FDA 510(k) Applications Received During January, 2019

FDA 510(k) Number Submission Date Device Name Applicant Contact
K193085 11/05/2019 PuraDERM Gel 3-D Matrix, Inc. Lisa Spirio
K190044 01/09/2019 VSP Orthopedics System 3D Systems, Inc. Kim Torluemke
K193055 11/01/2019 Purzir Dental Zirconia 3DBioCAD Gyu D. Cho
K193254 11/26/2019 3M Attest Steam Chemical Integrator 3M Company Mary Fretland
K193154 11/14/2019 3M Attest Super Rapid 5 Steam-Plus Challenge Pack 3M Company Mary Fretland
K193110 11/12/2019 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E 3M Health Care Andrew Wingen
K193293 11/27/2019 XV Lung Ventilation Analysis Software 4Dx Limited Terrence Thiel
K190119 01/24/2019 Foryou NPWT Dressing Kit 4L Health Co., Ltd. Jackie Jian
K190167 01/31/2019 MitraClip G4 Steerable Guide Catheter Abbott Ekta Lad
K193310 11/29/2019 myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) Abbott (St. Jude Medical) Vanessa Powell
K193126 11/12/2019 HI-TORQUE InfilTrac Guide Wire Family Abbott Vascular Aniket Khakhadiya
K193183 11/18/2019 ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter ACIST Medical Systems, Inc. Angela Johnson
K190131 01/28/2019 AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc. Serena Sanginthirath
K193262 11/26/2019 DR 600 with Tomosynthesis Agfa N.V. Wim Govaerts
K190072 01/15/2019 BriefCase Aidoc Medical, Ltd. Nimrod Epstein
K193298 11/27/2019 BriefCase Aidoc Medical, Ltd. Nimrod Epstein
K193069 11/04/2019 AIROS 6 Sequential Compression Device AIROS Medical, Inc. Darren Behuniak
K193068 11/04/2019 AIROS 8 Sequential Compression Device AIROS Medical, Inc. Darren Behuniak
K190045 01/09/2019 DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives Alcon Laboratories, Inc. Heather Smith
K193095 11/07/2019 Ambu aScope 4 Cysto Ambu A/S Anita Fjaestad
K190095 01/22/2019 Powder-Free Clear Vinyl Patient Examination Gloves Anhui Intco Medical Products Co. Ltd Jacken Cai
K193256 11/26/2019 Anjon Bremer Halo System Anjon Holdings LLC Kenneth A Collins
K190018 01/04/2019 Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs Ansell Healthcare Products, LLC. Don Cronk
K193292 11/27/2019 Voyant 5mm Fusion Device, Voyant Maryland Fusion Device Applied Medical Resources Corp. Blake Stacy
K193268 11/26/2019 APrioCore Plus AprioMed AB Katrin Svensson
K190129 01/28/2019 AC5 Topical Gel Arch Therapeutics, Inc. Terrence Norchi
K190117 01/24/2019 Fiberoptix IAB Arrow International, Inc. Niyati Boghani
K190101 01/22/2019 UltraFlex IAB Arrow International, Inc. Niyati Boghani
K190069 01/15/2019 Arrowhead Hexapod Fixator Arrowhead DE, LLC Thomas J. Twardzik
K193157 11/14/2019 Arthrex 3.9mm Corkscrew Suture Anchor Arthrex Inc. Jessica L. Singelais
K193156 11/14/2019 Arthrex Mini Comprehensive Fixation System - 1.0mm Screws Arthrex Inc. Rebecca R. Homan
K190110 01/23/2019 NanoBone SBX PUTTY, NanoBone QD Artoss Gmbh Walter Gerike
K193116 11/12/2019 MRopen EVO ASG Superconductors S.p.A. DeBenedetti Luisella
K190151 01/30/2019 COBRA Fusion Ablation System AtriCure, Inc. Melissa Smallwood
K193162 11/15/2019 EPi-Sense Guided Coagulation System with VisiTrax AtriCure, Inc. Caitlin Wunderlin
K193066 11/04/2019 Steripack cases and Tray Systems Avalign Technologies, Inc. Hiren Patel
K190149 01/29/2019 Vial Adapter ?20 mm Avenir Performance Europeenne Medical (APEM) Fatoumata Dao
K193101 11/08/2019 Omnifix Low Dead Space Luer Lock Syringe B. Braun Medical Inc. Tracy Larish
K193137 11/13/2019 EASYGRIP FLO-41 Precision MIS Delivery System Baxter Healthcare Corportation Jeanette Licata
K193124 11/12/2019 Unicel DxH 800 Coulter Cellular Analysis System Beckman Coulter Samy Puccio
K190109 01/23/2019 MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) Beckman Coulter, Inc. Elaine Duncan
K190054 01/11/2019 BD Insulin Syringe Becton Dickinson and Company Meriam Youssef
