FDA 510(k) Decisions During January, 2018  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K181643 11/16/2018 SmartBag (SmartPouch) 11 Health Technologies Limited Michael Seres
K173584 01/22/2018 3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader 3M Company Hilary B. Hovde
K183159 11/26/2018 3M Clarity Aligners 3M Company Yanine Garcia-Quezada
K171634 01/17/2018 Ortho System 3Shape A/S Antje Marquardsen
K173159 01/08/2018 Cervical Spinal Truss System (CSTS) Interbody Fusion Device 4Web, Inc. Jessee Hunt
K181381 11/23/2018 A.B. Dental Devices Dental Implants System A.B Dental Device Ltd. Gabi Krauss
K171411 01/12/2018 IRRIS (Infra-Red-Red Intubation System) A.R Guide In Medical Ltd. Ariel Shrem
K173795 01/12/2018 HI-TORQUE TurnTrac Guide Wire Family Abbott Vascular Aniket Khakhadiya
K171761 01/16/2018 ACCLARENT AERA Eustachian Tube Balloon Dilation System Acclarent, Inc. James Patrick Garvey II
K173430 01/26/2018 SeQure« NF and SeQure« Microcatheters Accurate Medical Therapeutics Ltd. Eran Miller
K182687 11/23/2018 Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System ACCURAY INCORPORATED Keith Picker
K163451 01/12/2018 Action Trackstander models TR1816, TR1820, TR2016, and TR2020 Action Manufacturing Inc. Alan Macht
K181911 11/02/2018 Interlude 100% Cotton Tampon ALBAAD fem Shlomo Helvits
K181454 11/21/2018 DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal Alcon Laboratories, Inc. Sherri Lakota
K171148 01/12/2018 Aleo BME Liquid Bandage Aleo BME Inc. Chao Liu
K173932 01/26/2018 Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 Alere Scarborough, Inc. Angela Drysdale
K182988 11/29/2018 Afinion HbA1c Dx on Afinion 2 Alere Technologies AS Monica Vallestad
K180207 11/28/2018 Non-contact Infrared Thermometer Alicn Medical (Shenzhen), Inc Meisong Fang
K172193 01/09/2018 Modified Alma Lasers Soprano XLÖ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules Alma Lasers Inc. Rekha Anand
K182808 11/09/2018 Aspida« Anterior Lumbar Plating System Alphatec Spine, Inc. Ruby Zheng
K182746 11/27/2018 ATEC ALIF and LLIF Spacer System Alphatec Spine, Inc. Cynthia Adams
K181286 11/30/2018 Ambu aScope RLS Slim Ambu A/S Camilla Wismar
K182083 11/09/2018 Catalys Precision Laser System AMO Manufacturing USA, LLC James Patrick Garvey II
K180650 11/15/2018 Amsel Endo Occluder Amsel Medical Corporation Yoram Levy
K172701 01/04/2018 BIO-C SEALER Angelus Industria de Produtos Odontologicos S/A Paulo Sergio Calixto de Oliveira
K182992 11/28/2018 BGM014 Blood Glucose Monitoring System Apex Biotechnology Corp. Lisa Liu
K181123 11/21/2018 ApnoDent Appliance ApnoMed, Inc. Joseph Yousefian
K182090 11/16/2018 AposTherapy System APOS Medical Assets Ltd. Cliff Bleustein
K182653 11/14/2018 Voyant Maryland Fusion Device Applied Medical Resources Corp. Andrew Nguyen
K182815 11/30/2018 XVWeb 3D Apteryx, Inc. Mark Gniewek
K182779 11/21/2018 ARK EDDP Assay ARK Diagnostics, Inc. Cherry Mun
K182391 11/30/2018 ASI Automated ASI RPR Test for Syphilis on the ASI Evolution Arlington Scientific, Inc. (ASI) David Binks
K180395 11/09/2018 EZ-IO Intraosseous Vascular Access System Arrow International, Inc. (Subsidiary of Teleflex, Inc.) Frank Pelc
K173542 01/25/2018 Arterys Oncology DL Arterys Inc. John Axerio-Cilies
K173240 01/16/2018 Arthrex PushLock Arthrex Inc. David L. Rogers
K180430 11/23/2018 Digistat Smart Central ASCOM UMS srl unipersonale Paolo Burchietti
K182248 11/13/2018 Aspire Venting Tube Aspire Bariatrics, Inc Monica Ferrante
K181288 11/05/2018 Athelas One Athelas Inc. Tanay Tandon
K182418 11/29/2018 V3 Segmental Plating System Atlas Spine, Inc. Thomas Smith
K180010 01/31/2018 AtriClip FLEX-V AtriCure, Inc. Brittany Lowe
