| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K173435 |
11/03/2017 |
3M Attest Rapid Readout Biological Indicator |
3M Company |
Nadia Battah |
| K173437 |
11/03/2017 |
3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H |
3M Company |
Hilary B. Hovde |
| K173584 |
11/20/2017 |
3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader |
3M Company |
Hilary B. Hovde |
| K173519 |
11/14/2017 |
3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader |
3M Company |
Hilary B. Hovde |
| K170196 |
01/23/2017 |
A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor |
A&D Company, Ltd. |
Jerry Wang |
| K173579 |
11/20/2017 |
ThoreconÖ Fixation System |
A&E Medical Corporation |
Dana Rodriguez |
| K170183 |
01/23/2017 |
Cetus system, Cetus probe |
A.R.C. Laser GmbH |
Angela Thyzel |
| K170160 |
01/18/2017 |
Abbott ARCHITECT Free T3 |
Abbott Laboratories |
Linda Sohn |
| K173628 |
11/24/2017 |
Acclarent ENT Navigation System |
Acclarent, Inc |
James Patrick Garvey |
| K173430 |
11/02/2017 |
SeQure« NF and SeQure« Microcatheters |
Accurate Medical Therapeutics Ltd. |
Eran Miller |
| K170300 |
01/31/2017 |
Restrata Wound Matrix |
Acera Surgical, Inc. |
Tamas Kovacs |
| K170007 |
01/03/2017 |
Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens |
Acuity Polymers, Inc. |
James A. Bonafini |
| K170001 |
01/03/2017 |
Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens |
Acuity Polymers, Inc. |
James A. Bonafini, Jr. |
| K170214 |
01/24/2017 |
Additive Orthopaedics Locking Lattice Plate |
Additive Orthopaedics, LLC |
Greg Kowalczyk |
| K170009 |
01/03/2017 |
Esophageal Cooling Device |
ADVANCED COOLING THERAPY, LLC |
Erik Kulstad |
| K170039 |
01/05/2017 |
STERRAD VELOCITY Biological Indictator and Reader |
Advanced Sterilization Products (ASP) |
Sun Choi |
| K173444 |
11/06/2017 |
Quantitative Total Extensible Imaging (QTxI) |
AIQ Solutions, Inc. |
Dona Alberti |
| K170075 |
01/09/2017 |
AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) |
AirXpanders, Inc. |
Belinda Pinedo |
| K173550 |
11/16/2017 |
Akros FibuLinkÖ Syndesmosis Repair Kit |
Akros Medical |
Charles Horrell |
| K173538 |
11/15/2017 |
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc |
Alcon Laboratories, Inc. |
Katryna Warren |
| K173660 |
11/29/2017 |
LenSx Laser System |
Alcon Laboratories, Inc. |
James Arganda |
| K173502 |
11/13/2017 |
Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit |
Alere Scarborough, Inc. |
Benjamin Crystal |
| K173653 |
11/28/2017 |
Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit |
Alere Scarborough, Inc. |
Danielle A. Briggeman |
| K170178 |
01/19/2017 |
Ultravision Visual Field Clearing System |
Alesi Surgical Ltd. |
DAVID BRODERICK |
| K170241 |
01/26/2017 |
GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System |
All Medicus Co., Ltd. |
Hong-Joo Park |
| K173522 |
11/14/2017 |
Solanas« Posterior Stabilization System |
Alphatec Spine, Inc |
Natalia Shirina |
| K170069 |
01/09/2017 |
AmCAD-UV |
AmCad BioMed Corporation |
Jack Yang |
| K173453 |
11/06/2017 |
Valeo« C+CSC with Lumen Interbody Fusion Device |
Amedica Corp. |
Jason Parberry |
| K170222 |
01/25/2017 |
Rapid Tox Cup II |
AMERICAN BIO MEDICA CORP. |
MELISSA WATERHOUSE |
| K173665 |
11/29/2017 |
AMSafe Sure-Lok Needle-Free Connector |
Amsino International, Inc. |
Cathy Hong |
| K170231 |
01/25/2017 |
iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)á |
Andon health Co., Ltd |
Yi Liu |
| K170258 |
01/27/2017 |
SpeedLyser Infusion Catheter |
AngioDynamics, Inc. |
Teri Juckett |
| K170267 |
01/27/2017 |
BGM009 Plus Blood Glucose Monitoring System |
Apex Bio Technology Corp. |
Hsue-mei Lee |
| K173658 |
11/29/2017 |
Confidence Blood Glucose Monitoring System |
Applied Biomedical LLC |
Zakir Murtaza |
| K170064 |
01/09/2017 |
GLUCOCARD W Blood Glucose Monitoring System |
ARKRAY FACTORY, INC. |
KAZUYA YORIMITSU |
| K173542 |
11/16/2017 |
Arterys Oncology DL |
Arterys Inc. |
John Axerio-Cilies |
| K170206 |
01/24/2017 |
Arthrex FiberTape Cerclage |
ARTHREX, INC. |
IVETTE GALMEZ |
| K173656 |
11/29/2017 |
Arthrex FibuLock Nail |
Arthrex, Inc. |
Rebecca R. Homan |
| K170147 |
01/17/2017 |
Lucica Glycated Albumin-L |
ASAHI KASEI PHARMA CORPORATION |
HIDEJI HIRAOKA |
| K170223 |
01/25/2017 |
Progreat |
ASHITAKA FACTORY OF TERUMO CORPORATION |
LAUREN P. NITAHARA |
| K170049 |
01/05/2017 |
AssureTech Panel Dip Test, AssureTech Quick Cup Test |
ASSURE TECH (HANGZHOU) CO., LTD. |
SHISHENG LING |
| K170304 |
01/31/2017 |
Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers |
Astell Scientific Limited |
Gary Doughty |
| DEN170004 |
01/10/2017 |
Ellipsys Vascular Access System |
Avenu Medical, Inc |
Rebecca K. Pine |
| K173531 |
11/15/2017 |
Lockbox for Perfusor Space PCA Infusion Pump |
B. Braun Medical Inc. |
Tracy Maddock |
| K173480 |
11/13/2017 |
Crystalsert Lens Delivery System |
Bausch & Lomb, Inc |
Gary Rauvola |
| K170052 |
01/05/2017 |
Stellaris Elite vision enhancement system |
Bausch + Lomb |
Dan Regan |
| K170283 |
01/30/2017 |
BD Nexiva Diffusics Closed IV Catheter System |
Becton, Dickinson and Company |
Amy Honey |
| K173523 |
11/14/2017 |
BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL) |
Becton, Dickinson and Company |
Monica E. Giguere |
| K170281 |
01/30/2017 |
MSA100BT Peak Flow Meter |
Beijing M&B Electronic Instruments Co., Ltd. |
Yang Shisheng |
| K170228 |
01/25/2017 |
Belimed Steam Sterilizer MST-H TOP 5000 |
Belimed AG |
Christoph Hermens |
| K173556 |
11/17/2017 |
Injection Screw |
Biedermann Medtech, Inc. |
Michelle Montesino |
| K173643 |
11/27/2017 |
Trilor Disks, Blocks and Arches |
Bioloren S.R.L. |
Ratti Umberto |
| K173623 |
11/24/2017 |
Anchor plate |
BioMaterials Korea, Inc |
Jiyea Kim |
| K170013 |
01/03/2017 |
Eztetic BellaTek Encode Healing Abutments |
BIOMET 3I |
KRUPAL PATEL |
| K173411 |
11/01/2017 |
Comprehensive Segmental Revision System (SRS) |
Biomet Manufacturing Corp. |
Patricia Sandborn Beres |
| K170143 |
01/17/2017 |
GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, |
Bionime Corporation |
Kay Wu |
| K173638 |
11/24/2017 |
Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus |
Bionime Corporation |
