| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K162375 |
08/24/2016 |
Envision 3D: Image Guidance System |
7D SURGICAL INC. |
DANIEL ZISKIND |
| K162322 |
08/19/2016 |
the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model |
ACCESS SCIENTIFIC, LLC |
WALTER CORDIGLIA |
| K162348 |
08/22/2016 |
ABCcolla Collagen Matrix |
ACRO BIOMEDICAL CO., LTD |
DAR-JEN HSIEH |
| K162230 |
08/08/2016 |
Fully Automatic Electronic Blood Pressure Monitor |
ADON HEALTH CO., LTD. |
Liu Yi |
| K162134 |
08/01/2016 |
ENNOVATE Spinal System |
Aesculap Implant Systems, LLC |
Paul Amudala |
| K162228 |
08/08/2016 |
TorqVue Low Profile Delivery Catheter |
AGA MEDICAL CORPORATION (WHOLLY OWNED BY ST.JUDE MEDICAL COR |
Mary Johnson |
| K162160 |
08/02/2016 |
Preference Elite Pedicle Screw System |
AMEDICA CORPORATION |
Shanna Ryan |
| K162144 |
08/01/2016 |
iHealth Wireless Blood Pressure Monitor |
ANDON HEALTH CO.,LTD |
Liu Yi |
| K162316 |
08/18/2016 |
Pirouette 014 |
ArraVasc Ltd |
Aoife Donoghue |
| K162126 |
08/01/2016 |
Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW) |
ArthroCare Corporation |
Ashley M. Johnson |
| K162391 |
08/26/2016 |
AlignMATEÖ Lapidus Arthrodesis System |
ARTHROSURFACE, INC. |
PHANI PUPPALA |
| K162248 |
08/10/2016 |
Asahi ViE-U Series Dialyzer |
ASAHI KASEI MEDICAL CO., LTD. |
Masaharu Aritomi |
| K162336 |
08/22/2016 |
Contour Next EZ Blood Glucose Monitoring System |
Ascensia Diabetes Care US Inc. |
Jennifer L. Gregory |
| K162153 |
08/02/2016 |
Integra« CAPTUREÖ Screw System & Integra« Ti6« Internal Fixation System |
ASCENSION ORTHOPEDICS |
GABRIELLA BECKER |
| K162392 |
08/26/2016 |
Avazzia |
AVAZZIA, INC. |
TAMMY LAHUTSKY |
| K162326 |
08/19/2016 |
Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled |
Avinger, Inc |
Patty Hevey |
| K162342 |
08/22/2016 |
Stellaris Elite Vision Enhancement System |
Bausch + Lomb |
Ken Nehmer |
| K162208 |
08/05/2016 |
DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent |
BECKMAN COULTER INC. |
Geraldine Fuentespina |
| K162414 |
08/29/2016 |
UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System |
BECKMAN COULTER, INC. |
NANCY NADLER |
| K162380 |
08/24/2016 |
Locking Plate System |
BEIJING KEYI MEDICAL DEVICE TECHNOLOGY CO., LTD. |
CINDY NIE |
| K162398 |
08/26/2016 |
CO2 Laser Therapy Systems |
BEIJING SINCOHEREN SCIENCE AND TECHNOLOGY DEVELOPMENT CO. |
XIN WANG |
| K162431 |
08/31/2016 |
Luna 3D Interbody Fusion System |
Benvenue Medical, Inc. |
Jeff Emery |
| K162180 |
08/04/2016 |
Disposable Insulin Syringe |
BERPU MEDICAL TECHNOLOGY CO., LTD |
JUNDONG TAN |
| K162232 |
08/08/2016 |
MOSS 100 Pedicle Screw System |
Biedermann Motech GmbH & Co. KG |
Gerd Federle |
| K162373 |
08/24/2016 |
LC Bead LUMI |
Biocompatibles UK Limited |
Simon Leppard |
| K162385 |
08/25/2016 |
RAPIDEC CARBA NP |
BIOMERIEUX SA |
ASA KARLSSON |
| K162424 |
08/30/2016 |
Ulna Plating System |
BIOMET INC |
Julie Largent |
| K162407 |
08/29/2016 |
L300 Go System |
BIONESS INC. |
MERCEDES BAYANI |
| DEN160040 |
08/05/2016 |
Embosphere Microspheres |
Biosphere Medical S.A. |
Alix Fonlladosa |
| K162192 |
08/04/2016 |
BluePro |
BlueSom |
Erwan Floch |
| K162205 |
08/05/2016 |
