FDA 510(k) Decisions During May, 2018  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K173940 05/15/2018 Astroid Planning App .decimal, LLC. Kevin Erhart
K180352 05/02/2018 7D Surgical System 7D Surgical Inc. Daniel Ziskind
K180582 05/31/2018 Sternal Cable System A & E Medical Corporation Hollie Johnson
K180087 05/18/2018 A.M. Surgical Intramedullary Fixation Device A.M. Surgical, Inc Gavriel Feuer
K173294 05/18/2018 Magnesium Abbott Laboratories Kimberly Senseman
K180776 05/11/2018 Cytal Wound Particulate ACell, Inc. Andrea Artman
K180771 05/18/2018 Acro HCG Pregnancy Rapid Test ACRO Biotech, Inc. Joseph Fan
K181077 05/24/2018 ActiGraph CentrePoint Insight Watch ActiGraph Brian Bell
K180239 05/16/2018 Additive Orthopaedics Patient Specific 3D Printed Bone Segments Additive Orthopaedics, LLC Gregory Kowalczyk
K180742 05/17/2018 EnsoETM Advanced Cooling Therapy, Inc. d/b/a Attune Medical Erik Kulstad
K180464 05/31/2018 AEVUMED PHANTOM Suture Anchors Aevumed, Inc. Saif Khalil
K173653 05/02/2018 Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit Alere Scarborough, Inc. Danielle A. Briggeman
K180296 05/07/2018 Afinion HbA1c Dx Alere Technologies AS Monica Vallestad
DEN170086 05/17/2018 TrueTear Intranasal Tear Neurostimulator Allergan Nooshin Azizi
K180480 05/31/2018 ATEC Universal Spacer System Alphatec Spine, Inc Jeremy Markovich
K172430 05/18/2018 ArgenIS Titanium Abutments Argen Corporation Paul Cascone
K180662 05/22/2018 Arthrex FastThread Interference Screw Arthrex Inc. Jessica L. Singelais
K180848 05/01/2018 AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches ArthroCare Corporation Shruthi Bhat
K173862 05/22/2018 Pantheris System Avinger, Inc. Thomas Lawson
K172412 05/01/2018 BacterioScan 216Dx System BacterioScan, Inc. Rhonda Soest
K173084 05/11/2018 Spectrum IQ Infusion System, Dose IQ Safety Software Baxter Healthcare Corporation Dhiraj Bizzul
K173913 05/04/2018 MEDRAD« Imaging Bulk Package Transfer Set Bayer U.S. LLC Leslie S. O'Nan
K180174 05/29/2018 Belun Ring Belun Technology Company Limited Leung Lap Wai Lydia
K173956 05/21/2018 Biowy PlCC Catheter Biowy Corporation Andre von Muller
K181042 05/17/2018 Ultra ICE Plus û PI 9 MHz Peripheral Imaging Catheter Boston Scientific Corporation Jennifer L. Foley
K180375 05/18/2018 The IQoolTM Warm System Brain Cool AB Martin Waleij
K181179 05/18/2018 BrainScope One BrainScope Company Inc. Michael E Singer
K173540 05/03/2018 Brainsway Deep (DTMS) System Brainsway Ltd. Ahava Stein
K172209 05/18/2018 AURA ICP MONITORING SYSTEM Branchpoint Technologies, INC. Nicholas Hu
K172717 05/25/2018 Automatic Tissue Processing Unit BSL Co. Jun Suk Lee
K172614 05/04/2018 Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medic Caldera Medical, Inc. Vicki Gail
K180162 05/03/2018 VivaScope System Caliber Imaging & Diagnostics, Inc. Joel Radford
K181150 05/25/2018 ProtekDuo Mini Veno-Venous Cannula Set CardiacAssist Inc Greg Johnson
K171007 05/03/2018 Fluorescence Mode Carl Zeiss Suzhou Co., Ltd. Huang XiaoDong
K180003 05/10/2018 FORE-SIGHT ELITE Module Tissue Oximeter CAS Medical Systems, Inc. Ron Jeffrey
K180293 05/30/2018 Retia 2 CenterVue SpA Roberto Gabriotti
K173347 05/08/2018 STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX Centinel Spine, Inc. Jessica Staub
