| 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 |
| K172907 |
11/09/2018 |
ELAN 4 Air Motor System |
Aesculap, Inc. |
Jessica Stigliano |
| DEN170056 |
11/02/2018 |
Parathyroid Detection (Model PTeye) System |
AiBiomed, Corp. |
Al Memmolo |
| 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 |
| 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 |
| DEN170049 |
11/06/2018 |
Innovo |
Bio-Medical Research Ltd. |
Anne-Marie Keenan |
| 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 Endovascular System |
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 |
Gⁿnther 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 |
| K173744 |
11/21/2018 |
ProFuse CAD |
Eigen |
William Mandel |
| 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 |
| K172602 |
11/14/2018 |
Miracu |
Feeltech Co., Ltd. |
Keun-Sik Kim |
| K180047 |
11/08/2018 |
ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System |
Fiab SpA |
Alberto Calabro |
| K173916 |
11/06/2018 |
Finapres Nova Noninvasive Hemodynamic Monitor |
Finapres Medical Systems B.V. |
Iris van Uitert |
| 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 |
| DEN170092 |
11/02/2018 |
Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System |
Fluoptics |
Odelie Allard |
| 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 |
| K173589 |
11/30/2018 |
Prizma |
G-Medical Innovations Ltd. |
N. Epstein |
| 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 |
| K173701 |
11/29/2018 |
Implant-One System |
Implant Logistics, Inc. |
Thomas Arendt |
| 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 |
| K180732 |
11/08/2018 |
MiroCam Capsule Endoscope System |
IntroMedic Co., Ltd. |
Jinyoung Lee |
| K170438 |
01/30/2018 |
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 Equipment 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 |
| K183023 |
11/30/2018 |
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) |
Luminex Molecular Diagnostics, Inc. |
Tina Ip |
| K183030 |
11/30/2018 |
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) |
Luminex Molecular Diagnostics, Inc. |
Tina Ip |
| K180180 |
11/02/2018 |
HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) |
M.I. Tech Co., Ltd. |
Inae Kim |
| K181559 |
11/09/2018 |
Neurosign V4 Intraoperative Nerve Monitor |
Magstim Company Ltd. |
Tom Campbell |
| K172159 |
01/30/2018 |
Getinge GSS67N Series Steam Sterilizer |
Maquet GmbH |
Holger Ullrich |
| K172890 |
01/26/2018 |
SedLine Sedation Monitor |
Masimo Corporation |
Matthew Tiacharoen |
| K182077 |
11/02/2018 |
Mazor X System (Mazor X Stealth Edition) |
Mazor Robotics Ltd. |
Marina Hefetz |
| K171958 |
01/12/2018 |
PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE |
Mectron SPA |
Franco Zunino |
| K181693 |
11/28/2018 |
SMS Femoral Stem |
Medacta International SA |
Stefano Baj |
| K180643 |
11/23/2018 |
MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) |
MedCu Technologies, Ltd. |
Gadi Borkow |
| K180415 |
11/02/2018 |
Invia White Foam NPWT |
Medela AG |
Georges Hakim |
| K182352 |
11/21/2018 |
SP-LINKÖ System |
Medical Designs LLC |
Kristi Vondra |
| K173170 |
01/10/2018 |
Epicardia Anywhere |
Medicomp, Inc. |
Sean Marcus |
| K173581 |
01/25/2018 |
Gallant PTCA Dilatation Catheter |
Medinol, Ltd. |
Marina Tikhonov Demishtein |
| K173113 |
01/17/2018 |
Medline Disposable Electronic Thermometer Probe Cover |
Medline Industries, Inc. |