K190126 01/28/2019 Bendit2.7 Steerable Microcatheter Bend It Technologies Ltd Nitza Shoham
K193185 11/18/2019 Anscare SIMO Negative Pressure Wound Therapy (NPWT) System BenQ Materials Corporation Miranda Chang
K193172 11/15/2019 Luna XD Ti Interbody Fusion System Benvenue Medical, Inc. Laurent Schaller
K193122 11/12/2019 Biocore9 Humeral Resurfacing System Biocore9, LLC. Stan Matlak
K190139 01/29/2019 Zircos-Com Bioden Co., Ltd Kim Hye Min
K193168 11/15/2019 Agilon Moldable Biogennix, LLC. Timothy Bumbalough
K190154 01/30/2019 ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) bioMerieux SA Marine Taravant
K190035 01/08/2019 Biomet Headless Compression and Twist-Off Screws Biomet Inc Andrew Steward
K193092 11/06/2019 TunneLoc Tibial Fixation Device Biomet Inc. Haley Pioch
K190047 01/09/2019 StimRouter Neuromodulation System Bioness Inc. Sageev George
K193237 11/25/2019 Carto Octaray Mapping Catheter with Trueref Technology Biosense Webster, Inc. Richard Lauhead
K193120 11/12/2019 Real Intelligence Cori Blue Belt Technologies, Inc. Corrine Herlinger
K193279 11/27/2019 Comet II Pressure Guidewire Boston Scientific Corporation Kimberly Berg
K193202 11/20/2019 EXALT Model D Single-Use Duodenoscope, EXALT Controller Boston Scientific Corporation Carter Navarro
K190042 01/09/2019 Brainlab Elements Image Fusion Angio Brainlab AG Rainer Birkenbach
K193307 11/29/2019 HIP7 Brainlab AG Cherita James
K193201 11/20/2019 BTL-785F BTL David Chmel
K190023 01/04/2019 BTL-084 BTL Industries, Inc. David Chmel
K193181 11/18/2019 Serranator PTA Serration Balloon Catheter Cagent Vascular, LLC Carol Burns
K193153 11/13/2019 SPIRA-C Integrated Fixation System Camber Spine Technologies Daniel Pontecorvo
K193097 11/07/2019 Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation Paul Biggins
K193270 11/26/2019 CapLOX II«/TowerLOX« MIS Pedicle Screw System Captiva Spine, Inc. George Chaux
K193177 11/18/2019 CER-S CardioCalm Fabio Badilini
K193173 11/18/2019 CareView 1800Le CareRay Digital Medical System Co., Ltd. Leilei Li
K190106 01/22/2019 Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle Centerline Biomedical, Inc. Vikash Goel
K190076 01/16/2019 Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems Cepheid Yi-Ping Lin
K190074 01/16/2019 Presero 3D Scanning System Certis Health Richard Vogel Vogel
K190029 01/07/2019 Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar Changzhou Xin Neng Yuan Medical Stapler Co., Ltd. Boping Ma
K193317 11/29/2019 CoreLite X-Ray Specimen Cabinet Cirdan Imaging Limited Jenna McGarry
K190080 01/16/2019 Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) Comfort Rubber Gloves Industries Sdn. Bhd. Chan Yew Men
K193105 11/08/2019 iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System Conformis, Inc. Nancy Giezen
K190114 01/24/2019 Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) ConvaTec Limited Karen Howes
K190084 01/17/2019 McLean-Ring Enteral Feeding Tube Set Cook Incorporated Paul Meyer
K193220 11/21/2019 AVIEW LCS Coreline Soft Co., Ltd Hyeyi Park
K190016 01/03/2019 Lateral Plate System CoreLink, LLC Steven Mounts
K190143 01/29/2019 LARS AC Band Device Corin USA Lucinda Gerber
K190099 01/22/2019 Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch Corinth MedTech, Inc. Sandeep Saboo
K190113 01/24/2019 Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags Corinth MedTech, Inc. Sandeep Saboo
K193077 11/05/2019 Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff Covidien Stacy Barton
K193232 11/25/2019 Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology Covidien LLC Hilla Debby
K190073 01/16/2019 Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub Current Health Ltd Edwin Lindsay
K190025 01/07/2019 EVOL« -SI Joint Fusion System Cutting Edge Spine, LLC Kyle Kuntz
