FDA 510(k) Applications Received During December, 2017

FDA 510(k) Number Submission Date Device Name Applicant Contact
K173940 12/26/2017 Astroid Planning App .decimal, LLC. Kevin Erhart
K173795 12/14/2017 HI-TORQUE TurnTrac Guide Wire Family Abbott Vascular Aniket Khakhadiya
K173947 12/27/2017 Lumbar Interbody Fusion System (OLLIF) Advanced Research Medical, LLC John D Siegel
K173932 12/26/2017 Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 Alere Scarborough, Inc. Angela Drysdale
K173715 12/04/2017 AlertWatch:OB AlertWatch, Inc. Justin Adams
K173727 12/05/2017 Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor Ambu A/S Maja Brons
K173762 12/11/2017 AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters AngioDynamics, Inc. Teri Juckett
K173788 12/14/2017 Arthrex Corkscrew FT Arthrex Inc. David L Rogers
K173845 12/19/2017 Arthrex SwiveLock Arthrex Inc. David L Rogers
K173900 12/22/2017 Arthrex Univers Revers Modular Glenoid System Arthrex Inc. Courtney Smith
K173964 12/29/2017 OVOMotion Shoulder Arthroplasty System Arthrosurface, Inc. Dawn J. Wilson
K173760 12/11/2017 Monarch Endoscopy Platform (Monarch Platform) Auris Surgical Robotics, Inc. Joy Sacmar
K173862 12/20/2017 Pantheris System Avinger, Inc. Thomas Lawson
K173867 12/20/2017 Axis Anterior Cervical Plate System Axis Orthopaedics Craig Wilcox
K173803 12/15/2017 Omnican fine B. Braun Medical Inc. Kimberly Smith
K173699 12/04/2017 The Pump by Babyation Babyation, LLC Jared Miller
K173780 12/12/2017 EchoMD Automated Ejection Fraction Software Bay Labs, Inc. Charles Cadieu
K173773 12/12/2017 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Bayer Medical Care Inc. Lisa A Ewing
K173913 12/22/2017 MEDRAD« Imaging Bulk Package Transfer Set Bayer U.S. LLC Leslie S. O'Nan
K173873 12/20/2017 BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial Becton Dickinson and Company Ashanti Brown
K173973 12/29/2017 TV-100 Bio-Med Devices, Inc. Ken Close
K173767 12/11/2017 A. L. P. S. Clavicle Plating System Biomet Inc. Dhaval Saraiya
K173826 12/18/2017 THP Hip Fracture Plating System Biomet, Inc. Annette Minthorn
K173682 12/01/2017 L300 Go System Bioness, Inc. Mercedes Bayani
K173977 12/29/2017 CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module Biosense Webster, Inc. Phuong Chau
K173978 12/29/2017 CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module Biosense Webster, Inc. Phuong Chau
K173956 12/28/2017 Biowy PlCC Catheter Biowy Corporation Andre von Muller
K173820 12/18/2017 OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU) Boston Scientific Corporation Mugdha Dongre
K173837 12/18/2017 RHYTHMIA HDx Mapping System (with software Version 2.0) Boston Scientific Corporation Gregory Neal
K173877 12/21/2017 BOWA Neutral Electrodes BOWA-electronics GmbH & Co. KG Wolf-Ruediger Fritz
K173800 12/14/2017 Camber Spine Technologies SPIRA - VÖ Open Matrix Corpectomy Cage Camber Spine Technologies Michael Black
K173839 12/18/2017 Tissue of Origin Test Kit-FFPE Cancer Genetics, Inc. Janet Graff
K173689 12/01/2017 Ophthalmic Software Platform RX Canon Inc. -Medical Equipment Group Shinji Mori
K173924 12/26/2017 DRX-Revolution Nano Mobile X-ray System Carestream Health, Inc. Victoria A. Wheeler
K173771 12/11/2017 IOLMaster 700 Carl Zeiss Meditec AG Christian Muenster
K173812 12/15/2017 Catalyst CSR 3 Peg Glenoids Catalyst OrthoScience, Inc Dale Davison
K173904 12/22/2017 CATS Tonometer Prism CATS Tonometer, LLC Sean J. McCafferty
K173942 12/26/2017 Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Central Medicare Sdn. Bhd. Arivalagan Subramaniam
K173840 12/18/2017 Xpert CT/NG Cepheid Yi-Ping Lin
K173848 12/19/2017 Model WP-3840 and WP-3040 CNMC Co., Inc. Thomas Kraus
K173686 12/01/2017 Guardia Access Embryo Transfer Catheter Sets and Sydney IVF« Transfer Catheter Cook Incorporated Naomi Funkhouser