Kay Wu |
| K170138 |
01/17/2017 |
NEURONAUTE |
BIOSERENITY |
Quang TRAN |
| K173569 |
11/20/2017 |
Ultrasound System 1300 |
BK Medical ApS |
Karen Provencher |
| K170232 |
01/25/2017 |
AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer |
BODITECH MED INC. |
HYUNG-JU OH |
| K170204 |
01/23/2017 |
FFR Link, FFR Signal Processing Module |
Boston Scientific Corporation |
Dan Krause |
| K170188 |
01/23/2017 |
Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator |
Bovie Medical Corporation |
Rubiela Maldonado |
| K173540 |
11/15/2017 |
Brainsway Deep (DTMS) System |
Brainsway Ltd. |
Ahava Stein |
| K170037 |
01/04/2017 |
Breathe Technologies Life2000Ö Ventilation System |
Breathe Technologies |
Samir Ahmad |
| K170158 |
01/18/2017 |
PowerGlide ST Midline Catheter |
C. R. Bard, Inc. |
JACOB LEE |
| K170278 |
01/30/2017 |
OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners |
C.R. BARD INC. |
KATHERINE EARLE |
| K170058 |
01/06/2017 |
TheraView TBI |
Cablon Medical B.V. |
Jurjen Weistra |
| K173432 |
11/02/2017 |
ENZA-A Titanium ALIF |
Camber Spine Technologies |
Damian Heinz |
| K173487 |
11/13/2017 |
CarboClear« Pedicle Screw System |
CarboFix Orthopedics Ltd. |
Hila Wachsler-Avrahami |
| K173652 |
11/28/2017 |
Piccolo Composite Nailing System |
CarboFix Orthopedics Ltd. |
Yael Rubin |
| K170198 |
01/23/2017 |
Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White) |
Cardinal Health, Inc. |
Megan Middaugh |
| K173547 |
11/16/2017 |
ImagenUniversal |
Cardiovascular Imaging Technologies |
James A. Case |
| K173478 |
11/13/2017 |
OnSight 3D Extremity System |
Carestream Health, Inc. |
Victoria A. Wheeler |
| K173407 |
11/01/2017 |
VT - 100, VT - 200 |
Carilex Medical, Inc. |
Henry Kao |
| K170171 |
01/19/2017 |
IOLMaster 700 |
Carl Zeiss Meditec AG |
Christian Muenster |
| K170102 |
01/11/2017 |
Pekkton Ivory |
CENDRES+METAUX SA |
Uli DIERMANN |
| K170163 |
01/18/2017 |
Erisma« LP Spinal Fixation System |
CLARIANCE SAS |
Pascal ROKEGEM |
| K173501 |
11/13/2017 |
Meridian Vaginal Positioning System (VPS) |
Coloplast |
Diane Brinza |
| K173527 |
11/14/2017 |
Digitex Delivery Device |
Coloplast A/S |
Nikita Basandra |
| K170226 |
01/25/2017 |
iTotal Family Reusable Instrument Tray |
CONFORMIS, INC |
Emmanuel O. Nyakako |
| K173675 |
11/30/2017 |
AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber |
ConvaTec Limited |
Justin Lovelace |
| K170016 |
01/03/2017 |
Biodesign Fistula Plug |
Cook Biotech Incorporated |
Perry W Guinn |
| K170193 |
01/23/2017 |
Advance 14LP Low Profile PTA Balloon Dilatation Catheter |
COOK INCORPORATED |
DANIEL J. CORBIN |
| K173414 |
11/01/2017 |
Advance Biliary Balloon Catheter |
Cook Incorporated |
Colin Jacob |
| K170298 |
01/31/2017 |
Liberator Beacon Tip Locking Stylet |
Cook Incorporated |
Steven Lawrie |
| K170008 |
01/03/2017 |
Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set |
COOK INCORPORATED |
ERUM B. NASIR |
| K170020 |
01/03/2017 |
Peel-Away Introducer Set |
Cook Incorporated |
Colin Jacob |
| K173657 |
11/29/2017 |
Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter |
Cook Incorporated |
Samuel Engelman |
| K170010 |
01/03/2017 |
Salle Intraoperative Pyeloplasty Stent Set |
COOK INCORPORATED |
MINJIN CHOI |
| K173654 |
11/28/2017 |
Ureteral Dilator Sets, Ureteral Dilators |
Cook Incorporated |
Kotei Aoki |
| K170243 |
01/26/2017 |
LOSPA IS TLIF & DLIF Cages |
CORENTEC CO., LTD |
J.S. DANIEL |
| K173678 |
11/30/2017 |
Diode Laser Cap |
Cosmo Far East Technology Limited |
Bob An |
| K173559 |
11/17/2017 |
Barrx SB RFA Endoscopic Catheter |
Covidien llc |
Saket Bhatt |
| K170170 |
01/19/2017 |
Valleylab FT10 Electrosurgical Platform |
Covidien llc |
Sharon McDermott |
| K170166 |
01/19/2017 |
CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture |
CPT Sutures Co., Ltd. |
Khoa Do |
| K170294 |
01/31/2017 |
VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5ö) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4öx 6ö) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6ö) Circle, VENTRALIGHT ST Mesh with ECHO 2 P |
CR BARD |
CHRISTINE LLOYD |
| K170154 |
01/18/2017 |
Creavo Vitalscan Magnetocardiograph |
Creavo Medical Technologies, Ltd. |
David Dimambro |
| K170100 |
01/11/2017 |
CreoDent Solidex Customized Abutment and Screw |
CreoDent Prosthetics, Ltd. |
Calvin Shim |
| K173590 |
11/21/2017 |
System 83 Plus Washer/Disinfector |
Custom Ultrasonics, Inc. |
Mario P. Infanti |
| K170005 |
01/03/2017 |
FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) |
DAKO DENMARK A/S |
LASSE POST MOLLER |
| K170028 |
01/03/2017 |
FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) |
DAKO DENMARK A/S |
Lasse Post Moller |
| K173465 |
11/08/2017 |
Concentrix MX-AC High-Speed Handpiece |
DentalEZ, Inc. |
Dan Laskowitz |
| K170220 |
01/25/2017 |
OneQ-SL s-Clean Implant System |
DENTIS CO., LTD. |
SUN CHU SHIN |
| K173528 |
11/15/2017 |
Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System |
Devon Medical Products (Jiangsu) Ltd. |
Julian Chu |
| K173498 |
11/13/2017 |
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack |
DiaSorin Molecular LLC |
Sharon Young |
| K170104 |
01/12/2017 |
COMPACT S, COMPACT S (LED) |
DMETEC CO., LTD. |
Lee Seung Dae |
| K170122 |
01/13/2017 |
Delta III Lithotripter |
Dornier MedTech America |
John Hoffer |
| K173644 |
11/27/2017 |
Gazelle Polypropylene Suture and Delivery Device |
Dura Tap LLC |
Ann R. Lee |
| K170031 |
01/04/2017 |
Internal Octa Implant System |
EBI Inc. |
Mi Sook Kim |
| K170167 |
01/19/2017 |
True 3D Viewer Software |
EchoPixel Inc. |
Sergio Aguirre |
| K173586 |
11/20/2017 |
VAMP Venous/Arterial Blood Management Protection System |
Edwards Lifesciences, LLC |
Ye Seul Kim |
| K173442 |
11/06/2017 |
gammaCore-S |
electroCore, LLC |
Mike Romaniw |
| K170107 |
01/12/2017 |
Surgi Max Ultra |
elliquence, LLC |
Paul D. Buhrke IV |
| K173587 |
11/20/2017 |
Magseed Magnetic Marker Systtem |
Endomagnetics Ltd. |
Andrew Shawcross |
| K170240 |
01/26/2017 |
Truliant Femoral Components |
Exactech Inc |
Patrick Hughes |
| K173583 |
11/20/2017 |
Exactech« Novation« and AcuMatch« E-HXL Acetabular Liners |
Exactech, Inc. |