K193144 11/13/2019 T-Line Hernia Mesh Deep Blue Medical Advances, Inc. William Perry
K190059 01/11/2019 CEREC Guides Dentsply Sirona Karl J. Nittinger
K190043 01/09/2019 Halley resin Dentsply Sirona Karl Nittinger
K193078 11/05/2019 MIS CONNECT Conical Connection System Dentsply Sirona Karl Nittinger
K193064 11/04/2019 Atlantis suprastructures Dentsply Sirona Inc. Karl Nittinger
K193057 11/01/2019 ATTUNE All-Polyethylene Tibia DePuy Ireland UC Kathy Harris Brocato
K190091 01/18/2019 Diapaste Diadent Group International Myung Sub Kim
K193051 11/01/2019 LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set DiaSorin Inc. John C. Walter
K190048 01/10/2019 UF(II) Anatomic abutment DIO Corporation Jiae Park
K193212 11/21/2019 DSM Biomedical Dental Bone Graft Plus DSM Biomedical Susan Pileggi
K193245 11/25/2019 Dunamis PunchTac Suture Anchors Dunamis LLC Prithviraj Chavan
K193139 11/13/2019 ProVecta 3D Prime Ceph Durr Dental SE Oliver Lange
K190090 01/17/2019 DynoSense Vital Sign Measuring System DynoSense Corp. Saeed Azimi
K190124 01/25/2019 EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One E.M.S Electro Medical Systems S.A. Gaelle Pacaud
K193149 11/13/2019 True 3D Viewer Software EchoPixel Inc. Michael Gabler
K193121 11/12/2019 GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims ECO Medi Glove SDN BHD Suresh Kumar
K193179 11/18/2019 EV1000 Clinical Platform Edwards Lifesciences, LLC Jamie Byun
K190130 01/28/2019 The ClearSight finger cuffs Edwards Lifesciences, LLC Christine J. Chun
K190153 01/30/2019 RadiForce MX216 EIZO Corporation Hiroaki Hashimoto
K193226 11/22/2019 AltiVate Anatomic Canal-Sparing (CS) Shoulder Encore Medical, L.P Teffany Hutto
K190057 01/11/2019 DJO Acetabular System Encore Medical, L.P. Teffany Hutto
K190098 01/22/2019 Endophys Pressure Sensing Sheath Endophys Holdings LLC Phillip Purdy
K193115 11/12/2019 EUROIMMUN Anti-BP230-CF ELISA (IgG) Euroimmun US, Inc. Kruti Shah
K190087 01/17/2019 EzDent-i / E2 / Prora View EWOO SOFT Co., Ltd. Young Seok Kim
K193098 11/07/2019 Exactech« Equinoxe« Reverse Shoulder Glenospheres Exactech, Inc Zach Sharrah
K190150 01/30/2019 Sage 2-in-1 Personal Lubricant and Moisturizer Fairhaven Health, LLC Suzanne Munson
K190112 01/23/2019 Non-Sterile Zirconia Block Fine Advanced Compound Co., Ltd Jeong Kwang-Ho
K193045 11/01/2019 gekoÖ W-2 Firstkind Limited Neil Buckley
K193255 11/26/2019 Largo PEEK Interbody System FloSpine, LLC Peter Harris
K193209 11/21/2019 Wego-Stainless Steel Foosin Medical Supplies Inc., Ltd. Zhipeng Yang
K190034 01/07/2019 REMY Medical Therapy Laser System Footdocprenur, LLC David Zuckerman
K193123 11/12/2019 FUJIFILM Distal Cap Models 33-40 FUJIFILM Corporation Randy Vader
K190152 01/30/2019 Vit Kit- Freeze NX and Vit Kit- Warm NX FUJIFILM Irvine Scientific, Inc. Jayme Yamaguchi-Owens
K190136 01/29/2019 Fusion Silastic System Fusion Orthopedics, LLC Eli Jacobson
K193219 11/21/2019 G Surgical Marksman System G Surgical LLC Donald Grafton
K193061 11/01/2019 G3 40 Radiopaque Bone Cement G21 S.r.l Flilippo Foroni
K193059 11/01/2019 G1 40 Radiopaque Bone Cement G21 S.r.l. Filippo Foroni
K193113 11/12/2019 GC Temp Print GC America Inc. Mark Heiss
K190008 01/02/2019 Carescape One GE Healthcare Joel Kent
K193282 11/27/2019 SIGNA Premier GE Healthcare (GE Medical Systems, LLC) Glen Sabin
K193170 11/15/2019 Deep Learning Image Reconstruction GE Healthcare Japan Corporation Tomohiro Ito
K193261 11/26/2019 FlightPlan for Embolization GE Medical Systems SCS Ning Wen
K193281 11/27/2019 Hepatic VCAR GE Medical Systems SCS Lifeng Wang
K190161 01/30/2019 Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray Gebauer Company Brittney Cooper
K190028 01/07/2019 UNO 30 Genadyne Biotechnologies Andrew Goh
K190168 01/31/2019 Aquas Probes Genicon, Inc. Katlyn Kachman