K173685 12/01/2017 Peel-Away Introducer Set Cook Incorporated Colin Jacob
K173687 12/01/2017 Strange Bile Duct Stone Exploration Set Cook Incorporated Colin Jacob
K173731 12/06/2017 SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) CooperSurgical, Inc Tove Kjaer
K173880 12/21/2017 Corin TriFit CF Hip Stem Corin USA Limited Rachel King
K173884 12/21/2017 Unity Total Knee System Corin USA Limited Lorraine Mander
K173806 12/15/2017 CorPath GRX System Corindus, Inc. Robert Lavado
K173922 12/26/2017 C-PTFETM Surgical Suture CP Medical Inc. John Hartigan
K173710 12/04/2017 MotoBAND CP Implant System CrossRoads Extremity Systems, LLC Chad Hollis
K173814 12/15/2017 DeGen Medical E3 MIS Pedicle Screw System Degen Medical Craig Black
K173785 12/13/2017 Custom Clear Aligner System Derby Dental Laboratory Reed Nunnally
K173846 12/19/2017 DermaScalp Laser Cap DermaScalp LLC John Carullo
DEN170088 12/08/2017 Dexcom G6 Continuous Glucose Monitoring System Dexcom, Inc. Neeta Sharma
K173683 12/01/2017 LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers DiaSorin Inc. John C Walter
K173798 12/14/2017 Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack DiaSorin Molecular LLC Sharon Young
K173975 12/29/2017 UF(II) Wide Fixture DIO Corporation Jiae Park
K173769 12/11/2017 DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid DMAX CO., LTD. Hyeon Seok Cho
K173876 12/21/2017 Cybird LED Curing Light DXM Co., Ltd Seung Hyun Kim
K173861 12/20/2017 Drug Relief DyAnsys, Inc. San Mateo
K173843 12/18/2017 illumiflow 148 Laser Cap EGlobal, LLC Wayne De Stefano
K173789 12/14/2017 Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon Elekta Instrument AB Alf Laurell
K173791 12/14/2017 Leksell GammaPlan Elekta Instrument AB Matilda Forsberg
K173723 12/05/2017 EMPOWR Universal Tibial Baseplate Encore Medical, L.P. Teffany Hutto
K173923 12/26/2017 Temporary Cardiac Pacing Wire Ethicon, Inc. Joice Pappan
K173863 12/20/2017 Ez3D-i /E3 Ewoo Soft Co., Ltd. Young Seok Kim
K173777 12/12/2017 BreathID Hp Lab System Exalenz Bioscience Ltd. Raffi Werner
K173772 12/12/2017 BreathID Hp System Exalenz Bioscience Ltd. Raffi Werner
K173775 12/12/2017 Clench Compression Staple F & A Foundation LLC d.b.a. Reign Medical Daniel Lanois
K173929 12/26/2017 CipherOx CRI M1 Flashback Technologies, Inc. Gregory Z. Grudic
DEN170089 12/14/2017 Curve Positive Airway Pressure System FRESCA Medical Mary Lou Mooney
K173972 12/29/2017 2008T BlueStar Hemodialysis Machine Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K173718 12/05/2017 Liberty Cycler Set Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K173684 12/01/2017 g.Estim PRO g.tec medical engineering GmbH Christoph Guger
K173816 12/15/2017 NM/CT 850, NM/CT 860 GE Healthcare George Mashour
K173885 12/21/2017 Genesys Spine Binary Lumbar Plate System Genesys Spine Brian J. Bergeron
K173722 12/05/2017 PATRIOT COLONIAL Spacer, SUSTAIN Spacer Globus Medical Inc. Kelly Baker
K173757 12/11/2017 VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set Greiner Bio-One NA Inc Manfred Abel
K173703 12/04/2017 Sonata Sonography-Guided Transcervical Fibroid Ablation System Gynesonics, Inc. Diane King
K173819 12/18/2017 MyPlant II Implant System Hager & Meisinger GmbH Adam Tomczak
K173955 12/28/2017 Mic-Key* SF Over-the-Wire Stoma Measuring Device Halyard Health, Inc. David M Lee
K173903 12/22/2017 Granada Medium Hardy Diagnostics Rianna Malherbe
K173739 12/07/2017 ALOKA ARIETTA 850 Hitachi Healthcare Americas Corporation Doug Thistlethwaite
K173901 12/22/2017 MyoSure MANUAL Tissue Removal Device Hologic, Inc. Anne-Marie Keefe
K173919 12/22/2017 HX Device Human Extension Ltd. Dalit Doron
K173811 12/15/2017 TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System In2Bones SAS Morgane Grenier
K173709 12/04/2017 Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm InNeuroCo, Inc Marc Litzenberg
