| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K160666 |
10/05/2016 |
Dentiq3D |
3D INDUSTRIAL IMAGING CO.,LTD. |
Jin Sa Kim |
| K161697 |
10/24/2016 |
Acclarent NavWire Sinus Navigation Guidewire |
ACCLARENT, INC. |
ANNA HWANG |
| K161698 |
10/24/2016 |
Relieva UltirraNav Sinus Balloon Catheter |
ACCLARENT, INC. |
JAMES PATRICK GARVEY |
| K162554 |
10/21/2016 |
Gentrix Surgical Matrix |
Acell, Inc. |
Salman Elmi |
| K160203 |
10/19/2016 |
ADAMANT ZIRCONIA DISC |
Adamant Co., Ltd. |
Deborah Lavoie Grayeski |
| K162579 |
10/14/2016 |
VascuCel |
Admedus Regen Pty Ltd |
Mary E. Donlin |
| K161241 |
10/05/2016 |
e-fix E35/E36 |
Alber GmbH |
MICHAEL VENT |
| K162596 |
10/13/2016 |
AIR OPTIX COLORS |
Alcon Laboratories, Inc. |
Sherri Lakota |
| K162597 |
10/19/2016 |
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc |
Alcon Laboratories, Inc. |
Sherri Lakota |
| K161981 |
10/14/2016 |
Olive Plus |
AMA NETWORK INC |
YONG BAIK KIMM |
| K161842 |
10/13/2016 |
Overwatch Spine System |
Amendia, Inc. |
Bruce Hooper |
| K160782 |
10/14/2016 |
BracePaste Adhesive |
American Orthodontics |
Trang Adams |
| K160974 |
10/28/2016 |
Gammex Cut-Resistant Glove Liner |
ANSELL HEALTHCARE PRODUCTS LLC |
ROBERT MAHLER |
| K161605 |
10/27/2016 |
Smart External Drain (SED) System |
AQUEDUCT CRITICAL CARE, INC. |
Thomas Clement |
| K160062 |
10/07/2016 |
AUTION ELEVEN Semi-Automated Urinalysis System |
ARKRAY, Inc. |
Tom Speikers (U.S. Agent) |
| K162513 |
10/28/2016 |
Arterys Software v2.0 |
ARTERYS INC. |
GOLNAZ MOEINI |
| K161481 |
10/21/2016 |
Ambient HipVac 50 Wand with Integrated Finger Switches |
ARTHROCARE CORPORATION |
Ashley M. Johnston |
| K161351 |
10/26/2016 |
NanoBone SBX Putty |
ARTOSS GMBH |
Walter Gerike |
| K161912 |
10/14/2016 |
ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip |
ASAHI INTECC CO., LTD. |
Yasuyuki Kawahara |
| K161584 |
10/06/2016 |
ASAHI« Peripheral Vascular Guide Wire ASAHI Meister«16 |
ASAHI INTECC CO.,LTD. |
Yoshihiko Fukui |
| K161546 |
10/14/2016 |
R2P SlenGuide |
ASHITAKA FACTORY OF TERUMO CORPORATION |
PHEBE VARGHESE |
| K162326 |
10/18/2016 |
Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled |
Avinger, Inc |
Patty Hevey |
| K161925 |
10/05/2016 |
CO2 Laser Therapy Machine |
Beijing ADSS Development Co., Ltd |
Gao Yurong |
| K160268 |
10/14/2016 |
Fingertip Pulse Oximeter MD300CG11/MD300CG51 |
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. |
LEI CHEN |
| K161560 |
10/05/2016 |
Fingertip Pulse Oximeter MD300CN310 |
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. |
LEI CHEN |
| K161050 |
10/04/2016 |
ACTABOND Topical Skin Adhesive |
BERGEN MEDICAL PRODUCTS, INC. |
Tom Stephens |
| K160260 |
10/25/2016 |
Tempo Temporary Pacing Lead |
BIO TRACE MEDICAL, INC. |
Laura N. Dietch |
| K161687 |
10/14/2016 |
D-10 Hemoglobin A1c Program |
BIO-RAD LABORATORIES, INC. |
JACKIE BUCKLEY |
| K161109 |
10/06/2016 |
iSR'obot MRI-US Fusion |
BIOBOT SURGICAL PTE LTD |