K181080 05/24/2018 McKesson Cardiology Change Healthcare Israel Ltd. Nadia Marchant
K180519 05/16/2018 HARRIER-SAÖ Lumbar Interbody System Choice Spine, LP Kim Finch
K180799 05/14/2018 Clarius Ultrasound Scanner Clarius Mobile Health Corp. Brendan Seward
K180476 05/15/2018 Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Comfort Rubber Gloves Industries Sdn. Bhd. Chan Yew Men
K180906 05/16/2018 Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Conformis, Inc. Emmanuel Nyakako
K180028 05/02/2018 Cook 810 Set, Desilets-Hoffman Introducer Set Cook Incorporated Carly Powell
K173035 05/01/2018 Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets Cook Incorporated Erum B. Nasir
K172980 05/03/2018 Micropuncture Pedal Access Set Cook Incorporated Daniel J Corbin
K180756 05/24/2018 Safety Wire Guide Introducer COOK Incorporated Carly Powell
K180034 05/07/2018 Weinmann Tracheostomy Exchange Set Cook Incorporated Paul Meyer
K180727 05/11/2018 LineUp CurveBeam, LLC Stuti Singh
K180891 05/04/2018 EVOL Spinal Interbody System, EVOS Lumbar Interbody System Cutting Edge Spine, LLC Kyle Kuntz
K181122 05/31/2018 CARDIOSAVE Intra-Aortic Balloon Pump Datascope Corp. Hemang Kotecha
K172640 05/14/2018 Dentium Implantium & SuperLine Prosthetics Dentium Co., Ltd. Sangpil Yoon
K181024 05/23/2018 DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips DFI Co., Ltd. Bella Cho
K180932 05/09/2018 Diamond Orthopedic Bone Fixation Screws and Pins Diamond Orthopedic, LLC Roy Bivens
K171505 05/17/2018 Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) Dimesol, Inc. Stephen P. Callaghan
K172656 05/01/2018 BiliLux Draeger Medical Systems, Inc. Gale Winarsky
K173861 05/02/2018 Drug Relief DyAnsys, Inc. San Mateo
K171577 05/03/2018 Smartcord, Smartcord X EASTDENT Co., Ltd Hyonsu Kim
K180862 05/24/2018 Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System Edan Instruments, Inc Alice Yang
K180961 05/10/2018 RadiForce MX194 EIZO Corporation Hiroaki Hashimoto
K180524 05/18/2018 EEG-Now EncephaloDynamics, Inc. J. Chris Sackellares
K180197 05/21/2018 Erchonia FX-635 Erchonia Corporation Steven Shanks
K180031 05/07/2018 Endopath Electrosurgery Probe Plus II Ethicon Endo-Surgery, LLC Carmen Ortiz
K180403 05/23/2018 ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length Ethicon Endo-Surgery, LLC Sigfrido Delgado
K172582 05/24/2018 EUROIMMUN IFA Granulocyte MosaicÖ EUROPattern and EUROIMMUN EUROPLUS Granulocyte MosaicÖ EUROPattern Euroimmun US, Inc. Michael A. Locke
K181067 05/23/2018 AlignX Ankle Fusion System Extremity Medical, LLC Brian Smekal
K180808 05/22/2018 Omni Foot Plating System Extremity Medical, LLC Brian Smekal
K173309 05/09/2018 Faxitron VisionCT Faxitron Bioptics Llc Douglas C. Wiegman
K172661 05/08/2018 Fetzer Medical Gynecological Forceps Fetzer Medical GmbH & Co. KG Harald Jung
K180513 05/15/2018 CustomizedBone Service Fin-Ceramica Faenza S.p.A Marina Monticelli
K181059 05/23/2018 geko T-3 Neuromuscular Stimulator Firstkind Limited Neil Buckley
K170663 05/11/2018 Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer Foremount Enterprise Co., Ltd. John Yang
K172570 05/11/2018 ALGS6 Ag Alginate Wound Dressing Foshan United Medical Technologies, Ltd. Una Chen