K180010 01/31/2018 AtriClip FLEX-V AtriCure, Inc. Brittany Lowe
K182565 11/09/2018 AtriCure cryoICE cryoSPHERE cryoablation probe AtriCure, Inc. Jonathan McElwee
K172029 01/05/2018 EnsoETM Attune Medical Erik Kulstad
K171528 01/24/2018 Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5) Avantsonic Technology Co., Ltd. Cuiling Wu
K181140 11/16/2018 Axis Chena Cervical PEEK Spacer System Axis Orthopaedics Craig Wilcox
K182255 11/15/2018 CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large) Aziyo Biologics, Inc. Wendy Perreault
K180801 11/05/2018 Actreen Hi-Lite Cath, Actreen Hi-Lite Set B. Braun Medical Inc. Anita J. Nemeth
K172575 01/18/2018 BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap BAROnova, Inc. Lian Cunningham
K182249 11/30/2018 Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens Bausch & Lomb Incorporated Barbara Klube-Falso
K182276 11/01/2018 MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit Bayer Medical Care Inc. Katie Dillon
K182273 11/01/2018 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
K181427 11/29/2018 BD MAX Enteric Viral Panel, BD MAX Instrument Becton, Dickinson and Company Laura Stewart
K181221 11/30/2018 BD PhaSeal Optima Closed System Transfer Device Becton, Dickinson and Company Amy Honey
K173252 01/05/2018 BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL) Becton, Dickinson, and Company Laura Stewart
K172804 01/11/2018 Besmed Peak Flow Meter Besmed Health Business Corp. Lawrence Wu
K172942 01/08/2018 Pristeen (Latex SurgeonÆs Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein Beta Healthcare Products Pvt.Ltd. Boney Moolayil
K182600 11/30/2018 Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) Better Care Plastic Technology Co., Ltd Zhu Chuyan
K182270 11/02/2018 Cellene CO2 Laser System Bio-Med USA Inc. Young Chi
K171517 01/11/2018 Digital Electrocardiograph Biocare Bio-Medical Equipment Co., Ltd. Hongbo Zhong
K180966 11/09/2018 FilmArray Pneumonia Panel BioFire Diagnostics, LLC Kristen J. Kanack
K181324 11/15/2018 FilmArray Pneumonia Panel plus BioFire Diagnostics, LLC Kristen J. Kanack
K173278 01/05/2018 ToggleLoc System Biomet Inc. Kyle Ponce
K172502 01/03/2018 Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate Biomet Manufacturing Corp Patricia Sandborn Beres
K182764 11/27/2018 Biop Digital Colposcope Biop Medical Ltd. Ilan Landesman
K171297 01/31/2018 AR_N Type Implant System Biotem Co., Ltd. Hong Koo Yeo
K182030 11/08/2018 Faros Mobile Bittium Biosignals Ltd. Taneli Vaaraniemi
K182338 11/09/2018 Blue Sky Bio Computerized Orthodontic Bracket System Blue Sky Bio Albert Zickmann
K180343 11/16/2018 LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer Bonraybio Co., Ltd. Clare Huang
K182169 11/27/2018 AdVance XP Male Sling Boston Scientific Corporation Kaitlyn Rainbow
K172929 01/10/2018 Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath Boston Scientific Corporation Daniel FitzDaniel
K173820 01/17/2018 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
K171410 01/04/2018 ePatch Braemar Manufacturing, LLC Kent Sayler
K182324 11/26/2018 EkoSonic MACH 4 Endovascular Device with EkoSonic Control Unit BTG International, Inc. Benjamin Hornsey
K181497 11/14/2018 HPM-6000UF BTL Industries, Inc. David Chmel
K163684 01/23/2018 C2 CryoBalloon Ablation System C2 Therapeutics, Inc. Theresa Brandner-Allen
K182427 11/02/2018 Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System Canon Medical Systems Corporation Paul Biggins
K181646 11/16/2018 Celesteion, PCA-9000A/3, V6.5 Canon Medical Systems Corporation Paul Biggins
K183013 11/26/2018 Vitrea Software Package, VSTP-001A Canon Medical Systems Corporation Paul Biggins