Shing Jen Tai |
| K173439 |
11/03/2017 |
Bloom2 Programmable Electrophysiology Stimulator |
Fischer Medical |
Wes Rogers |
| K173505 |
11/13/2017 |
FORA GTel Blood Glucose Monitoring System |
ForaCare Inc. |
Anne Kuo |
| K173608 |
11/21/2017 |
Forest Dental Unit |
Forest Dental Products, Inc. |
Erin-Kate Barton |
| K170040 |
01/05/2017 |
BePOD Cannulated Arthrodesis Screws |
Fournitures Hospitalieres Industrie |
PATRICIA DONNARD |
| K173651 |
11/28/2017 |
Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K173593 |
11/21/2017 |
stayòsafe catheter extension set with Safe-Lock, 12 inch, stayòsafe catheter extension set with Luer-Lock, 6 inch, stayòsafe catheter extension set with Luer-Lock, 12 inch, stayòsafe catheter extension set with Luer-Lock, 18 inch, stayòsafe to Luer-Lock a |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K170084 |
01/10/2017 |
InterLock Trocar |
FUJIFILM New Development U.S.A., Inc. |
Stephen Mariano |
| K170038 |
01/05/2017 |
FuzeFix Screw System |
Fusion Orthopedics, LLC |
Adam Cundiff |
| K170032 |
01/04/2017 |
QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP |
Fysicon BV |
C.W.A (Eric) Van Antwerpen |
| K170181 |
01/19/2017 |
Prizma |
G-Medical Innovations Ltd. |
N. Epstein |
| K173589 |
11/20/2017 |
Prizma |
G-Medical Innovations Ltd. |
N. Epstein |
| K173494 |
11/13/2017 |
OrthoSteady G Bone Cement |
G21 s.r.l. |
Filippo Foroni |
| K173645 |
11/27/2017 |
JASPER Spinal Fixation System |
GBS Commonwealth Co., Ltd. |
Jimmy Kim |
| K173500 |
11/13/2017 |
NMF004A |
GC America Inc. |
Mark Heiss |
| K173555 |
11/17/2017 |
LOGIQ E10 |
GE Healthcare |
Bryan Behn |
| K173576 |
11/20/2017 |
Pristina Serena |
GE Healthcare |
Gregory Pessato |
| K170199 |
01/23/2017 |
Unity Network ID |
GE Healthcare |
Robert Casarsa |
| K173612 |
11/22/2017 |
Optima XR646 HD |
GE Hualun Medical Systems Co., Ltd |
Kenny Ma |
| K170155 |
01/18/2017 |
EK12 Algorithm |
GE Medical Systems Information Technologies, Inc. |
Amy Yang |
| K173456 |
11/07/2017 |
ViewPoint 6 |
GE Medical Systems Ultrasound and Primary |
Tracey Ortiz |
| K173602 |
11/21/2017 |
Optima XR240amx, AutoGrid |
GE Medical Systems, LLC |
Chris Paulik |
| K170276 |
01/30/2017 |
Safety Blood Collection Device for Single Use |
Gemtier Medical (Shanghai) Inc. |
Lenny Cao |
| K170210 |
01/24/2017 |
PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 |
Given Imaging Ltd. |
Hilla Debby |
| K170157 |
01/18/2017 |
INDEPENDENCE« Spacers |
Globus Medical Inc. |
Kelly J. Baker |
| K170284 |
01/30/2017 |
Great Basin Bordetella Direct Test |
GREAT BASIN SCIENTIFIC, INC. |
SUZETTE CHANCE |
| K170229 |
01/25/2017 |
Dental High-speed Turbine Handpiece |
GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD. |
KRISTI YANG |
| K170236 |
01/25/2017 |
Dental Low-speed Turbine Handpiece |
Guangdong JINME Medical Technology Co., Ltd. |
Kristi Yang |
| K170287 |
01/30/2017 |
Dental Implants OKTAGON Bone Level Tapered Design |
Hager& Meisinger GmbH |
Melanie May |
| K170127 |
01/13/2017 |
HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40 |
Hardy Diagnostics |
Rianna Malherbe |
| K170152 |
01/17/2017 |
POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN) |
HARTALEGA SDN BHD |
KUAN KAM HON |
| K173509 |
11/13/2017 |
Biodegradable Nitrile Powder Free Examination Glove (Blue) |
Hartalega Sdn. Bhd. |
Kuan Kam Hon |
| K170180 |
01/19/2017 |
Will3D |
HDX WILL CORP. |
Seung-Il Chun |
| K170085 |
01/10/2017 |
SONON Ultrasound Imaging System, Model: 300L |
HEALCERION CO., LTD |
JAEYEOB JUNG |
| K170090 |
01/10/2017 |
RTHawk, HeartVista Cardiac Package |
HeartVista, Inc. |
James J Rogers |
| K173648 |
11/27/2017 |
Spectralis HRA + OCT and variants |
Heidelberg Engineering GmbH |
Christoph Schoess |
| K173603 |
11/21/2017 |
Monarch Airway Clearance System |
Hill-Rom Holdings, Inc. |
Joseph Braido |
| K173676 |
11/30/2017 |
A-FIT |
HIRONIC Co., Ltd. |
Sangwon Hwang |
| K170077 |
01/09/2017 |
LUOFUCON Silicone Ag Foam Dressing with Border |
HUIZHOU FORYOU MEDICAL DEVICES Co., Ltd. |
Guosheng Tan |
| K170134 |
01/17/2017 |
Reperen Surgical Mesh |
IconLab Inc. |
Pavel Paul Artemow |
| K170110 |
01/12/2017 |
Diana Medication Transfer Set |
ICU MEDICAL INC |
Jason Ma |
| K173477 |
11/13/2017 |
ChemoCLAVE Cytotoxic Medication Preparation and Delivery System |
ICU Medical, Inc. |
Catherine E. Kang |
| K173474 |
11/09/2017 |
RetiCapture |
Ilooda Co., Ltd. |
Yun-Jung Ha |
| K170202 |
01/23/2017 |
Aquarius 8600 |
IMAGING DYNAMICS COMPANY LTD. |
Nicole Wherry |
| K173541 |
11/15/2017 |
EPINAUT |
Imedicom Co., Ltd. |
Priscilla Chung |
| K173663 |
11/29/2017 |
Electronic Stethoscope DS3011A |
IMEDIPLUS INC. |
Shirley Lai |
| K170209 |
01/24/2017 |
ImPACT |
IMPACT APPLICATIONS, INC |
MICHAEL ZAGORSKI |
| K173616 |
11/22/2017 |
DIP Arthrodesis System |
In2Bones SAS |
Morgane Grenier |
| K173491 |
11/13/2017 |
RTS Lesser MTP Implant System |
In2Bones USA, LLC |
Rebecca Wahl |
| K173470 |
11/08/2017 |
ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath |
Inari Medical |
Eben Gordon |
| K173672 |
11/30/2017 |
FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter |
Inari Medical |
Eben Gordon |
| K173571 |
11/20/2017 |
Element System with IBT Electrodes |
Infinite Biomedical Technologies, LLC |
Rahul Kaliki |
| K173677 |
11/30/2017 |
InMode VLaze |
InMode MD Ltd. |
Amit Goren |
| K170211 |
01/24/2017 |
Insight Dental System |
Insight Dental System |
Matthew Kaupp |
| K173410 |
11/01/2017 |
n!ce for Planmill |
Institut Straumann AG |
Shokoufeh Khodabandeh |
| K173594 |
11/21/2017 |
Straumann cerabone |
Institut Straumann AG |
Christelle Gerspach-Gasser |
| K173562 |
11/17/2017 |
Straumann Jason Membrane |
Institut Straumann AG |
Christopher Klaczyk |
| K170101 |
01/11/2017 |
Valiant Curing Light |
Inter-Med / Vista Dental Products |
Alex Johnson |
| K173567 |
11/20/2017 |
Sera |
Interacoustics A/S |
Amy Yanta |
| K173516 |
11/14/2017 |
NuBorne Infant Warmer |
International Biomedical |
Amy Pieper |
| K170029 |
01/04/2017 |
FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile |
INTERNATIONAL BIOPHYSICS CORPORATION |
Geoff Marcek |
| K170112 |
01/12/2017 |
IMD's Lumbar Puncture Needle |