Arc EndoCuff and Arc EndoCuff Vision |
BODDINGTONS PLASTICS LTD |
SARAH GIBSON |
| K162350 |
08/23/2016 |
Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous |
Boston Scientific Corporation |
Ka Zoua Xiong |
| K162404 |
08/29/2016 |
Express SD Biliary Monorail Premounted Stent System |
BOSTON SCIENTIFIC CORPORATION |
Ka Zoua Xiong |
| K162186 |
08/04/2016 |
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12ö, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM |
BRIGHTWAY HOLDINGS SDN BHD |
G. BASKARAN |
| K162294 |
08/15/2016 |
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12ö, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
BRIGHTWAY HOLDINGS SDN BHD. |
G. BASKARAN |
| K162146 |
08/01/2016 |
Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) |
BRIGHTWAY HOLDINGS SDN BHD. |
G. BASKARAN |
| K162193 |
08/04/2016 |
XenMatrix AB Surgical Graft |
C.R. Bard |
Tony John |
| K162441 |
08/31/2016 |
PowerPICC Provena Catheters with SOLO Valve Technology |
C.R. BARD, INC |
BRYAN STONE |
| K162377 |
08/24/2016 |
PowerGlide Pro Midline Catheter |
C.R. BARD, INC. |
JACOB LEE |
| K162443 |
08/31/2016 |
PowerPICC Provena Catheters |
C.R. BARD, INC. |
BRYAN STONE |
| K162383 |
08/25/2016 |
Cadwell Sierra Summit, Cadwell Sierra Ascent |
CADWELL INDUSTRIES, INC. |
CHRISTOPHER BOLKAN |
| K162199 |
08/05/2016 |
Cascade IOMAX Intraoperative Monitor |
CADWELL INDUSTRIES, INC. |
MELISSA KIRKUP |
| K162201 |
08/05/2016 |
Desara TV, Desara Blue TV |
CALDERA MEDICAL, INC. |
Vicki Gail |
| K162121 |
08/01/2016 |
Siconus SI Joint Fixation System |
CAMBER SPINE TECHNOLOGIES |
DAMIAN HEINZ |
| K162394 |
08/26/2016 |
CRC-77tHR |
Capintec, Inc. |
Mary Anne Yusko |
| K162214 |
08/08/2016 |
Protek Solo 24 Fr Venous Cannula Set |
CARDIAC ASSIST, INC. |
GREG JOHNSON |
| K162181 |
08/04/2016 |
Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set |
CARDIACASSIST INC. |
GREG JOHNSON |
| K162440 |
08/31/2016 |
CardioInsight Cardiac Mapping System |
CARDIOINSIGHT TECHNOLOGIES, INC |
LAURIE LEWANDOWSKI |
| K162432 |
08/31/2016 |
Multi-Link X2 ECG Cable and Lead Wire System |
CAREFUSION 2200 INC. |
ERIKA FERNANDEZ |
| K162178 |
08/04/2016 |
CareView 1500P X-ray Flat Panel Detectors |
CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. |
XU WEI |
| K162254 |
08/10/2016 |
Cedic Enteral ENFit Transition Connectors |
CEDIC S.R.L. |
TIZIANA MELIS |
| K162444 |
08/31/2016 |
Xpert MRSA NxG |
CEPHEID |
SCOTT A. CAMPBELL |
| K162331 |
08/19/2016 |
Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System |
CEPHEID |
SCOTT A. CAMPBELL |
| K162352 |
08/23/2016 |
derma+flex QS High Viscosity Tissue Adhesive |
CHEMENCE MEDICAL INC |
Kenneth Broadley |
| K162172 |
08/03/2016 |
EBit Series Diagnostic Ultrasound System |
CHISON MEDICAL IMAGING CO., LTD. |
QIFEI LIU |
| K162367 |
08/23/2016 |
Erisma« LP MIS |
CLARIANCE SAS |
Pascal ROKEGEM |
| K162224 |
08/08/2016 |
ArtPix Mobile EZ2GO |
CMT MEDICAL TECHNOLOGIES, LTD. |
LILIA SCHLOSBERG |
| K162437 |
08/31/2016 |
Codman EDS3 CSF External Drainage System |
Codman & Shurtleff, Inc. |
Christopher Garete |
| K162158 |
08/02/2016 |
Porcine Anorganic Bone Mineral in Delivery Applicator |
Collagen Matrix, Inc. |
Peggy Hansen |