K173961 12/28/2017 Straumann BLX Implant System Institut Straumann AG Viviana Horhoiu
K173968 12/29/2017 Straumann Variobase for Bridge/Bar Cylindrical Institut Straumann AG Gordon Dodds
K173717 12/05/2017 Integra TITAN Reverse Shoulder System Integra LifeSciences Corporation Kathleen McGuire
K173935 12/26/2017 Mediant Anterior Cervical Plating System Intelligent Implant Systems, LLC Michael Nutt
K173721 12/05/2017 SureForm 60 and SureForm 60 Reloads Intuitive Surgical Nadine Nasr
K173842 12/18/2017 da Vinci Xi Surgical System, da Vinci X Surgical System Intuitive Surgical, Inc Brandon Hansen
K173906 12/22/2017 da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories Intuitive Surgical, Inc. Elaine Lee
K173808 12/15/2017 VoutiaÖ Jeffrey Ward Cash, DDS Jeffrey Ward Cash
K173902 12/22/2017 Neodent Implant System û GM Line JJGC Industria e Comercio de Materiais Dentarios S.A. Julianne de Oliveira Capucho Lechechem
K173730 12/06/2017 Kinsa QuickCare Thermometer KINSA, Inc. David Gal
K173886 12/21/2017 CPRmeter 2 CPR Feedback Device Laerdal Medical AS Mari Kaada
K173696 12/01/2017 TBL-ABI System LD Technology LLC Albert Maarek
K173817 12/15/2017 Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 ?g/mL Liofilchem s. r. l. Fabio Brocco
K173700 12/04/2017 PICOPLUS Laser System Lutronic Corporation Jhung Won Vojir
K173805 12/15/2017 NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Ti Marvao Medical Devices, Ltd. Christopher Davey
K173970 12/29/2017 Materialise PKA Guide System Materialise NV Oliver Clemens
K173794 12/14/2017 AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared Medacta International SA Stefano Baj
K173890 12/21/2017 GMK Sphere - Kinematic Alignment Medacta International SA Stefano Baj
K173969 12/29/2017 Medicalgorithmics Unified Cardiac Rehabilitation System Medicalgorithmics S.A. Marek Dziubinski
K173782 12/13/2017 UNiD Patient Specific 3D printed cage Medicrea International S.A. David Ryan
K173911 12/22/2017 Medline Burn and Wound Dressing Medline Industries, Inc. Bethany Benoit-DiMaria
K173889 12/21/2017 Medline Cautery Electrode (PTFE) Medline Industries, Inc. Matt Clausen
K173859 12/20/2017 HEALIX ADVANCE Anchor with DYNACORD Suture Medos International SARL Tatyana Tatyana Korsunsky
K173787 12/14/2017 X-MESH« Expandable Cage System, OCELOT« Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE« System, CONCORDE« Inline Lumbar Interbody System, CONCORDE« Curve Lumbar Interbody Medos International SARL Sheree Geller
K173855 12/20/2017 Sharpsite AC Rigid Endsocope Medtronic Xomed Inc. Shravan Chawla
K173750 12/08/2017 Prelude IDeal Hydrophilic Sheath Introducer Merit Medical Systems, Inc. David Thomas
K173963 12/28/2017 DRI Benzodiazepine Assay Microgenics Corporation Minoti Patel
K173943 12/26/2017 Dental High-speed Handpiece and Accessories MicroP Technology (Taiwan), Inc. Ina Lin
K173776 12/12/2017 BIOLOX delta Option and Extra-long Heads MicroPort Orthopedics Inc. Allen Mamaril
K173931 12/26/2017 MindMotion(TM) GO MindMaze SA Sylvian Bourriquet
K173856 12/20/2017 Express 4 Sleep appliance/CPAP Sidekick appliance Moses Appliances LLC Allen J. Moses
K173763 12/11/2017 iovera system Myoscience, Inc Kent Jones
K173905 12/22/2017 Surgic Pro, Surgic Pro+ Nakanishi Inc. Kimihiko Satoh
K173865 12/20/2017 trophon2 Nanosonics Limited Ruth Cremin
K173815 12/15/2017 Allergan Botox Needle Electrode Natus Manufacturing Limited Maria Connolly
K173690 12/01/2017 Grass TWin Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Shane Sawall
K173936 12/26/2017 Natus Photic Stimulator Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Sanjay Mehta
K173938 12/26/2017 IS-III HActive Fixture Neobiotech Co., Ltd. Young-Ko Heo
K173725 12/05/2017 NeuMoDx GBS Assay NeuMoDx Molecular, Inc. Kay Fuller