Lai Chee LIEW |
| K152579 |
10/03/2016 |
FilmArray Respiratory Panel EZ (RP EZ) |
BIOFIRE DIAGNOSTICS, LLC |
KRISTEN J. KANACK |
| K162076 |
10/25/2016 |
chromID MRSA |
bioMerieux, Inc. |
Karen Russell |
| K162424 |
10/12/2016 |
Ulna Plating System |
BIOMET INC |
Julie Largent |
| K161701 |
10/24/2016 |
CARTO ENT System |
BIOSENSE WEBSTER |
MELISSA C. SCHULTZ |
| K162571 |
10/13/2016 |
Bioflux Software |
Biotricity Inc. |
Tom Elias |
| K160985 |
10/07/2016 |
Pantera Pro |
BIOTRONIK, INC |
Jon Brumbaugh |
| K161960 |
10/17/2016 |
bk2300 |
BK MEDICAL APS |
MICHAEL J. DOYLE |
| K162487 |
10/14/2016 |
BSD3543 Digital Flat Panel X-ray Detector |
BONTECH INC. |
KWANG S. CHOI |
| K162404 |
10/12/2016 |
Express SD Biliary Monorail Premounted Stent System |
BOSTON SCIENTIFIC CORPORATION |
Ka Zoua Xiong |
| K160992 |
10/21/2016 |
HPM-6000 |
BTL INDUSTRIES, INC. |
JAN ZARSKY |
| K162443 |
10/25/2016 |
PowerPICC Provena Catheters |
C.R. BARD, INC. |
BRYAN STONE |
| K161773 |
10/21/2016 |
CapsoCam Plus (SV-3) Capsule Endoscope System |
CapsoVision, Inc |
Azimun Jamal |
| K160450 |
10/31/2016 |
Pleurx Pleural Catheter System |
CAREFUSION |
JOY GREIDANUS |
| K161410 |
10/13/2016 |
VT╖One, VT╖One 60days |
CARILEX MEDICAL, INC. |
Henry Kao |
| K161194 |
10/26/2016 |
PLEX Elite 9000 SS-OCT |
CARL ZEISS MEDITEC, INC. |
CHRISTINE DUNBAR |
| K160081 |
10/19/2016 |
TENS Electrodes |
CATHAY MANUFACTURING CORP. |
Ren Ren |
| K160731 |
10/04/2016 |
LumFix Spinal Fixation Sytem |
CG BIO CO., LTD. |
YUNA JEONG |
| K162367 |
10/27/2016 |
Erisma« LP MIS |
CLARIANCE SAS |
Pascal ROKEGEM |
| DEN150059 |
10/06/2016 |
APAS Compact with Urine Analysis Module |
CLEVER CULTURE SYSTEMS AG |
Lusia Guthrie |
| K162437 |
10/28/2016 |
Codman EDS3 CSF External Drainage System |
Codman & Shurtleff, Inc. |
Christopher Garete |
| K161471 |
10/06/2016 |
MR Syringe Dual Pack for Solaris Injectors |
Coeur, Inc. |
Priscilla Clinner |
| K160181 |
10/20/2016 |
COLORADO THERAPEUTICS XENOGRAFT IMPLANT |
Colorado Therapeutics LLC |
WILLIAM JACKSON |
| K162741 |
10/31/2016 |
AxoGuard Nerve Connector |
COOK BIOTECH INCORPORATED |
PERRY W. GUINN |
| K161822 |
10/27/2016 |
Torcon NB Advantage Catheters |
Cook Incorporated |
Jennifer Allman |
| K161496 |
10/07/2016 |
Turbo-Flo PICC Sets |
COOK INCORPORATED |
Steven Lawrie |
| K160217 |
10/06/2016 |
uVue HSG/SHG Catheter |
COOK INCORPORATED |
Kara Kanorr |
| K160121 |
10/27/2016 |
CorPath GRX System |
Corindus, Inc. |
Michael Douglas |
| K161537 |
10/13/2016 |
OTC TENS Device, Model PTS-IV |
COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD |
WENDY POON |
| K162584 |
10/18/2016 |
VersaOne Bladeless Trocar |
COVIDIEN |
TRANG HUYNH |
| K162695 |
10/25/2016 |
truFreeze System |
CSA MEDICAL, INC. |
SHERRIE COVAL-GOLDSMITH |
| K161937 |
10/06/2016 |
CuattroDR |
Cuattro, LLC |
Matthew Taylor |
| K160488 |
10/28/2016 |
Cutera enlighten III Laser System |
Cutera, Inc. |
Bradley Renton |
| K161674 |
10/20/2016 |