| K162405 |
08/29/2016 |
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 |
| K162127 |
08/01/2016 |
Bencox M Stem Lateralized & Bencox Mirabo Cup System |
CORENTEC CO., LTD |
J. S. DANIEL |
| K162253 |
08/10/2016 |
Trapper Exchange Device |
CREGANNA MEDICAL ASLO BUSINESS AS CREGGANNA TACTX MEDICAL |
ORLA HICKEY |
| K162388 |
08/25/2016 |
CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF) |
CURASEAL, INC. |
HAROLD F. CARRISON |
| K162120 |
08/01/2016 |
Scope-Assist Flushing Sink |
Custom Ultrasonics Inc. |
Elizabeth Lazaro |
| K162231 |
08/08/2016 |
iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert |
CYDEN LIMITED |
MIKE KIERNAN |
| K162397 |
08/26/2016 |
Titan 3 Low Speed Angle Attachments |
DENTALEZ, INC |
Dan Laskowitz |
| K162124 |
08/01/2016 |
Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins |
DePuy Synthes |
CHRISTOPHER J. MEDBERRY |
| K162227 |
08/08/2016 |
STA« - Liatest« D-Di |
Diagnostica Stago |
Arnaud Berthier |
| K162297 |
08/16/2016 |
Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set |
Diazyme Laboratories |
Abhijit Datta |
| K162220 |
08/08/2016 |
DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage |
DIO MEDICAL CO., LTD |
SUNG HEE-LEE |
| K162421 |
08/30/2016 |
IntelliCartTM System |
DORNOCH MEDICAL SYSTEMS |
LARRY SMITH |
| K162283 |
08/15/2016 |
DCM Kyphoplasty System |
Dragon Crown Medical Co., Ltd. |
Zhi Yong Song |
| K162408 |
08/29/2016 |
Nano Varnish, Plaquit, Lightpaint on Surface |
DREVE DENTAMID GMBH |
REINER ALTMANN |
| K162285 |
08/15/2016 |
EBM iDO Viewer 1.2.1 |
EBM Technologies Incorporated |
John Su |
| K162184 |
08/04/2016 |
Edwards eSheath Introducer Set |
Edward Lifesciences |
Yi Gao |
| K162140 |
08/01/2016 |
RemLogic |
EMBLA SYSTEMS |
SHANE T. SAWALL |
| K162197 |
08/05/2016 |
EndoClot |
EndoClot Plus Co., Ltd. |
Hendry Zhang |
| K162152 |
08/02/2016 |
ErbeÆs CO2 Tubing/Cap Sets |
Erbe USA, Inc. |
John Tartal |
| K162290 |
08/15/2016 |
MyLabSix CrystaLine |
ESAOTE S.P.A. |
MASSIMO POLIGNANO |
| K162167 |
08/03/2016 |
Caphosol Artifical Saliva Tablets |
EUSA Pharma (UK) Limited |
Paul Davisson |
| K162325 |
08/19/2016 |
Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw |
Exactech Inc |
Zach Sharrah |
| K162150 |
08/02/2016 |
BreathID Hp Lab System |
Exalenz Bioscience Ltd. |
Raffi Werner |
| K162319 |
08/19/2016 |
BabyDance Fertility Lubricant |
Fairhaven Health, LLC |
Suzanne Munson |
| K162176 |
08/03/2016 |
Fiagon Navigation System |
Fiagon GmbH |
Dirk Mucha |
| K162287 |
08/15/2016 |
Synapse 3D Perfusion Analysis |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
Jyh-Shyan Lin |
| K162288 |
08/15/2016 |
SonoSite iViz Ultrasound System |
FUJIFILM SONOSITE, INC. |
Patricia Liau |
| K162268 |
08/12/2016 |
Senographe Pristina |
GE HEALTHCARE |
Gregory Pessato |
| K162269 |
08/12/2016 |
Voluson E6, Voluson E8, Voluson E10 |
GE Healthcare |
Bryan Behn |
| K162403 |
08/29/2016 |
HyperBand |
GE Medical Systems, LLC |
Jason Ma |
| K162409 |
08/29/2016 |
Gems Vitrification Set, Gems Warming Set |
GENEA BIOMEDX PTY LTD |
Kea Dent |
| K162315 |
08/18/2016 |
FORTIFY Corpectomy Spacers |
GLOBUS MEDICAL INC. |
Kelly J. Baker |
| K162207 |
08/05/2016 |