K190147 01/29/2019 COLOSSEUM Mesh Globus Medical Inc. Kelly J. Baker
K193303 11/29/2019 Tinnitus Sound Generator Module GN Hearing A/S Lars Hagander
K193272 11/26/2019 GTK Trocars Guangzhou TK Medical Instrument Co., Ltd. Tracy Weng
K190118 01/24/2019 Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III) Guangzhou Xinbo Electronic Co., Ltd. Sammy Li
K193228 11/22/2019 Hamilton-G5 Hamilton Medical AG Simone Haller
K190032 01/07/2019 Disposable Sclerotherapy Needle Hangzhou AGS MedTech CO., Ltd Xiangyong Yu
K193132 11/12/2019 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
K190134 01/28/2019 Full Automatic (NIBP) Blood Pressure Monitor-HL158TB Health & Life Co., Ltd. JS Hsu
K190133 01/28/2019 Full Automatic (NIBP) Blood Pressure Monitor-HL158UB Health & Life Co., Ltd. JS Hsu
K193189 11/19/2019 RFID Localization System Health Beacons, Inc. Nancy Confrey
K193152 11/13/2019 Affinity Hermes Medical Solutions AB Joakim Arwidson
K193148 11/13/2019 VaPro Plus Pocket, VaPro Plus Hollister Incorporated Michelle Schiltz-Taing
K190009 01/03/2019 Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) Hong Qiangxing (Shen Zhen) Electronics Limited Xu Jianhua
K193233 11/25/2019 Restoration« Modular Hip System Howmedica Osteonics Corp. (aka Stryker Orthopaedics) Nora O'Connor
K190157 01/30/2019 Diana ChemoClave Transfer Set ICU Medical Jason Ma
K190121 01/25/2019 IDS SHBG Immunodiagnostic Systems Ltd. Mick Henderson
K193263 11/26/2019 Reprocessed Achieve Catheter Connecting Cable Innovative Health, LLC. Rick Ferreira
K190127 01/28/2019 Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter Innovative Health, LLC. Amanda Babcock
K193218 11/21/2019 Innovision Audio Innovere Medical Inc. Lynsie Thomason
K190088 01/17/2019 QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents Inova Diagnostics, Inc. Roger Albesa
K190040 01/08/2019 Straumann BLX Line Extension - New Abutments Institut Straumann AG Ana C.M. Vianna
K190082 01/17/2019 Straumann BLX Variobase Abutment Institut Straumann AG Viviana Horhoiu
K190097 01/22/2019 Straumann CARES Screw-Retained Bridges and Bars Institut Straumann AG Gordon Dodds
K193046 11/01/2019 Straumann« Retentive System û Novaloc TiN Abutments Institut Straumann AG Ana C.M. Vianna
K193192 11/19/2019 Tamper Evident Cap International Medical Industries Inc. David Meily
K193087 11/06/2019 Rapid ICH iSchemaView Incorporated James Rosa
K193234 11/25/2019 NUVO IF Implant System JJGC Industria e Comercio de Materiais Dentarios S.A. Luiza Vaccari Toppel
K193203 11/20/2019 MOJAVE Expandable Interbody System K2M, Inc. Oonagh Lahiff
K193129 11/12/2019 Yukon OCT Spinal System K2M, Inc. Oonagh Lahiff
K193235 11/25/2019 Telepack + Karl Storz Endoscopy America, Inc. Winkie Wong
K193213 11/21/2019 Vicks VNT200 No Touch Forehead Thermometer Kaz USA, Inc., a Helen of Troy Company Matt J. Baun
K193174 11/18/2019 Keos Lumbar IBFD Keos Scott Peterson
K193250 11/25/2019 Irrigation Tubing with CO2 or Air KeyMed (Medical and Industrial Equipment) Ltd. Andy Hollingsworth
K193311 11/29/2019 Aluna Knox Medical Diagnostics, Inc. Charvi Shetty
K193225 11/22/2019 KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography Konica Minolta Healthcare Americas, Inc Jan Maniscalco
K190056 01/11/2019 KOWA VK-2s KOWA Co. Ltd. CHOFU Rinji Kondo
K193288 11/27/2019 Koya Ripple Koya, Inc. Andy Doraiswamy
K193060 11/01/2019 Noritake Super Porcelain EX-3 Kuraray Noritake Dental Inc. Yasujiro Ohara
K190006 01/02/2019 Magnetic Surgical System Levita Magnetics International Corp. Alberto Rodrigues-Navarro
K193258 11/26/2019 ProLift Expandable System Life Spine Inc. Angela Batker
K193284 11/27/2019 Physica LMC Knee System Limacorporate S.p.A Michela Zanotto
K193259 11/26/2019 Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer Little Doctor Electronic (Nantong)Co.,Ltd Iris Du