QuantumCam |
DDD-DIAGNOSTIC A/S |
Niels Sorensen |
| K153760 |
10/03/2016 |
Volumetric Infusion Controller |
DEKA RESEARCH & DEVELOPMENT |
Julie Perkins |
| K161330 |
10/06/2016 |
Pour Acrylic |
Dentsply Sirona |
Helen Lewis |
| K160199 |
10/19/2016 |
Advocate Insulin Pen Needles |
Diabetic Supply of Suncoast, Inc. |
Victoria Thuss |
| K161497 |
10/28/2016 |
Dental Implants and Abutments |
Ditron Precision Ltd |
Moshe Orlev |
| K160060 |
10/03/2016 |
DMi Dental Implant System |
DMi Innovative Medical Technology Ltd. |
Yaniv Haim Buchacho |
| K152970 |
10/03/2016 |
Dynarex Xeroform Petrolatum Dressing |
DYNAREX CORPORATION |
JAMES HURLMAN |
| K160279 |
10/14/2016 |
ANYVIEW-500R Fluoroscopic Mobile X-Ray System |
ECOTRON CO.,LTD |
Sang Bong Lee |
| K162474 |
10/21/2016 |
Artemis |
EIGEN |
William Mandel |
| K161973 |
10/25/2016 |
G-scan Brio, S-scan |
Esaote S.p.A. |
Maria Marzapane |
| K162290 |
10/14/2016 |
MyLabSix CrystaLine |
ESAOTE S.P.A. |
MASSIMO POLIGNANO |
| K153784 |
10/21/2016 |
NOSOGARD FILTERS |
Evoqua Water Technologies, LLC |
Robert Dudek |
| K162150 |
10/31/2016 |
BreathID Hp Lab System |
Exalenz Bioscience Ltd. |
Raffi Werner |
| K161727 |
10/04/2016 |
Eyenez Ophthalmic Camera |
EYENEZ LLC |
DR. KISLINGER |
| K161676 |
10/20/2016 |
Q13 SPIROLYSER« |
FIM MEDICAL |
LIZA PERRAT |
| K162622 |
10/18/2016 |
Fujifilm Endoscope Models EC-600HL and EC-600LS |
FUJIFILM Medical Systems U.S.A., Inc. |
Shraddha More |
| K161449 |
10/11/2016 |
HammerTech Fixation System |
Fusion Orthopedics, LLC |
Adam Cundiff |
| K162599 |
10/11/2016 |
IcePearl 2.1 CX L, IceForce 2.1 CX L |
GALIL MEDICAL LTD. |
LYNNE DAVIES |
| K160116 |
10/07/2016 |
SpiroScout |
GANSHORN MEDIZIN ELECTRONIC GMBH |
Stefan Ponto |
| K162269 |
10/03/2016 |
Voluson E6, Voluson E8, Voluson E10 |
GE Healthcare |
Bryan Behn |
| DEN160001 |
10/28/2016 |
BD MAX Vaginal Panel, BD MAX Instrument |
GENEOHM SCIENCES CANADA , INC (BD DIAGNOSTICS) |
MANON RICHARD |
| K161815 |
10/12/2016 |
FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band |
Genesee BioMedical, Inc. |
Woodrow G. Mathison |
| K161886 |
10/14/2016 |
Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device |
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD |
ADA ZHANG |
| K153016 |
10/20/2016 |
aoni Natural Rubber Latex Condom |
Guangzhou Daming United Rubber Products Ltd. |
Yongbing Xie |
| K161038 |
10/07/2016 |
PK Morcellator |
GYRUS ACMI, INC. |
GRAHAM A.L. BAILLIE |
| K162117 |
10/25/2016 |
NIRO-200NX DP |
Hamamatsu Photonics K.K. |
Susumu Suzuki |
| K160562 |
10/13/2016 |
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs |
HARTALEGA SND. BHD. |
KUAN KAM HON |
| K152533 |
10/28/2016 |
Xonrid Gel |
Helsinn Healthcare SA |
Valentina Tombolini Bossi |
| K153332 |
10/27/2016 |
ETIII SA Fixture System (O3.2mm) |
HIOSSEN INC. |
PATRICK LIM |
| K160559 |
10/18/2016 |
NOBLUSÖ Ultrasound Diagnostic System |
HITACHI MEDICAL CORPORATION |
ANGELA VAN ARSDALE |