K182596 11/02/2018 Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System Canon Medical Systems Corporation Paul Biggins
K171099 01/05/2018 EON Portable Reverse Osmosis Water Purification System Cantel Mike Halliday
K173547 01/12/2018 ImagenUniversal Cardiovascular Imaging Technologies James A. Case
K173478 01/19/2018 OnSight 3D Extremity System Carestream Health, Inc. Victoria A. Wheeler
K181667 11/29/2018 Thoraguard System Centese, Inc. Evan Luxon
K173263 01/09/2018 Xpert Carba-R Cepheid Yi-Ping Lin
K182967 11/23/2018 Visor System Cerebrotech Medical Systems, Inc. Dawnel Scott
K180683 11/07/2018 Certa Dose Pediatric Midazolam 5mg/mL IM Syringe Certa Dose, Inc. Caleb Hernandez
K173215 01/19/2018 Choice Spine LaminoplastyÖ Fixation System Choice Spine, LP Kim Finch
K172816 01/26/2018 TiGer SharkÖ System Choice Spine, LP. Kim Finch
K171835 01/30/2018 Irradiation Aesthetic Device Chongqing Peninsula Medical Technology Co., Ltd. Zhang Sudi
K182306 11/22/2018 Sunkingdom Slit Lamp Chongqing Sunkingdom Medical Instrument Co Ltd Joy Tse
K171954 01/25/2018 ClearLine IV ClearLine MD Rick Romeo
K181292 11/15/2018 PrimeSightÖ UNITY 9000 Video Processor, PrimeSightÖ UNITY 9100 Video Processor Cogentix Medical, Inc. Christa Blaisdell
K181963 11/14/2018 ostaPek Interbody Fusion Cages coLigne, AG Robert Lange
K182757 11/29/2018 Espire Elbow Pro, Espire Elbow Hybrid College Park Industries, Inc. Deborah Mackmin
K180469 11/06/2018 ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent Coloplast Corp Cori Ragan
K171328 01/08/2018 cNeuro cMRI Combinostics Oy Lennart Thurfjell
K182134 11/26/2018 ARiX RAD Radiographic System Compania Mexicana De Radiologia CGR, S.A. DE C.V. Tonatiuh Monroy Soberon
K172791 01/18/2018 Lumilisse IPL Hair Remover Conair Corporation Mike Cantrell
K182882 11/14/2018 CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control Conmed Corporation Orjada Dervishleri
K182304 11/23/2018 Hyper GP (tisilfocon A) Daily Wear Contact Lens CONTAMAC LTD. Rob McGregor
K171360 01/22/2018 CONTECÖ Electrocardiograph Contec Medical Systems Co., LTD. Xueyong Li
K171445 01/10/2018 Amplatz Support Wire Guide with Apex Curve Cook Incorporated Jennifer Allman
K180792 11/30/2018 Arterial Pressure Monitoring Set/Tray Cook Incorporated Johnathan Liu
K181757 11/06/2018 G?nther Tulip« Vena Cava Filter Retrieval Set Cook Incorporated Steven Lawrie
K180557 11/23/2018 Greene Renal Transplant Stent Set Cook Incorporated Yuan Zhou
K172051 01/10/2018 GuardiaÖ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter Cook Incorporated Naomi Funkhouser
K171948 01/05/2018 Roadrunner Extra Support Wire Guide Cook Incorporated Jennifer Allman
K171264 01/25/2018 Royal Flush Catheter Cook Incorporated Jessica Swafford
K182980 11/16/2018 Zilver 518 Biliary Stent, Zilver 635 Biliary Stent Cook Ireland Ltd Cathrina McHale
K183038 11/26/2018 Corin Optimized Positioning System (OPS) Plan Corin USA Lucinda Gerber
K173884 01/17/2018 Unity Total Knee System Corin USA Limited Lorraine Mander
K182772 11/19/2018 Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil Covidien Jennie van Diemen
K173559 01/18/2018 Barrx SB RFA Endoscopic Catheter Covidien llc Saket Bhatt
K182451 11/06/2018 BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider Covidien, LLC Rebecca Clark
K171819 01/04/2018 Attain Assist CS Access Catheter Creganna Medical also doing business as Ceganna Tactx Medica Olivia Odhiambo
K181434 11/14/2018 SporView Rapid Read Biological Indicator SteamPlus Test Pack Crosstex/SPSmedical, A Division of Cantel Medical Megan Skaar
K172212 01/09/2018 MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEKÖ CTL Medical Corporation Tosan Onosode
K182220 11/07/2018 Curbell branded Patient Monitoring Cables Curbell Medical Products, Inc. Michael Winter