K193167 11/15/2019 NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software Luminex Molecular Diagnostics, Inc. Jennifer Grimes
K193072 11/04/2019 Lucent : IPL LUVO Medical Technologies, Inc. Gregory Berzak
K190141 01/29/2019 HANAROSTENT LowAx Colon/Rectum (NNN) M.I.Tech Co., Ltd. Inae Kim
K193128 11/12/2019 Mako Total Hip Application Mako Surgical Corp. Liza Gordillo
K193242 11/25/2019 Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories Masimo Corporation Sindura Penubarthi
K190022 01/04/2019 SafeBreath Filter Mouthpiece MD Diagnostics Limited Glen Hillsley
K193175 11/18/2019 Lateralized Glenosphere Medacta Inernational SA Stefano Baj
K193083 11/05/2019 M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System Medacta International SA Stefano Baj
K193165 11/15/2019 MectaFix CL Fixation Button with Continuous Loop Medacta International SA Stefano Baj
K193104 11/08/2019 Unified Arrhythmia Diagnostic System PocketECG IV Medicalgorithmics S.A. Marek Dziubinski
K190092 01/18/2019 UNiD Patient specific 3D printed TLIF cage Medicrea International S.A. David Ryan
K193188 11/18/2019 MiiS Horus Eye Anterior Camera Medimaging Integrated Solution Inc. (MiiS) Yi-Ying Chen
K193217 11/21/2019 SensiCare PI and SensiCare PI Micro Surgical Gloves Medline Industries, Inc. Jennifer Mason
K193305 11/29/2019 DynaClip Bone Staple MedShape, Inc. Jack Griffis
K193278 11/27/2019 MedSource CathMED IV Catheter MedSource Labs Emilie Andrews
K190012 01/03/2019 OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid Medtrade Product Ltd Mina Patel
K190132 01/28/2019 Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter Medtronic Matthew Lobeck
K190165 01/31/2019 Capstone ControlÖ Spinal System Medtronic Sofamor Danek USA, INC. Justin O'Connor
K193145 11/13/2019 Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch Megadyne Medical Products, Inc. Sharon Sussex
K190096 01/22/2019 R2GATE MegaGen Implant Co., Ltd. HyeJin Jung
K190015 01/03/2019 Ballancer Gold, 1212 Mego Afek AC Ltd. Reuven Yunger
K193082 11/05/2019 Fountain ValveTip Infusion Catheter Merit Medical Systems, Inc Spriha Pandey
K190030 01/07/2019 Embrella Endoscopic Distal Attachment Micro-Tech (Nanjing) Co., Ltd. Becky Li
K190086 01/17/2019 Cepheid Xpert Respiratory Control Panel Microbiologics, Inc. Tina Sobania
K190123 01/25/2019 MicroPort CoCr Femoral Heads MicroPort Orthopedics Inc. Tejas Patel
K193252 11/25/2019 Contour ProtegeAI MIM Software Inc. Lynn Hanigan
K190115 01/24/2019 MHD TENS MingHuangDa Electronic Co., Ltd Zhang Guixiang
K190160 01/30/2019 neXus Ultrasonic Surgical Aspirator System Misonix, Inc. John Salerno
K190077 01/16/2019 Biogel« PI UltraTouch S Surgical Glove, Biogel« Pl Ultra Touch S Indicator Underglove Molnlycke Health Care, US LLC Leonard Stewart
K193239 11/25/2019 MPowRx Snoring Solution (also known as Good Morning Snore Solution) MPowRx Health and Wellness Products 2012 Inc Nancy Markley
K193102 11/08/2019 MRIaudio PREM System with MRIview MRIaudio, Inc. Joseph Caruso
K193130 11/12/2019 MVP Aligner System MVP Aligners, LLC Daniel Michaeli
K193211 11/21/2019 Nano FortiFix« System Nanovis Spine LLC Matthew Hedrick
K193094 11/07/2019 Naviswiss Hip Navigation System Naviswiss AG Jan Stifter
K193269 11/26/2019 UroLift System (UL400) Neotract, Inc. Brian Gall
K193063 11/04/2019 EMBOTRAP III Revascularization Device Neuravi, Ltd. Niall Fox
K193264 11/26/2019 Disposable High Speed Air Turbine Handpiece Ningbo HPDOVE Dental Instruments Co., Ltd. Liyue Huang
K190037 01/08/2019 Cronus HP PTA Balloon Catheter Nipro Medical Corporation Jessica Oswald-McLeon
K190083 01/17/2019 Leaf Photocoagulator Norlase ApS Jan Forstberg
K193246 11/25/2019 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation Rachel Gilbert
K193074 11/04/2019 Bevel Up Holder NSP Tech Pte Ltd HC TAN