| K161569 |
10/14/2016 |
Trident« II Tritanium« Acetabular Shells and 6.5 mm Low Profile Hex Screws |
Howmedica Osteonics Corp. aka Stryker Orthopaedics |
Valerie Giambanco |
| K160312 |
10/28/2016 |
FRAXIS DUO |
ILOODA CO., LTD |
YUN JUNG HA |
| K161714 |
10/14/2016 |
Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators |
IMMUNALYSIS CORPORATION |
JOSEPH GINETE |
| K160174 |
10/06/2016 |
I.B.S. 2.0 Osteosynthesis screw |
In2Bones SAS |
Morgane Grenier |
| K161426 |
10/24/2016 |
NeoSpan Compression Staple Impant w/instruments |
IN2BONESUSA, LLC |
JOE CLIFT |
| K161458 |
10/03/2016 |
Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care |
Indiba USA Inc. |
Carles Janer |
| K161010 |
10/20/2016 |
HICP200 Patient/Monitor Interconnect Cable |
InnerSpace Neuro Solutions, Inc. |
Gary G. Frugard |
| K161393 |
10/26/2016 |
Reprocessed Orbiter ST Steerable Diagnostic EP Catheter |
Innovative Health, LLC. |
Rafal Chudzik |
| K161677 |
10/07/2016 |
Straumann Sterile Healing Solution |
Institut Straumann AG |
Christopher Klaczyk |
| K160885 |
10/27/2016 |
HemosIL D-Dimer HS |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K161882 |
10/14/2016 |
CUSA Clarity Ultrasonic Surgical Aspirator System |
INTEGRA LIFESCIENCES CORPORATION |
RESHAM RAMSAY |
| K162629 |
10/20/2016 |
IQM Integral Quality Monitor (also IQM) |
IRT SYSTEMS |
Juergen Oellig |
| K162169 |
10/27/2016 |
EdgeOne CO2 Laser |
Jeisys Medical Inc. |
Erica Seo |
| K160143 |
10/28/2016 |
ClearVision ExamVue Flat Panel Detector |
JPI HEALTHCARE, INC |
JANG WON LEE |
| K162664 |
10/07/2016 |
Pyrenees Cervical Plate System |
K2M, Inc. |
NANCY GIEZEN |
| K161555 |
10/21/2016 |
KARL STORZ NAV1 Electromagnetic Navigation System |
KARL STORZ Endoscopy America, Inc. |
Leigh Spotten |
| K162386 |
10/25/2016 |
KATOR Suture Anchor |
KATOR LLC |
Robert Hoy |
| K161897 |
10/04/2016 |
PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
MARGARET MARSH |
| K160864 |
10/07/2016 |
Cryotop Vitrification Kit and Cryotop Thawing Kit |
KITAZATO BIOPHARMA CO., LTD. |
FUTOSHI INOUE |
| K151970 |
10/21/2016 |
KJ Mini Implant System |
KJ MEDITECH CO., LTD. |
GOONG-SAN NAM |
| K162504 |
10/03/2016 |
SKR 3000 |
KONICA MINOLTA, INC |
TSUTOMU FUKUO |
| K162065 |
10/19/2016 |
Ultrasound System SONIMAGE HS1 |
KONICA MINOLTA, INC. |
Tsutomu Fukui |
| K161042 |
10/25/2016 |
CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack |
Kuraray Noritake Dental, Inc. |
Michio Takigawa |
| K160643 |
10/18/2016 |
ENROUTE 0.014 Guidewire |
LAKE REGION MEDICAL |
MICHAEL DUNNING |
| K162445 |
10/20/2016 |
LiVac Retractor System |
Livac Pty Ltd |
Anabela Correia |
| K153769 |
10/05/2016 |
R:GEN Laser System |
Lutronic Corporation |
Jhung Won Vojir |
| K160316 |
10/27/2016 |
SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles |
M.D.L. S.r.l. |
Marcello Dell'Oca |
| K161718 |
10/27/2016 |
MaxBlend 2, MaxBlend Lite |
Maxtec, LLC |
Bruce Brierley |
| K162061 |
10/21/2016 |