INTERNATIONAL MEDICAL DEVELOPMENT, INC.(IMD) |
WALTER ZOHMANN |
| K173577 |
11/20/2017 |
Guarded Luer Connector |
International Medical Industries Inc. |
Brandon Hunt |
| K170120 |
01/13/2017 |
EndoRotor |
Interscope, Inc |
Jeffrey Ryan |
| K173585 |
11/20/2017 |
da Vinci Xi Surgical System, da Vinci X Surgical System |
Intuitive Surgical, Inc. |
Brandon Hansen |
| K173415 |
11/01/2017 |
EndoWrist 5mm Thoracic Grasper |
Intuitive Surgical, Inc. |
Gayle Perry |
| K170207 |
01/24/2017 |
Obturys |
Itena Clinical |
Charles Peyre |
| K173573 |
11/20/2017 |
Tetric CAD |
Ivoclar Vivadent AG |
Sandra Cakebread |
| K170275 |
01/30/2017 |
Tri Auto ZX2 |
J. MORITA USA, INC. |
KEISUKE MORI |
| K170105 |
01/12/2017 |
Jac-Cell Medic testers |
JAC-CELL MEDIC |
MARK MELTZER |
| K170054 |
01/06/2017 |
iSurg |
JACO, LLC dba Macan Manufacturing and BNA Burz North America |
John Marsillo |
| K170080 |
01/10/2017 |
Neodent Implant System - CM Pro PEEK Abutment |
JJGC Industria e Comercio de Materiais Dentarios SA |
Julianne Lechechem |
| K173565 |
11/17/2017 |
Sunrise 6200, Sunrise 7200 |
JK-Holding GmbH |
Juergen Gerstenmeier |
| K173553 |
11/16/2017 |
LUCAS 3 Chest Compression System |
Jolife AB |
Malin Melander |
| K173434 |
11/02/2017 |
2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300 |
JVC KENWOOD Corporation |
Masafumi Yugami |
| K170262 |
01/27/2017 |
Digital Thermometer |
K-Jump Health Co., Ltd. |
JM Lin |
| K170055 |
01/06/2017 |
CAPRI Corpectomy Cage System |
K2M |
Nancy Giezen |
| K173508 |
11/13/2017 |
Everest Spinal System |
K2M |
Nancy Giezen |
| K170247 |
01/27/2017 |
Lacriflow CL |
KANEKA PHARMA AMERICA LLC |
Masaaki Fukunishi |
| K173426 |
11/02/2017 |
PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System |
KCI USA, INC. |
Margaret Marsh |
| K173447 |
11/06/2017 |
V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit |
KCI USA, Inc. |
Melanie Avila |
| K173572 |
11/20/2017 |
DSM Biomedical Calcium Phosphate Cement with Microspheres |
Kensey Nash Corporation dba DSM Biomedical |
Susan Pileggi |
| K170245 |
01/26/2017 |
DSM Biomedical Dental Bone Graft |
Kensey Nash Corporation dba DSM Biomedical |
Susan Pileggi |
| K173669 |
11/30/2017 |
K-D Balance |
King-Devick Technologies, Inc. |
Lori Grover |
| K170124 |
01/13/2017 |
Level One Hand Plating System |
KLS MARTIN LP |
Jennifer Damato |
| K170203 |
01/23/2017 |
System, Applicator, Radionuclide, Remote Controlled |
Kobold, LLC |
Deanna Hughes |
| K170286 |
01/30/2017 |
Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan (hioxifilcon A) Daily Wear Soft (Hydrophilic) Contact Lens for PRESBYOPIA |
Largan Medical Co. Ltd. |
Amy Tien |
| K170239 |
01/26/2017 |
Leica FL560 |
LEICA MICROSYSTEMS (SCHWEIZ) AG |
GRAINNE GRIFFIN |
| K173443 |
11/06/2017 |
AEON Endoscopic Stapler |
Lexington Medical Inc. |
Donna Gasper |
| K170299 |
01/31/2017 |
Ion PGM Dx System |
LIFE TECHNOLOGIES CORPORATION |
EMILY FINNEGAN |
| K170073 |
01/09/2017 |
LightMed Dental Laser System |
LIGHTMED DENTALTECHNOLOGY CORP. |
APRIL CHENG |
| K170046 |
01/05/2017 |
Lilium a-200E |
Lilium Otsuka Co., Ltd. |
Hiroaki Takahashi |
| K173484 |
11/13/2017 |
CorticaLINK Spinal Fusion Platform |
LinkSPINE Inc |
Nickolas Kriska |
| K170270 |
01/27/2017 |
Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline |
LS Scientific Inc. D.B.A. KSE Scientific |
Jordan Reynolds |
| K173436 |
11/03/2017 |
Luma Light System |
Luma Therapeutics |
Tiffini Wittwer |
| K170179 |
01/19/2017 |
LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity |
Lumenis Ltd. |
Amaya De Levie |
| K170121 |
01/13/2017 |
Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories |
Lumenis Ltd. |
Yehudit Kraizer |
| K170060 |
01/06/2017 |
M22 and ResurFx Systems |
LUMENIS, LTD. |
Naama Jacoby |
| K170175 |
01/19/2017 |
ENDOSEAL MTA |
MARUCHI |
Jang Sung Wook |
| K170168 |
01/19/2017 |
Masimo Rad-97 and Accessories |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K173445 |
11/06/2017 |
Materialise TKA Guide System |
Materialise NV |
Oliver Clemens |
| K173619 |
11/22/2017 |
Mimics inPrint |
Materialise NV |
Oliver Clemens |
| K170272 |
01/30/2017 |
TruMatch CMF Titanium 3D Printed Implant System |
Materialise NV |
Lina Ramirez |
| K173510 |
11/13/2017 |
BioStamp nPoint |
MC10 Inc. |
Rakesh Lal |
| K170149 |
01/17/2017 |
3DMetal Tibial Cones |
Medacta International SA |
Stefano Baj |
| K170106 |
01/12/2017 |
MyKnee PPS-Pin Positioners |
Medacta International SA |
Stefano Baj |
| K173472 |
11/09/2017 |
MySpine Pedicle Screw Placement Guides û MC and Drill Pilot Instruments |
Medacta International SA |
Stefano Baj |
| K170088 |
01/10/2017 |
Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film |
MEDELA, AG |
Markus Butler |
| K170103 |
01/12/2017 |
Laparoscope Lens Shield Device (LENS) |
Medeon Biodesign, Inc |
Greta Chang |
| K173605 |
11/21/2017 |
iQMR |
Medic Vision - Imaging Solutions Ltd |
Eyal Aharon |
| K173667 |
11/30/2017 |
15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodia |
Medical Components, Inc. (Dba Medcomp) |
Courtney Nix |
| K170172 |
01/19/2017 |
UNiD Spine Analyzer |
MEDICREA INTERNATIONAL |
David Ryan |
| K173506 |
11/13/2017 |
LigaPASS |
Medicrea International S.A. |
David Ryan |
| K170095 |
01/11/2017 |
Vial2Bag Direct Connect |
Medimop Medical Project Ltd. |
Ilanit Goldgraber |
| K173581 |
11/20/2017 |
Gallant PTCA Dilatation Catheter |
Medinol, Ltd. |
Marina Tikhonov Demishtein |
| K170078 |
01/09/2017 |
Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley |
MEDISONO, LLC |
JORGE MILLAN |
| K170002 |
01/03/2017 |
Medline Blood Collection Set |
Medline Industries, Inc. |
Matt Clausen |
| K173537 |
11/15/2017 |
CONCORDE LIFTÖ |
Medos International, SARL |
Karen Sylvia |
| K173526 |
11/14/2017 |
SENTIO MMG Gen 2 |
Medos International, SARL |
Karen Sylvia |
| K170296 |
01/31/2017 |
CoreCath 2.7S |
Medtronic Advanced Energy |
Lydia Sakakeeny |
| K173664 |
11/29/2017 |
Medtronic O-arm O2 Imaging System |
Medtronic Inc. |
Dean Honkonen |
| K170011 |
01/03/2017 |
StealthStation S8 Spine Software v1.0.0 |
MEDTRONIC NAVIGATION |
JOHN CONNOR |
| K170018 |
01/03/2017 |
StealthStationTM S8 ENT Software |
Medtronic Navigation, Inc. |