Restore Moisturizing Vaginal Lubricant |
Good Clean Love |
Wendy Strgar |
| K162299 |
08/16/2016 |
Spiral Shape Dental Implant System |
GP Implants |
Pivovarov German |
| K162179 |
08/04/2016 |
osteo-WEDGE II « Open Wedge Bone Locking Plate System |
GRAHAM MEDICAL TECHNOLOGIES, L.L.C. DBA GRAMEDICA |
Angela Recchia |
| K162442 |
08/31/2016 |
ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 |
GRI MEDICAL & ELECTRICAL TECHNOLOGY CO., LTD. |
Martin D. Paugh |
| K162234 |
08/09/2016 |
Truscope Ultra Patient Monitor |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
Jing Liang |
| K162333 |
08/22/2016 |
Wondfo One Step Fecal Occult Blood (FOB) Test |
GUANGZHOU WONDFO BIOTECH CO., LTD. |
Bin Chen |
| K162423 |
08/30/2016 |
Haemonetics Cell Saver Elite/Elite+ Autotransfusion System |
HAEMONETICS CORPORATION |
MARK ANZALONE |
| K162338 |
08/22/2016 |
Full Automatic (NIBP) Blood Pressure Monitor |
HEALTH & LIFE CO., LTD. |
SARAH SU |
| K162381 |
08/24/2016 |
HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs |
HEALTHY GLOVE CO., LTD |
Teoh Choh Shee |
| K162390 |
08/26/2016 |
ET Hybrid Abutment |
HIOSSEN INC. |
David Kim |
| K162412 |
08/29/2016 |
Hoggan Scientific« microFET2Ö |
Hoggan Scientific, LLC |
Spencer Walker |
| K162314 |
08/18/2016 |
IMACTIS CT-Navigation system |
IMACTIS, SAS |
MADY BATAILH |
| K162344 |
08/22/2016 |
INNOLUX RIC |
INNOLUX CORPORATION |
Andy Kuo |
| K162236 |
08/09/2016 |
Ax Stand-Alone ALIF System |
INNOVASIS, INC. |
Marshall McCarty |
| K162143 |
08/01/2016 |
FixxSure« X-Link |
INNOVASIS, INC. |
MARSHALL MCCARTY |
| K162251 |
08/10/2016 |
Reprocessed Viking Diagnostic Electrophysiology Catheters |
Innovative Health, LLC. |
Sharon Higgins |
| K162311 |
08/18/2016 |
Straumann PrefGel |
INSTITUT STRAUMANN AG |
CHRISTOPHER KLACZYK |
| K162296 |
08/16/2016 |
OmniPod Insulin Management System |
INSULET CORPORATION |
MATTHEW KING |
| K162364 |
08/23/2016 |
Intellijoint HIP Generation 2A System |
INTELLIJOINT SURGICAL INC. |
BRANDON GINGRICH |
| K162411 |
08/29/2016 |
da Vinci Xi 12 û 8 mm Reducer |
Intuitive Surgical, Inc. |
Vishal Kanani |
| K162203 |
08/05/2016 |
POGO Automatic Blood Glucose Monitoring System |
Intuity Medical, Inc. |
Robb Hesley |
| K162177 |
08/04/2016 |
dS FootAnkle I6CH 1.5T Coil |
Invivo Corporation |
Ken Revennaugh |
| K162416 |
08/30/2016 |
IRIDEX Cyclo G6 Laser System, G-Probe Illuminate |
IRIDEX CORPORATION |
KATHY MAYNOR |
| K162265 |
08/11/2016 |
CushionCast Moldable Cushions |
IZI Medical Products LLC |
Qiang Cao |
| K162169 |
08/03/2016 |
EdgeOne CO2 Laser |
Jeisys Medical Inc. |
Erica Seo |
| K162264 |
08/11/2016 |
Cascadia Interbody System |
K2M, Inc. |
NANCY GIEZEN |
| K162427 |
08/30/2016 |
Vado Bi-Directional Steerable Sheath |
KALILA MEDICAL, INC. |
CARRIE NEUBERGER |
| K162410 |
08/29/2016 |
TIPCAM 1S 3D System |
KARL STORZ Endoscopy America, Inc |
Winkie Wong |
| K162386 |
08/25/2016 |
KATOR Suture Anchor |
KATOR LLC |
Robert Hoy |
| K162436 |
08/31/2016 |
EndoVac Pure |
Kerr Corporation |
Mohammad Saad Ansari |
| K162164 |
08/03/2016 |
GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord |
KERR CORPORATION |
MOHAMMAD SAAD ANSARI |
| K162257 |
08/11/2016 |
