FDA 510(k) Decisions During July, 2018  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K180289 07/10/2018 3D Bolus Software 3D Bolus, Inc. Peter Hickey
K180629 07/19/2018 DentiqGuide 3D Industrial Imaging Co., Ltd Jin Sa Kim
K180874 07/31/2018 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield 3M Health Care Linda Johnsen
K180948 07/20/2018 TruDi NAV Suction Instruments Acclarent, Inc. Leena Sorathia
K180407 07/25/2018 Smartinhaler Adherium (NZ) Ltd Chris Mander
K173947 07/25/2018 Lumbar Interbody Fusion System (OLLIF) Advanced Research Medical, LLC John D Siegel
K181342 07/19/2018 JGH1 Bone Graft Substitute AgNovos Healthcare USA, LLC Felipe Aguel
K181585 07/20/2018 JGH1 Core Deccompression Procedure Kit AgNovos Healthcare USA, LLC Felipe Aguel
K173444 07/23/2018 Quantitative Total Extensible Imaging (QTxI) AIQ Solutions, Inc. Dona Alberti
K181453 07/25/2018 ATEC ALIF Spacer System Alphatec Spine, Inc. Cynthia Adams
K181339 07/24/2018 Altus Spine Pedicle Screw System Altus Partners, LLC Mark Melton
K173359 07/05/2018 Fractional CO2 Surgical Laser System AMI Inc. Hae Youn Lee
K172862 07/24/2018 Portable ECG Monitor (ECG3) Andon Health Co., Ltd. Liu Yi
K181044 07/05/2018 400um Perforator and Accessory Vein Ablation Kit AngioDynamics, Inc. Deepa R. Godhiya
K173762 07/18/2018 AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters AngioDynamics, Inc. Teri Juckett
K173656 07/26/2018 Arthrex FibuLock Nail Arthrex, Inc. Rebecca R. Homan
K180784 07/18/2018 ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES ASAHI INTECC CO., LTD. Yasuyuki Kawahara
K173277 07/05/2018 ASAHI PTCA Guide Wire ASAHI SION black Asahi Intecc Co., Ltd. Yasuyuki Kawahara
K180725 07/11/2018 Aspire Introducer Needle Aspire Bariatrics, Inc. Monica Ferrante
K181139 07/06/2018 OLYMPIC Posterior Spinal Fixation System Astura Medical, LLC Parker Kelch
K172543 07/11/2018 High-speed Turbine Handpieces for Single Use Beijing Dongbo Dental Handpiece Co., Ltd. Chengfei Yan
K172616 07/27/2018 Pulse Oximeter Beijing Safe Heart Technology Ltd. Xiaoming Yang
K173556 07/13/2018 Injection Screw Biedermann Medtech, Inc. Michelle Montesino
K173973 07/20/2018 TV-100 Bio-Med Devices, Inc. Ken Close
K181493 07/05/2018 FilmArray Blood Culture Identification (BCID) Panel BioFire Diagnostics, LLC Kristen J. Kanack
K181565 07/13/2018 Aquarius 8600 Digital Radiography Sensor Biokinemetrics Inc. Steven Kraus
K172971 07/08/2018 BMLS16-1 BioMedical Life Systems, Inc. Gary Bussett
K181092 07/06/2018 CHROMID CARBA agar (CARB) bioMerieux SA Asa Karlsson
K180936 07/03/2018 ETEST Telavancin (TLA) (0.002-32 ug/mL) bioMerieux SA Asa Karlsson
K181300 07/16/2018 Embosphere Microspheres Biosphere Medical, S.A. Alix Fonlladosa
K181554 07/27/2018 Stowe Pedicle Screw System Black Box Medical Todd Stanaford
K180864 07/20/2018 WATCHMAN TruSeal Access System Boston Scientific Nikki M Ibis
K173837 07/25/2018 RHYTHMIA HDx Mapping System (with software Version 2.0) Boston Scientific Corporation Gregory Neal
K171414 07/01/2018 qEEG-Pro Brainmaster Technologies, Inc. Tom Collura
K180269 07/17/2018 Cadwell Apollo System Cadwell Industries, Inc. Alison Hull