K. Elizabeth Waite |
| K173515 |
11/14/2017 |
Admiral Xtreme |
Medtronic Vascular |
Maddalena Pinsi |
| K170191 |
01/23/2017 |
SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System |
MEDTRONIC VASCULAR, INC. |
AARON HAGE |
| K173460 |
11/07/2017 |
NeuroEEG |
MemoryMD Inc. |
Abdus-Salaam Muwwakkil |
| K173475 |
11/09/2017 |
Merge PACS |
Merge Healthcare Incorporated |
Carol Nakagawa |
| K173621 |
11/22/2017 |
Advocate PTA Catheter |
Merit Medical Systems Inc. |
Mark Mullaney |
| K173548 |
11/16/2017 |
Merit Pursue Microcatheter |
Merit Medical Systems, Inc. |
Niloufar Samimi |
| K173601 |
11/21/2017 |
Merit Syringe |
Merit Medical Systems, Inc. |
Cory Marsh |
| K170108 |
01/12/2017 |
Xultan 5.5 Pedicle Screw System |
Met One Technologies |
Dan Gerbec |
| K170050 |
01/05/2017 |
Z-CAD smile |
Metoxit AG |
Dipl.-Ing Stefan Leyen |
| K170219 |
01/25/2017 |
Microlife Digital Infrared Ear Thermometer |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
GERHARD FRICK |
| K170288 |
01/30/2017 |
BIOFOAM« Additive Manufacturing (BIOFOAM« AM), ADVANCE« BIOFOAM« Tibial Base, EVOLUTION« BIOFOAM« Tibial Base, DYNASTY« BIOFOAM« Acetabular Shell |
MicroPort Orthopedics, Inc. |
Grace Johnson-Bann |
| K173420 |
11/01/2017 |
Radiomics App v1.0 |
Microsoft Corp. |
Ivan Tarapov |
| K170165 |
01/19/2017 |
Osteo-P Bone Graft Substitute |
Molecular Matrix, Inc. |
Charles Lee |
| K173492 |
11/13/2017 |
MRDx BCR-ABL Test, MRDx BCR-ABL Test Software |
MolecularMD Corporation |
Kevin Hawkins |
| K173512 |
11/13/2017 |
MFI-Cardiac |
MultiFunctional Imaging, LLC |
Dan Kadrmas |
| K170132 |
01/17/2017 |
MyoCycle Home, MyoCycle Pro |
MYOLYN, LLC |
Matthew Bellman |
| K173423 |
11/01/2017 |
MR Wire Guide Wire Straight, MR Wire Guide Wire Angled |
Nano4Imaging GmbH |
Christoph R. Manegold |
| K173544 |
11/16/2017 |
Phoenix Wound Matrix |
Nanofiber Solutions, Inc. |
Ronald L. Bracken |
| K170285 |
01/30/2017 |
AED Sinuscope |
National Advanced Endoscopy Devices, Inc. |
Gayle Butler |
| K173486 |
11/13/2017 |
NTU-USB Ultrasound USB Box |
National Taiwan University |
Pai-Chi Li |
| K173580 |
11/20/2017 |
Vinyl Patient Examination Glove (Yellow) |
Nature Medical Products Co.,Ltd. |
Chao Kevin |
| K173450 |
11/06/2017 |
PRESS DUO elite, PRESS DUO elite AG |
Nemoto Kyorindo Co., Ltd. |
Jim Knipfer |
| K173409 |
11/01/2017 |
Wireless Audio System |
NeoCoil, LLC |
Michael Leigh |
| K173452 |
11/06/2017 |
EmboTrap ll Revascularization Device |
Neuravi Ltd. |
Mairsil Claffey |
| K170238 |
01/26/2017 |
BodyTom Elite |
NeuroLogica Corporation, a Subsidiary of Samsung Electronics |
Ninad Gujar |
| K170161 |
01/18/2017 |
New Deantronics E GreenÖ Electrosurgical Monopolar Pencils |
New Deantronics Taiwan, LTD |
Jane Liu |
| K173641 |
11/24/2017 |
Activ Ankle |
Newclip Technics |
Gaelle Lussori |
| K170012 |
01/03/2017 |
Foot and Hand Motion |
NEWCLIP TECHNICS |
Celine CHEVRIER |
| K170297 |
01/31/2017 |
Tranquil Interbody System |
Nexus Spine, LLC |
Jared Crocker |
| K170302 |
01/31/2017 |
YELLOW LASER PHOTOCOAGULATOR YLC-500 |
NIDEK CO., LTD. |
Yoneji Mizuno |
| K173418 |
11/01/2017 |
NobelParallel Conical Connection |
Nobel Biocare AB |
Charlemagne Chua |
| K170135 |
01/17/2017 |
TREFOIL System |
Nobel Biocare AB |
Charlemagne Chua |
| K170030 |
01/04/2017 |
NOVATECH TALCAIR |
NOVATECH S.A. |
JENNIFER NEFF |
| K173479 |
11/13/2017 |
NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) |
Novo Nordisk Inc. |
Devraj Chakravarty |
| K173631 |
11/24/2017 |
Intelli-C |
NRT X-ray A/S |
Jan Malling |
| K170169 |
01/19/2017 |
PRECICE Intramedullary Limb Lengthening System |
NuVasive Specialized Orthopedics, Inc. |
Cora Sim |
| K170271 |
01/27/2017 |
NuVasive(r) Monolith Corpectomy System |
NuVasive, Incorporated |
Cynthia Adams |
| K170126 |
01/13/2017 |
NuVasive« Reline« 4.5-5.0 System |
NUVASIVE, INCORPORATED |
Olga Lewis |
| K170074 |
01/09/2017 |
nvc |
Nvision Biomedical Technologies, LLC |
Diana L Langham |
| K173459 |
11/07/2017 |
Olympus Small Intestinal Capsule Endoscope System |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K173495 |
11/13/2017 |
Single Use Hot Biopsy Forceps FD-231 |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K170260 |
01/27/2017 |
BC-001+ Acne Purifier |
Oriental Inspiration Limited |
Andy Wu |
| K170269 |
01/27/2017 |
Hee HR Mini |
Oriental Inspiration Limited |
Andy Wu |
| K173624 |
11/24/2017 |
ORIGIO« HandlingÖ without phenol red (Cat. No. 8310), ORIGIO« HandlingÖ with phenol red (Cat. No. 8311) |
Origio a/s |
Tove Kjaer |
| K173440 |
11/06/2017 |
Carriere SLX 3D Clear |
Ortho Organizers, Inc. |
Colleen Boswell |
| K170093 |
01/11/2017 |
AcceleDent Optima |
OrthoAccel Technology Inc. |
Jouana Harris-Livings |
| K170146 |
01/17/2017 |
Galaxy UNYCO System |
Orthofix Srl |
Gianluca Ricadona |
| K173458 |
11/07/2017 |
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System |
Orthofix Srl |
Gianluca Ricadona |
| K173525 |
11/14/2017 |
NovoGro |
OsteoNovus, Inc. |
Brian M. Schlossberg |
| K173575 |
11/20/2017 |
OsteoReady Dental Implant System |
OsteoReady LLC |
Robert Gottlander |
| K170305 |
01/31/2017 |
Spinal Manometer NRFit; Spinal Manometer LUER |
PAJUNK GmbH Medizintechnologie |
Christian G.H. Quass |
| K173646 |
11/27/2017 |
FS Ergo |
PaloDEx Group Oy |
Anni Lundholm |
| K173466 |
11/08/2017 |
Panthera Dental Milled Bars |
Panthera Dental Inc. |
Martine Fortin |
| K173615 |
11/22/2017 |
Stryker Universal Select Sterilization Tray System |
Paragon Medical |
Rebecca Walker |
| K173530 |
11/15/2017 |
Indego(R) |
Parker-Hannifin Corporation |
Achilleas Dorotheou |
| K170215 |
01/24/2017 |
LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock |
Patient Pocket LLC |
Allen D. Seftel |
| K173554 |
11/17/2017 |
PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope |
PENTAX of America, Inc. |
James W. Monroe |
| K173614 |
11/22/2017 |
Penumbra Coil 400, Ruby Coil System, POD System |
Penumbra, Inc. |
Aditi Kolla |
| K173507 |
11/13/2017 |
Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 |
Philips Healthcare (Suzhou) Co., Ltd. |
Gordon Shu |
| K170144 |
01/17/2017 |
StentBoost Live |
Philips Medical Stystems Nederland BV |