M.U.S.T. Pedicle Screw System |
MEDACTA INTERNATIONAL SA |
Stefano Baj |
| K161725 |
10/28/2016 |
Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail |
MEDELA, INC |
ROBERT SOKOLOWSKI |
| K151139 |
10/18/2016 |
EasyMap MAP Catheter |
MedFact Engineering GmbH |
Joerg Reinhardt |
| K161282 |
10/30/2016 |
FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W |
MEDICO ELECTRODES INTERNATIONAL LTD. |
AMIT SETH |
| K161473 |
10/19/2016 |
Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr) |
MEDLINE, INDUSTRIES, INC. |
Jennifer Mason |
| K162469 |
10/26/2016 |
CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps |
Medos International SARL |
Jennifer Siu |
| K162494 |
10/04/2016 |
CD HORIZON« Spinal System |
MEDTRONIC SOFAMOR DANEK USA, INC |
Justin O'Connor |
| K162027 |
10/21/2016 |
TRAcelet Compression Device |
MEDTRONIC VASCULAR |
COLLEEN MULLINS |
| K161361 |
10/14/2016 |
HawkOne Directional Atherectomy System |
Medtronic Vascular, Inc. |
Rupali Gupta |
| K162550 |
10/12/2016 |
Medtronic Model 5392 External Pulse Generator (EPG) |
Medtronic, Inc. |
Brenna Loufek |
| K162054 |
10/18/2016 |
Medtronic Temporary External Pacemaker 53401 |
MEDTRONIC, INC. |
SYED SUMRAN MOHIUDDIN |
| K162687 |
10/21/2016 |
Paragon 2 |
MERIDIAN MEDICAL SYSTEMS, LLC |
Larry Cornell |
| K162777 |
10/31/2016 |
Squirt Fluid Delivery System |
Merit Medical Systems, Inc. |
Angela Brady |
| K162635 |
10/21/2016 |
Distal Radius Plating System |
Miami Device Solutions, LLC |
Michelle Montesino |
| K161152 |
10/12/2016 |
Navien Intracranial Support Catheter |
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
Ingrid Takeuchi |
| K160706 |
10/19/2016 |
ReNew V Handpiece Laparoscopic Instruments |
MICROLINE SURGICAL, INC. |
ANU GAUR |
| K162419 |
10/28/2016 |
FIREFLY« Pedicle Screw Navigation Guide |
MIGHTY OAK MEDICAL INC. |
Mark A. Wylie |
| K160141 |
10/31/2016 |
miraDry System |
Miramar Labs, Inc. |
Kathy O'Shaughnessy |
| K161797 |
10/19/2016 |
Avance Tubing, Avance Y-Connector, Avance ViewPad |
MOLNLYCKE HEALTH CARE, US LLC |
MEGAN BEVILL |
| K162762 |
10/26/2016 |
NeuroBlate System |
Monteris Medical, Inc. |
David H. Mueller |
| K160909 |
10/04/2016 |
ATTO Mobility Scooter |
Moving Life Ltd |
Nino A. Ransenberg |
| K153577 |
10/14/2016 |
FREND Testosterone Test System |
NanoEnTek USA Inc. |
Jimmy Chen |
| K162250 |
10/26/2016 |
FortiBridge Anterior Cervical Plate System |
NANOVIS SPINE LLC |
MATTHEW HEDRICK |
| K160442 |
10/21/2016 |
Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers |
NEURAL ANALYTICS, INC. |
JAY YONEMOTO |
| K162060 |
10/24/2016 |
Ahmed Glaucoma Valve |
NEW WORLD MEDICAL, INC. |
SUHAIL ABDULLAH |
| K161448 |
10/31/2016 |
Footmotion Plating System |
NEWCLIP TECHNICS |
Gaelle Lussori |
| K151995 |
10/05/2016 |
Painmaster MCT Patch |
NEWMARK, INC. |
Francis Powell |
| K160371 |
10/14/2016 |
NovaPACS |
NOVARAD CORPORATION |
DOUG MERRILL |
| K162602 |
10/18/2016 |
NovoPen Echo |
Novo Nordisk Inc. |
Elizabeth D'Amato |