K181670 07/25/2018 Alphenix, INFX-8000V/B, V8.0 Canon Medical Systems Corporation Paul Biggins
K181834 07/19/2018 Ultimax-i, DREX-UI80 (V1.60) Canon Medical Systems Corporation Paul Biggins
K173487 07/18/2018 CarboClear« Pedicle Screw System CarboFix Orthopedics Ltd. Hila Wachsler-Avrahami
K181287 07/12/2018 Catalyst CSR Shoulder System Catalyst OrthoScience, Inc. Dale Davison
K170369 07/19/2018 Disposable Electrosurgical Pencils Cathay Manfacturing Corp. Ren Ren
K173274 07/10/2018 Ceevra Reveal 2.0 Ceevra, Inc. Russ Yoshinaka
K181736 07/30/2018 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, Centers for Disease Control and Prevention (CDC) Yon Yu
K180526 07/16/2018 EIDON FA CenterVue SpA Roberto Gabriotti
K180218 07/24/2018 Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV Cepheid Yi-Ping Lin
K172273 07/30/2018 308nm Excimer System Chongqing Peninsula Medical Technology Co., Ltd. Zhang Sudi
K170820 07/18/2018 Capnograph and Oximeter CMI Health Inc. Jiacheng Ren
K181327 07/06/2018 InPen Dose Calculator Companion Medical, Inc. Jasper Benke
K180763 07/19/2018 CuffLink Implant System Biocomposite CONMED Corporation Diana L. Nader-Martone
K181276 07/12/2018 CONOD Enteral Feeding Sets Conod Medical Co., Limited Cheng Run
K173675 07/20/2018 AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber ConvaTec Limited Justin Lovelace
K171272 07/17/2018 Cook-Swartz Doppler Flow Probe Cook Incorporated Tom Kardos
K181431 07/30/2018 Laser Ureteral Catheter Cook Incorporated Carly Powell
K180552 07/12/2018 Modified Novy Cornual Cannulation Set Cook Incorporated Naomi Funkhouser
K181712 07/26/2018 San Antonio Stopcock Cook Incorporated James O. Ebot Rnaw
K173654 07/17/2018 Ureteral Dilator Sets, Ureteral Dilators Cook Incorporated Kotei Aoki
K180868 07/06/2018 Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set Cook Ireland Jacinta Kilmartin
K180556 07/27/2018 Corelink Foundation 3D Anterior Lumbar System Corelink, LLC Steven D. Mounts
K180752 07/25/2018 Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole Corinth MedTech, Inc. Sandeep Saboo
K180915 07/17/2018 Sonicision Reusable Sterilization Tray Covidien Candice Bautista-Biddle
K180485 07/27/2018 Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender Covidien, llc Carol Ming
K181261 07/09/2018 Curiteva Cervical Interbody Fusion System Curiteva, LLC Eric Linder
K172778 07/05/2018 CheckMyHeart Plus DailyCare Biomedical, Inc Ming Da Lee
K172991 07/10/2018 Advanced Dental Applicance DaSoft Partners Dante Togliatti
K181189 07/18/2018 ATLANTIS Conus Structure Dentsply Sirona Karl Nittinger
K181156 07/27/2018 Panther Fusion GBS Assay Diagenode Geraldine Poncin
K181398 07/23/2018 DV-300 Aspirator Ding Hwa Co., Ltd. Eric Han
K172440 07/13/2018 Solax Electric Scooter, Models: S302121, S302131, S302141, S302151 Dongguan Prestige Sporting Goods., Ltd. Zhang Zhao
K181579 07/26/2018 eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K E&E Optics Inc. Bonnie Wan
K181574 07/10/2018 Uscan EchoNous, Inc. Trish Liau
K181547 07/09/2018 FibroScan« Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) Echosens Karine Bonenfant
K181095 07/24/2018 RF-Relief EL Global Trade Ltd Martin Gurovich