Elaine Alan |
| K170086 |
01/10/2017 |
Pinnacle Radiation Therapy Planning System |
Philips Medical Systems (Cleveland), Inc. |
Michelle Godin |
| K170113 |
01/12/2017 |
pixium 4343RCE |
Philips Medical Systems DMC GmbH |
Ming Xiao |
| K173433 |
11/02/2017 |
ProxiDiagnost N90 |
Philips Medical Systems DMC GmbH |
Ming Xiao |
| K173467 |
11/08/2017 |
Advanced Diffusion Analysis (ADA) application |
Philips Medical Systems Nederland B.V. |
Yoram Levy |
| K173451 |
11/06/2017 |
Ingenia Elition S and Ingenia Elition X |
Philips Medical Systems Nederland B.V. |
Jan van de Kerkhof |
| K170130 |
01/13/2017 |
Dynamic Coronary Roadmap |
Philips Medical Systems Nederland BV |
Elaine Alan |
| K173588 |
11/20/2017 |
Illumeo System |
Philips Medical Systems Technologies, Ltd. |
Yoram Levy |
| K170133 |
01/17/2017 |
FFR V2.5 |
Philips Volcano |
Elaine Alan |
| K173533 |
11/15/2017 |
Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter |
Poiesis Medical, LLC |
Greg Wiita |
| K173503 |
11/13/2017 |
Pollogen Legend System |
Pollogen Ltd. |
Einat Shammai |
| K170213 |
01/24/2017 |
SupraSDRM Biodegradable Matrix Wound Dressing |
PolyMedics Innovations GmbH |
Kenneth K. Kleinhenz |
| K170061 |
01/06/2017 |
ProMISÖ Fixation System |
Premia Spine Ltd. |
Kobi Arbus |
| K170261 |
01/27/2017 |
Premium Plus Prophy Air Motor |
PREMIUM PLUS INTERNATIONAL LIMITED |
JESSICA MAO |
| K170044 |
01/05/2017 |
Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System |
PRISMATIK DENTALCRAFT, INC. |
MARIA E. WAGNER |
| K170306 |
01/31/2017 |
FIBERGRAFT BG Putty Bone Graft Substitute |
Prosidyan, Inc |
Charanpreet S. Bagga |
| K170111 |
01/12/2017 |
Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 |
Pulsaderm LLC |
Gloria Avendano |
| K173469 |
11/08/2017 |
16ch T/R Hand Wrist Coil |
Quality Electrodynamics, LLC |
Eric Yeh |
| K173446 |
11/06/2017 |
Contour 24 |
Quality Electrodynamics, LLC |
Eric Yeh |
| K170067 |
01/09/2017 |
Easyret |
Quantel Medical |
Bruno Pages |
| K170195 |
01/23/2017 |
QuantX |
Quantitative Insights, Inc. |
Robert Tomek |
| K173496 |
11/13/2017 |
Sofia 2 Lyme FIA, Sofia Lyme Control Set |
Quidel Corporation |
Jennifer S. Rial |
| K173504 |
11/13/2017 |
K-Y Silicone |
Reckitt Benckiser LLC |
Elizabeth Viguerie |
| K173662 |
11/29/2017 |
speX Support Catheter |
ReFlow Medical, Inc. |
Rebecca K Pine |
| K173661 |
11/29/2017 |
Wingman 35 Crossing Catheter |
ReFlow Medical, Inc. |
Rebecca K Pine |
| K170150 |
01/17/2017 |
Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags |
S.A.L.F. spa |
Carmelo Gagliano |
| K173513 |
11/13/2017 |
WS80A Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Ji Yea Lee |
| K170182 |
01/23/2017 |
CARDIOVIT FT-1 |
SCHILLER AG |
ZHENRONG YU |
| K173521 |
11/14/2017 |
SeaSpine Cabo ACP (Anterior Cervical Plate) System |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K173606 |
11/21/2017 |
SeaSpine Vu aòPOD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu aòPOD Prime Intervertebral Body Fusion Device |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K173425 |
11/02/2017 |
SRT-100+ |
Sensus Healthcare, Inc. |
Nicolas Soro |
| K170136 |
01/17/2017 |
Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs |
SHANDONG FEIYANG PROFESSIONAL GLOVES CO., LTD |
KEN LU |
| K170025 |
01/03/2017 |
Angiography Syringe |
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. |
Xu Jianhai |
| K170014 |
01/03/2017 |
High Pressure Tubing |
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. |
Xu Jianhai |
| K170027 |
01/03/2017 |
Inflation Device |
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. |
Xu Jianhai |
| K170024 |
01/03/2017 |
Y-Connector Kit |
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. |
Xu Jianhai |
| K170290 |
01/30/2017 |
Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr |
Shen Wei USA Inc. |
Cheryl Reep |
| K173454 |
11/06/2017 |
Multi-parameter Patient Monitor, models C30 |
Shenzhen Comen Medical Instruments Co.,Ltd. |
Hongbo Yan |
| K170047 |
01/05/2017 |
All-in-One Health Monitor, PC-303 |
Shenzhen Creative Industry Co., Ltd. |
Jia Wang |
| K173462 |
11/08/2017 |
Wireless Pain Relieve Device Model: LT5018C |
Shenzhen Dongdixin Technology Co.,Ltd. |
Siping Yuan |
| K170145 |
01/17/2017 |
Digital TENS Unit |
SHENZHEN EAPPLY TECHNOLOGY CO., LTD |
LISA HUANG |
| K170205 |
01/23/2017 |
Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 |
Shenzhen Kentro Medical Electronics Co., Ltd |
Zewu Zhang |
| K170277 |
01/30/2017 |
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
YANG ZHAOHUI |
| K173471 |
11/08/2017 |
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic |
Shenzhen Mindray Bio-medical Electronics Co., LTD |
Yang Zhaohui |
| K170151 |
01/17/2017 |
Electronic Blood Pressure Monitor |
Shenzhen Pango Electronic Co., Ltd. |
Xiaoyun Yang |
| K173517 |
11/14/2017 |
RADspeed fit |
SHIMADZU corporation |
Toshio Kadowaki |
| K170293 |
01/31/2017 |
Emit II Plus Cocaine Metabolite Assay |
SIEMENS HEALTHCARE DIAGNOSTICS INC. |
ALAN HALEY |
| K170065 |
01/09/2017 |
ADVIA« Chemistry Total Bilirubin_2 (TBIL_2) |
Siemens Healthcare Diagnostics, Inc. |
Julie Warren |
| K170221 |
01/25/2017 |
syngo.CT Cardiac Planning |
Siemens Healthcare GmbH |
Martin Knoppik |
| K170263 |
01/27/2017 |
AcuNav Diagnostic Ultrasound Catheter 8F,10F |
Siemens Medical Solutions USA, Inc. |
Shelly Pearce |
| K173618 |
11/22/2017 |
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter |
Siemens Medical Solutions USA, Inc. |
HyunJung Lee |
| K173578 |
11/20/2017 |
Biograph mCT Family of PET/CT Systems |
Siemens Medical Solutions USA, Inc. |
Tabitha Estes |
| K173592 |
11/21/2017 |
MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit |
Siemens Medical Solutions USA, Inc. |
Cordell L. Fields |
| K173600 |
11/21/2017 |
MAGNETOM Amira |
Siemens Medical Solutions USA, Inc. |
Martin Rajchel |
| K173617 |
11/22/2017 |
MAGNETOM Vida with Compressed Sensing GRASP-VIBE |
Siemens Medical Solutions USA, Inc. |
Cordell L. Fields |
| K173597 |
11/21/2017 |
Scenium VE20 Software |
Siemens Medical Solutions USA, Inc. |
Veronica Padharia |
| K173607 |
11/21/2017 |
SOMATOM Edge Plus |
Siemens Medical Solutions USA, Inc. |
