FDA 510(k) Applications Received During January, 2019

FDA 510(k) Number Submission Date Device Name Applicant Contact
K190044 01/09/2019 VSP Orthopedics System 3D Systems, Inc. Kim Torluemke
K190167 01/31/2019 MitraClip G4 Steerable Guide Catheter Abbott Ekta Lad
K190131 01/28/2019 AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc. Serena Sanginthirath
K190072 01/15/2019 BriefCase Aidoc Medical, Ltd. Nimrod Epstein
K190045 01/09/2019 DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives Alcon Laboratories, Inc. Heather Smith
K190095 01/22/2019 Powder-Free Clear Vinyl Patient Examination Gloves Anhui Intco Medical Products Co. Ltd Jacken Cai
K190018 01/04/2019 Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs Ansell Healthcare Products, LLC. Don Cronk
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
K190110 01/23/2019 NanoBone SBX PUTTY, NanoBone QD Artoss Gmbh Walter Gerike
K190151 01/30/2019 COBRA Fusion Ablation System AtriCure, Inc. Melissa Smallwood
K190149 01/29/2019 Vial Adapter ?20 mm Avenir Performance Europeenne Medical (APEM) Fatoumata Dao
K190109 01/23/2019 MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) Beckman Coulter, Inc. Elaine Duncan
K190126 01/28/2019 Bendit2.7 Steerable Microcatheter Bend It Technologies Ltd Nitza Shoham
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
K190042 01/09/2019 Brainlab Elements Image Fusion Angio Brainlab AG Rainer Birkenbach
K190023 01/04/2019 BTL-084 BTL Industries, Inc. David Chmel
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
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
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
K190016 01/03/2019 Lateral Plate System CoreLink, LLC Steven Mounts
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
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
K190059 01/11/2019 CEREC Guides Dentsply Sirona Karl J. Nittinger
K190043 01/09/2019 Halley resin Dentsply Sirona Karl Nittinger
K190048 01/10/2019 UF(II) Anatomic abutment DIO Corporation Jiae Park
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
K190130 01/28/2019 The ClearSight finger cuffs Edwards Lifesciences, LLC Christine J. Chun
K190153 01/30/2019 RadiForce MX216 EIZO Corporation Hiroaki Hashimoto
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
K190087 01/17/2019 EzDent-i / E2 / Prora View EWOO SOFT Co., Ltd. Young Seok Kim
K190150 01/30/2019 Sage 2-in-1 Personal Lubricant and Moisturizer Fairhaven Health, LLC Suzanne Munson
K190034 01/07/2019 REMY Medical Therapy Laser System Footdocprenur, LLC David Zuckerman
K190152 01/30/2019 Vit Kit- Freeze NX and Vit Kit- Warm NX FUJIFILM Irvine Scientific, Inc. Jayme Yamaguchi-Owens
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
K190168 01/31/2019 Aquas Probes Genicon, Inc. Katlyn Kachman
K190147 01/29/2019 COLOSSEUM Mesh Globus Medical Inc. Kelly J. Baker
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
K190121 01/25/2019 IDS SHBG Immunodiagnostic Systems Ltd. Mick Henderson
K190127 01/28/2019 Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter Innovative Health, LLC. Amanda Babcock
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
K190056 01/11/2019 KOWA VK-2s KOWA Co. Ltd. CHOFU Rinji Kondo
K190006 01/02/2019 Magnetic Surgical System Levita Magnetics International Corp. Alberto Rodrigues-Navarro
K190141 01/29/2019 HANAROSTENT LowAx Colon/Rectum (NNN) M.I.Tech Co., Ltd. Inae Kim
K190022 01/04/2019 SafeBreath Filter Mouthpiece MD Diagnostics Limited Glen Hillsley
K190092 01/18/2019 UNiD Patient specific 3D printed TLIF cage Medicrea International S.A. David Ryan
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
K190096 01/22/2019 R2GATE MegaGen Implant Co., Ltd. HyeJin Jung
K190015 01/03/2019 Ballancer Gold, 1212 Mego Afek AC Ltd. Reuven Yunger
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
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
K190083 01/17/2019 Leaf Photocoagulator Norlase ApS Jan Forstberg
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
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
K190102 01/22/2019 DyeVertÖ Plus Contrast Reduction System, DyeTectÖ Contrast Monitoring System, DyeVertÖ Plus EZ Contrast Reduction System Osprey Medical Inc. Melanie Hess
K190010 01/03/2019 Penumbra System Reperfusion Catheter JET 7 Penumbra, Inc. Micaela Victoria
K190017 01/03/2019 LiverMultiScan (LMSv3) Perspectum Diagnostics Ltd Jaco Jacobs
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
K190063 01/15/2019 Servator C SALF Solution S.A.L.F. Spa Carmelo Gagliano
K190062 01/15/2019 STATCLAVE G4 Chamber Autoclave SciCan Ltd. Teresa Boyce
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
K190011 01/03/2019 Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) Shenzhen Mindray Bio-medical Electronics Co., LTD. Yanhong Bai
K190159 01/30/2019 Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove Showa Best Glove, Inc. Jefferey Richardson
K190138 01/29/2019 MAGNETOM Aera Siemens Medical Solutions USA, Inc. Cordell L. Fields
K190049 01/10/2019 Sim&Size Sim&Cure Krishna Mahadea
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
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
K190055 01/11/2019 Duo Lumbar Interbody Fusion Device Spineology Inc. Andrew Adams
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
K190070 01/15/2019 Sonopet iQ Ultrasonic Aspirator System Stryker Corporation Julia Helgeson
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
K190079 01/16/2019 ArgenZ HT+ The Argen Corporation Craig Jolicoeur
K190001 01/02/2019 Supercath 5 TOGO MEDIKIT Co., Ltd. Daisuke Nagamizu
K190027 01/07/2019 SteriStay Toul Meditech AB Tomas Hansson
K190166 01/31/2019 TriMed Nitinol Staple System TriMed, Inc. David Medoff
K190024 01/07/2019 Smart-C Turner Imaging Systems, Inc. Michael Drake
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
K190100 01/22/2019 USTAR II System United Orthopedic Corporation Lois Ho
K190060 01/11/2019 Urethrotech UCD Urethrotech Daniela Andrich
K190146 01/29/2019 Nexus DR Digital X-ray Imaging System Varex Imaging Corporation Michael G. Van Ryn
K190137 01/29/2019 Identify Varian Medical Systems Inc. Peter J. Coronado
K190155 01/30/2019 FibermarX Radiopaque Tissue Marker Viscus Biologics, LLC Justin Baker
K190078 01/16/2019 IntraSight Volcano Corporation Kimberly Simon
K190007 01/02/2019 Vydence Laser Family Vydence Medical Industria E Comercio Ltda Kathy Maynor
K190107 01/22/2019 VeriSplint Whip Mix Corporation John Waters
K190038 01/08/2019 Xbody Newave USA XBody Hungary Kft. Peter Tar
K190051 01/11/2019 TD Clip Zephyr Sleep Technologies, Inc. Sabina Bruehlmann
K190068 01/15/2019 Vanguard XP Knee System Zimmer Inc. Charles Neitzel


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