K173868 12/20/2017 Serenity Body Position Sensor, Serenity RIP Sensors Neurotronics, Inc. David Pezet
K173746 12/08/2017 Activmotion Range Newclip Technics Gaelle LUSSORI
K173980 12/29/2017 Specular Microscope CEM-530 Nidek Co., Ltd. Yoneji Mizuno
K173797 12/14/2017 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation Adam Heroux
K173892 12/21/2017 NuVasive« XLX Interbody System NuVasive, Incorporated Cynthia Adams
K173707 12/04/2017 P200TE Optos plc Geoff Fatzinger
K173894 12/21/2017 Jade PTA Balloon Dilatation Catheter OrbusNeich Medical Trading Inc. John Pazienza
K173680 12/01/2017 Sapphire II PRO OrbusNeich Medical Trading Inc. John Pazienza
K173874 12/21/2017 StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO Origami Surgical LLC John Gillespie
K173951 12/27/2017 Legend Acetabular Liners Ortho Development Corporation Drew Weaver
K173693 12/01/2017 Orbitum Bone Staple Implant, X and VI Orthovestments, LLC Robert Weinstein
K173967 12/29/2017 Remedy Acetabular Cup Osteoremedies LLC Chris Hughes
K173881 12/21/2017 Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G Owen Mumford Ltd Darren Mansell
K173679 12/01/2017 PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes PENTAX of America, Inc. James W. Monroe
K173761 12/11/2017 Penumbra System Reperfusion Catheter JET 7 Penumbra, Inc. Michaela Mahl
K173792 12/14/2017 EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay Phadia AB Carina Magnusson
K173726 12/05/2017 ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut Phadia AB Ulf Karlberg
K173704 12/04/2017 ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip Phadia AB Carina Magnusson
K173729 12/06/2017 REVIAN RED PhotonMD, Inc William A Knape
K173807 12/15/2017 Accu O2 Oxygen Analyzer Precision Medical Inc. James Parker
K173878 12/21/2017 PreXion3D Excelsior PreXion Corporation Katsumi Hayashi
K173734 12/06/2017 RocaJJ Soft Stents Promepla SAM Alexandre Bareille
K173939 12/26/2017 Quantib Brain Quantib BV Floor van Leeuwen
K173691 12/01/2017 Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack Quidel Corporation Jennifer S. Rial
K173768 12/11/2017 Tempus Pro Patient Monitor Remote Diagnostic Technologies Ltd. James Hamlyn
K173741 12/07/2017 Reprocessed ArthoCare Ablation Wand ReNovo, Inc. Mark K. Wells
K173740 12/07/2017 Reprocessed DePuy Mitek Ablation Wand ReNovo, Inc. Mark K. Wells
K173927 12/26/2017 Elecsys BRAHMS PCT Roche Diagnostics Wes Gerbig
K173887 12/21/2017 cobas CT/NG for use on cobas 6800/8800 systems Roche Molecular Systems, Inc. Nobuko Nakajima
K173828 12/18/2017 GU60A & GU60A-65 Samsung Electronics Co.,Ltd. Noh Jaesang
K173713 12/04/2017 HS70A Diagnostic Ultrasound System Samsung Medison Co., Ltd. Ji Yea Lee
K173882 12/21/2017 SeaSpine Mariner Pedicle Screw System SeaSpine Orthopedics Corporation Gina Flores
K173953 12/27/2017 uDR 780i Shanghai United Imaging Healthcare Co., Ltd. Xin GAO
K173766 12/11/2017 PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs Shen Wei USA Inc. Cheryl Reep
K173801 12/14/2017 Transcranial Doppler Ultrasound System Shenzhen Delica Medical Equipment Co., Ltd. Zhenhua Xiao
K173869 12/20/2017 Med-link Reusable Blood Pressure Cuff Shenzhen Med-link Electronics Tech Co., Ltd Baihan Feng
K173909 12/22/2017 Dimension Hemoglobin A1c Assay Siemens Healthcare Diagnostics Inc. Alan Haley
K173957 12/28/2017 ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc. Sulgue Choi
K173897 12/22/2017 syngo.via MI Workflows Siemens Medical Solutions USA, Inc. Veronica Padharia
K173981 12/29/2017 ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc. Ultrasound Group Sulgue Choi
K173779 12/12/2017 REXMONO, PDREX SM ENG CO., LTD Soon-Gu Lee
K173912 12/22/2017 BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Trache Smiths Medical ASD, Inc. Donna M. Semlak
K173784 12/13/2017 Smylic Invisible Clear Aligners Smylio, Inc Ken Menon