| K161941 |
10/19/2016 |
Pulsaderm Acne Device |
NUTRA LUXE MD, LLC |
GLORIA AVENDANO |
| K160352 |
10/21/2016 |
MAGEC« Spinal Bracing and Distraction System |
NuVasive Specialized Orthopedics, Inc. |
LANCE JUSTICE |
| K162138 |
10/26/2016 |
NuVasive CoRoent Small Ti-C System |
NUVASIVE, INCORPORATED |
MICHELLE CHEUNG |
| K161828 |
10/03/2016 |
kneeEOS |
ONEFIT Medical |
Julien Simon |
| K161520 |
10/28/2016 |
ELEOS Limb Salvage System |
Onkos Surgical, Inc. |
Jan Triani |
| K162209 |
10/06/2016 |
Sapphire NC Plus |
OrbusNeich Medical, Inc |
John D. Pazienza |
| K160495 |
10/18/2016 |
VITROS« Automation Solutions |
Ortho-Clinical Diagnostics, Inc. |
Darlene J Phillips |
| K161447 |
10/06/2016 |
HydroSet XT |
ORTHOVITA, INC. |
TINA MORNAK |
| K160519 |
10/28/2016 |
Link Abutment for CEREC |
Osstem Implant Co., Ltd |
Hee Kwon |
| K161604 |
10/17/2016 |
OSSTEM Implant System |
OSSTEM IMPLANT CO., LTD. |
Hee Kwon |
| K160363 |
10/20/2016 |
OPTIMUS CMF SYSTEM |
OSTEONIC Co., Ltd. |
Jisun Lee |
| K160076 |
10/13/2016 |
XCageÖ Interbody Fusion System |
Ouroboros Medical, Inc. |
John To |
| K153550 |
10/12/2016 |
FTRD System Set |
OVESCO ENDOSCOPY AG |
MARC O. SCHURR |
| K160295 |
10/27/2016 |
SPROTTE NRFit, Quincke NRFit |
PAJUNK GmbH Medizintechnologie |
Christian G. H. Quass |
| K160294 |
10/21/2016 |
SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN G.H. QUASS |
| K160296 |
10/27/2016 |
SPROTTE SPECIAL NRFit |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN G.H. QUASS |
| K160297 |
10/28/2016 |
Tuohy NRFit |
PAJUNK GmbH Medizintechnologie |
Christian G.H. Quass |
| K162549 |
10/03/2016 |
Lumify Ultrasound System |
Philips Healthcare |
Chuck Morreale |
| K162025 |
10/18/2016 |
IntelliSpace Portal Platform |
PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V. |
Ilana Ben Moshe |
| K161931 |
10/12/2016 |
Toricolors (hioxifilcon D) Soft Contact Lenses |
POLYDEV LTD. |
JOHN MULVIHILL |
| K161580 |
10/18/2016 |
Premier Sealant |
PREMIER DENTAL COMPANY PRODUCTS |
VINCENT D'ALESSANDRO |
| K160100 |
10/07/2016 |
Prestige Ameritech Pediatric/ChildÆs Face mask |
Prestige Ameritech |
RODNEY GREGORY |
| K161881 |
10/03/2016 |
PreXion3D Excelsior |
PreXion Corporation |
Shumpeita Torii |
| K161642 |
10/07/2016 |
CAVUXÖ Cervical Cage |
PROVIDENCE MEDICAL TECHNOLOGY, INC |
Margaret Wong |
| K161295 |
10/21/2016 |
MiniBox + |
PULMONE ADVANCED MEDICAL DEVICES, LTD |
Avi Lazar |
| K162029 |
10/18/2016 |
16ch T/R Knee Coil |
Quality Electrodynamics, LLC |
Kathleen Aras |
| K162276 |
10/01/2016 |
SeraQuest Herpes Type 1 Specific IgG |
QUEST INTERNATIONAL, INC |
DAVID J. KIEFER |
| K162274 |
10/25/2016 |
Solana Strep Complete Assay |
Quidel Corporation |
Ronald H Lollar |
| K161480 |
10/05/2016 |
R2 Dermal Cooling System |
R2 Dermatology |
Kristine Tatsutani |
| K162519 |
10/06/2016 |
1717WCC / 1717WGC |
RAYENCE CO., LTD |
KEVIN KIM |
| K162518 |
10/06/2016 |
1012WCC, 1012WGC |
RAYENCE CO., LTD. |