K180247 11/01/2018 DAEHAN Adhesive Surface Electrodes Daehan Medical Systems Co., Ltd. Da Pin Jeong
K172702 01/04/2018 Tec 820, Tec 850 Datex-Ohmeda, Inc. Trishia Mercier
K173814 01/29/2018 DeGen Medical E3 MIS Pedicle Screw System Degen Medical Craig Black
K180184 11/16/2018 Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System Dentalpoint AG Anja Lieberherr
K171622 01/11/2018 Dentium Ti-Base Dentium Co., Ltd. Sangpil Yoon
K171122 01/11/2018 CEREC Ortho Software Dentsply Sirona Karl J. Nittinger
K182288 11/20/2018 TPH Spectra ST Flowable Composite Restorative Dentsply Sirona Karl Nittinger
K170748 01/11/2018 GLOBAL UNITE Platform Shoulder System DePuy Ireland UC Carol Sandberg Ming
K182405 11/02/2018 Dexcom Pro Q Continuous Glucose Monitoring System Dexcom, Inc Luke Olson
K182467 11/07/2018 Simplexa GBS Direct, Simplexa GBS Positive Control Pack DiaSorin Molecular LLC Sharon Young
K172992 01/11/2018 Diazyme EZ Vitamin D Assay Diazyme Laboratories Abhijit Datta
K182329 11/08/2018 SureCure Orthodontic Aligner System Digital Orthodontic Care Jeff Sheppard
K171772 01/31/2018 Ecosite Bulk Fill DMG USA Inc. Gordon Craig
K182977 11/21/2018 Isolette 8000 Plus Draeger Medical Systems, Inc. Karen Otrupchak
K173876 01/24/2018 Cybird LED Curing Light DXM Co., Ltd Seung Hyun Kim
K173234 01/10/2018 Swiss LithoClast Trilogy E.M.S Electro Medical Systems SA Sonia Callegaro
K171836 01/04/2018 EarlySense Bed Sensing Unit EarlySense Ltd. Dalia Argaman
K171942 01/24/2018 Electrocardiograph Edan Instruments, Inc. Alice Yang
K182245 11/30/2018 EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System Edwards Lifesciences, LLC Christine Chun
K180881 11/16/2018 HemoSphere Advanced Monitor, HemoSphere Pressure Cable Edwards Lifesciences, LLC Chirag Shah
K181684 11/08/2018 VAMP Plus Venous/Arterial Blood Management Protection System Edwards Lifesciences, LLC Ye Seul Kim
K173843 01/26/2018 illumiflow 148 Laser Cap EGlobal, LLC Wayne De Stefano
K182369 11/27/2018 gammaCore Sapphire Electrocore, Inc. Mike Romaniw
K173442 01/23/2018 gammaCore-S electroCore, LLC Mike Romaniw
K171799 01/15/2018 Elos Accurate Customized Abutment, Elos Prosthetic Screw Elos Medtech Pinol A/S Tina Friis Poulsen
K171860 01/05/2018 Sureclear aligners Emergo Global Consulting, LLC Stuart R. Goldman
K172935 01/26/2018 Embrace Empatica Srl Simone Tognetti
K172858 01/08/2018 PreOp Epilog Gregor Strobbe
K171247 01/17/2018 epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test Epocal Inc. Jennifer Armstrong
K182444 11/06/2018 ERBEFLO Olympus Scope Port Connector Erbe USA, Inc. John Tartal
K173291 01/12/2018 6440 Ultrasound System Esaote S.p.A Massimo Polignano
K181886 11/14/2018 VivaSight-DL System ETView Ltd. Yoram Levy
K181880 11/29/2018 VivaSight-SL (TVT) system ETView Ltd. Yoram Levy
K182462 11/08/2018 Exactech Alteon Highly Polished Femoral Stem Exactech, Inc. Zach Sharrah
K182346 11/26/2018 TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws Exactech, Inc. Meredith May
K171056 01/04/2018 WAVE Clinical Platform Excel Medical Electronics, LLC Lance Burton
K172205 01/11/2018 ExoToe Staple ExoToe LLC Avi Roop
K180047 11/08/2018 ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System Fiab SpA Alberto Calabro
K182663 11/30/2018 Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System FineMEC Co., Ltd. William H. McGrail
K180363 11/01/2018 Clear-Tip EUS-FNA Finemedix Co. Ltd. Heon Sik Lee
K173060 01/25/2018 F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version Fisher and Paykel Healthcare Limited Ashley Nguyen
K171789 01/23/2018 ARROW Reverse Porous Glenoid Fournitures Hospitalieres Industrie Patricia Donnard