K173972 05/10/2018 2008T BlueStar Hemodialysis Machine Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K181108 05/24/2018 Fresenius Liberty Select Cycler Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K173718 05/01/2018 Liberty Cycler Set Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K173593 05/21/2018 stayòsafe catheter extension set with Safe-Lock, 12 inch, stayòsafe catheter extension set with Luer-Lock, 6 inch, stayòsafe catheter extension set with Luer-Lock, 12 inch, stayòsafe catheter extension set with Luer-Lock, 18 inch, stayòsafe to Luer-Lock a Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K180711 05/25/2018 FUJIFILM Endoscopic CO2 Regulator GW-100 FUJIFILM Corporation Randy Vader
K180414 05/24/2018 EPX-4440FN Digital Video Processor with Light Source FUJIFILM New Development U.S.A., Inc. Stephen Mariano
K173684 05/04/2018 g.Estim PRO g.tec medical engineering GmbH Christoph Guger
K181153 05/15/2018 ICEfx Cryoablation System Galil Medical Inc. Rachel Owens
K180641 05/04/2018 Invenia ABUS Viewer GE Healthcare Bryan Behn
K173576 05/14/2018 Pristina Serena GE Healthcare Gregory Pessato
K180599 05/02/2018 Venue GE Medical Systems Ultrasound and Primary Care Diagnostics, Tracey Ortiz
K173395 05/21/2018 MECALL CLISIS SYSTEMS, Discovery RF180 General Medical Merate S.P.A Luca Bianchessi
K180817 05/21/2018 AERIALÖ Interspinous Fixation Globus Medical Inc. Kelly J. Baker
K173722 05/23/2018 PATRIOT COLONIAL Spacer, SUSTAIN Spacer Globus Medical Inc. Kelly Baker
K172867 05/10/2018 Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange GMP MEDICARE SDN BHD (F25) Noraini Raus
K180264 05/02/2018 Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit Gold Standard Diagnostics Napoleon Monce
K173157 05/29/2018 Dr's Light2 Good Doctors Co.,Ltd. Sungro Joo
K180287 05/11/2018 GSI Corti Grason-Stadler Inc. Amy Yanta
K180545 05/21/2018 VACUETTE SAFELINK Holder with male luer lock Greiner Bio-One NA Inc. Manfred Abel
K180360 05/10/2018 OKTAGON Implant System Hager & Meisinger GmbH Adam Tomczak
K172871 05/29/2018 SpineKure Kyphoplasty System Hanchang Co., Ltd. An Kwon Ho
K172729 05/21/2018 Polypectomy Snare Hangzhou AGS MedTech CO., Ltd Chunqi Han
K172719 05/11/2018 HealthBeacon HB2 Sharps Bin HealthBeacon Ltd Joyce Power
K180385 05/11/2018 Infrared Body Thermometer HeTaiDa Technology Co., Ltd. Tom Chen
K180079 05/07/2018 Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation Hill-Rom Inc. Sarah Marie Fitzgerald
K180527 05/16/2018 IS3 Hiossen, Inc. David Kim
K180901 05/16/2018 Low Dose CT Lung Cancer Screening Option Hitachi Healthcare Americas Doug Thistlethwaite
K173901 05/08/2018 MyoSure MANUAL Tissue Removal Device Hologic, Inc. Anne-Marie Keefe
K180279 05/09/2018 Silk'n MODEL H5003 device Home Skinovations Ltd. Amit Goren
K172554 05/01/2018 LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing Huizhou Foryou Medical Devices Co., Ltd. Huida Huang
K172480 05/17/2018 icotec Interbody Cage System icotec ag Valeria Consiero
K172690 05/31/2018 ToFscan Idmed Fr?d?ric BERNERT
DEN180005 05/24/2018 OsteoDetect Imagen Technologies, Inc. Alex Dresner
K180466 05/17/2018 FlowTriever Catheter, 6-10 mm; FlowTreiver Catheter, 11-14 mm; FlowTreiver Catheter, 15-18 mm; Aspiration Guide Catheter; Retraction Aspirator Inari Medical Eben Gordon