KEVIN KIM |
| K161684 |
10/06/2016 |
Quantum LB |
Reliance Orthodontic Products Inc. |
Paula Wendland |
| K162593 |
10/19/2016 |
HDL-Cholesterol Gen.4 |
Roche Diagnostics Operations (RDO) |
Barbara McWhorter |
| K160847 |
10/20/2016 |
Rockwell Medical CitraPure Acid Concetrate |
ROCKWELL MEDICAL |
ROBERT CHIOINI |
| K153539 |
10/03/2016 |
RS80A Diagnostic Ultrasound System |
SAMSUNG MEDISON CO., LTD. |
Kyeong-Mi Park |
| K151399 |
10/24/2016 |
Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow |
SCHUTZ DENTAL GMBH |
ANTJE MAURER |
| K162715 |
10/28/2016 |
SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K153521 |
10/14/2016 |
IH Implant System |
Sewon Medix Inc. |
Bum-keun Park |
| K161851 |
10/31/2016 |
Glass Ionomer Cement (Luting) |
SHANDONG HUGE DENTAL MATERIAL CORPORATION |
STEVEN SONG |
| K153188 |
10/24/2016 |
Caremed patient cable and leadwires |
SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD. |
XINLIN XIAO |
| K161893 |
10/18/2016 |
Neuromonitoring Kit |
SI-BONE, INC. |
ROXANNE DUBOIS |
| K161964 |
10/13/2016 |
ADVIA Centaur HAV IgM Assay |
Siemens Healthcare Diagnostics, Inc. |
Philip Liu |
| K162736 |
10/25/2016 |
Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT |
Siemens Medical Solutions USA, Inc. |
ALAINE MEDIO |
| K162370 |
10/25/2016 |
syngo.via RT Image Suite |
Siemens Medical Solutions USA, Inc. |
Kimberly Mangum |
| K162011 |
10/14/2016 |
MedDream |
SOFTNETA UAB |
LAURA BARONIENE |
| K162750 |
10/27/2016 |
Libra Pedicle Screw System |
Spinal Balance, Inc. |
Anand Agarwal |
| K160074 |
10/18/2016 |
Rampart D Lumbar Interbody Fusion Device |
Spineology Inc. |
Karen Roche |
| K160187 |
10/21/2016 |
Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 |
ST. JUDE MEDICAL |
MELISSA FRANK |
| K160186 |
10/07/2016 |
EnSite Velocity Surface Electrode Kit |
ST. JUDE MEDICAL |
YUMI WACKERFUSS |
| K162317 |
10/21/2016 |
Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens |
ST. SHINE OPTICAL CO., LTD. |
ELLA LEE |
| K161720 |
10/24/2016 |
Standard Clamp |
STANDARD BARIATRICS |
Alison Sathe |
| K160912 |
10/07/2016 |
Sterilization Tray |
STERIS CORPORATION |
ANTHONY PIOTRKOWSKI |
| K161483 |
10/31/2016 |
Unger Quad Injector |
STRADIS HEALTHCARE |
Joseph Trznadel |
| K162341 |
10/12/2016 |
Stryker OrthoMap Precision Knee system |
Stryker Leibinger GmbH & Co. KG |
N/A N/A |
| K153685 |
10/13/2016 |
Sunmed Haemostatic Valves |
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD. |
James Qi Zhang |
| K161065 |
10/27/2016 |
ColpoWaveÖ Colpotomizer and CerviGripÖ Uterine Manipulator |
Surgitools Pty Ltd. |
Jai Singh |
| K160103 |
10/12/2016 |
Spetzler Malis Dual Illuminating Bipolar Forceps |
SYNERGETICS |
DAN REGAN |
| K160541 |
10/21/2016 |
Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control |
SYSMEX AMERICA, INC. |
Michelle Parker |
| K162080 |
10/25/2016 |
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater |
Tandem Diabetes Care, Inc. |
Michael Sarrasin |