K173363 01/24/2018 Cycler Drain Bag Set Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K171291 01/19/2018 FUJIFILM Bronchoscope Model EB-530P FUJIFILM Medical Systems U.S.A., Inc. Shraddha S. More
K171207 01/11/2018 FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M FUJIFILM Medical Systems U.S.A., Inc. Jeffrey Wan
K182684 11/23/2018 HammerTechTM Fixation System Fusion Orthopedics, LLC Eli Jacobson
K180917 11/20/2018 GC Acrylic Primer GC America Inc. Mark Heiss
K171673 01/19/2018 Focus Cap GCE Medical Corporation Stanley Chang
K181403 11/02/2018 Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR GE Healthcare Michel Genuer
K181985 11/15/2018 Voluson E6, Voluson E8, Voluson E10 GE Healthcare Bryan Behn
K182626 11/16/2018 OEC One GE Hualun Medical Systems Co., Ltd. Lifeng Wang
K181934 11/06/2018 Vivid T8, Vivid T9 GE Medical Systems Ultrasound & Primary Care Diagnostics LLC Tracey Ortiz
K173456 01/05/2018 ViewPoint 6 GE Medical Systems Ultrasound and Primary Tracey Ortiz
K182277 11/21/2018 Versana Premier GE Medical Systems Ultrasound and Primary Care Diagnostics, Tracey Ortiz
K173602 01/12/2018 Optima XR240amx, AutoGrid GE Medical Systems, LLC Chris Paulik
K182838 11/08/2018 Geistlich Derma-Gide Geistlich Pharma AG Marco Steiner
K180840 11/30/2018 UNO Negative Pressure Wound Therapy System Genadyne Biotechnologies, Inc. Andrew Goh
K172438 01/12/2018 ARBOR External Fixation System Globus Medical Inc. Kelly J. Baker
K181846 11/06/2018 ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolu Globus Medical Inc. Lori Burns
K180495 11/30/2018 Tinnitus Sound Generator Module GN Hearing A/S Lars Hagander
K180463 11/14/2018 Apoller Flow Light Cure Flowable Composite Greenway YW LLC Scott Yin
K181696 11/30/2018 ChitoZolve Gyrus ACMI, Inc Dolan Mills
K182528 11/15/2018 Nitrile Glove Powder Free Black Haining Medical Products Co., Ltd. Zhiming Yao
K173955 01/26/2018 Mic-Key* SF Over-the-Wire Stoma Measuring Device Halyard Health, Inc. David M Lee
K180645 11/16/2018 Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green) Hartalega Sdn Bhd Mr. Kuan Kam Hon
K180786 11/02/2018 Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff HARTALEGA SDN. BHD. Kuan Kam Hon
K181297 11/21/2018 DENTIOIII series (DENTIOIII, DENTIOIII-S) HDX WILL CORP. Lee Myoung-Joon
K183009 11/26/2018 HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES Hemostatix Medical Technologies, LLC Jeff Cobb
K170421 01/11/2018 ET Hybrid Abutment Hiossen Inc. David Kim
K172110 01/11/2018 ECHELON OVAL V6.0A MRI System Hitachi Healthcare Americas Corporation Doug Thistlethwaite
K181604 11/28/2018 Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite HRS Co., Ltd. Seunghwan Go
K173196 01/24/2018 SUNTOUCH Dental Dressing Huizhou Foryou Medical Devices Co., Ltd. Junfeng Zhang
K181273 11/01/2018 GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System i-SENS, Inc. Joon Ho Jung
K181939 11/06/2018 icobrain icometrix NV Jan Verheyden
K182298 11/16/2018 hemochroma PLUS System Immunostics, Inc. Junghee Kim
K173616 01/19/2018 DIP Arthrodesis System In2Bones SAS Morgane Grenier
K173709 01/26/2018 Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm InNeuroCo, Inc Marc Litzenberg
K181897 11/15/2018 Reprocessed Marinr Diagnostic EP Catheter Innovative Health, LLC. Amanda Babcock
K172798 01/03/2018 Straumann CARES Abutments CoCr Institut Straumann AG Shokoufeh Khodabandeh
K182265 11/20/2018 CodMan Certas Plus Programmable Valve Integra LifeSciences Corp. Nancy MacDonald
K182801 11/27/2018 Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable Integra LifeSciences Corporation Jennifer Siu
K181639 11/02/2018 Panta 2 Arthrodesis Nail System Integra Lifesciences Corporation Blesson Abraham