Dinah Rincones |
| K181820 |
11/01/2018 |
Medline Unite Mini Plates and Screws |
Medline Industries, Inc. |
Jennifer Mason |
| K171237 |
01/18/2018 |
FMS VUE II Fluid Management and Tissue Debridement System |
Medos International SARL |
Tatyana Korsunsky |
| K172796 |
01/18/2018 |
Flex Robotic System and Flex Transabdominal Drive |
MEDROBOTICS CORPORATION |
Linda J Varroso |
| K181781 |
11/05/2018 |
DynaClipTM Bone Staple |
MedShape, Inc. |
Jack Griffis |
| K183174 |
11/26/2018 |
FlexCath Advance Steerable Sheath and Dilator |
Medtronic CryoCath LP |
Natalie Sadeghi |
| K182104 |
11/02/2018 |
NavLock Trackers, Robotic Reference Frame |
Medtronic Navigation |
Jainam Shah |
| K182121 |
11/02/2018 |
CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition |
Medtronic Sofamor Danek USA, Inc. |
Erikka Edwardsen |
| K173338 |
01/18/2018 |
Navigated INFINITYÖ Instruments |
Medtronic Sofamor Danek USA, Inc. |
Tejas Patel |
| K182957 |
11/21/2018 |
Heli-FX EndoAnchor System |
Medtronic Vascular, Inc. |
Janelle Wong Keller |
| K181918 |
11/08/2018 |
CardioInsight Cardiac Mapping System |
Medtronic, Inc. |
Janell Colley |
| DEN180040 |
11/30/2018 |
Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit |
Meridian Bioscience, Inc. |
Jack Rogers |
| K182559 |
11/05/2018 |
PREMIER Platinum HpSA PLUS |
Meridian Bioscience, Inc. |
Jack Rogers |
| K182216 |
11/06/2018 |
Merit Syringe |
Merit Medical Systems, Inc |
John Skousen |
| K182279 |
11/06/2018 |
Merit Syringe |
Merit Medical Systems, Inc. |
John Skousen |
| K173601 |
01/31/2018 |
Merit Syringe |
Merit Medical Systems, Inc. |
Cory Marsh |
| K181443 |
11/23/2018 |
Accula RSV Test |
Mesa Biotech, Inc. |
Barbara Stevens |
| K172655 |
01/11/2018 |
Automated ankle brachial pressure index measuring device |
Mesi D.O.O.; Mesi, Development of medical devices, Ltd. |
Jakob Susteric |
| K171498 |
01/12/2018 |
MSD CRP Assay Kit and MESO SECTOR S 700 Instrument |
Meso Scale Diagnostics, LLC |
Lillian Quintero |
| K181689 |
11/15/2018 |
Nexcomp |
Meta Biomed Co., Ltd. |
Suk Song Oh |
| K182097 |
11/14/2018 |
React 71 Catheter |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Ryan Kenney |
| K182101 |
11/14/2018 |
Riptide Aspiration System (React 71 Catheter) |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Ryan Kenney |
| K181819 |
11/06/2018 |
SMARTRELEASE Endoscopic Soft Tissue Release System |
MicroAire Surgical Instruments LLC |
Glenn Gerstenfeld |
| K182472 |
11/08/2018 |
Cepheid Xpert GBS LB Control Panel |
Microbiologics, Inc. |
Tina Sobania |
| DEN180030 |
11/19/2018 |
QMS Plazomicin Immunoassay |
Microgenics Corporation |
Minoti Patel |
| K162665 |
01/26/2018 |
MiCor A100 Wearable ECG Recorder |
MITAC INTERNATIONAL CORP. |
YIHAO HUANG |
| K181195 |
11/02/2018 |
ClearPoint System |
MRI Interventions, Inc. |
Pete Piferi |
| K181731 |
11/20/2018 |
MR Compatible Aspiration Kit |
MRI Interventions, Inc. |
Pete Piferi |
| K172240 |
01/31/2018 |
SPI Dental Implant System |
MSI France |
Gerard Bouna |
| K171354 |
01/13/2018 |
MR4 Laser |
Multi Radiance Medical |
Andrey Godes |
| K172977 |
01/16/2018 |
Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel |
Nanova Biomaterials Inc |
Andrew C. Ritts |
| K171312 |
01/22/2018 |
FortiCore« |
Nanovis LLC |
Matthew Hedrick |
| K181137 |
11/16/2018 |
IT-III active System |
Neobiotech Co., Ltd. |
Young-Ku Heo |
| K182958 |
11/16/2018 |
