| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K163629 |
03/10/2017 |
Audit MicroControls Linearity FD Tumor Markers II |
Aalto Scientific, Ltd. |
Robert Burda |
| K170009 |
03/30/2017 |
Esophageal Cooling Device |
ADVANCED COOLING THERAPY, LLC |
Erik Kulstad |
| K161918 |
03/03/2017 |
SREE MRI Transport Incubator |
ADVANCED IMAGING RESEARCH DBA SREE MEDICAL SYSTEMS |
RAVI SRINIVASAN |
| K162070 |
03/16/2017 |
JOINIX CANNULAR SYSTEM |
AJU Pharm Co.,Ltd. |
Kim Jung Gil |
| K170520 |
03/22/2017 |
HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ |
Alcon Research, Ltd. |
Karen Mudd |
| K162529 |
03/03/2017 |
DigiX FDX |
Allengers Medical Systems Limited |
Manmohan Singh |
| K170512 |
03/10/2017 |
Altus Spine Titanium Interbody Fusion System |
Altus Partners, LLC |
Claudia Hill |
| K162589 |
03/10/2017 |
Adscope 658 Electronic Stethoscope |
AMERICAN DIAGNOSTIC CORP. |
Michael Falco |
| K170743 |
03/30/2017 |
AngioDynamics Total Abscession Biliary Drainage Catheter |
AngioDynamics, Inc. |
Teri Juckett |
| K170267 |
03/09/2017 |
BGM009 Plus Blood Glucose Monitoring System |
Apex Bio Technology Corp. |
Hsue-mei Lee |
| K161077 |
03/17/2017 |
RnD TE and RnD SE |
Apex Dental Materials, Inc |
Scott Lamerand |
| K160581 |
03/24/2017 |
K3PRO Konus Additional Abutments and Implants |
ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH CO KG |
RICHARD DONACA |
| K162820 |
03/31/2017 |
AC3 Series IABP System |
ARROW INTERNATIONAL, INC. |
Alifiya Jagmag |
| K170350 |
03/03/2017 |
ToeMATE« Hammertoe Correction System |
Arthrosurface, Inc. |
Phani Puppala |
| K161257 |
03/31/2017 |
MultiPulse HoPLUS |
ASCLEPION LASER TECHNOLOGIES GMBH |
ANTJE KATZER |
| K170635 |
03/30/2017 |
Chameleon PTA Balloon Catheter |
AV Medical Technologies Ltd |
Limor Sandach |
| K163529 |
03/29/2017 |
ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm) |
AVERY DENNISON CORPORATION |
LISA BARTAKOVICS |
| K170539 |
03/20/2017 |
Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm |
Avitus Orthopaedics, Inc |
Maxim Budyansky |
| K161880 |
03/14/2017 |
NIVR58-T kit |
Barco N.V. |
Lieven De Wandel |
| K170476 |
03/28/2017 |
Nio Color 5.8MP (MDNC-6121) |
Barco NV |
Helena Soenen |
| K162342 |
03/24/2017 |
Stellaris Elite Vision Enhancement System |
Bausch + Lomb |
Ken Nehmer |
| K162562 |
03/17/2017 |
OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY |
BCG MEDICAL, LLC |
LISA GIAP |
| K162740 |
03/21/2017 |
MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL) |
BECKMAN COULTER, INC. |
SHANNON POPSON |
| K163637 |
03/21/2017 |
BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL) |
BECTON, DICKINSON & COMPANY |
MONICA E. GIGUERE |
| K170336 |
03/10/2017 |
BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector |
Becton, Dickinson and Company |
Kimberly Geisler |
| K161898 |
03/08/2017 |
Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set |
BEIJING FERT TECHNOLOGY CO., LTD |
MENG ZHANG |
| K161892 |
03/02/2017 |
Slimming Treatment Device |
BEIJING HONKON TECHNOLOGIES CO., LTD |
Li Yanzhe |
| K163563 |
03/13/2017 |
VITEK 2 AST-GN Gentamicin (<=1 û >=16 ╡g/mL) |
bioMerieux, Inc |
Cherece L. Jones |
| K161816 |
03/28/2017 |
BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO |
bioMerieux, Inc. |
Jolyn Tenllado |
| K162559 |
03/31/2017 |
Move Forward 3D Motion Simulation Service |
BIOMET INC. |
PAUL HARDY |
| K163608 |
03/21/2017 |
HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm |
BioStable Science & Engineering Inc. |
Julie Thomas |
| K170628 |
03/31/2017 |
BioMonitor 2-AF, BioMonitor 2-S |
BIOTRONIK, Inc |
Jon Brumbaugh |
| K163700 |
03/29/2017 |