K170438 01/30/2018 MiroCam Capsule Endoscope System IntroMedic Co., Ltd. Jinyoung Lee
K180732 11/08/2018 MiroCam Capsule Endoscope System IntroMedic Co., Ltd. Jinyoung Lee
K172643 01/31/2018 da Vinci Xi Surgical System; da Vinci X Surgical System Intuitive Surgical, Inc. Brandon Hansen
K181090 11/14/2018 Invacare« Solara« 3G and Solara« 3G Spree Manual Wheelchairs Invacare Corporation Elijah N. Wreh
K173085 01/08/2018 invendoscopy E210 System invendo medical GmbH Oliver v. Ruepprecht
K181806 11/20/2018 ARIX Sternal System Jeil Medical Corporation Ahhyeon Woo
K180546 11/21/2018 Jet Power Injectable PICC Jet Medical, Inc. Courtney Nix
K182649 11/09/2018 Enteral Feeding Syringes with Enfit Connectors Jiangsu Kangbao Medical Experiment Co., Ltd Qian Li
K182498 11/30/2018 Advanced Skin Renewing Device Jiangsu Unimed Laser Technology Co., Ltd. Simon Wang
K181890 11/09/2018 Brainlab Compatible K2M Navigation Instruments K2M Nancy Giezen
K173508 01/09/2018 Everest Spinal System K2M Nancy Giezen
K171556 01/16/2018 K2M Navigation Instruments K2M Nancy Giezen
K182182 11/15/2018 YUKON OCT Spinal System K2M Nancy Giezen
K180665 11/28/2018 SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System K2M, LLC. Nancy Giezen
K182652 11/20/2018 COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10 Kangfu Medical Equipment Factory Zelong Cao
K182696 11/20/2018 Telepack X LED KARL STORZ Endoscopy-America, Inc Winkie Wong
K182162 11/07/2018 OptiBond eXTRa Universal Kerr Corporation Mohammad Saad Ansari
K173730 01/17/2018 Kinsa QuickCare Thermometer KINSA, Inc. David Gal
K181469 11/09/2018 Cryotop«US-flash and Cryotop«US-scoop Kitazato Corporation Futoshi Inoue
K182431 11/26/2018 Konicaminolta DI-X1 Konica Minolta, Inc. Tsutomu Fukui
K181750 11/15/2018 SITZMARKS Konsyl Pharmaceuticals Frank Gunsallus III
K181857 11/20/2018 Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Kossan International Sdn. Bhd. Cho Sow Fong
K182699 11/26/2018 Selethru PTCA Balloon Dilatation Catheter Kossel Medtech (Suzhou) Co., Ltd. Zane Wang
K171731 01/19/2018 KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit Kronus, Inc. Brian Deis
K180607 11/23/2018 Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit KRONUS, Inc. Brian Deis
K183117 11/15/2018 PathLoc-L MIS Spinal System L&K Biomed Co., Ltd. Jihyeon Seo
K182674 11/13/2018 Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia Largan Medical Co., Ltd Amy Tien
K182523 11/01/2018 Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens Largan Medical Co., Ltd. Amy Tien
K172662 01/09/2018 reVive Perioral LED Technologies, Inc. Lloyd Nelson
K182916 11/16/2018 Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr LeMaitre Vascular John N. Bradsher
K182380 11/28/2018 AEON Endoscopic Stapler Lexington Medical, Inc. Douglas MacBride
K182470 11/26/2018 Plateau Spacer System Life Spine Angela Batker
K172456 01/04/2018 Bone Screws 6.5mm LimaCorporate S.p.A. Michela Zanotto
K171113 01/04/2018 LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module LiNA Medical ApS Natalia Szychulska
K182557 11/02/2018 MTS Eravacycline 0.002 - 32 ?g/mL Liofilchem s. r. l. Fabio Brocco
K171971 01/25/2018 Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer Lite-On Technology Corp. H.S.P.B. John Lo
K173436 01/30/2018 Luma Light System Luma Therapeutics Tiffini Wittwer
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K182160 11/05/2018 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM Stryker April Malmborg
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K173866 01/18/2018 Stryker AIM Light Source and SafeLight cable Stryker Jay Nayar
K173476 01/18/2018 Tritanium« TL Curved Posterior Lumbar Cage Stryker Nikin Desai