K190064 01/15/2019 nView system 1 nView medical, Inc. Lisa Last
K190093 01/18/2019 Rezum Delivery Device, Rezum Generator NxThera (A Boston Scientific Company) Justin Kapitan
K193182 11/18/2019 Evis Exera III Duodenovideoscope Olympus TJF-Q190V Olympus Medical Systems Corp. Toshiyuki Nakajima
K190164 01/31/2019 CleverLock Guidewire Locking Device and Biopsy Cap Olympus Surgical Technologies America Mary Anne Patella
K190162 01/31/2019 SmartCeph Ortho2, LLC Amy Schmidt
K193052 11/01/2019 HBP6 Settable, Resorbable Hemostatic Bone Paste Orthocon, Inc. Howard Schrayer
K190003 01/02/2019 Vivid Aligners Orthodent Laboratory, Inc. Michael Wright
K193100 11/08/2019 RESPONSEÖ Spine System, RESPONSEÖ 4.5/5.0 Spine System, RESPONSEÖ 5.5/6.0 Spine System OrthoPediatrics, Corp Jackie Jaskula
K190102 01/22/2019 DyeVertÖ Plus Contrast Reduction System, DyeTectÖ Contrast Monitoring System, DyeVertÖ Plus EZ Contrast Reduction System Osprey Medical Inc. Melanie Hess
K193207 11/20/2019 TaiChiA Our United Corporation Qi Liu
K193295 11/27/2019 Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor Parcus Medical, LLC Paul Vagts
K193244 11/25/2019 Indigo Aspiration System û Lightning Aspiration Tubing Penumbra, Inc. Micaela Victoria
K190010 01/03/2019 Penumbra System Reperfusion Catheter JET 7 Penumbra, Inc. Micaela Victoria
K193103 11/08/2019 NeoBase 2 Non-derivatized MSMS Kit PerkinElmer Inc. Eva Nalian
K190017 01/03/2019 LiverMultiScan (LMSv3) Perspectum Diagnostics Ltd Jaco Jacobs
K193109 11/08/2019 MRCAT brain Philips Medical Systems MR Finland Janne Marvola
K193215 11/21/2019 Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems Philips Medical Systems Nederland BV Jan Van de Kerkhof
K193204 11/20/2019 Cryocheck Chromogenic Factor VIII Precision BioLogic Karen Black
K193161 11/15/2019 Pristine Scope Pristine Surgical Stewart B. Davis
K193243 11/25/2019 Alta Multipurpose Device Qfix Alexandra Low Smythe
K193140 11/13/2019 Flex Body SPEEDER Quality Electrodynamics, LLC Eric Yeh
K193300 11/27/2019 AIMI-Triage CXR PTX RADLogics, Inc. Moshe Becker
K190075 01/16/2019 Aurora Evacuator Rebound Therapeutics Donald Atienza
K190122 01/25/2019 Renovis A200 PS Knee System as part of the Renovis A200 Knee System Renovis Surgical Technologies Anthony Debenedictis
K193313 11/29/2019 Elecsys Anti-TSHR Roche Diagnostics Reanna Toney
K193053 11/01/2019 Tina-quant Hemoglobin A1cDx Gen.3 Roche Diagnostics Operations (RDO) Leslie Patterson
K193274 11/26/2019 Rodo Abutment System RODO Medical, Inc. James Park
K190063 01/15/2019 Servator C SALF Solution S.A.L.F. Spa Carmelo Gagliano
K193096 11/07/2019 S.I.N. Dental Implant System S.I.N. -Sistema de Implante Nacional S.A. Denise Domiciano
K190062 01/15/2019 STATCLAVE G4 Chamber Autoclave SciCan Ltd. Teresa Boyce
K193194 11/19/2019 CrossTorq 14 Guidewire Scientia Cardio Access LLC Amy McManus
K193229 11/22/2019 Transpara ScreenPoint Medical B.V. Umar Waqas
K193224 11/22/2019 Daytona« Small Stature Growth Rod Conversion Set SeaSpine Orthopedics Corporation Jesse Albright
K193054 11/01/2019 Sectra Digital Pathology Module Sectra AB Edoardo Mastrovito
K190002 01/02/2019 Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use Shanghai Kohope Medical Devices Co., Ltd Yibing Wang
K193241 11/25/2019 Emission Computed Tomography System Shanghai United Imaging Healthcare Co., Ltd Shumei Wang
K193176 11/18/2019 uMR 780 Shanghai United Imaging Healthcare Co., Ltd Xin Gao
K193073 11/04/2019 Deep Recon Shanghai United Imaging Healthcare Co., Ltd. Shumei Wang
K193210 11/21/2019 HYPER DLR Shanghai United Imaging Healthcare Co., Ltd. Shumei Wang
K193200 11/20/2019 uMR Omega Shanghai United Imaging Healthcare Co., Ltd. Xin Gao
K193253 11/18/2019 Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 Shenzhen Changkun Technology Co., Ltd. Steve Li