K173906 05/31/2018 da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories Intuitive Surgical, Inc. Elaine Lee
K173415 05/31/2018 EndoWrist 5mm Thoracic Grasper Intuitive Surgical, Inc. Gayle Perry
K173005 05/25/2018 SURECELL Gelling Fiber Wound Dressing Jiangsu Newvalue Medical Producst Co.,Ltd Julie Chen
K180259 05/18/2018 Sterile Hypodermic Needle for Single Use Jiangsu Shenli Medical Production Co., Ltd Tina Cai
K181188 05/30/2018 EVEREST Spinal System K2M Inc. Nancy Giezen
K173269 05/30/2018 KATOR Suture Anchor KATOR LLC Robert Hoy
K173572 05/09/2018 DSM Biomedical Calcium Phosphate Cement with Microspheres Kensey Nash Corporation dba DSM Biomedical Susan Pileggi
K180445 05/15/2018 reVive Light Therapy LED Ultrasonic Wrinkle System LED Technologies, Inc. Lloyd Nelson
K180071 05/03/2018 STYLO Interbody Fusion Device Legend Spine Technologies Gwendolyn DeBoer
K180642 05/10/2018 Pro-Link« Ti Stand-Alone Cervical Spacer System Life Spine Inc. Randy Lewis
K172271 05/04/2018 Trackit T4 EEG Amplifier Lifelines Ltd. Michael Hulin
K180886 05/18/2018 Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL Liofilchem s. r. l. Fabio Brocco
K180663 05/18/2018 LaVid FMTS DIAGNOSTIC X-RAY SYSTEM LIVERMORETECH Inc. Jae Hong Kim
K173405 05/22/2018 DiLumen Endolumenal Interventional Scissors (DiLumen Is) Lumendi, LLC Dennis Daniels
K180313 05/04/2018 Apollo TMS Therapy System Mag & More GmbH Kerstin Haringer
K180270 05/22/2018 Cellvizio 100 Series Systems with Confocal Miniprobes Mauna Kea Technologies Veronique Dentan
K172864 05/02/2018 Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Maxter Glove Manufacturing Sdn Bhd Yap Peak Geeh
K173510 05/08/2018 BioStamp nPoint MC10 Inc. Rakesh Lal
K172145 05/09/2018 Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion û 120 days, Invia Motion û 60 days, Invia Motion û 30 days, Invia Motion û 15 days, Invia Motion û 7 days), Invia Liberty Negati Medela AG Georges Hakim
K173667 05/17/2018 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodia Medical Components, Inc. (Dba Medcomp) Courtney Nix
K173360 05/17/2018 Athena 190 Medical Rehab Products, LLC Brad Evans
K180101 05/10/2018 HEALIX ADVANCE KNOTLESS BR Anchor Medos International SARL Ashley Goncalo
K181132 05/29/2018 Tri-Ad 2.0 Adams Tricuspid Band Medtronic Tracy Gray
K181001 05/03/2018 Medtronic Confida Brecker Guidewire Medtronic Core Valve, LLC. Gerardine Drummond
K180700 05/18/2018 KYPHON HV-R Bone Cement Medtronic Sofamor Danek USA, Inc. Laveeda Leflore
K181111 05/17/2018 Navigated INFINITY Instruments Medtronic Sofamor Danek USA, Inc. Tejas Patel
K180819 05/16/2018 One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens Menicon Co., Ltd. Kenichi Tanaka
K181023 05/17/2018 Mozec û Rx PTCA Balloon Dilatation Catheter, Mozec NC û Rx PTCA Balloon Dilatation Catheter Meril Life Sciences Private Limited Utpal Thakor
K171449 05/15/2018 Metacem Meta Biomed Co., Ltd Suk Song Oh
K172813 05/18/2018 Esophageal Stent System Micro-Tech (Nanjing) Co.,Ltd. Becky Li
K180317 05/04/2018 EVOLUTION« Knee Systems û MR Labeling, EVOLUTION« BIOFOAM« Tibial System, EVOLUTION« Revision Tibial System, EVOLUTION« Revision CCK System MicroPort Orthopedics, Inc. Grace Johnson-Bann
K173931 05/17/2018 MindMotion(TM) GO MindMaze SA Sylvian Bourriquet