Bodycad Unicompartmental Knee System |
Bodycad Laboratories, Inc. |
Marc Chaunet |
| K163248 |
03/27/2017 |
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle |
Boston Scientific Corporation |
Yingying Gao |
| K170636 |
03/22/2017 |
Fathom-16 Steerable Guidewires |
Boston Scientific Corporation |
Keith Neligan |
| K170204 |
03/24/2017 |
FFR Link, FFR Signal Processing Module |
Boston Scientific Corporation |
Dan Krause |
| K163314 |
03/23/2017 |
Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter |
Boston Scientific Corporation |
Nikki Wahlberg |
| K162793 |
03/10/2017 |
RHYTHMIA HDx Mapping System |
Boston Scientific Corporation |
Regina Holmes |
| K170188 |
03/08/2017 |
Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator |
Bovie Medical Corporation |
Rubiela Maldonado |
| K162186 |
03/31/2017 |
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12ö, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM |
BRIGHTWAY HOLDINGS SDN BHD |
G. BASKARAN |
| K163267 |
03/24/2017 |
NITRILE EXAMINATION GLOVE |
BRIGHTWAY HOLDINGS SDN BHD |
G. BASKARAN |
| K170058 |
03/03/2017 |
TheraView TBI |
Cablon Medical B.V. |
Jurjen Weistra |
| K162383 |
03/01/2017 |
Cadwell Sierra Summit, Cadwell Sierra Ascent |
CADWELL INDUSTRIES, INC. |
CHRISTOPHER BOLKAN |
| K162199 |
03/02/2017 |
Cascade IOMAX Intraoperative Monitor |
CADWELL INDUSTRIES, INC. |
MELISSA KIRKUP |
| K170332 |
03/01/2017 |
DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS |
Canon, Inc. |
SHINJI MORI |
| K162394 |
03/08/2017 |
CRC-77tHR |
Capintec, Inc. |
Mary Anne Yusko |
| K162503 |
03/24/2017 |
Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software |
Cardiac Insight, Inc. |
Brad Harlow |
| K163157 |
03/21/2017 |
SmartGrid |
Carestream Health |
Diane Koetter |
| K162947 |
03/03/2017 |
Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler |
CHONGQING QMI SURGICAL CO., LTD |
KANG LI |
| K162870 |
03/07/2017 |
CIMLRE F1 and CIMILRE S3 |
CIMILRE CO., LTD. |
Ko Bong Jae |
| K162905 |
03/15/2017 |
SleepWeaver 3D Nasal Mask |
Circadiance, LLC |
JAMES GIANOUTSOS |
| K163323 |
03/20/2017 |
Dolphix« External Fixation System MR Conditional |
CITIEFFE s.r.l |
Stefano Pullega |
| K163103 |
03/23/2017 |
Tranberg CLS Diffusor Laser Fiber |
Clinical Laserthermia Systems AB |
Lars-Erik Eriksson |
| K162405 |
03/28/2017 |
Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue) |
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD |
CHAN YEW MEN |
| K162789 |
03/28/2017 |
Foresight Intracardiac Echocardiology (ICE) System |
Conavi Medical Inc. |
Sam Mostafavi |
| K170501 |
03/17/2017 |
CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver |
ConMed Corporation |
Diana L. Nader-Martone |
| K162906 |
03/07/2017 |
Flexi-Seal PROTECT Fecal Management System |
ConvaTec |
Karen Howes |
| K170622 |
03/31/2017 |
Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component |
Cook Incorporated |
Naomi Funkhouser |
| K170243 |
03/31/2017 |
LOSPA IS TLIF & DLIF Cages |
CORENTEC CO., LTD |
J.S. DANIEL |
| K162979 |
03/24/2017 |
Veloxion System |
Corinth MedTech, Inc. |
Sandeep Saboo |
| K170348 |
03/02/2017 |
Signia Four-Bay Smart Charger (to be used with Signia Stapler) |
Covidien |
Katherine Y. Choi |
| K163654 |
03/08/2017 |
VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar |
Covidien llc |
Gary LeMere |
| K162506 |
03/09/2017 |
PhotoFix Decellularized Bovine Pericardium |
CryoLife, Inc. |
Heather Emerick |
| K163552 |
03/03/2017 |
iPulse SmoothSkin BARE Hair Removal Device |
CYDEN LIMITED |
MIKE KIERNAN |
| K162967 |
03/24/2017 |
nuance UNIVERSAL |
Den-Mat Holdings, LLC |
Helen Ragus |
| K162044 |