1.5T 16ch Breast Coil |
NeoCoil, LLC |
Katie Gonzalez |
| K172962 |
01/18/2018 |
Nurture Rest |
Neonatal Loving Kare, Inc. |
Nicole Sawyers |
| K173917 |
11/08/2018 |
neoClose PDS |
neoSurgical Ltd |
Orla Brennan |
| K182195 |
11/09/2018 |
ArcoÖ-SA Lumbar Cage System |
NeuroStructures, Inc. |
Kathleen Wong |
| K181590 |
11/08/2018 |
Neurostructures Cavetto« [MAX] Cervical Cage System |
NeuroStructures, Inc. |
Kathleen Wong |
| K181709 |
11/16/2018 |
Serenity Piezo Sensor, Serenity Thermocouple Sensor |
Neurotronics, Inc. |
David Pezet |
| K181501 |
11/02/2018 |
Afina |
NeuroVision Imaging, LLC |
Pepe Davis |
| K173641 |
01/16/2018 |
Activ Ankle |
Newclip Technics |
Gaelle Lussori |
| K171372 |
01/04/2018 |
Alians Elbow Locking Plating System |
Newclip Technics |
Gaelle Lussori |
| K182201 |
11/16/2018 |
StratumÖ Foot Plating System |
Nextremity Solutions, Inc. |
Adam Finley |
| K182508 |
11/13/2018 |
SaxxonyÖ Posterior Cervical Thoracic System |
Nexxt Spine LLC |
Andy Elsbury |
| K182616 |
11/02/2018 |
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System |
NinePoint Medical, Inc. |
Eman Namati |
| K172224 |
01/11/2018 |
DTX Studio diagnose |
Nobel Biocare AB |
Charlemagne Chua |
| K163600 |
01/22/2018 |
Kit Boxes and Kit Plates |
Nobel Biocare AB |
Charlemagne Chua |
| K182606 |
11/21/2018 |
PINPOINT Endoscopic Fluorescence Imaging System |
Novadaq Technologies ULC (now a part of Stryker) |
Agatha Szeliga |
| K173479 |
01/17/2018 |
NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) |
Novo Nordisk Inc. |
Devraj Chakravarty |
| K181266 |
11/01/2018 |
Implantswiss Dental Implant System, Implantswiss Dental Abutment System |
Novodent SA |
Cem Kocer |
| K180550 |
11/20/2018 |
NuVasive Monolith Cervical Corpectomy System |
NuVasive, Incorporated |
Martin Yahiro |
| K180498 |
11/28/2018 |
NuVasive Reline Fenestrated Screws, High V+ Bone Cement |
NuVasive, Incorporated |
Martin Yahiro |
| K171396 |
01/31/2018 |
ODFS Pace XL |
Odstock Medical Ltd |
Steven Crook |
| K180668 |
11/15/2018 |
Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K173495 |
11/30/2018 |
Single Use Hot Biopsy Forceps FD-231 |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K182587 |
11/29/2018 |
Device Electrosurgical Generator ESG-150 |
Olympus Winter & Ibe GmbH |
Jan-Oliver Upmeier |
| K181992 |
11/09/2018 |
Heat Pain Pro |
Omron Healthcare, Inc. |
Renee Thornborough |
| K182481 |
11/09/2018 |
HEM-6410T-ZM Wrist Blood Pressure Monitor |
Omron Healthcare, Inc. |
Renee Thornborough |
| K182166 |
11/08/2018 |
Wrist Blood Pressure Monitor Model BP4350 |
Omron Healthcare, Inc. |
Renee Thornborough |
| K182127 |
11/02/2018 |
Wrist Blood Pressure Monitor Model BP6100 |
Omron Healthcare, Inc. |
Renee Thornborough |
| K182274 |
11/20/2018 |
Orbit Subretinal Delivery System |
Orbit Biomedical, Inc. |
Michael Keane |
| K182360 |
11/09/2018 |
Teleport Microcatheter |
OrbusNeich Medical Trading Inc. |
John Pazienza |
| K181112 |
11/26/2018 |
Orchestrate 3D |
Orchestrate 3D |
Todd Ehrler |
| K172845 |
01/31/2018 |
Symetri Clear |
Ormco Corporation |
Tara Bonny |
| K180025 |
01/22/2018 |
Centurion POCT System |
Orthofix Inc. |
Jacki Koch |
| K172696 |
01/19/2018 |
FORZA« XP Expandable Spacer System |
Orthofix Inc. |
Natalia Volosen |
| K172183 |
01/09/2018 |
Guided Growth Plate System Plus |
Orthofix Srl |
Gianluca Ricadona |
| K182096 |
11/02/2018 |
Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs |
Owens & Minor Halyard, Inc. |
Angela L. Bunn |
| K173466 |
01/26/2018 |
Panthera Dental Milled Bars |
Panthera Dental Inc. |
Martine Fortin |
| K173530 |
01/31/2018 |
Indego(R) |
Parker-Hannifin Corporation |
Achilleas Dorotheou |
| K181396 |
11/16/2018 |
Oral Device OA, Oral Device S |
Passion for Life Healthcare (UK) Limited |
Paul Earps |
| K173554 |
01/19/2018 |
PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope |
PENTAX of America, Inc. |
James W. Monroe |
| K182181 |
11/29/2018 |
Persyst 14 EEG Review and Analysis Software |
Persyst Development Corporation |
Dari Darabbeigi |
| K182353 |
11/27/2018 |
EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay |
Phadia AB |
Carina Magnusson |
| K163026 |
01/09/2018 |
Ultra/Phonic Scanning Gel |
Pharmaceutical Innovations Inc. |
Shirley J. Bergman |
| K163023 |
01/08/2018 |
Other-Sonic Transmission Gel |
PHARMACEUTICAL INNOVATIONS, INC. |
SHIRLEY J. BERGMAN |
| K163024 |
01/08/2018 |
Ultra/Phonic Conductivity Gel |
PHARMACEUTICAL INNOVATIONS, INC. |
SHIRLEY J. BERGMAN |
| K163027 |
01/09/2018 |
Ultra/Phonic Free Conductivity Gel |
PHARMACEUTICAL INNOVATIONS, INC. |
SHIRLEY J. BERGMAN |
| K172920 |
01/22/2018 |
3D APT |
Philips Medical Systems Nederland B.V. |
Jan van de Kerkhof |
| K173588 |
01/12/2018 |
Illumeo System |
Philips Medical Systems Technologies, Ltd. |
Yoram Levy |
| K181831 |
11/15/2018 |
IntelliVue Multi-Measurement Module MMX |
Philips Medizin Systeme Boeblingen GmbH |
Stefan Breuer |
| K182857 |
11/09/2018 |
EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System |
Philips Ultrasound, Inc. |
Kym Rupp |
| K180918 |
11/30/2018 |
Planmed Verity |
Planmed Oy |
Lars Moring |
| K182581 |
11/21/2018 |
PlayMakar Sport Muscle Stimulator, Model PRO-500 |
PlayMakar Inc. |
Mike Williams |
| K182598 |
11/13/2018 |
VersaLinkÖ Fixation System |
Premia Spine Ltd. |
Ron Sacher |
| K173878 |
01/19/2018 |
PreXion3D Excelsior |
PreXion Corporation |
Katsumi Hayashi |
| K172358 |
01/10/2018 |
Instalief |
Privi Medical Pte Ltd |
Prusothman M Sinha Raja |
| K172164 |
01/17/2018 |
PROPEL Device |
Propel Orthodontics LLC |
Bryce Way |
| K173020 |
01/17/2018 |
OBA-MCP, Orthodontic Bracket Adhesive with MCP |
Pulpdent Corporation |
Kenneth J. Berk |
| K172169 |
01/05/2018 |
Pulpdent (Activa) Pit and Fissure Sealant with MCP |
Pulpdent Corporation |
Kenneth J. Berk |
| K172259 |
01/18/2018 |
PulsioFlex Monitoring System |
PULSION Medical Systems SE |
Marc Bergenthal |
| K172287 |
01/12/2018 |
ipsogen JAK2 RGQ PCR Kit |
QIAGEN, Inc. |
Lindsey Howard |
| K181816 |
11/29/2018 |
Ceramic Denture Zirconia Ceramics Block |
Qinhuangdao Silide Ceramic Technology Co., Ltd |
Lou ChunHua |
| K180478 |
11/13/2018 |
RectalPro 75 Endorectal Balloon |
QLRAD International Ltd. |
Arjen Winkel |
| K173469 |
01/09/2018 |
16ch T/R Hand Wrist Coil |
Quality Electrodynamics, LLC |
Eric Yeh |
| K182442 |
11/06/2018 |
MiniGuard Arterial Safety Valve |
Quest Medical, Inc. |
Tosan Onosode |
| K181948 |
11/16/2018 |
1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil |
RAPID Biomedical GmbH |
Christian Zimmermann |
| K173504 |
01/12/2018 |
K-Y Silicone |
Reckitt Benckiser LLC |
Elizabeth Viguerie |
| K173283 |
01/19/2018 |
Reliance Lumbar IBF System |
Reliance Medical Systems, LLC |
Bret M. Berry |
| K173768 |
01/10/2018 |
Tempus Pro Patient Monitor |