K173796 12/14/2017 Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) Sofradim Production Benjamin Rochette
K173759 12/11/2017 Thermage CPT System and Accessories Solta Medical Ken Nehmer
K173934 12/26/2017 Reza Band, Reflux Band Somna Therapeutics, L.L.C. James S. Miller
K173896 12/22/2017 Microcyn Antimicrobial Hydrogel Sonoma Pharmaceuticals, Inc. Brian Martin
K173706 12/04/2017 Piccolo Implants and Accessories Southern Implants (Pty) Ltd. Lauranda Breytenbach
K173844 12/19/2017 Titan Ag 200 Specialty Fibres and Materials Ltd Lindie Marx
K173834 12/18/2017 Quantum Pump Console Spectrum Medical Ltd Mark Drain
K173702 12/04/2017 Juliet Ti LL SPINEART Franck Pennesi
K173875 12/21/2017 GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert StelKast, Inc. Dave Stumpo
K173692 12/01/2017 D-Actor 200 Vibration Massage System Storz Medical AG Pavel Novak
K173841 12/18/2017 AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm Stryker Angelica Beckmann
K173866 12/20/2017 Stryker AIM Light Source and SafeLight cable Stryker Jay Nayar
K173946 12/27/2017 ADAPT for Gamma3 Stryker GmbH Nesli Karakaya
K173849 12/19/2017 Triathlon Total Knee System Stryker Orthopaedics Margaret Crowe Klippel
K173823 12/18/2017 Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System Summit Industries LLC Tom Boon
K173908 12/22/2017 DESS Dental Smart Solutions Terrats Medical SL Roger Terrats
K173799 12/14/2017 NaviCross 0.018 Terumo Corporation Yuko Watanabe
K173831 12/18/2017 Glidesheath Slender Terumo Medical Corporation Liang Lu
K173732 12/06/2017 Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit The Binding Site Group Ltd Christopher Bradshaw
K173915 12/22/2017 Test of Variables of Attention (T.O.V.A.) The TOVA Company Chris Holder
K173821 12/18/2017 LungQ Software Thirona Corporation Eva van Rikxoort
K173962 12/28/2017 Viamo c100 TUS-VC100 Diagnostic Ultrasound System Toshiba Medical Systems Corporation Paul Biggins
K173736 12/06/2017 TrackX TrackX Technology, LLC Calley Herzog
K173930 12/26/2017 PYTHON Plate Trial Instruments Treace Medical Concepts, Inc. Rachel Osbeck
K173825 12/18/2017 MC 300R* Nebulizer Trudell Medical International Marianne Tanton
K173918 12/22/2017 VersaPAP Positive Airway Pressure (PAP) Device Trudell Medical International Marianne Tanton
K173694 12/01/2017 STERIZONE VP4 Sterilizer TSO3, Inc. Alexandre Jokci
K173879 12/21/2017 MiniMed Mio Advance infusion set Unomedical A/S Heidi Bjerre Lovkvist
K173864 12/20/2017 Peekplus« Interbody Fusion Device Vallum Corporation Stephen Blinn
K173838 12/18/2017 ARIA Radiation Therapy Management Varian Medical Systems, Inc. Peter J. Coronado
K173891 12/21/2017 Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume Vascular Solutions, Inc. Lisa Gallatin
K173952 12/27/2017 Universal SmartECG VectraCor, Inc. Andrew Schreck
K173810 12/15/2017 Ventripoint Medical System Plus (VMS+) Ventripoint Diagnostics, Ltd. Desmond Hirson
K173958 12/28/2017 OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens Visco Vision Inc Evan Huang
K173860 12/20/2017 s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System Volcano Corporation Nora York
K173914 12/22/2017 VORTRAN Cuff Inflator (VCI) VORTRAN Medical Technology 1, Inc. James Lee
K173711 12/04/2017 Wallaby Avenir Coil System Wallaby Medical, Inc. Rebecca K. Pine
K173829 12/18/2017 NeoLSD MSMS kit Wallac Oy, a subsidiary of PerkinElmer Kay A Taylor
K173832 12/18/2017 InTiceÖ-C Porous Ti Cervical Interbody System X-Spine Systems, Inc. Charlene Brumbaugh
K173752 12/08/2017 SI Screw System Zavation Medical Products, LLC James M. Phillips
DEN170090 12/21/2017 MATRx plus Zephyr Sleep Technologies Sabrina Bruehlmann
K173758 12/11/2017 Disposable Biopsy Valve Zhejiang Chuangxiang Medical Technology Co., LTD. Lucius Long


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