03/03/2017 |
Dentca Denture Base II |
DENTCA, Inc. |
Jason Lee |
| K163350 |
03/31/2017 |
Multibase Abutments EV and ATLANTIS Suprastructures |
DENTSPLY SIRONA |
KARL NITTINGER |
| K162124 |
03/29/2017 |
Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins |
DePuy Synthes |
CHRISTOPHER J. MEDBERRY |
| K162654 |
03/13/2017 |
mollosil plus |
DETAX GmbH & Co.KG |
Antje Reeps |
| K161929 |
03/29/2017 |
Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove |
Dipped Products (Thailand) Limited |
Nilaksha Pushpakumara |
| K170391 |
03/09/2017 |
ANSiStim-PP |
DyAnsys Inc |
Srini Nageshwar |
| K162509 |
03/10/2017 |
Infrared Non-contact Thermometer, Model ACT8100 |
EASYWELL BIOMEDICALS, INC. |
Arthur Chen |
| K170167 |
03/03/2017 |
True 3D Viewer Software |
EchoPixel Inc. |
Sergio Aguirre |
| K163497 |
03/02/2017 |
EXPRTÖ Revision Hip System - EXPRTÖ Hip Distal Stem, EXPRTÖ Hip Standard Offset Proximal Body Implant, EXPRTÖ Hip Lateral Offset Proximal Body Implant, EXPRTÖ Hip Capture Bolt |
ENCORE MEDICAL, L.P. |
Teffany Hutto |
| K162627 |
03/31/2017 |
EnsoSleep |
EnsoData, Inc. |
Chris Fernandez |
| K163082 |
03/16/2017 |
6200 Ultrasound System and 6250 Ultrasound System |
ESAOTE S.P.A |
MASSIMO POLIGNANO |
| K162811 |
03/02/2017 |
MR Conditional CGA 870 |
Essex Industries, Inc. |
Russ Jacobsmeyer |
| K163152 |
03/11/2017 |
PROLENE Soft Polypropylene Mesh |
Ethicon, Inc. |
Debbie Fazen |
| K162167 |
03/31/2017 |
Caphosol Artifical Saliva Tablets |
EUSA Pharma (UK) Limited |
Paul Davisson |
| K162325 |
03/06/2017 |
Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw |
Exactech Inc |
Zach Sharrah |
| K162693 |
03/29/2017 |
VertebraLINK Fusion Platform |
FACETLINK DBA LINKSPINE |
MASSIMO CALAFIORE |
| K163300 |
03/22/2017 |
ThermoShield HME Filter |
Flexicare Medical Limited |
Joel Biddle |
| K170701 |
03/24/2017 |
GEN_2 and GEN_3 Mechanical Wheelchairs |
Free Wheelchair Mission |
Don Schoendorfer |
| K160139 |
03/20/2017 |
Luggie Chair |
FREERIDER CORPORATION |
Arthur Wang |
| K170451 |
03/16/2017 |
FDX Console (DR-ID300CL) Software |
FUJIFILM Medical Systems U.S.A., Inc. |
Peter Altman |
| K162836 |
03/13/2017 |
FUJIFILM Surgical System |
FUJIFILM New Development U.S.A., Inc. |
Stephen Mariano |
| K170084 |
03/10/2017 |
InterLock Trocar |
FUJIFILM New Development U.S.A., Inc. |
Stephen Mariano |
| K163331 |
03/17/2017 |
Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist |
GE Medical Systems, LLC |
Mary A. Mayka |
| K162023 |
03/24/2017 |
CardioDay V2.5 |
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
BERT SCHADOW |
| K163017 |
03/22/2017 |
Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs |
GMP MEDICARE SDN BHD |
EVA VINONI BT MUSTAFA |
| K163096 |
03/31/2017 |
GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System |
GPC MEDICAL LIMITED |
VIKAS NARANG |
| K170284 |
03/31/2017 |
Great Basin Bordetella Direct Test |
GREAT BASIN SCIENTIFIC, INC. |
SUZETTE CHANCE |
| K163436 |
03/06/2017 |
Greiner Vacuette Urine Count and Culture, Mannitol tube |
GREINER BIO-ONE NA INC. |
MANFRED ABEL |
| K162850 |
03/24/2017 |
GuideMia Ortho+ |
GUIDEMIA TECHNOLOGIES, LLC |
FEI GAO |
| K153600 |
03/17/2017 |
Consult Station TS |
H4D SAS |
MARTA RIVAS |
| K162471 |
03/30/2017 |
Hach CM130 Chlorine Monitoring System |
HACH COMPANY |
Jeff Ryberg |
| K170127 |
03/14/2017 |
HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40 |
Hardy Diagnostics |
Rianna Malherbe |
| K162646 |
03/03/2017 |
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) |
HARTALEGA NGC SDN. BHD. |
KUAN MUN LEONG |
| K163378 |
03/17/2017 |
Monarch Airway Clearance System |
HILL-ROM SERVICES PTE LTD |