Remote Diagnostic Technologies Ltd. |
James Hamlyn |
| K170924 |
01/03/2018 |
AirFit F20 |
ResMed Ltd |
Johanna Wright |
| K182218 |
11/30/2018 |
FerriSmart Analysis System |
Resonance Health Analysis Services Pty Ltd |
Celine Royet |
| K171235 |
01/04/2018 |
OmniCap |
Respirion, Inc. |
Ed Fadel |
| K180573 |
11/23/2018 |
Responsive Arthroscopy Interference Screw System |
Responsive Arthroscopy LLC |
Doug Kohrs |
| K173389 |
01/30/2018 |
Rex Medical Aspiration Pump |
Rex Medical, L.P. |
Erich Bressler |
| K180949 |
11/08/2018 |
Steribite |
RJR Surgical, Inc. |
John Redmond |
| K173857 |
11/06/2018 |
Elecsys Tacrolimus |
Roche Diagnostics |
Khoa Tran |
| K182095 |
11/05/2018 |
Tina-quant Transferrin ver.2 (urine application) |
Roche Diagnostics Operations (RDO) |
Lindsay Jones |
| K172913 |
01/12/2018 |
cobas Factor II and Factor V Test |
Roche Molecular Systems, Inc. |
Pooja Shah |
| K171436 |
01/05/2018 |
STRONG Dental Handpieces |
Saeshin Precision Co., Ltd. |
Choi Jong Woo |
| K182654 |
11/19/2018 |
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card |
Safecare Biotech (Hangzhou) Co., Ltd. |
Alex Qiu |
| K180838 |
11/06/2018 |
SaliPen |
Saliwell Ltd. |
Ben Z. Beiski |
| K173828 |
01/12/2018 |
GU60A & GU60A-65 |
Samsung Electronics Co.,Ltd. |
Noh Jaesang |
| K181998 |
11/15/2018 |
CardioBand ECG Event Recorder |
Samsung Strategy and Innovation Center (SSIC) |
Bhupinder Singh |
| K171367 |
01/26/2018 |
SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) |
Sanrea Healthcare Products Pvt Ltd |
Jose Paul M |
| K173235 |
01/22/2018 |
Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile |
Scientia Vascular LLC |
David Sabodski |
| K173285 |
01/29/2018 |
JOULE SYSTEM |
Sciton, Inc |
Jay M. Patel |
| K171529 |
01/02/2018 |
Snorer's Friend |
Scope Healthcare Technologies Pty Ltd |
Ben Olsen |
| K181704 |
11/21/2018 |
Transpara |
ScreenPoint Medical BV |
Nico Karssemeijer |
| K173521 |
01/24/2018 |
SeaSpine Cabo ACP (Anterior Cervical Plate) System |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K172195 |
01/11/2018 |
HYDRASHIFT 2/4 daratumumab, daratumumab Control |
Sebia |
Karen Anderson |
| K173299 |
01/26/2018 |
DRAGON X SPSL4HC, DRAGON X SPSL8HC |
Sedecal SA |
MaLuisa Gomez de Aguero |
| K173953 |
01/26/2018 |
uDR 780i |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin GAO |
| K173001 |
11/07/2018 |
uWS-CT |
Shanghai United Imaging Healthcare Co.,Ltd. |
Shumei Wang |
| K172999 |
11/07/2018 |
uWS-MR |
Shanghai United Imaging Healthcare Co.,Ltd. |
Shumei Wang |
| K180381 |
11/07/2018 |
Powder Free Vinyl Patient Examination Gloves |
Shanxi Hongjin Plastic Technology Co., Ltd |
Wu Zhigang |
| K172969 |
01/26/2018 |
Essence 55S Large Monitor System |
Shenyang Torch-Bigtide Digital Technology Co., Ltd. |
Fu Ailing |
| K182133 |
11/20/2018 |
Infrared Thermometer |
Shenzhen AOJ Medical Technology Co., Ltd. |
Qihuan Zhao |
| K182291 |
11/20/2018 |
6MP Color LCD Monitor (C61W+) |
Shenzhen Beacon Display Technology Co., Ltd. |
Fu Ailing |
| K182530 |
11/09/2018 |
BIOEASY Multi-Drug Test Cup |
Shenzhen Bioeasy Biotechnology Co.,Ltd. |
Wenhau Yan |
| K180432 |
11/19/2018 |
AI-ECG Platform |
Shenzhen Carewell Electronics., Ltd |
Chang Liu |
| K171833 |
01/10/2018 |
Digital Blood Pressure Monitor-Wrist Style |
Shenzhen Combei Technology CO., LTD |
Huaguang Meng |
| K172792 |
11/13/2018 |
Handheld Pulse Oximeter, Model SP-20 |