K170703 05/31/2018 Single Use Arthroscopic Electrode (with Pencil) Modern Medical Equipment Manufacturing Limited Jerry Cheung
K173279 05/14/2018 RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder MYCO Medical Supplies, Inc. Sanjiv Kumar
K173938 05/24/2018 IS-III HActive Fixture Neobiotech Co., Ltd. Young-Ko Heo
K180455 05/22/2018 NeuralBot Neural Analytics, Inc. Javad Seyedzadeh
K173452 05/09/2018 EmboTrap ll Revascularization Device Neuravi Ltd. Mairsil Claffey
K180908 05/18/2018 Irrigation Tubing Bipolar Cord Set New Deantronics Taiwan Ltd Jane Liu
K172625 05/11/2018 Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor Nonin Medical Inc. Kim E. Aves
K173892 05/04/2018 NuVasive« XLX Interbody System NuVasive, Incorporated Cynthia Adams
K172555 05/01/2018 SAPPHIRE, ELEVARE SAPPHIRE Omm Imports, Inc. d/b/a Zero Gravity Zivan Habibi
K171828 05/31/2018 ETCO2 Sensor Orantech Inc. Yunxi Xiong
K173874 05/04/2018 StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO Origami Surgical LLC John Gillespie
K180740 05/04/2018 VitriGuard ORIGIO a/s Roaida Johnson
K173951 05/30/2018 Legend Acetabular Liners Ortho Development Corporation Drew Weaver
K180624 05/15/2018 Guided Growth Plate System Plus Orthofix Srl Gianluca Ricadona
K172583 05/10/2018 OrthoPediatrics PediNail Intramedullary Platform OrthoPediatrics, Inc. Adam Cargill
K173391 05/10/2018 OsteoMed QuickFix Hybrid MMF Sterilization Tray OsteoMed LLC Jessica M. Ruperto
K172777 05/03/2018 Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7 PAJUNK GmbH Medizintechnologie Christian G. H. Quass
K173012 05/10/2018 ANGIO-PRESS LITE DVT Compression Device Pegasus Medical Supply, Inc. Pao-Ming Shih
K180412 05/15/2018 Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump; Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump Canister Penumbra, Inc. Richard Kimura
K180939 05/03/2018 Indigo Aspiration System - Modified 110 Aspiration Tubing Penumbra, Inc. Richard Kimura
K172959 05/01/2018 PeraServer and PeraTrend PeraHealth, Inc. Joseph Beals
K181177 05/31/2018 Interventional Workspot Philips Medical Systems Nederland BV Chandrika Srinivasan
K180019 05/03/2018 CAAS Workstation Pie Medical Imaging BV Annemiek Bouts
K180976 05/24/2018 PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels Pixxgen Corporation John Ross
K180167 05/30/2018 Playtex Stella Tampons Playtex Manufacturing, Inc. Ludjane Fiorillo
K172568 05/04/2018 Cervage PRECIFIT MEDICAL LTD Zhen Yu (Eric) Wu
K173807 05/02/2018 Accu O2 Oxygen Analyzer Precision Medical Inc. James Parker
K180876 05/18/2018 DTRAX Spinal System Providence Medical Technology, Inc. Edward Liou
K180111 05/25/2018 ClearGuard HD Antimicrobial Barrier Cap Pursuit Vascular, Inc. Douglas Killion
K180157 05/04/2018 QT ECG QT Medical, Inc. Ruey-Kang Chang
K180922 05/08/2018 Empower H100, Cyber Ho 100, Litho 100 quanta system spa Francesco Dell'Antonio
K180687 05/15/2018 Reliance Lumber IBF System Reliance Medical Systems Bret M Berry
K180051 05/18/2018 XSTAT 30, 1-Pack RevMedx, Inc. Amy K. Pointer
K180625 05/10/2018 Rondek PGA Suture (Beige or Violet) RK Manufacturing Corporation Joshua Hubbard
K180609 05/23/2018 Rodo Smilekey Rodo Medical, Inc. Michael Parsons
K180201 05/23/2018 Route 92 Medical Access System Route 92 Medical, Inc. Kirsten Valley
