTek Express and BellaTek Flex Abutments |
Biomet 3i LLC |
Krupal Patel |
| 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 |
| K192224 |
12/05/2019 |
BTL-899 |
BTL |
David Chmel |
| K192313 |
12/19/2019 |
Halo One Thin-Walled Guiding Sheath |
C.R. Bard, Inc. |
Elizabeth Delahunty |
| K192374 |
12/02/2019 |
Cardinal HealthÖ Level 3 Surgical Mask with Anti-Fog Foam Strip |
Cardinal Health 200, LLC |
Dominic Tunzi |
| 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 |
| K191879 |
12/20/2019 |
DRX-Evolution with Carestream Digital Tomosynthesis |
Carestream Health, Inc. |
Duane Gutowski |
| K192442 |
12/09/2019 |
FFRangio |
CathWorks Ltd |
Asaf Azulay |
| K191823 |
12/20/2019 |
Clear-Aligners |
CDB Corporation |
Leah M. Lehman |
| K192885 |
12/09/2019 |
C.T.M. Mobility Scooter HS-268 |
Chien Ti Enterprise Co., Ltd. |
Vivian Lo |
| 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 |
| K190382 |
12/06/2019 |
Intraocular Pressure Tonometer EASYTON |
Company Elamed |
Mikhail Kuzin |
| 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 |
| 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 |
| 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 |
| DEN180067 |
12/23/2019 |
Mucosal Integrity Conductivity (MI) Test System |
Diversatek Healthcare Inc. |
Laura L Boll |
| K190612 |
12/06/2019 |
EQUINOX Balloon Dilatation Catheter |
Dornier MedTech America Inc |
John Hoffer |
| 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 |
| 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 |
| 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 |
| K183052 |
12/06/2019 |
ID-Cap System |
etectRx, Inc. |
Susan Baumgartner |
| 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 |
| 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 |
| K192473 |
12/03/2019 |
Exsomed Wrist Plating System |
Exsomed Corporation |
Michael Zwolinski |
| 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 |
| 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 |
| 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 |
| K182718 |
12/23/2019 |
Mini and Micro Fragments Reconstruction System û GMReis |
Gm Dos Reis Industria E Comerico Ltda. |
Paula Oliveira |
| 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 |
| K191305 |
12/19/2019 |
Hereaeus Poseidon Microcatheter |
Heraeus Medical Components, LLC |
Chelsea Pioske |
| K191751 |
12/16/2019 |
EM Provisional |
Hiossen, Inc. |
Peter Lee |
| K193148 |
12/13/2019 |
VaPro Plus Pocket, VaPro Plus |
Hollister Incorporated |
Michelle Schiltz-Taing |
| K190009 |
12/02/2019 |
Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) |
Hong Qiangxing (Shen Zhen) Electronics Limited |
Xu Jianhua |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K192670 |
12/18/2019 |
Neodent Instrument Kit Cases |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Luiza Vaccari Toppel |
| K190665 |
12/23/2019 |
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 |
| 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 |
| K193174 |
12/16/2019 |
Keos Lumbar IBFD |
Keos |
Scott Peterson |
| K192196 |
12/27/2019 |
Medical Radiation Dosimetry System microSTARii |
Landauer |
Matt Ennis |
| 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 |
| 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 |
| K191059 |
12/27/2019 |
Masimo Rad-97 and Accessories |
Masimo Corporation |
Linus Park |
| K182758 |
12/05/2019 |
MCI - CMF System |
MCI Medical Concept Innovation Inc. |
Carlos Lacerda |
| 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 |
| 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 |
| K190012 |
12/18/2019 |
OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid |
Medtrade Product Ltd |
Mina Patel |
| 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 |
| 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 |
| K193004 |
12/19/2019 |
Monopolar Cord |
New Deantronics Taiwan Ltd |
Jane Liu |
| K192578 |
12/31/2019 |
InCore TMT System |
Nextremity Solutions, Inc. |
Elise Fox |
| 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 |
| K192645 |
12/23/2019 |
TrigonÖ Ti Stand-Alone Wedge Fixation System |
Nvision Biomedical Technologies, Inc. |
Diana Langham |
| K192362 |
12/13/2019 |
Aero Blue Performance Surgical Gowns |
O&M Halyard, Inc. |
Kimberly Lewis |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K192450 |
12/17/2019 |
Precision Casting Solutions Total Hip System |
Precision Casting Solution, LLC |
Jim Moore |
| 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 |
| K191861 |
12/06/2019 |
Aurora Surgiscope System |
Rebound Therapeutics |
Naomi Gong |
| 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 |
| DEN190016 |
12/05/2019 |
cobas vivoDx MRSA |
Roche Molecular Systems, Inc. |
Nobuko Nakajima |
| 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 |
| K192569 |
12/13/2019 |
Diode Laser Therapy System |
San He Lefis Electronics Co., Ltd. |
Ning Li |
| 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 |
| 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 |
| 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 |
| 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 |
| K192763 |
12/17/2019 |
syngo.CT CaScoring |
Siemens Medical Solutions USA, Inc. |
Tabitha Estes |
| K192755 |
12/20/2019 |
Soli-Lite LG4 Galileo |
Silhouet-Tone Corporation |
Eric Ghedin |
| K190467 |
12/26/2019 |
iHelmet Hair Growth System |
Slinph Technologies Co., LTD |
Zou Jian |
| 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 |
| 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 |
| 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 |
| 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 |
| DEN190034 |
12/13/2019 |
Control-IQ Technology |
Tandem Diabetes Care, Inc. |
Michael Sarrasin |
| K192324 |
12/06/2019 |
Sheridan Spiral-Flex Endotracheal Tubes |
TeleflexMedical, Inc |
Lori Pfohl |
| K193160 |
12/03/2019 |
Glidesheath Slender Tibial Pedal Kit |
Terumo Medical Coporation |
Liang Lu |
| K193135 |
12/11/2019 |
TSolution One Total Knee Application |
Think Surgical, Inc. |
Meliha Mulalic |
| K193071 |
12/17/2019 |
Bashir Plus Endovascular Catheter |
Thrombolex, Inc. |
Amy Katsikis |
| K193107 |
12/03/2019 |
TriSalus Infusion System |
TriSalus Life Sciences |
Patrick McCain |
| 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 |
| 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 |
| K190987 |
12/02/2019 |
Uroject12 Syringe Lever |
UroGen Pharma Ltd. |
Liz Schindel |
| K193238 |
12/20/2019 |
Nexus DR Digital X-Ray Imaging System (with vSharp) |
Varex Imaging Corporation |
Michael Van Ryn |
| K192607 |
12/19/2019 |
LiteWalk |
Viasonix Ltd. |
Shlomi Deler |
| K192225 |
12/09/2019 |
Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses |
VizionFocus, Inc. |
Angus Shih |
| 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 |
| 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 |
| K190829 |
12/19/2019 |
Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) |
Wilson-Cook Medical, Inc. / Cook Endoscopy |
Tiffanny A Thomas |
| K190990 |
12/31/2019 |
Digital Thermometer |
Xiamen Ants Bro Technology Co., Ltd. |
Jane Xu |
| 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 |