Huifang Zhu |
| K163528 |
03/03/2017 |
HITACHI Supria Whole-body X-ray CT System Phase 3 |
Hitachi Medical Systems America, Inc. |
Doug Thistlethwaite |
| K162412 |
03/09/2017 |
Hoggan Scientific« microFET2Ö |
Hoggan Scientific, LLC |
Spencer Walker |
| K163052 |
03/29/2017 |
Brevera Biopsy System with Corlumina Imaging Technology |
HOLOGIC, INC. |
SARAH FAIRFIELD |
| K162784 |
03/25/2017 |
Silk'n HST |
Home Skinovations Ltd. |
Amit Goren |
| K161469 |
03/28/2017 |
Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module |
Hospira, Inc |
Keith Dunn |
| K170077 |
03/30/2017 |
LUOFUCON Silicone Ag Foam Dressing with Border |
HUIZHOU FORYOU MEDICAL DEVICES Co., Ltd. |
Guosheng Tan |
| K163343 |
03/21/2017 |
Icare HOME tonometer |
Icare Finland Oy |
Matti Tulikoura |
| K153538 |
03/02/2017 |
Dextramer CMV Kit |
Immudex Aps |
Liselotte Brix |
| K163290 |
03/24/2017 |
INFINITT ULite |
INFINITT CO., LTD. |
Heejin Lim |
| K170420 |
03/02/2017 |
n!ce Glass Ceramic Blocks for Amann Girrbach |
Institut Straumann AG |
Christopher Klaczyk |
| K162311 |
03/07/2017 |
Straumann PrefGel |
INSTITUT STRAUMANN AG |
CHRISTOPHER KLACZYK |
| K170314 |
03/03/2017 |
ACL AcuStar |
INSTRUMENTATION LABORATORY CO. |
NIKITA MALLADI |
| K162364 |
03/02/2017 |
Intellijoint HIP Generation 2A System |
INTELLIJOINT SURGICAL INC. |
BRANDON GINGRICH |
| K162037 |
03/23/2017 |
Eclipse with VEMP |
INTERACOUSTICS A/S |
Erik Nielsen |
| K163488 |
03/20/2017 |
Flex-Thread Clavicle Pin System |
INTRAFUSE LLC |
Robert Hoy |
| K170508 |
03/10/2017 |
EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads |
Intuitive Surgical, Inc. |
Cheryl Wu |
| K161865 |
03/07/2017 |
iSage Rx (iSage Rx Basal Insulin Titration) |
iSag Rx, Inc. |
RYAN SYSKO |
| K162960 |
03/14/2017 |
TotalC-Ram |
ITENA CLINICAL |
Charles Peyre |
| K161991 |
03/03/2017 |
Curasite |
IZUN PHARMACEUTICALS |
JACK TALLEY |
| K163224 |
03/09/2017 |
JAZZ SOLO Sensor |
Jazz Imaging LLC |
Todd C. Miller |
| K163093 |
03/14/2017 |
Safety Blood Collection Set |
Jiangsu Shenli Medical Production Co., Ltd |
Tina Cai |
| K163162 |
03/20/2017 |
Sterile Hypodermic Safety Syringes for Single Use |
JiangXi HongDa Medical Equipment Group Ltd. |
Yang Xiaohua |
| K163161 |
03/20/2017 |
Sterile Single-use Syringe with Needle |
JiangXi HongDa Medical Equipment Group Ltd. |
Yang Xiaohua |
| K161979 |
03/22/2017 |
ENFit enteral syringe |
JIANGYIN CAINA TECHNOLOGY CO., LTD. |
JUN LU |
| K162868 |
03/17/2017 |
Exam Vue PACS |
JPI Healthcare Solutions, Inc |
Jang Won Lee |
| K163364 |
03/15/2017 |
MOJAVE Expandable Interbody System |
K2M |
Nancy Giezen |
| K160721 |
03/07/2017 |
Vado Steerable Sheath |
KALILA MEDICAL, INC. |
Carrie Neuberger |
| K163471 |
03/16/2017 |
Kalitec Direct InSePtionÖ MIS Fixation System |
KALITEC DIRECT, LLC |
KEITH CANNAN |
| K163239 |
03/17/2017 |
SMARTmatic |
Kaltenbach & Voigt GmbH |
Stefan Trampler |
| K162880 |
03/16/2017 |
TIPCAM 1S 3D System |
KARL STORZ Endoscopy America, Inc |
Winkie Wong |
| K162410 |
03/02/2017 |
TIPCAM 1S 3D System |
KARL STORZ Endoscopy America, Inc |
Winkie Wong |
| K161554 |
03/02/2017 |
ENDOFLATOR 40, ENDOFLATOR 50 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
SUSIE S. CHEN |
| K163405 |
03/21/2017 |
360KS Implant Positioning System |
Kico Knee Innovation Company PTY Limited |
Karl Rentsch |
| K170124 |
03/09/2017 |
Level One Hand Plating System |
KLS MARTIN LP |
Jennifer Damato |
| K163201 |
03/16/2017 |
KYMCO EQ10D Scooter |
KWANG YANG MOTOR CO., LTD. |
Wang Ching Yun |
| K162235 |
03/24/2017 |
LUVENA VAGINAL MOISTURIZER & LUBRICANT |
LACLEDE, INC. |
MICHAEL PELLICO |
| K163247 |