Shenzhen Creative Industry Co., Ltd. |
Jia Wang |
| K172896 |
01/26/2018 |
Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312 |
Shenzhen Jiacom Technology Co ., Ltd |
Luo Tianfeng |
| K171721 |
01/05/2018 |
Electrodes with silver conductive |
Shenzhen Konmed Technology Co., Ltd |
Tony Tony |
| K171722 |
01/10/2018 |
Electrodes with snap / Electrodes with pigtail |
Shenzhen Konmed Technology Co., Ltd |
Tony Tony |
| K163288 |
01/18/2018 |
Pelvifine Pelvic Muscle Trainer |
Shenzhen Konmed Technology Co., Ltd. |
Tony Tony |
| K173471 |
01/08/2018 |
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic |
Shenzhen Mindray Bio-medical Electronics Co., LTD |
Yang Zhaohui |
| K172860 |
01/02/2018 |
Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System |
ShenZhen Mindray Bio-Medical Electronics Co., Ltd |
Ma Chao |
| K182603 |
11/14/2018 |
Z6 Diagnostic Ultrasound System |
Shenzhen Mindray Bio-medical Electronics Co., LTD |
Jiang Xiaoyong |
| K171311 |
01/12/2018 |
A5 Anesthesia System |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
Yanhong Bai |
| K171292 |
01/12/2018 |
A7 Anesthesia System |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
Yanhong Bai |
| K172837 |
11/26/2018 |
Low-frequency Multi-function physiotherapy instrument |
Shenzhen OSTO Technology Co., Ltd. |
Li Yang |
| K163712 |
01/02/2018 |
Clover 50/Clover60/Clover70 Diagnostic Ultrasound System |
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD. |
JIANG XIAOSAN |
| K182715 |
11/20/2018 |
Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System |
Shenzhen Wisonic Medical Technology Co., Ltd. |
Jiang Xiaosan |
| K182983 |
11/27/2018 |
iFuse Implant System« |
SI-BONE, Inc. |
Roxanne Dubois |
| K182098 |
11/01/2018 |
N Latex FLC kappa assay, N Latex FLC lambda assay |
Siemens Healthcare Diagnostics Products GmbH |
Christine Perkins |
| K181613 |
11/06/2018 |
MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D |
Siemens Medical Solutions USA, Inc. |
Cordell L. Fields |
| K173635 |
01/12/2018 |
syngo.via RT Image Suite |
Siemens Medical Solutions USA, Inc. |
Kimberly Mangum |
| K182179 |
11/16/2018 |
AdvantageRib Anterior System |
SIG Medical Corp. |
Andrew Davison |
| K163081 |
01/29/2018 |
40-42mm BiPolar Head and 22mm Femoral Head |
SIGNATURE ORTHOPAEDICS PTY LTD. |
Declan Brazil |
| K171421 |
01/10/2018 |
VERTICALE« Posterior Spinal Fixation System/VERTICALE« System |
Silony Medical GmbH |
Bircan Yilmaz |
| K172452 |
01/11/2018 |
Bruxor |
Sleep Specialties, LLC |
James S. Fallon |
| K181759 |
11/09/2018 |
PowerDot PD-01MT |
Smartmissimo Technologies Pte Ltd |
Alexey Pisarev |
| K171827 |
01/19/2018 |
ReddyPort NIV Access Elbow |
SMD Manufacturing, LLC |
Rian Wendling |
| K171674 |
01/19/2018 |
Angel Align System |
Smile Development Corp |
Ian Kitching |
| K173293 |
01/08/2018 |
EVOS Small Fragment Upper Extremity Plates |
Smith & Nephew, Inc. |
Samantha Staubach |
| K182535 |
11/19/2018 |
R3 Anteverted Liners |
Smith & Nephew, Inc. |
Meenakshi Gupta |
| K182109 |
11/16/2018 |
REDAPT Modular Acetabular Shell |
Smith & Nephew, Inc. |
Meenakshi Gupta |
| K172336 |
01/10/2018 |
Smith & Nephew Patient Matched Cutting Blocks |
Smith & Nephew, Inc. |
Brad Sheals |
| K183010 |
11/28/2018 |
Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks |
Smith & Nephew, Inc. |
Brad Sheals |
| K171968 |
01/25/2018 |
EchoGlo Needle |