K190011 01/03/2019 Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) Shenzhen Mindray Bio-medical Electronics Co., LTD. Yanhong Bai
K193275 11/26/2019 Nerve and Muscle Stimulator Shenzhen XFT Medical Limited Cindy Peng
K190159 01/30/2019 Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove Showa Best Glove, Inc. Jefferey Richardson
K193178 11/18/2019 Biograph Horizon Siemens Medical Solution USA, Inc. Alaine Medio
K193283 11/27/2019 AI-Rad Companion Prostate MR Siemens Medical Solutions USA Inc. Lauren Bentley
K193257 11/26/2019 ACUSON Sequoia Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc Sulgue Choi
K193248 11/25/2019 Biograph Vision, Biograph mCT Family of PET/CTs Siemens Medical Solutions USA, Inc Tabitha Estes
K193290 11/27/2019 AI-Rad Companion Brain MR Siemens Medical Solutions USA, Inc. Lauren Bentley
K193294 11/27/2019 AI-Rad Companion Engine Siemens Medical Solutions USA, Inc. Lauren Bentley
K193267 11/26/2019 Al-Rad Companion (Musculoskeletal) Siemens Medical Solutions USA, Inc. Alaine Medio
K190138 01/29/2019 MAGNETOM Aera Siemens Medical Solutions USA, Inc. Cordell L. Fields
K193166 11/15/2019 MAMMOMAT Revelation Siemens Medical Solutions USA, Inc. Martin Rajchel
K193089 11/06/2019 MULTIX Impact Siemens Medical Solutions USA, Inc. Martin Rajchel
K193277 11/27/2019 SOMATOM On.site and On.scene Siemens Medical Solutions USA, Inc. Alaine Medio
K193216 11/21/2019 syngo.CT Lung CAD Siemens Medical Solutions, Inc Abhineet Johri
K190049 01/10/2019 Sim&Size Sim&Cure Krishna Mahadea
K193075 11/04/2019 Osteo3 ZP Putty Sirakoss Ltd. Jordan Conway
K190058 01/11/2019 PureSleep (OTC use) Sleep Science Partners, Inc. Noel P. Lindsay
K190085 01/17/2019 Journey II Unicompartmental Knee System Smith & Nephew Inc Amy Winegarden
K193058 11/01/2019 SonarMed AirWave Airway Monitoring System SonarMed, Inc. Laura Lyons
K190039 01/08/2019 EchoSure Diagnostic Ultrasound System Sonavex, Inc David Narrow
K190050 01/10/2019 Tech Dots - Adhesive and conductive gel Spes Medica S.r.l. Giorgio Facco
K190071 01/15/2019 Perla« Posterior Cervico-Thoracic Fixation System SPINEART Franck Pennesi
K193106 11/08/2019 SpineFrontier Lumbar Interbody Fusion Device System SpineFrontier, Inc. Vito Lore
K190055 01/11/2019 Duo Lumbar Interbody Fusion Device Spineology Inc. Andrew Adams
K193147 11/13/2019 Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System Stereotaxis, Inc. Kenneth H. Lock
K190005 01/02/2019 Sterilucent HC 80TT Hydrogen Peroxide Sterilizer Sterilucent, Inc. Peter Kalkbrenner
K190081 01/16/2019 RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector STERIS Corporation Marcia L Benedict
K190103 01/22/2019 V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System STERIS Corporation Anthony Piotrkowski
K190104 01/22/2019 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System Steris Corporations Jennifer Nalepka
K193136 11/13/2019 Stryker Customized Mandible Recon Plate Kit Stryker Zainab Amini
K193143 11/13/2019 Stryker Facial iD Plating System Stryker Zainab Amini
K190070 01/15/2019 Sonopet iQ Ultrasonic Aspirator System Stryker Corporation Julia Helgeson
K193118 11/12/2019 TGS Guidewire and updated Scopis Software Stryker ENT Bruce Backlund
K193308 11/29/2019 T2 Alpha Tibia Nailing System, IMN Screws System Stryker Trauma GmbH Sanja Jahr
K190144 01/29/2019 MucoPEG SunBio, Inc. Sun S. Kim
K190163 01/31/2019 ALARA Neuro Access Kit SurGenTec, LLC Travis Greenhalgh
K190052 01/11/2019 Radio Frequency Ablation System Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Guofang Ma
K190125 01/28/2019 FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire T.A.G. Medical Products Corporation, Ltd Shlomi Dines
K190105 01/22/2019 ZOOM Aspiration Pump Taiwan Biomaterial Co., Ltd. Monoj Mon Kalita
K190026 01/07/2019 Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) Teleflex Medical Lakshmi Kanuri