K180627 07/27/2018 Macroduct Advanced Model 3710 ELITechGroup Inc. Stacey Pahulu
K180930 07/09/2018 EMPOWR VVC TIBIAL INSERT Encore Medical, L.P. Teffany Hutto
K181720 07/30/2018 Epiphany Cardio Server Mobile Epiphany Healthcare, LLC Pat White
K180910 07/02/2018 ULTRAPRO Mesh and ULTRAPRO ADVANCED Ethicon Inc Melina Escobar
K173019 07/06/2018 GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar Ethicon Inc. Melina Escobar
K181268 07/26/2018 PROLENE (Polypropylene) 3D Patch Ethicon, Inc. Melina Escobar
K180755 07/06/2018 Vail ALIF Buttress Plate System Evolution Spine, LLC Douglas Davis
K180632 07/25/2018 Exactech Equinoxe Small Reverse Shoulder System Exactech Inc. Zach Sharrah
K180695 07/12/2018 FBC 921 (ALIF) FBC Device ApS Finn Bjarke Christensen
K180348 07/17/2018 Field Orthopaedics Micro Screw System Field Orthopaedics Pty. Ltd. Christopher Jeffery
K172952 07/03/2018 Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit Figaro Crowns, Inc. Kyle Rose
K173929 07/24/2018 CipherOx CRI M1 Flashback Technologies, Inc. Gregory Z. Grudic
K181763 07/27/2018 FUJIFILM Ultrasonic Endoscope FUJIFILM Corporation Randy Vader
K181741 07/30/2018 IceSphere 1.5 CX Cryoablation Needle Galil Medical Ltd. Stacey Backlund
K173645 07/23/2018 JASPER Spinal Fixation System GBS Commonwealth Co., Ltd. Jimmy Kim
K181011 07/12/2018 AIM2 GC America Inc. Mark Heiss
K172987 07/13/2018 Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001) GMAX Industries, Inc. Julia Huang
K180518 07/23/2018 GME LinScan Lite 808 Laser System GME German Medical Engineering GmbH Stefan Schulze
K181586 07/13/2018 Tinnitus Sound Generator Module GN Hearing A/S Lars Hagander
K181855 07/26/2018 RadialSeal Introducer Kit Greatbatch Medical Phyllis Piet-Hughes
K181019 07/16/2018 Diode Laser System Guangzhou Huafei Tongda Technology Co., Ltd. Liu Pengqi
K181790 07/26/2018 CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup Hangzhou Clongene Biotech Co.,Ltd. Zheng Shujian
K181700 07/10/2018 HardyDisk AST Plazomicin 30ug (PLZ30) Hardy Diagnostics Anna Klavins
K173327 07/18/2018 DIP/U.S. Urine Analysis Test System Healthy.io Ltd Ron Zohar
K171888 07/23/2018 Non-contact infrared body thermometer Hetaida Technology Co., Ltd ZhenGuang Chen
K181376 07/18/2018 ARIETTA 65 Hitachi Healthcare Americas Corporation Doug Thistlethwaite
K173474 07/27/2018 RetiCapture Ilooda Co., Ltd. Yun-Jung Ha
K180263 07/20/2018 EcoFit Vit E Acetabular System implantcast Gmbh Juliane Hoeppner
K172389 07/18/2018 ePTFE-Coated Auricular Implant Implantech Associates Inc. Craig Arthur
K181694 07/27/2018 Apiration Guide Catheter, Retraction Aspirator, FlowTriever Catheter Inari Medical Eben Gordon
K181201 07/10/2018 Synermed ISE Reagents Infrared Laboratory Systems, LLC (dba Synermed) Julie Paschal
K181115 07/16/2018 CxHA PEEK Cervical IBF System Innovasis, Inc. Marshall McCarty
K181063 07/13/2018 KestrelÖ Buttress Plate System Innovasis, Inc. Marshall McCarty
K173562 07/09/2018 Straumann Jason Membrane Institut Straumann AG Christopher Klaczyk
K173968 07/17/2018 Straumann Variobase for Bridge/Bar Cylindrical Institut Straumann AG Gordon Dodds
K173721 07/05/2018 SureForm 60 and SureForm 60 Reloads Intuitive Surgical Nadine Nasr