K180543 05/24/2018 GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 Samsung Electronics Co.,Ltd. Jaesang Noh
K180409 05/11/2018 HS40 Diagnostic Ultrasound System Samsung Medison Co, Ltd. Ji Yea Lee
K180883 05/15/2018 5D Viewer Samsung Medison Co., Ltd. Ji Yea Lee
K172137 05/03/2018 PIEZOTOME CUBE Satelec - Acteon Group Philippe Girard
K180356 05/25/2018 inui In-Home Urine Analysis Test System Scanadu, Inc. Daya Ranamukhaarachchi
K180508 05/18/2018 JOULE SYSTEM Sciton, Inc. Jay M/ Patel
K180686 05/14/2018 SeaSpine Daytona Small Stature Spinal System SeaSpine Orthopedics Corporation Gina Flores
K172517 05/11/2018 SeaSpine Navigation System SeaSpine Orthopedics Corporation Gina Flores
K173108 05/18/2018 Smoklean Sejong Medical Co., Ltd. Yoojung Choi
K173202 05/09/2018 CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set Sekisui Medical Co., Ltd. Kazunori Saito
K180773 05/22/2018 Reusable and Self-Adhesive Electrodes Shaoxing DongZhi Electrical Technology Co., Ltd. Haze XU
K180383 05/11/2018 Light based hair removal device Shenzhen GSD Tech Co., Ltd Ziyi Gui
K172894 05/17/2018 Infrared Thermometer Shenzhen Jiacom Technology Co ., Ltd Luo Tianfeng
K172889 05/25/2018 Infrared Thermometer Shenzhen Pacom Medical Instruments Co., Ltd. Liangzhou Zhong
K180461 05/09/2018 Navi e/Navi s/Navi X Diagnostic Ultrasound System Shenzhen Wisonic Medical Technology Co., Ltd. Jiang Xiaosan
K172242 05/25/2018 DripAssist Plus Shift Labs, Inc. Beth Kolko
K181082 05/25/2018 ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) Siemens Healthcare Diagnostics, Inc. Kathleen Dray-Lyons
K181098 05/31/2018 ACUSON SC2000 Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc Christine Dunbar
K180811 05/23/2018 Biograph Vision Siemens Medical Solutions USA, Inc. Alaine Medio
K172147 05/25/2018 STAR 65 Skanray Technologies Pvt Ltd Mahadevan J
K180361 05/30/2018 MICRORAPTOR REGENESORB Suture Anchor Smith and Nephew, Inc Katherine Marcaccio
K173912 05/08/2018 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
K172592 05/17/2018 CADD Yellow High Volume Administration Set with NRFit connector Smiths Medical ASD, Inc. Michael R. Johnson
K180606 05/31/2018 SOMAVAC Device SOMAVAC Medical Solutions, Inc. Esra Roan
K173834 05/25/2018 Quantum Pump Console Spectrum Medical Ltd Mark Drain
K180220 05/21/2018 SAGICO OSI Spinal System by Osimplant Spinal Analytics & Geometrical Implant Co, LLC James J Gibson Jr.
K172484 05/08/2018 A-CIFT SoloFuse SpineFrontier, Inc. Vito Lore
K180796 05/02/2018 Spineology Navigation Instruments Spineology Inc. Jacqueline A. Hauge
K180807 05/24/2018 Celling Aspiration Needle SpineSmith Holdings, LLC Clifton (Chris) Naivar
K180437 05/04/2018 Hexanium« TLIF SpineVision, SAS Anaella Gallego
K180553 05/29/2018 VERIFY Spore Test Strip for S40 Sterilant Steris Corporation Marcia L. Benedict
K173946 05/02/2018 ADAPT for Gamma3 Stryker GmbH Nesli Karakaya
K173004 05/08/2018 SB Soft Hood - Straight type, SB Soft Hood - Undercut type Sumitomo Bakelite Co., Ltd Shiro Agehama
K173110 05/18/2018 GRAFTSITE Summit Medical Ltd. Robyn Cochrane
K180572 05/29/2018 AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 Supersonic Imagine Laurence Hermitte
K180937 05/10/2018 Graftgun Universal Graft Delivery System Surgentec, LLC Boca Raton
K170697 05/24/2018 GBR system SURGIDENT Duck-su Hur