03/09/2017 |
3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider |
LAURIMED LLC |
Brian R DuBois |
| K163517 |
03/14/2017 |
Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 ╡g/mL |
LIOFILCHEM S.R.L. |
FABIO BROCCO |
| K163572 |
03/15/2017 |
LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source |
LV Liberty Vision Corp. |
Paul T. Finger |
| K162935 |
03/10/2017 |
Rapid2 Therapy System |
MAGSTIM COMPANY LTD. |
Kevyn Beard |
| K163522 |
03/14/2017 |
FilmArray Warrior Control Panel M290 |
Maine Molecular Quality Controls, Inc. |
Joan Gordon |
| K163498 |
03/16/2017 |
VALIDATE Heparin Calibration Verification/Linearity Test Kit |
MAINE STANDARDS COMPANY, LLC |
JAMES CHAMPLIN |
| K153688 |
03/02/2017 |
Edi Catheter ENFit |
MAQUET CRITICAL CARE AB |
MIRVA BOOTHE |
| K160665 |
03/29/2017 |
FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 |
MAQUET CRITICAL CARE AB |
CARINA LUNDBERG |
| K161635 |
03/31/2017 |
AMIStem-H Proximal Coating |
MEDACTA INTERNATIONAL SA |
STEFANO BAJ |
| K162035 |
03/06/2017 |
GMK Sphere |
Medacta International SA |
Stefano Baj |
| K170455 |
03/16/2017 |
MectaLIF Anterior Stand Alone |
Medacta International SA |
Stefano Baj |
| K161680 |
03/24/2017 |
MEDICON Spinal Spreading Systems |
MEDICON EG |
Joachim Schmid |
| K170095 |
03/08/2017 |
Vial2Bag Direct Connect |
Medimop Medical Project Ltd. |
Ilanit Goldgraber |
| K163401 |
03/21/2017 |
Nix Ultra Lice Treatment Kit |
MEDTECH PRODUCTS INC. |
JEAN BOYKO |
| K170296 |
03/20/2017 |
CoreCath 2.7S |
Medtronic Advanced Energy |
Lydia Sakakeeny |
| K162309 |
03/31/2017 |
StealthStation S8 System Platforms and StealthStation Cranial Software |
MEDTRONIC NAVIGATION, INC. |
Tia Fushimi-Bain |
| K163182 |
03/23/2017 |
Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories |
Medtronic Powered Surgical Solutions |
Deep Pal |
| K163565 |
03/28/2017 |
MR8 Drill System |
MEDTRONIC POWERED SURGICAL SOLUTIONS |
Deep Pal |
| K170583 |
03/17/2017 |
Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface |
Medtronic, Inc. |
Gayatri Ghadge |
| K163575 |
03/03/2017 |
Inqwire Diagnostic Guide Wire |
Merit Medical Systems, Inc. |
Mark Mullaney |
| K162898 |
03/17/2017 |
Olecranon Plating System |
MIAMI DEVICE SOLUTIONS, LLC |
Michelle Montesino |
| K160641 |
03/08/2017 |
Solitaire Platinum Revascularization Device, 6x40 mm |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Ryan Kenney |
| K162026 |
03/01/2017 |
EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions |
MicroPort Orthopedics, Inc. |
Byron Ledbetter |
| K162524 |
03/03/2017 |
AZUR CX Detachable 18 Peripheral Coil System |
MicroVention, Inc |
Laraine Pangelina |
| K162999 |
03/29/2017 |
V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System |
MICROVENTION, INC |
Laraine Pangelina |
| K163376 |
03/10/2017 |
Mikro-Cath Pressure Catheter |
Millar, Inc. |
Jacqueline Jean-Baptiste |
| K170449 |
03/31/2017 |
Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection |
Millennium Medical Technologies, Inc. |
Jim Barley |
| K170329 |
03/24/2017 |
Basic, Dominant Flex |
Modela AG |
Markus Butler |
| K163249 |
03/24/2017 |
GoSpiro |
MONITORED THERAPEUTICS, INC. |
William Zimlich |
| K160287 |
03/14/2017 |
Rapid Barostat Bag (RBB) Pump and Catheter |
MUI SCIENTIFIC |
TAMMY MUI |
| K161737 |
03/02/2017 |
RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed |
MYCO MEDICAL |
Sanjiv Kumar |
| K161835 |
03/24/2017 |
iovera system |
Myoscience, Inc |
Tracey Henry |
| K163425 |
03/24/2017 |
NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System |
NARANG MEDICAL USA CORPORATION |
Reginald Swift |
| K161430 |
03/02/2017 |