K173585 07/19/2018 da Vinci Xi Surgical System, da Vinci X Surgical System Intuitive Surgical, Inc. Brandon Hansen
K181395 07/27/2018 Universal Cannula Seal (5-12 mm) Intuitive Surgical, Inc. Cheryl Wu
K171880 07/13/2018 IRRAflow CNS System IRRAS Inc. Dessi Lyakov
K180515 07/06/2018 GammaTile Isoray Medical Inc. Bill Joy
K173808 07/27/2018 VoutiaÖ Jeffrey Ward Cash, DDS Jeffrey Ward Cash
K173340 07/13/2018 Yikang Latex Foley Catheter Jiangxi Yikang Medical Instrument Group Co., LTD. Nicholas Su
K180977 07/18/2018 KARL STORZ New Generation Trocars KARL STORZ Endoscopy-America, Inc. AnnaLisa Smullin
K181015 07/18/2018 Braun BFH175 Infrared Forehead Thermometer Kaz USA, Inc., A Helen of Troy Company Matt J. Baun
K181242 07/23/2018 Braun BNT400 No Touch + Forehead Thermometer Kaz USA, Inc., A Helen of Troy Company Matt J. Baun
K180970 07/10/2018 Disposable guides KDNG00 Koelis Pauline Nicole
K181600 07/16/2018 PathLoc-SI Joint Fusion System L&K BIOMED Co., Ltd. Jihyeon Seo
K180967 07/11/2018 Dental Diode Laser System Lazon Medical Laser Co., Ltd. Gen Cheng
K181708 07/31/2018 MTS Plazomicin 0.016-256 ?g/mL Liofilchem s. r. l. Fabio Brocco
K173970 07/06/2018 Materialise PKA Guide System Materialise NV Oliver Clemens
K173039 07/10/2018 TruMatch CMF Titanium 3D Printed Implant Materialise NV Lina Ramirez
K180151 07/16/2018 MC3 Jugular Dual Lumen Catheter MC3 Incorporated Adam Viitala
DEN170009 07/20/2018 Bonebridge MED-EL Elektromedizinische Geraete GmbH Elizabeth Gfoeller
K172095 07/24/2018 Autokeeper MedExel Co.,Ltd. Cha Dong Ik
K181175 07/05/2018 12F Tri-Flow Triple Lumen Catheter Medical Components Inc. (Dba Medcomp) Courtney Nix
K173969 07/11/2018 Medicalgorithmics Unified Cardiac Rehabilitation System Medicalgorithmics S.A. Marek Dziubinski
K173911 07/19/2018 Medline Burn and Wound Dressing Medline Industries, Inc. Bethany Benoit-DiMaria
K173276 07/02/2018 Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP Medline Industries, Inc. Claire Pigman
K180816 07/11/2018 Ziehm RFD 3D Tracker Medtronic Navigation Nicole Zimmerman
K180022 07/20/2018 Athena Cervical Plate System Medyssey USA, Inc. Shawn Kim
K172857 07/19/2018 Latitud Hip Replacement System Meril Healthcare Pvt. Ltd. Bhavik Gondaliya
K181062 07/18/2018 Ultra Facial Toning System Micro Current Technology, Inc. David Suzuki
K180715 07/04/2018 React 68 Catheter Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ryan Kenney
K180705 07/04/2018 Riptide Aspiration System React 68 Catheter Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ryan Kenney
K180018 07/05/2018 Disposable Hot Biopsy Forceps Micro-Tech (Nanjing) CO., Ltd. Becky Li
K181499 07/06/2018 DRI Cocaine Metabolite Assay Microgenics Corporation Emily Chien
K173943 07/24/2018 Dental High-speed Handpiece and Accessories MicroP Technology (Taiwan), Inc. Ina Lin
K173776 07/06/2018 BIOLOX delta Option and Extra-long Heads MicroPort Orthopedics Inc. Allen Mamaril
K180798 07/09/2018 Prime Acetabular Cup System MicroPort Orthopedics Inc. Sarah Evonne Stroupe
K181399 07/24/2018 FIREFLY« Pedicle Screw Navigation Guide Mighty Oak Medical Inc. Mark A. Wylie