| K162514 |
10/26/2016 |
Multichem A1c |
Technopath Manufacturing |
Bernd Hass |
| K161075 |
10/04/2016 |
Arrow Epidural Catheter Kit |
TELEFLEX MEDICAL, INC. |
ANGELA BOUSE |
| K161854 |
10/04/2016 |
Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS |
THE BINDING SITE GROUP LTD |
ANDREA THOMAS |
| K161184 |
10/14/2016 |
iNSitu Total Hip System |
Theken Companies, LLC |
Dale Davison |
| K162614 |
10/17/2016 |
Infinix, INFX-8000V, V6.35 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K162256 |
10/27/2016 |
Klassic Femur, Porous, Klassic Tibial Baseplate, Porous |
TOTAL JOINT ORTHOPEDICS, INC. |
CHRIS WEABER |
| K162422 |
10/28/2016 |
Klassic Knee System |
Total Joint Orthopedics, Inc. |
Chris Weaber |
| K161073 |
10/19/2016 |
Klassic HD Hip System |
Total Joint Othopedics, Inc. |
Chris Weaber |
| K161846 |
10/24/2016 |
Automatic Arm Bluetooth Blood Pressure Monitor |
TRULY INSTRUMENT LIMITED |
YANG JIAN-HO |
| K160401 |
10/19/2016 |
Tyto Stethoscope |
Tyto Care Ltd. |
Yoni Iger |
| K161885 |
10/05/2016 |
The Cellfina System |
ULTHERA, INC. |
SUZON LOMMEL |
| K161540 |
10/20/2016 |
Advanced Breast Template System |
VARIAN MEDICAL SYSTEMS, INC. |
Peter J. Coronado |
| K161576 |
10/02/2016 |
Esophagus Bougie Set |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K162272 |
10/20/2016 |
Fluent inflation device |
VASCULAR SOLUTIONS, INC. |
BEKA VITE |
| K162660 |
10/20/2016 |
Green Smart (Model: PHT-35LHS) |
VATECH CO., LTD |
Daniel Kim |
| K160882 |
10/28/2016 |
PaX-i3D Green Premium (Model: PCT-90LH) |
VATECH CO., LTD |
Daniel Kim |
| K162145 |
10/25/2016 |
vRad PACS with Mammography |
Virtual Radiologic Corporation |
Melinda Sewell |
| K160245 |
10/24/2016 |
Visco (olifilcon A) soft contact lens |
Visco Vision Inc |
Evan Huang |
| K160327 |
10/05/2016 |
ALADDIN HW3.0 |
VISIA IMAGING S.R.L |
Silvia Fantechi |
| K162547 |
10/06/2016 |
Viveve System |
Viveve Inc. |
Jim Talbot |
| K160583 |
10/26/2016 |
REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip |
VOLCANO CORPORATION |
BRIAN PARK |
| K161786 |
10/18/2016 |
ClearLumen II Thrombectomy System |
Walk Vascular, LLC |
David Look |
| K161110 |
10/12/2016 |
ClearPetra Suction-Evacuation Sheath |
WELL LEAD MEDICAL CO., LTD. |
Han Guang Yuan |
| K161422 |
10/20/2016 |
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
WRP ASIA PACIFIC SDN. BHD. |
SARALA DEVI JAYARAMAN |
| K160246 |
10/06/2016 |
SimulCare II(TM) |
XANACARE TECHNOLOGIES, LLC |
THOMAS C SIIROLA |
| K160313 |
10/21/2016 |
Xenco Medical Cervical Interbody System |
XENCO MEDICAL, LLC |
GUSTAVO PRADO |
| K161016 |
10/19/2016 |
Z-Clamp ISP System |
Zavation, LLC |
James M Philips |
| K152472 |
10/31/2016 |
Disposable Pressure Transducer |
ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. |
Junbin Hu |
| K161976 |
10/06/2016 |
Ziehm Solo FD |
ZIEHM IMAGING GMBH |
RICHARD L. WESTRICH |
| K161830 |
10/26/2016 |
Zimmer M/L Taper Hip Prosthesis |
ZIMMER, INC. |
RHONDA MYER |