Smiths Medical ASD, Inc. |
Michael R. Johnson |
| K182543 |
11/14/2018 |
Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package |
snap40 Ltd |
Edwin Lindsay |
| K180631 |
11/08/2018 |
Silk Voice |
Sofregen Medical, Inc. |
Anh Hoang |
| K173759 |
01/08/2018 |
Thermage CPT System and Accessories |
Solta Medical |
Ken Nehmer |
| K180388 |
11/30/2018 |
Transcend 365 miniCPAP System |
Somnetics International, Inc. |
Eric Becker |
| K180979 |
11/16/2018 |
PureFlex Arterial Cannulae |
Sorin Group Italia S.r.l |
Luigi Vecchi |
| K181850 |
11/14/2018 |
Inversa Implants |
Southern Implants (Pty) Ltd |
Lauranda Breytenbach |
| K182484 |
11/09/2018 |
VERITON CT whole body SPECT/CT system |
Spectrum Dynamics Medical Ltd |
Igor Naroditsky |
| K181837 |
11/02/2018 |
Spinal Elements Ti-Bond coated devices |
Spinal Elements Inc. |
Julie Lamothe |
| K173702 |
01/03/2018 |
Juliet Ti LL |
SPINEART |
Franck Pennesi |
| K172518 |
01/05/2018 |
Spineology Navigation Instruments |
Spineology Inc. |
Jacqueline Hauge |
| K171228 |
01/19/2018 |
Fiji Anchor |
SportWelding GmbH |
Joerg Mayer |
| K173875 |
01/19/2018 |
GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert |
StelKast, Inc. |
Dave Stumpo |
| K182604 |
11/14/2018 |
New Era |
Step Up Skin Laser, LLC |
Michelle Hokama |
| K172319 |
01/18/2018 |
AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System |
STERIS Corporation |
Bill Brodbeck |
| K182931 |
11/20/2018 |
VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag |
Steris Corporations |
Jennifer Nalepka |
| K173448 |
01/25/2018 |
CliniCloud Stethoscope |
StethoCloud Pty.Ltd (CliniCloud) |
Andrew Lin |
| K171784 |
01/19/2018 |
Straumann Dental Implant System |
Straumann USA, LLC |
Jennifer M. Jackson |
| 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 |
| K181258 |
11/05/2018 |
ConnectedOR Hub with Device and Voice Control |
Stryker |
April Malmborg |
| K171391 |
01/26/2018 |
Stryker 90-S Max SERFAS Energy Probe |
Stryker |
Ben Krebs |
| 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 |
| K172774 |
01/12/2018 |
T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System |
Stryker Trauma Gmbh |
Heike Gustke |
| K171628 |
01/12/2018 |
HBS2 Headless Bone Screw |
Stuckenbrock Medizintechnik GmbH |
Fabian Stuckenbrock |
| K182336 |
11/30/2018 |
SubtlePET |
Subtle Medical, Inc. |
Enhao Gong |
| K180528 |
11/16/2018 |
InstruSafe(R) Sterilization Container |
Summit Medical Inc. |
Nicole Dove |
| K172384 |
01/16/2018 |
Quickie(r) Q700-UP M |
Sunrise Medical (US) LLC |
Nancy J. Gertlar |
| K173021 |
01/09/2018 |
Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems |
Supersonic Imagine |
Laurence Hermitte |
| K173560 |
01/12/2018 |
Microcatheter |
Surmodics, Inc. |
Sherri Mellingen |
| K171665 |
01/11/2018 |
Microcatheter and guide-wire system |
Suzhou Hengrui Disheng Medical Co.,Ltd. |
Jingwen Li |
| K173301 |
01/19/2018 |
BioSphere MIS Putty (BioSphere MIS) |
Synergy Biomedical, Llc |
Mark Borden |
| K180310 |
11/01/2018 |
DePuy Synthes Trauma Orthopedic Plates and Screws |
Synthes (USA) Products LLC/DePuy Orthopaedics Inc |
Jeffrey Krawiec |
| K180541 |
11/21/2018 |
DePuy Synthes 2.0 mm Quick Insertion Screws |
Synthes USA Products, LLC |
Nicholas Fountoulakis |
| K173558 |
01/26/2018 |
SyMRI |
SyntheticMR AB |
Maria Almesaker |
| K181588 |
11/30/2018 |
POPS! one Blood Glucose Monitoring System |
TaiDoc Technology Corporation |
