FDA 510(k) Decisions During February, 2019  

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
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
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
K183549 02/16/2019 GEM Premier ChemSTAT Instrumentation Laboratory Co. Gabriella Erdosy
K183555 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


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