Alaine Medio |
| K173630 |
11/24/2017 |
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence |
Siemens Medical Solutions USA, Inc. |
Kimberly Mangum |
| K173632 |
11/24/2017 |
SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO |
Siemens Medical Solutions USA, Inc. |
Kimberly Mangum |
| K173625 |
11/24/2017 |
syngo.CT Clinical Extensions |
Siemens Medical Solutions USA, Inc. |
Kimberly Mangum |
| K173637 |
11/24/2017 |
syngo.CT Coronary Analysis; syngo.CT Vascular Analysis |
Siemens Medical Solutions USA, Inc. |
Kimberly Mangum |
| K173635 |
11/24/2017 |
syngo.via RT Image Suite |
Siemens Medical Solutions USA, Inc. |
Kimberly Mangum |
| K173639 |
11/24/2017 |
Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax |
Siemens Medical Solutions, Inc |
Denise Adams |
| K173408 |
11/01/2017 |
Mammomat Revelation |
Siemens Medical Solutions, Inc. |
Denise Adams |
| K173611 |
11/22/2017 |
syngo Application Software |
Siemens Medical Solutions, USA Inc. |
Patricia D. Jones |
| K170264 |
01/27/2017 |
Gold AQ Blood Glucose Monitoring System |
Sinocare Meditech, Inc. |
Qian Zhou |
| K170071 |
01/09/2017 |
SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer |
Sleep Group Solutions |
Rani Ben-David |
| K173461 |
11/07/2017 |
ECG recorder and Arrhythmia Detector |
Smart Solutions Technologies SL |
Daniel Llorca |
| K170250 |
01/27/2017 |
SmartTarget |
SmartTarget, Ltd. |
Dean Barratt |
| K170282 |
01/30/2017 |
Smith & Nephew VISIONAIRE Adaptive Guides |
Smith & Nephew, Inc |
Brad Sheals |
| K170280 |
01/30/2017 |
Smith & Nephew SURESHOT Distal Targeting System V4.0 |
Smith & Nephew, Inc. |
Allison Chan |
| K170021 |
01/03/2017 |
SMV Scientific Cannulated Screws |
SMV Scientific |
Nephi Zufelt |
| K170022 |
01/03/2017 |
Klockner Vega TiBase for CEREC |
SOADCO S.L. |
MARIA MITJANETA |
| K173642 |
11/24/2017 |
KLOCKNER SURGICAL BOX |
Soadco, S.L. |
Maria Mitjaneta |
| K170303 |
01/31/2017 |
E5 Series Digital Color Doppler Ultrasound System |
SONOSCAPE MEDICAL CORP. |
Toki Wu |
| K170291 |
01/31/2017 |
IontoDC |
SOTERIX MEDICAL,INC. |
ABHISHEK DATTA |
| K170059 |
01/06/2017 |
Spectranetics Turbo-Elite Laser Atherectomy Catheters |
Spectranetics, Inc. |
Rebecca Spelich |
| K173591 |
11/21/2017 |
Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas |
Spectrum Medical Ltd |
Mark Drain |
| K173518 |
11/14/2017 |
Spectrum Spine Expandable Cages (SSEC) |
Spectrum Spine, LLC |
James Robinson |
| K170235 |
01/25/2017 |
Lucent« |
Spinal Elements Inc. |
Julie Lamothe |
| K170045 |
01/05/2017 |
SwedgeÖ Pedicle Screw Fixation System |
Spinal Resources, Inc. |
Bernard Bedor |
| K170268 |
01/27/2017 |
FortressÖ Pedicular Fixation System |
Spineology Inc. |
Jacqueline Hauge |
| K170266 |
01/27/2017 |
PalisadeÖ Pedicular Fixation System |
Spineology Inc. |
Jacqueline Hauge |
| K170251 |
01/27/2017 |
ThresholdÖ Pedicular Fixation System |
SPINEOLOGY INC. |
JACQUELINE HAUGE |
| K170255 |
01/27/2017 |
ThresholdÖ V2 Pedicular Fixation System |
SPINEOLOGY INC. |
JACQUELINE HAUGE |
| K173574 |
11/20/2017 |
DenSeeMammo |
Statlife |
Stephane Ragusa |
| K173493 |
11/13/2017 |
Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 |
STERIS Corporation |
Anthony Piotrkowski |
| K173481 |
11/13/2017 |
Amsco Evolution Medium Steam Sterilizer |
STERIS Corporation |
Anthony Piotrkowski |
| K173485 |
11/13/2017 |
Amsco Evolution Medium Steam Sterilizer |
STERIS Corporation |
Anthony Piotrkowski |
| K173490 |
11/13/2017 |
Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) |
STERIS Corporation |
Anthony Piotrkowski |
| K173488 |
11/13/2017 |
CELERITY 20 HP Challenge Pack |
STERIS Corporation |
Anthony Piotrkowski |
| K173634 |
11/24/2017 |
CELERITY 20 Steam Biological Indicator |
STERIS Corporation |
Anthony Piotrkowski |
| K173670 |
11/30/2017 |
CELERITY 20 Steam Incubator |
STERIS Corporation |
Anthony Piotrkowski |
| K173626 |
11/24/2017 |
Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles |
STERIS Corporation |
Anthony Piotrkowski |
| K173629 |
11/24/2017 |
CELERITY 20 Steam Process Challenge Device for Gravity Cycles |
STERIS Corporation |
Anthony Piotrkowski |
| K173633 |
11/24/2017 |
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 Corporation |
Jennifer Nalepka |
| K170070 |
01/09/2017 |
VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles |
STERIS Corporation |
Anthony Piotrkowski |
| K173428 |
11/02/2017 |
VERIFY Chemical Indicator for S40 Sterilant |
STERIS Corporation |
Marcia L. Benedict |
| K173448 |
11/06/2017 |
CliniCloud Stethoscope |
StethoCloud Pty.Ltd (CliniCloud) |
Andrew Lin |
| K170141 |
01/17/2017 |
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit |
Stimwave Technologies Incorporated |
Elizabeth Greene |
| K170091 |
01/10/2017 |
UA-Cellular Complete |
Streck |
Deborah Kipp |
| K170098 |
01/11/2017 |
ICONIX TT All Suture Anchor |
Stryker |
Taylor White |
| K173476 |
11/09/2017 |
Tritanium« TL Curved Posterior Lumbar Cage |
Stryker |
Nikin Desai |
| K170242 |
01/26/2017 |
MultiGenÖ 2 RF Generator System |
STRYKER CORPORATION |
BECKY DITTY |
| K173499 |
11/13/2017 |
Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads |
Stryker Orthopaedics |
Kirsten Lehmuller |
| K173627 |
11/24/2017 |
Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector |
Surgical Instrument Service and Savings Inc |
Stephanie Boyle Mays |
| K173570 |
11/20/2017 |
SD Abutment |
Surgident Co., Ltd. |
Ju Youn Choi |
| K173455 |
11/07/2017 |
SurgTech Bipolar Head System |
SurgTech, Inc., |
Xuegong Yu |
| K173560 |
11/17/2017 |
Microcatheter |
Surmodics, Inc. |
Sherri Mellingen |
| K173424 |
11/01/2017 |
BioSphere Flex |
Synergy Biomedical |
Mark Borden |
| K173558 |
11/17/2017 |
SyMRI |
SyntheticMR AB |
Maria Almesaker |
| K173536 |
11/15/2017 |
T2Candida 1.1 Panel |
T2 Biosystems, Inc. |
Anne Marie Whalen |
| K170216 |
01/24/2017 |
Flexitouch System |
Tactile Systems Technology, Inc (dba Tactile Medical) |
Thomas A. Dold |
| K173511 |
11/13/2017 |
ActiveCare TD-4121 Blood Glucose Monitoring System |
TaiDoc Technology Corporation |
Sheena Song |
| K170131 |
01/17/2017 |
TAV Medical Dental Implants System |
Tav Medical Ltd. |
Revital Shabtai |
| K170118 |