Anne Kuo |
| K172668 |
11/06/2018 |
W Zirconia Implants |
TAV Medical Ltd. |
Revital Shabtai |
| K173219 |
01/22/2018 |
CAMPYLOBACTER CHEK |
Techlab, Inc. |
Donna T. Link |
| K173217 |
01/22/2018 |
CAMPYLOBACTER QUIK CHEK |
Techlab, Inc. |
Donna T. Link |
| K173596 |
01/29/2018 |
Rusch Intermittent Urethral Catheters |
Teleflex Medical |
Amanda Webb |
| K180253 |
11/02/2018 |
Sheridan Endobronchial Tubes |
Teleflex Medical |
Lori Pfohl |
| K181049 |
11/01/2018 |
Spectra Optia Apheresis System |
Terumo BCT, Inc. |
Nicholas Wong |
| K182110 |
11/02/2018 |
CDI Blood Parameter Monitoring System 550 |
Terumo Cardiovascular Systems Corporation |
Bryan K. Hann |
| K181369 |
11/13/2018 |
Immucise Intradermal Injection System |
Terumo Corporation |
Yuko Watanabe |
| K171213 |
01/12/2018 |
One Touch Condom with Benzocaine |
Thai Nippon Rubber Industry Public Company Limited |
Pisut Chanwatarungkull (Pete) |
| K171775 |
01/09/2018 |
Theradome LH80 PRO |
Theradome Inc. |
Tamim Hamid |
| K173582 |
01/17/2018 |
ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes |
ThermiGen, L.L.C |
Suzanne Cheang |
| K182797 |
11/30/2018 |
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 ╡g/mL |
Thermo Fisher Scientific |
Cynthia Knapp |
| 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 |
| K173382 |
01/26/2018 |
Vantage Galan 3T, V4.6 |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K173088 |
01/31/2018 |
Vitrea Software Toshiba Package VSTP-001A |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K182027 |
11/21/2018 |
Wet Organics Personal Lubricant |
Trigg Laboratories DBA Wet International |
Simone Buntin |
| K173622 |
01/16/2018 |
CS Imaging |
Trophy |
Marie-Pierre Labat-camy |
| K172304 |
01/23/2018 |
TruAbutment DS |
TruAbutment Inc. |
Brandon Kim |
| 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 |
| K173563 |
01/10/2018 |
ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE |
TZ Medical Inc |
John Lubisich |
| K173198 |
01/03/2018 |
Facet Screw Fixation System |
U&i Corporation |
Yeon-Jung Choi |
| K181829 |
11/14/2018 |
Velofix TLIF Cage |
U&I Corporation |
Jee-Ae Bang |
| K173054 |
01/16/2018 |
Navigo Workstation Version 2.0 |
UC-Care Ltd. |
Hadas Sheynise |
| K171295 |
01/09/2018 |
ULab Systems Treatment Planning Software |
ULab Systems, Inc. |
Charlie Wen |
| K181921 |
11/16/2018 |
Solidity Vertebral Body Replacement |
ulrich medical USA |
Hans Stover |
| K182105 |
11/14/2018 |
JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal Lubricant |
United Consortium |
Stephanie Morris |
| K173650 |
01/05/2018 |
AquaShield System CO2- Fujifilm |
United States Endoscopy Group, Inc. |
Carroll Martin |
| K182909 |
11/21/2018 |
Roth Net Retriever Product Line |
United States Endoscopy Group, Inc. |
Carroll Martin |
| K171500 |
01/30/2018 |
Uro-V Cystoscope |
UroViu Corporation |
Thomas Lawson |
| K181784 |
11/30/2018 |
Spectra S3 Plus |
Uzinmedicare Co. |
Nathan Ahn |
| 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 |
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 |
| K173373 |
11/16/2018 |
SafeT T-Piece Resuscitator |
Ventlab, LLC |
Rob Yamashita |
| 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 |
| K173971 |
11/15/2018 |
K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent |
Yeti Dentalprodukte Gmbh |
Thomas Biskupski |
| 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 |