K171019 05/30/2018 ScioCardio ECG Transmitter Synergen Technology Labs LLC Sunil Konda
K172708 05/24/2018 T2Bacteria Panel T2 Biosystems, Inc. Tom Lowery
K173345 05/04/2018 TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System TaiDoc Technology Corporation Sheena Song
K162021 05/04/2018 3.0 Dynamic TiBase TALLADIUM ESPANA, SL ESTEBAN XAM-MAR
K180585 05/11/2018 Collagentex Rx-6 Tanses Technologies inc. Kirk Kiremitci
K173831 05/08/2018 Glidesheath Slender Terumo Medical Corporation Liang Lu
K180460 05/18/2018 Theradome LH40 Theradome, Inc. Tamim Hamid
K180402 05/25/2018 PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar Topcon Medical Laser Systems, Inc. Sweta Srivastava
K180929 05/09/2018 Klassic HD« Hip System Total Joint Orthopedics, Inc. Chris Weaber
K180163 05/25/2018 TransEnterix Senhance Surgical System TransEnterix, Inc. Stephanie Fitts
K171690 05/08/2018 Trident Extremity Fixation System Trident Orthopedics Al Austin
K181136 05/24/2018 CS 9600 Trophy Marie-Pierre Labat-Camy
K172100 05/04/2018 URIS OMNI System TruAbutment Inc. Brandon Kim
K173825 05/02/2018 MC 300R* Nebulizer Trudell Medical International Marianne Tanton
K172191 05/09/2018 STERIZONE VP4 Sterilizer TSO3 Inc Alexandre Jokic
K172409 05/02/2018 Lite Tzora Active Systems Ltd. Adi Shemer
K172882 05/10/2018 UINCARE HOME UINCARE Corp. Youngbean You
K180623 05/04/2018 Ulthera System Ulthera, Inc Jessica Newhard
K180214 05/03/2018 Repris Bladder Injection System URO-1, Inc. Thomas Lawson
K181032 05/09/2018 Halcyon Varian Medical Systems Inc. Peter J. Coronado
K181145 05/18/2018 Eclipse Treatment Planning System Varian Medical Systems, Inc. Peter J. Coronado
K172675 05/16/2018 Varian Cervical Sleeves Varian Medical Systems, Inc. Peter J. Coronado
K180913 05/09/2018 VSI Micro-Introducer Kit Vascular Solutions, Inc. Jake Schultz
K172471 05/08/2018 VENTANA CD30 (Ber-H2) RxDx Assay Ventana Medical Systems, Inc. Jeffrey Catania
K173810 05/14/2018 Ventripoint Medical System Plus (VMS+) Ventripoint Diagnostics, Ltd. Desmond Hirson
K180217 05/18/2018 VESTEX Apparel Vestagen Protective Technologies, Inc. Scott Pease
K173300 05/01/2018 ViaTherm BOOST ViaTherm Therapeutics, Llc. Michael J. Thomas
K181003 05/15/2018 VIVIX-S 1717V Vieworks Co., Ltd. Jordin Kim
K173264 05/11/2018 EmbryoScope+ Vitrolife A/S Belinda Dueholm
K180386 05/08/2018 Meron Plus QM Voco GmbH M. Th. Plaumann
K173914 05/25/2018 VORTRAN Cuff Inflator (VCI) VORTRAN Medical Technology 1, Inc. James Lee
K172825 05/30/2018 MN-111 W&H Sterilization s.r.l. Marco Parolini
K173311 05/09/2018 ARTHRO-Pump PA304 W.O.M. World of Medicine GmbH Soeren Markworth
K173711 05/04/2018 Wallaby Avenir Coil System Wallaby Medical, Inc. Rebecca K. Pine
K173246 05/30/2018 ANEROID SPHYGMOMANOMETER Wenzhou Bokang Instruments Co., Ltd Youhua Xiang
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K173832 05/17/2018 InTiceÖ-C Porous Ti Cervical Interbody System X-Spine Systems, Inc. Charlene Brumbaugh
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K173483 05/30/2018 Pure Flow External Counter-Pulsation Device Xtreem Pulse, LLC Andrew Barile
K173758 05/14/2018 Disposable Biopsy Valve Zhejiang Chuangxiang Medical Technology Co., LTD. Lucius Long
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