01/13/2017 |
Scanostics UTI Check Application Test System |
Teco Diagnostics |
Ling Koh |
| K170200 |
01/23/2017 |
Carbon Dioxide Reagent Set |
Teco Diagnostics, Inc. |
Hyun Bin Song |
| K173441 |
11/06/2017 |
Neurosoft TMS (also CloudTMS) |
TeleEMG, LLC |
Joe F. Jabre |
| K173596 |
11/21/2017 |
Rusch Intermittent Urethral Catheters |
Teleflex Medical |
Amanda Webb |
| K173545 |
11/16/2017 |
TEMED Gas Diffuser |
TEMED |
Katie Evans |
| K170053 |
01/05/2017 |
Meridian PM |
The Center for Craniofacial & Dental Sleep Medicine |
Samuel Cress |
| K170082 |
01/10/2017 |
Test of Variables of Attention (T.O.V.A.) Version 9.0 |
THE TOVA COMPANY |
CHRIS HOLDER |
| K170116 |
01/13/2017 |
Thermi Injectable RF Electrodes |
Thermi |
Suzanne Cheang |
| K173582 |
11/20/2017 |
ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes |
ThermiGen, L.L.C |
Suzanne Cheang |
| K170185 |
01/23/2017 |
tremoFlo C-100 Airwave Oscillometry System |
THORASYS Thoracic Medical Systems, Inc. |
Sebastien Jutras |
| K170056 |
01/06/2017 |
IRENE Cannulated Screw System |
TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD |
WANG QI |
| K173535 |
11/15/2017 |
Endoskeleton« TAS Interbody Fusion Device, Endoskeleton« TAS Hyperlordotic Interbody Fusion Device and Endoskeleton« TCS Interbody Fusion Device |
Titan Spine, LLC |
Jane Rodd |
| K173620 |
11/22/2017 |
Mag Vita TMS Therapy System w/Theta Burst Stimulation |
Tonica Elektronik A/S |
Sanne Barsballe Jessen |
| K170114 |
01/12/2017 |
MagVita TMS Therapy - w/MagPro R20 |
TONICA ELEKTRONIK A/S |
LISE TERKELSEN |
| K170164 |
01/18/2017 |
3D OCT-1 Maestro |
Topcon Corporation |
James Lorkowski |
| K170019 |
01/03/2017 |
Aquilion Lightning, TSX-036A/1, V8.4 |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K170177 |
01/19/2017 |
Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K173468 |
11/08/2017 |
Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K173622 |
11/24/2017 |
CS Imaging |
Trophy |
Marie-Pierre Labat-camy |
| K170259 |
01/27/2017 |
TruAbutment DS |
TRUABUTMENT |
BRANDON KIM |
| K170079 |
01/10/2017 |
Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System |
TYSON BIORESEARCH, INC. |
WEN-HAI TSAI |
| K173563 |
11/17/2017 |
ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE |
TZ Medical Inc |
John Lubisich |
| K173524 |
11/14/2017 |
ANAX 5.5Ö Spinal System |
U&I Corporation |
Jee Ae Bang |
| K170279 |
01/30/2017 |
Disposable High Pressure Syringe |
Union Medical Shenzhen Co., Ltd. |
Wenguo Zhang |
| K170089 |
01/10/2017 |
U-Motion II Acetabular Systemù Additional sizes |
United Orthopedic Corporation |
Gimpel Chien |
| K173650 |
11/28/2017 |
AquaShield System CO2- Fujifilm |
United States Endoscopy Group, Inc. |
Carroll Martin |
| K170187 |
01/23/2017 |
Photodynamic Therapy Device |
UVBIOTEK, LLC |
Dave Oberhelman |
| K173549 |
11/16/2017 |
BIAFINE |
Valeant Pharmaceuticals |
Melissa Thomas |
| DEN170001 |
01/03/2017 |
Precision Flow« HVNI |
VAPOTHERM, INC. |
SOM KOVVURI |
| K173636 |
11/24/2017 |
Velocity |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K173532 |
11/15/2017 |
Raider Guidewire |
Vascular Solutions, Inc. |
Beka Vite |
| K170066 |
01/09/2017 |
Green16/Green18 (Model: PHT-65LHS) |
VATECH CO., LTD. |
Daniel Kim |
| K170023 |
01/03/2017 |
SPiN Thoracic Navigation System |
Veran Medical Technologies, Inc. |
Scott Wrightstone |
| K170162 |
01/18/2017 |
Vesco Medical Nasoenteric Feeding Tubes |
Vesco Medical, LLC |
Chris O'Keefe |
| K170218 |
01/25/2017 |
Vesco Medical NRFit Tip Syringes |
Vesco Medical, LLC |
Chris O'Keefe |
| K170094 |
01/11/2017 |
POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED |
Viet Glove Corporation |
Pham Ngoc Thanh |
| K170026 |
01/03/2017 |
Radiopaque Tissue Marker |
Viscus Biologics, LLC |
Leslie Rebecca Clark |
| K173489 |
11/13/2017 |
GYN-Pump PH304 |
W.O.M. World of Medicine GmbH |
Soeren Markworth |
| K173568 |
11/20/2017 |
NeoBase 2 Non-derivatized MSMS Kit |
Wallac Oy, Subsidiary of PerkinElmer, Inc. |
Brian Carney |
| K170068 |
01/09/2017 |
Softcure 96 |
WELLRAY MEDICAL LASER, INC. |
Richard O DeRoberts |
| K170257 |
01/27/2017 |
Sydney IVF Culture Oil |
William A. Cook Australia Pty Ltd |
Gordana Pozvek |
| K173431 |
11/02/2017 |
Towako Transmyometrial Embryo Transfer Set |
William A. Cook Australia PTY LTD |
Gordana Pozvek |
| K173673 |
11/30/2017 |
AcuSnare Polypectomy Snare |
Wilson-Cook Medical, Inc |
Theresa de Prat |
| K173659 |
11/29/2017 |
Howell D.A.S.H Extraction Balloon with Multiple Sizing |
Wilson-Cook Medical, Inc |
Tiffanny A. Thomas |
| K170292 |
01/31/2017 |
Tri-Ex Extraction Balloon With Multiple Sizing |
WILSON-COOK MEDICAL, INC |
TIFFANNY A. THOMAS |
| K170265 |
01/27/2017 |
GRAVITYTM PEEK-OPTIMA Suture Anchor |
Wright Medical Technology, Inc. |
Tara Conrad |
| K170249 |
01/27/2017 |
GRAVITYÖ Syndesmosis LP |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MICHAEL MULLINS |
| K173595 |
11/21/2017 |
Shear Wave Quantificational Ultrasound Diagnostic System |
Wuxi Hisky Medical Technologies Co., Ltd. |
Jinhua Shao |
| K170119 |
01/13/2017 |
Calix Lumbar Spinal Implant System |
X-Spine Systems, Inc. |
Charlene Brumbaugh |
| K170224 |
01/25/2017 |
Spider Cervical Plating System |
X-SPINE SYSTEMS, INC. |
KRISS ANDERSON |
| K170041 |
01/05/2017 |
XableCath Support Catheter |
XABLECATH, INC. |
RICK GAYKOWSKI |
| K173483 |
11/13/2017 |
Pure Flow External Counter-Pulsation Device |
Xtreem Pulse, LLC |
Andrew Barile |
| K173561 |
11/17/2017 |
Vinyl Patient Examination Glove (Yellow) |
Yurun Glove Co., Ltd. |
Chao Kevin |
| K170273 |
01/30/2017 |
Z-DOSE29 |
ZETTA MEDICAL TECHNOLOGIES, LLC. |
MAIN M. GHAZAL |
| K170233 |
01/25/2017 |
Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) |
Zhanjiang Star Enterprise Co., Ltd |
Rongsheng Tang |
| K170234 |
01/25/2017 |
Endotracheal tube; Reinforced Endotracheal tube |
Zhanjiang Star Enterprise Co., Ltd |
Rongsheng Tang |
| K170072 |
01/09/2017 |
Fitmore« Hip Stem |
Zimmer GmbH |
Thomas Lincoln |
| K173417 |
11/01/2017 |
Zimmer Persona Personalized Knee System |
Zimmer, Inc. |
Nicole Meredith |
| K170003 |
01/03/2017 |
Zip 4 Skin Closure Device |
ZipLine Medical, Inc. |
Trish Howell |
