FDA 510(k) Decisions During December, 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
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
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
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
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
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
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