K193160 11/15/2019 Glidesheath Slender Tibial Pedal Kit Terumo Medical Coporation Liang Lu
K193125 11/12/2019 R2P Destination Slender Guiding Sheath Terumo Medical Corporation Liang Lu
K190079 01/16/2019 ArgenZ HT+ The Argen Corporation Craig Jolicoeur
K193135 11/12/2019 TSolution One Total Knee Application Think Surgical, Inc. Meliha Mulalic
K193071 11/04/2019 Bashir Plus Endovascular Catheter Thrombolex, Inc. Amy Katsikis
K190001 01/02/2019 Supercath 5 TOGO MEDIKIT Co., Ltd. Daisuke Nagamizu
K193150 11/13/2019 Latex Examination Powder Free Glove, Aloe Vera Top Glove SDN BHD Noor Akilah BT Saidin
K193247 11/25/2019 LATITUDE EVÖ Total Elbow Arthroplasty Tornier Inc. Renee Stoffel
K190027 01/07/2019 SteriStay Toul Meditech AB Tomas Hansson
K190166 01/31/2019 TriMed Nitinol Staple System TriMed, Inc. David Medoff
K193107 11/08/2019 TriSalus Infusion System TriSalus Life Sciences Patrick McCain
K190024 01/07/2019 Smart-C Turner Imaging Systems, Inc. Michael Drake
K193222 11/22/2019 Tyber Medical Anatomical Plating System Tyber Medical LLC Mark Schenk
K190053 01/11/2019 SECULOKÖ ACP System U&i Corporation Kwang-Eun Song
K190067 01/15/2019 Velofix Interbody Fusion System U&i Corporation Jee-Ae Bang
K193312 11/29/2019 UNIKO PointCloudÖ Knee Instruments Unik Orthopedics, Inc. Charlie Chi
K190100 01/22/2019 USTAR II System United Orthopedic Corporation Lois Ho
K190060 01/11/2019 Urethrotech UCD Urethrotech Daniela Andrich
K193108 11/08/2019 Bonecam Suture Anchor Valeris Medical Inc. Brendan Thies
K190146 01/29/2019 Nexus DR Digital X-ray Imaging System Varex Imaging Corporation Michael G. Van Ryn
K193238 11/25/2019 Nexus DR Digital X-Ray Imaging System (with vSharp) Varex Imaging Corporation Michael Van Ryn
K190137 01/29/2019 Identify Varian Medical Systems Inc. Peter J. Coronado
K193240 11/25/2019 Universal Cylinder Applicator Family Varian Medical Systems, Inc. Peter J. Coronado
K193119 11/12/2019 Twin-Pass Dual Access Catheter Vascular Solutions LLC Iroquois Ledbeter
K193260 11/26/2019 U-Cem Premium & MAZIC Cem Vericom Co., Ltd. Yun Ki Kim
K190120 01/24/2019 VINNO 8, VINNO 6, VINNO 5 VINNO Technology (Suzhou) Co., Ltd. Wei Wang
K190155 01/30/2019 FibermarX Radiopaque Tissue Marker Viscus Biologics, LLC Justin Baker
K193197 11/20/2019 QuickClear Mechanical Thrombectomy System 6F- Straight, QuickClear Mechanical Thrombectomy System 8F- Straight, QuickClear Mechanical Thrombectomy System 8F- Shaped, QuickClear Mechanical Thrombectomy System 10F- Shaped, QuickClear Aspiration Pump Volcano AtheroMed Inc. Anna Gloria Stephen
K190078 01/16/2019 IntraSight Volcano Corporation Kimberly Simon
K190007 01/02/2019 Vydence Laser Family Vydence Medical Industria E Comercio Ltda Kathy Maynor
K190013 01/03/2019 WellDoc BlueStar WellDoc, Inc. Caroline York
K190107 01/22/2019 VeriSplint Whip Mix Corporation John Waters
K193067 11/04/2019 The INBONEÖ Total Ankle System, the INFINITYÖ Total Ankle System and the INVISIONÖ Total Ankle Revision System Wright Medical Technology, Inc. Antonio Ayala
K190038 01/08/2019 Xbody Newave USA XBody Hungary Kft. Peter Tar
K193315 11/29/2019 Xenocor Articulating Xenoscope Laparoscope Xenocor, Inc Evan Kelso
K190051 01/11/2019 TD Clip Zephyr Sleep Technologies, Inc. Sabina Bruehlmann
K193230 11/25/2019 Ziehm Vision FD Ziehm Imaging GmbH Steve Seeman
K193050 11/01/2019 Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem Zimmer GmbH Roberto Tommasini
K193099 11/07/2019 Anatomical Shoulder System Zimmer GmbH Roberto Tommasini
K193180 11/18/2019 Alliance Augmented Glenoid Zimmer Inc. Patricia Sandborn Beres
K190068 01/15/2019 Vanguard XP Knee System Zimmer Inc. Charles Neitzel
K193223 11/22/2019 Persona Personalized Knee System Zimmer, Inc Gregory Foster


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