K181572 07/10/2018 Workflow Box Mirada Medical Ltd. Gwilym Owen
K181623 07/19/2018 Clarifi Imaging System Modulated Imaging, Inc. David Cuccia
DEN180008 07/31/2018 MolecuLight i:X MolecuLight Inc. Jeffrey K. Shapiro
K181017 07/20/2018 Free Testosterone AccuBind ELISA Test System Monobind Inc. Anthony Shatola
K161085 07/05/2018 Nitrile Patient Examination Powder Free Glove, Textured, Black MULTISAFE SDN. BHD. THUM TECK LAM
K173486 07/11/2018 NTU-USB Ultrasound USB Box National Taiwan University Pai-Chi Li
K173366 07/20/2018 NicoletOne Natus Neurology Incorporated Shane T. Sawall
K181178 07/24/2018 S-mini active Fixture Neobiotech Co., Ltd. Young-Ku Heo
K181025 07/24/2018 I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System Neuro Kinetics, Inc. Robin C. Ashmore
K173868 07/02/2018 Serenity Body Position Sensor, Serenity RIP Sensors Neurotronics, Inc. David Pezet
K181345 07/19/2018 Image Filing Software NAVIS-EX Nidek Co., Ltd Yoneji Mizuno
K173797 07/17/2018 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation Adam Heroux
K181043 07/12/2018 StatStrip Glucose Hospital Meter System Nova Biomedical Corporation John Mchale
K173631 07/11/2018 Intelli-C NRT X-ray A/S Jan Malling
K180575 07/12/2018 THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type X Olympus Medical Systems Corp. Toshiyuki Nakajima
K181193 07/03/2018 PeriView FLEX Olympus Surgical Technologies America Mary Anne Patella
K181375 07/17/2018 Apex Femoral Nailing System OrthoXel Aisling O'Sullivan
K173881 07/11/2018 Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G Owen Mumford Ltd Darren Mansell
K180064 07/27/2018 OsteoFab Patient Specific Cranial Device Oxford Performance Materials, Inc. M. Beth Pashko
K180226 07/25/2018 TREND II Spinal Fixation System- STEP Series Paonan Biotech Co., Ltd. Vivi Tsai
K171011 07/18/2018 PENTAX Medical VIVIDEO ENT Videoscope Solution Pentax Medical James W. Monroe
K181522 07/09/2018 PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope PENTAX of America, Inc. William Goeller
K173679 07/03/2018 PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes PENTAX of America, Inc. James W. Monroe
K180923 07/09/2018 Personal Lubricating Jelly Perrigo New York, Inc. Karen Dombrowski
K181556 07/13/2018 EliA M2 Immunoassay Phadia AB Carina Magnusson
K180017 07/24/2018 MX40 Release C.01 Philips Medical Systems Theresa Poole
K180534 07/16/2018 Philips IntelliVue GuardianSoftware Philips Medizin Systeme Boeblingen GmbH Michael Asmalsky
K181485 07/27/2018 EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System Philips Ultrasound, Inc. Kym Rupp
K181659 07/26/2018 Avologi ENEO Premier North America Inc. Yaniv Applicant
K180655 07/13/2018 Viking Lumbar Polyaxial Screw System Presidio Surgical Meredith Lee May
K180011 07/13/2018 Pulmonx Chartis Tablet Console Pulmonx Corporation Sherry Kim
K173188 07/20/2018 The Graft Natural Bone Substitute Purgo Biologics Inc. Hana Jung
K181697 07/11/2018 16ch Foot/ Ankle SPEEDER Quality Electrodynamics, LLC Eric Yeh
K181029 07/15/2018 Solana Bordetella Complete Assay Quidel Corporation Ronald H. Lollar
K180027 07/18/2018 ACCUSYTE 3D Fiducial Marker Radiation Products LLC John D Corbitt