Myoject Luer Lock Needle Electrode |
Natus Manufacturing Limited |
Michael Galvin |
| K161304 |
03/02/2017 |
EndoPur Filter |
Nephros Inc. |
Hollie Johnson |
| K163118 |
03/09/2017 |
FLEX Microwave Ablation System and Accessories |
NEUWAVE MEDICAL, INC. |
DAN KOSEDNAR |
| K170161 |
03/29/2017 |
New Deantronics E GreenÖ Electrosurgical Monopolar Pencils |
New Deantronics Taiwan, LTD |
Jane Liu |
| K170310 |
03/30/2017 |
Alians Clavicle range |
Newclip Technics |
Gaelle Lussori |
| K163188 |
03/06/2017 |
Next Science Wound Gel (Rx) |
Next Science, LLC |
Matthew Myntti |
| K161681 |
03/08/2017 |
Nipro SafeTouch IV Catheter |
NIPRO MEDICAL CORPORATION |
JESSICA OSWALD-MCLEOD |
| K161416 |
03/16/2017 |
Multi-unit Abutment Plus |
NOBEL BIOCARE AB |
Charlemagne Chua |
| K161598 |
03/14/2017 |
NobelZygoma 0░ |
Nobel Biocare AB |
Charlemagne Chua |
| K162308 |
03/17/2017 |
Noris Medical MBI-2mm Dental Implant System |
Noris Medical Ltd |
Simha Sibony |
| K170030 |
03/13/2017 |
NOVATECH TALCAIR |
NOVATECH S.A. |
JENNIFER NEFF |
| K163230 |
03/16/2017 |
NuVasive Modulus XLIF Interbody System |
NUVASIVE INCORPORATED |
Cynthia Adams |
| K162313 |
03/16/2017 |
NuVasive Next Generation NVM5 System |
NUVASIVE INCORPORATED |
MARY ADAMS |
| K170346 |
03/07/2017 |
PRECICE Intramedullary Limb Lengthening System |
NuVasive Specialized Orthopedics, Inc. |
Lance Justice |
| K163491 |
03/24/2017 |
NuVasive CoRoent Small Interbody System |
NuVasive, Incorporated |
Martin Yahiro |
| K170126 |
03/09/2017 |
NuVasive« Reline« 4.5-5.0 System |
NUVASIVE, INCORPORATED |
Olga Lewis |
| K170271 |
03/30/2017 |
NuVasive(r) Monolith Corpectomy System |
NuVasive, Incorporated |
Cynthia Adams |
| K162217 |
03/23/2017 |
LOYON |
Oculus Innovative Sciences |
Brian W. Martin |
| K162746 |
03/03/2017 |
Ontex and other proprietary names |
ONTEX BVBA |
Henri Lesage |
| K161547 |
03/09/2017 |
Transem and EchoGen Embryo Transfer Catheters |
ORIGIO A/S |
TOVE KJAER |
| K163379 |
03/02/2017 |
KneeAlign 2 System |
OrthAlign, Inc. |
David Vancelette |
| K162995 |
03/30/2017 |
Ibis« Pedicle Screw System |
Ortho Development Corporation |
Lindsay Martin |
| K163489 |
03/08/2017 |
OrthoSolutions 'System26' Bone Screws |
Ortho SOlutions UK Limited |
Craig Bluett |
| K162921 |
03/13/2017 |
Navigated Instrument System |
ORTHOFIX INC. |
JACKI KOCH |
| K163054 |
03/08/2017 |
DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System |
OSPREY MEDICAL, INC. |
MELANIE HESS |
| K163109 |
03/22/2017 |
OxyHeal 4000 Multiplace Hyperbaric Chamber Family |
OXYHEAL MEDICAL SYSTEMS, INC. |
EDWARD J. CHOMAS |
| K170327 |
03/30/2017 |
Parcus SLiK Anchors |
Parcus Medical |
Paul Vagts |
| K161731 |
03/27/2017 |
Cleveland Multiport Ventricular Catheter Set |
Parker Hannifin Corp. |
George Austria |
| K163003 |
03/16/2017 |
Y3 Proximal Femoral Plate System |
PEGA MEDICAL INC. |
ARIEL R. DUJOVNE |
| K161141 |
03/22/2017 |
ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT |
PENTAFERTE ITALIA S.R.L. |
ROSA DI GIOIA |
| K163649 |
03/31/2017 |
SureSigns VS3; SureSigns VS4 |
Philips Medical Systems |
Greg Li |
| K161812 |
03/27/2017 |
Freedom Syringe |
Procedure Products, Inc. |
Doug Rowley |
| K163474 |
03/10/2017 |
CAVUX CervicalCage-L SA System |
PROVIDENCE MEDICAL TECHNOLOGY, INC. |
EDWARD LIOU |
| K161667 |
03/27/2017 |
Sapphire Infusion Pump |
Q Core Medical Ltd. |
Shimon Vaknin |
| DEN160028 |
03/27/2017 |
ipsogen JAK2 RGQ PCR Kit |
QIAGEN INC |
LINDSEY HOWARD |
| K170331 |
03/03/2017 |
Cyber Ho |
quanta system spa |
Francesco Dell'Antonio |
| K162804 |
03/08/2017 |
Q2 Low Pressure Power Injection Extension Set |
QUEST MEDICAL, INC. |