K172116 01/25/2018 Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) Stryker Corporation Kristi Ashton
K182425 11/06/2018 Universal Mesh - Sterile Stryker Leibinger GmbH & Co. KG Gregory Gohl
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K171313 01/19/2018 EM-4000 Specular Microscope Tomey Corporation Tomoko Watanabe
K173119 01/19/2018 DRI OCT Triton Topcon Corporation Charles Reisman
K173090 01/11/2018 Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 Toshiba Medical Systems Corporation Paul Biggins
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K182027 11/21/2018 Wet Organics Personal Lubricant Trigg Laboratories DBA Wet International Simone Buntin
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K172189 01/16/2018 Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt Truemed Group LLC Nina Galeana Rodriguez
K182046 11/30/2018 Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System Tyson Bioresearch, Inc. Vance Chang
K182047 11/29/2018 Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System Tyson Bioresearch, Inc. Vance Chang
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K173198 01/03/2018 Facet Screw Fixation System U&i Corporation Yeon-Jung Choi
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K173062 01/25/2018 Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) V&Q Manufacturing Corporation Jacky Jin
K172716 01/26/2018 V2K Rinspiration System, P7 Catheter - 9mm Rinse x 135cm Working Length, V2K Rinspiration System, P7 Catheter - 20mm Rinse x 135cm Working Length, V2K Rinspiration System, Filter Line - 108 Length V2K Medical Inc. Jake Wolenberg
K173838 01/17/2018 ARIA Radiation Therapy Management Varian Medical Systems, Inc. Peter J. Coronado
K173891 01/19/2018 Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume Vascular Solutions, Inc. Lisa Gallatin
K180601 11/02/2018 Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) Villa Sistemi Medicali S.p.A. Paolo Casagrande Santin
K181247 11/20/2018 Vitrea CT Brain Perfusion Vital Images, Inc. Susan Atwood
K181524 11/30/2018 Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART Vyaire Medical, Inc. Elmar Niedermeyer
K181208 11/02/2018 Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter Vygon USA Jillian Mikovich
K172567 01/31/2018 GORE Molding and Occlusion Balloon Catheter W.L Gore And Associates Inc Jeremiah Andrews
K171273 01/19/2018 LINK« BiMobile(TM) Dual Mobility System Waldemar Link Gmbh & Co. KG Stefanie Reimers
K180298 11/30/2018 welloStationX Wello, Inc Alan Camerik(Rik) Heller
K171625 01/12/2018 Single Lumen Ovum Aspiration Needles Willian A. Cook Australia Pty Ltd Gordana Pozvek
K172548 01/12/2018 Wiltrom Spinal Fixation System Wiltrom Corporation Limited Yi-Chun Su
K182562 11/16/2018 Hair Boom 69 WonTech Gyuri (Erin) Park
K182823 11/02/2018 PRODENSE Bone Graft Substitute Wright Medical Technology, Inc. Alayne Melancon
K180685 11/29/2018 AS-3XX Series Fingertip Pulse Oximeter Xiamen Acurio Instruments Co., Ltd Angel Liu
K172968 01/05/2018 Hair Up Y&J BIO Co., Ltd. Kwang Sic Kim
K172683 01/16/2018 Yamahachi Pink CAD/CAM Disk Yamahachi Dental Mfg., Co. Shogo Muramatsu
K173306 01/22/2018 EZ Plate Zavation Medical Products Llc Matt Jones
K181996 11/21/2018 MATRx Plus Zephyr Sleep Technologies Sabina Bruehlmann
K170234 01/17/2018 Endotracheal tube; Reinforced Endotracheal tube Zhanjiang Star Enterprise Co., Ltd Rongsheng Tang
K171518 01/05/2018 Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles Zhejiang kindly Medical Devices Co., Ltd Zenghua Zhang
K173417 01/30/2018 Zimmer Persona Personalized Knee System Zimmer, Inc. Nicole Meredith
K180482 11/30/2018 ZOLL Propaq M ZOLL Medical Corporation Pooja Dalvi


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