K181452 07/27/2018 RCT800 Ray Co., Ltd. Changhwan Lee
K181706 07/26/2018 neuromate Gen III Renishaw Mayfield Sarl Stephane Vinot
K181495 07/25/2018 Republic Spine Dark Star Spinal System Republic Spine, L.L.C. James Doulgeris
K180272 07/26/2018 Saniclave 250 REVOLUTIONARY SCIENCE Isaac Erickson
K173927 07/06/2018 Elecsys BRAHMS PCT Roche Diagnostics Wes Gerbig
K180654 07/13/2018 PINXEL-RF system Rohrer Aesthetics, LLC Mark Rohrer
K180697 07/10/2018 Pseudo-Patient RTsafe, Inc. Dimitris Makris
K181030 07/17/2018 Rubicon Lumbar Interbody Fusion System Rubicon Spine, LLC Mike Boyer
K181401 07/26/2018 RxSight Insertion Device RxSight, Inc. Maureen O'Connell
K180960 07/25/2018 FIXIT / ComposiTCP Threaded Anchor System S.B.M. SAS Sciences for Bio Materials Anne Cospin-Latapie
K181626 07/20/2018 Digital Diagnostic Mobile X-ray System Samsung Electronics Co., Ltd. Chang Soeun
K181629 07/20/2018 GC85A Samsung Electronics Co., Ltd. Noh Jaesang
K181631 07/20/2018 GR40CW Samsung Electronics Co., Ltd. Noh Jaesang
K171550 07/13/2018 Sterile Latex Surgical Gloves, Powder Free Sanrea Healthcare Products Pvt Ltd Jose Paul M
K181079 07/18/2018 SeaSpine Regatta Lateral System SeaSpine Orthopedics Corporation Gina Flores
K173206 07/12/2018 SEKURE HbA1c Assay Sekisui Diagnostics PEI Inc. Penny White
K180367 07/03/2018 Ureterorenoscope System Shanghai AnQing Medical Instrument CO., Ltd. Lina FEI
K173766 07/08/2018 PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs Shen Wei USA Inc. Cheryl Reep
K172694 07/06/2018 Sterile Disposable Syringes Shenyang MasTech Medical Device Co., Ltd. Liu Han
K173801 07/11/2018 Transcranial Doppler Ultrasound System Shenzhen Delica Medical Equipment Co., Ltd. Zhenhua Xiao
K180419 07/19/2018 Ultrasonic Doppler (Model YM-2T8) Shenzhen IMDK Medical Technology Co., Ltd. Yuan Xia
K172874 07/12/2018 Infrared Thermometer Shenzhen Jiacom Technology Co., Ltd Luo Tianfeng
K180912 07/30/2018 TE7/TE5 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd Yang Zhaohui
K180958 07/26/2018 Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable Shockwave Medical, Inc. Cindy Morrow
K171274 07/12/2018 ADVIA Centaur High-Sensitivity Troponin I (TNIH) Siemens Healthcare Diagnostics Inc. Matthew Gee
K181002 07/16/2018 Atellica IM BRAHMS Procalcitonin (PCT) Siemens Healthcare Diagnostics Inc. Fatima Pacheco
K171566 07/19/2018 Atellica IM High-Sensitivity Troponin I (TNIH) Siemens Healthcare Diagnostics Inc. Matthew Gee
K173909 07/13/2018 Dimension Hemoglobin A1c Assay Siemens Healthcare Diagnostics Inc. Alan Haley
K181213 07/30/2018 ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control Siemens Healthcare Diagnostics, Inc. Kira Gordon
K180963 07/11/2018 ROCCIA ALIF, ROCCIA TLIF Silony Medical GmbH Bircan Tasdelen
K181509 07/06/2018 Endorate Valve Sets Smartdata Suzhou Co., Ltd Cindy Ye
K181699 07/26/2018 Level 1 Convective Warmer Smiths Medical ASD, Inc. Donna M. Semlak
K181636 07/20/2018 Aurora Sodium Systems, LLC Brandon Bachler
K181440 07/30/2018 Proficient« Posterior Cervical Spine System Spine Wave, Inc. Amy Noccioli
K181350 07/06/2018 ASTRA-OCT Spine System SpineCraft LLC Ami Akallal-Asaad