Amy Clendening-Wheeler |
| K161691 |
03/20/2017 |
Direct LDL Cholesterol (LDL) |
RANDOX LABORATORIES LIMITED |
PAULINE ARMSTRONG |
| K170355 |
03/02/2017 |
RayStation 6 |
RaySearch Laboratories AB (publ) |
David Hedfors |
| K160067 |
03/07/2017 |
RenovoCath |
RenovoRx, Inc. |
Kamran Najmabadi |
| K163569 |
03/17/2017 |
Elecsys CMV IgM |
Roche Diagnostics |
Angelo Pereira |
| K170403 |
03/07/2017 |
CenterCross Ultra LV Catheter |
Roxwood Medical, Inc. |
Mehrdad Farhangnia |
| K170528 |
03/09/2017 |
SterispineÖ PS |
SAFE ORTHOPAEDICS |
Pierre Dumouchel |
| K170493 |
03/28/2017 |
HS50 / HS60 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Jiyeon Cho |
| K163099 |
03/22/2017 |
My Dose Coach |
Sanofi, Inc. |
Robert Ezzell |
| K163604 |
03/09/2017 |
SeaSpine« Daytona« Small Stature Spinal System |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K160345 |
03/03/2017 |
Glass Ionomer Cement |
SHANDONG HUGE DENTAL MATERIAL CORPORATION |
Steven Song |
| K163655 |
03/17/2017 |
Sparkling |
Shanghai Wonderful Opto-Electrics Tech. Co., Ltd |
Amy Lee |
| K161428 |
03/23/2017 |
PerfectSmooth |
SHEN ZHEN COSBEAUTY CO.,LTD. |
Nicole Hu |
| K161530 |
03/31/2017 |
Bluetooth blood pressure monitor |
SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. |
Dacheng Gong |
| K170277 |
03/23/2017 |
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 |
| K162733 |
03/10/2017 |
iFuse Implant System« - iFuse-3D implant |
SI-BONE, INC. |
ROXANNE DUBOIS |
| K161954 |
03/09/2017 |
Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) |
Siemens Healthcare Diagnostics |
Justin DiValentino |
| K162298 |
03/16/2017 |
LOCI Total Vitamin D Total Assay, LOCI VITD CAL |
SIEMENS HEALTHCARE DIAGNOSTICS |
KATHLEEN DRAY-LYONS |
| K170065 |
03/09/2017 |
ADVIA« Chemistry Total Bilirubin_2 (TBIL_2) |
Siemens Healthcare Diagnostics, Inc. |
Julie Warren |
| K163286 |
03/09/2017 |
ARTIS pheno |
SIEMENS MEDICAL SOLUTION USA, INC. |
PATRICIA D. JONES |
| K163297 |
03/24/2017 |
Scan&GO |
Siemens Medical Solutions USA, Inc. |
Kimberly Mangum |
| K163296 |
03/21/2017 |
SOMATOM go.Up, SOMATOM go.Now |
Siemens Medical Solutions USA, Inc. |
Kimberly Mangum |
| K163284 |
03/01/2017 |
syngo. CT Neuro Perfusion |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY MANGUM |
| K161633 |
03/02/2017 |
REXLON, REXSIL |
SM ENG CO., LTD |
SOON-GU LEE |
| K162356 |
03/02/2017 |
Vesair Cystoscopic Sheath |
Solace Therapeutics |
William Gruber |
| K161733 |
03/08/2017 |
INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C |
Sorin Group Italia S.r.l |
Luigi Vecchi |
| K163409 |
03/08/2017 |
Rampart(TM) T Lumbar Interbody Fusion Device |
Spineology Inc. |
Jacqueline A. Hauge |
| K163450 |
03/08/2017 |
VIVA combo RF System |
STARmed Co., Ltd. |
Jun-Young Jung |
| K162413 |
03/31/2017 |
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 |
| K162701 |
03/24/2017 |
VERIFY Assert Self-Contained Biological Indicator |
STERIS CORPORATION |
ANTHONY PIOTRKOWSKI |
| K163587 |
03/24/2017 |
VERIFY Incubator for Assert Self Contained Biological Indicators |
STERIS Corporation |
Anthony Piotrkowski |
| K162758 |
03/21/2017 |
VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack |
STERIS Corporation |
Anthony Piotrkowski |
| K162890 |
03/08/2017 |
BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment |
STRAUMANN USA, LLC |
JENNIFER M. JACKSON |
| K170098 |
03/31/2017 |
ICONIX TT All Suture Anchor |
Stryker |
Taylor White |
| K162028 |
03/24/2017 |
PREMIUM - SHELTA Prosthetic Components |
SWEDEN & MARTINA S.p.A. |
ALESSIA PEZZATO |
| K163558 |
03/23/2017 |
Synapsys Ulmer Video Nystagmograph |
Synapsys SA |
Laetitia Baconnier |
| K170654 |
03/29/2017 |
USS System |
Synthes USA Products LLC |
Eugene Bang |
| K162580 |
03/03/2017 |
Guardian Angel GA1000 Digital Vital Sign Monitoring System |
TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC. |
ALAN TANG |
| K163175 |
03/20/2017 |
Bel-Cypher Pro |
Takara Belmont Corporation |
Toshinori Kiyomatsu |
| K162530 |
03/31/2017 |
Multichem IA Plus |
TECHNO-PATH MANUFACTURING |
BERND HASS |
| K161318 |
03/20/2017 |
Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems |
TEDAN SURGICAL INNOVATIONS LLC |
John Willis |
| K162522 |
03/17/2017 |
UltraCath Continuous Nerve block Catheter |
TELEFLEX MEDICAL , INC. |
James A. Cochie |
| K161785 |
03/14/2017 |
THD ANOPRESS |
THD SPA |
GIUSEPPINA GIANNINI |
| K170116 |
03/13/2017 |
Thermi Injectable RF Electrodes |
Thermi |
Suzanne Cheang |
| K170430 |
03/06/2017 |
TSolution One Surgical System Model 210 |
THINK Surgical Inc. |
In K. Mun |
| K152534 |
03/21/2017 |
Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose M |
TIANJIN EMPECS MEDICAL DEVICE CO., LTD. |
CHAE CHUNG LYUEL |
| K162873 |
03/31/2017 |
MEP Monitor |
TONICA ELEKTRONIK A/S |
LISE TERKELSEN |
| K162626 |
03/31/2017 |
THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE |
TOP QUALITY GLOVE SDN. BHD |
HUE KON FAH |
| K170164 |
03/03/2017 |
3D OCT-1 Maestro |
Topcon Corporation |
James Lorkowski |
| K163586 |
03/17/2017 |
Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector |
TrovRx, Inc. dba Trovita Health Science |
William Brown |
| K161705 |
03/16/2017 |
U2 Total Knee System E-XPE products |
UNITED ORTHOPEDIC CORPORATION |
KAREN HO |
| K163495 |
03/10/2017 |
AdvanCE capsule endoscope delivery device |
United States Endoscopy Group, Inc. |
Carroll Martin |
| K162415 |
03/15/2017 |
Spectra 9Plus |
Uzinmedicare Company |
Nathan Ahn |
| K170335 |
03/24/2017 |
Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens |
Valley Contax, Inc. |
Josh Adams |
| K162615 |
03/24/2017 |
Mould Applicator Set |
Varian Medical Systems, Inc |
Peter J. Coronado |
| K160815 |
03/10/2017 |
Interstitial Needles |
VARIAN MEDICAL SYSTEMS, INC. |
PETER J. CORONADO |
| K163307 |
03/08/2017 |
Expro Elite Snare, Sympro Elite Snare |
Vascular Solutions, Inc. |
Jake Schultz |
| DEN160019 |
03/04/2017 |
CINtec Histology (50 tests), CINtec Histology (250 tests) |
VENTANA MEDICAL SYSTEMS, INC |
ROXANE BONNER |
| K161250 |
03/17/2017 |
OC-FLEX Flexible IntraOral Cannula |
Venture Therapeutics, Inc. |
Marilyn A. Friedly |
| K163346 |
03/17/2017 |
MAZIC Duro |
VERICOM CO., LTD. |
Myung-Hwan Oh |
| K162556 |
03/24/2017 |
LIGHTFUSION LED SYSTEM |
VITAGE LED LTD |
SUE D'ARCY |
| K163320 |
03/21/2017 |
LAP-Pump PP110 |
W.O.M. WORLD OF MEDICINE GMBH |
Soeren Markworth |
| K161840 |
03/16/2017 |
LINK« SP-CL« Hip System PoroLink« (microporous) and HX« (CaP) coated & LINK« LCU« Hip System PoroLink« (microporous) and HX« (CaP) coated |
Waldemar Link GmbH & Co. KG |
Lorenz Runge |
| K170783 |
03/31/2017 |
CX50N(CX50YQS) |
WIDE Corporation |
YeoJin Yun |
| K162033 |
03/06/2017 |
SALVATION External Fixation System |
WRIGHT MEDICAL |
LESLIE FITCH |
| K163039 |
03/13/2017 |
ORTHOLOC« 3Di Small Bones Plating |
Wright Medical Technology, Inc. |
Michael Mullins |
| K170530 |
03/22/2017 |
Butrex Lumbar Buttress Plating System |
X-Spine Systems, Inc. |
Kriss Anderson |
| K162575 |
03/03/2017 |
Z-LINKPC System |
ZAVATION, LLC |
FRANKIE CUMMINS |
| K162919 |
03/07/2017 |
Male Latex Condoms |
Zhejiang Xiangban Latex Products Co., Ltd. |
Huichao Lou |
| K162429 |
03/13/2017 |
ZipE Knotless Tissue Repair and Attachment Devices |
ZIPTEK, LLC |
William F. Bennett |