K181422 07/31/2018 SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit SPR Therapeutics, Inc. Kathryn Stager
K181382 07/20/2018 GuardianTM Burr Hole Cover System St Jude Medical Rebecca Brunson
K181686 07/24/2018 CELERITY 20 Steam Biological Indicator STERIS Corporation Tony Piotrkowski
K181083 07/23/2018 Stryker All-PEEK Knotless Anchor System Stryker Katie Farraro
K181014 07/18/2018 Tritanium PL Cage Stryker Spine Travis Catania
K181134 07/13/2018 GòUòM HYDRAL Dry Mouth Oral Gel, GòUòM HYDRAL Dry Mouth Oral Rinse, GòUòM HYDRAL Dry Mouth Oral Spray Sunstar Americas Inc Liz Bastian
K180580 07/27/2018 Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices Surgical Instrument Service and Savings Inc Stephanie Boyle Mays
K173627 07/12/2018 Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector Surgical Instrument Service and Savings Inc Stephanie Boyle Mays
K181523 07/11/2018 Syneron CO2RE System Syneron-Candela Corp Sharon Timberlake
K180544 07/24/2018 DePuy Synthes Static Staples Synthes (USA) Products, LLC Suchitra Basu
K173511 07/12/2018 ActiveCare TD-4121 Blood Glucose Monitoring System TaiDoc Technology Corporation Sheena Song
K180115 07/24/2018 TWBM Pump Taiwan Biomaterial Co., Ltd. Monoj Mon Kalita
K181184 07/27/2018 OIC Intramedullary Nail System The Orthopaedic Implant Company Douglas Fulton
K180613 07/12/2018 Estelite Universal Flow Tokuyama Dental Corporation Keith A. Barritt
K180590 07/06/2018 Tyber Medical PT Interbody Spacer System Tyber Medical, LLC Mark F Schenk
K180900 07/10/2018 LED Light Therapy Device Uvbiotek, LLC Dave Oberhelman
K173864 07/02/2018 Peekplus« Interbody Fusion Device Vallum Corporation Stephen Blinn
K181526 07/03/2018 XRpad2 4343 HWC-M Flat Panel Detector Varex Imaging Corporation Paul Sawicki
K181647 07/20/2018 Bandit guidewire Vascular Solutions, Inc. Becky Astrup
K173107 07/26/2018 Vios Central Station Monitor Software, Vios Central Server Software Vios Medical, Inc. Amit Patel
K180854 07/23/2018 Voyager Trajectory Array Guide (V-TAG) Voyager Therapeutics, Inc. Lynn E Bayless
K173829 07/18/2018 NeoLSD MSMS kit Wallac Oy, a subsidiary of PerkinElmer Kay A Taylor
K181016 07/16/2018 Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System Welch Allyn, Inc. Megan Pellenz
K173659 07/06/2018 Howell D.A.S.H Extraction Balloon with Multiple Sizing Wilson-Cook Medical, Inc Tiffanny A. Thomas
K181272 07/31/2018 Picocare Family WON TECH Co., Ltd. Hyunsik Yoon
K180730 07/11/2018 INVISION Total Ankle Revision System Wright Medical Technology, Inc. Alayne Melancon
K180024 07/11/2018 SALVATION Midfoot Nail Wright Medical Technology, Inc. Alayne Melancon
K180314 07/11/2018 Infrared Thermometer Xuzhou Yongkang Electronic Science Technology Co., Ltd Xuecheng Zhao
K180673 07/13/2018 Normandy VBR System Zavation Medical Products LLC Frankie Cummins
K181244 07/10/2018 Zavation Cervical Plate System Zavation Medical Products LLC Matt Jones
K181246 07/10/2018 Zavation IBF System Zavation Medical Products LLC Matt Jones
K180076 07/27/2018 Ti 3Z Interbody System Zavation Medical Products, LLc Katie Motley
K172653 07/18/2018 Power Infuser ZOLL Medical Corporation Pooja Dalvi


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