P1145 Dental Restorative |
Kerr Corporation |
Mohammad Saad Ansari |
| K162136 |
08/01/2016 |
CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System |
L&K BIOMED CO.,LTD. |
Yerim An |
| K162216 |
08/08/2016 |
GRI-FILL PERISTALTIC SET |
LABORATORIOS GRIFOLS, S.A. |
MARTA DANIELA SERRA DE FORTUNY |
| K162235 |
08/09/2016 |
LUVENA VAGINAL MOISTURIZER & LUBRICANT |
LACLEDE, INC. |
MICHAEL PELLICO |
| K162133 |
08/01/2016 |
VerteFIT Corpectomy Cage System |
LDR SPINE USA, INC. |
JAMIE WILSON |
| K162323 |
08/19/2016 |
Tooth Shade Resin Material |
LIAONING UPCERA CO.,LTD |
Charles Shen |
| K162266 |
08/11/2016 |
The Cranial Fusion System |
LIFE SPINE INC. |
RANDY LEWIS |
| K162445 |
08/31/2016 |
LiVac Retractor System |
Livac Pty Ltd |
Anabela Correia |
| K162428 |
08/30/2016 |
DiLumen Endolumenal Interventional Platform |
Lumendi, LLC |
Dennis Daniels |
| K162210 |
08/05/2016 |
touchTymp |
MAICO DIAGNOSTICS GMBH |
UWE LEDWORUSKI |
| K162273 |
08/12/2016 |
Materialise TKA Guide System |
MATERIALISE NV |
OLIVER CLEMENS |
| K162119 |
08/01/2016 |
UreTron PF Series Probe |
MED-SONICS CORP. |
JENNIFER RAUTINE |
| K162389 |
08/26/2016 |
Medcomp Vessel Dilator |
MEDCOMP ( MEDICAL COMPONENTS) |
COURTNEY NIX |
| K162271 |
08/12/2016 |
Pro-Lock CT Safety Infusion Set |
MEDCOMP (MEDICAL COMPONENTS, INC.) |
COURTNEY NIX |
| K162194 |
08/05/2016 |
MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System |
MEDICREA INTERNATIONAL S.A |
DAVID RYAN |
| K162434 |
08/31/2016 |
NC Gallant PTCA Catheter |
MEDINOL LTD. |
MICHAL HERSHKOVITZ |
| K162128 |
08/01/2016 |
Scope Buddy Plus Endoscope Flushing Aid |
MEDIVATORS INC. |
Kristin Bergeson Padilla |
| K162247 |
08/10/2016 |
PERMATAPE |
MEDOS INTERNATIONAL SARL |
TATYANA KORSUNSKY |
| K162327 |
08/19/2016 |
COUGAR« LS Lateral Cage System and COUGAR« System |
Medos International, Sarl |
Eric Zhu |
| K162330 |
08/19/2016 |
Flex Robotic System and Flex Colorectal Drive |
Medrobotics Corporation |
John D. Bonasera |
| K162309 |
08/17/2016 |
StealthStation S8 System Platforms and StealthStation Cranial Software |
MEDTRONIC NAVIGATION, INC. |
Tia Fushimi-Bain |
| K162379 |
08/24/2016 |
CD HORIZON« Spinal System |
MEDTRONIC SOFAMOR DANEK USA, INC. |
Nathaniel Hendricks |
| K162212 |
08/08/2016 |
DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
LEE GRANT |
| K162384 |
08/25/2016 |
TrailBlazer Angled Support Catheter |
Medtronic Vascular, Inc.(formerly ev3 Inc.) |
David Robertson |
| K162226 |
08/08/2016 |
Reliant Multistage Dilatation Balloon Catheter |
Micro-Tech (Nanjing) CO., Ltd. |
Becky Li |
| K162419 |
08/30/2016 |
FIREFLY« Pedicle Screw Navigation Guide |
MIGHTY OAK MEDICAL INC. |
Mark A. Wylie |
| K162395 |
08/26/2016 |
MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup |
MP BIOMEDICALS, LLC |
STAR HAN |
| K162378 |
08/24/2016 |
FREND PSA PLUS (reagent cartridge) |
NANOENTEK USA INC |
SUNMI HAN |
| K162250 |
08/10/2016 |
FortiBridge Anterior Cervical Plate System |
NANOVIS SPINE LLC |
MATTHEW HEDRICK |
| K162345 |
08/22/2016 |
UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge |
NEOTRACT, INC. |
LOUIS-PIERRE MARCOUX |
| K162332 |
08/19/2016 |
Nexcore GI Insufflator |
NEXCORE TECHNOLOGY, LLC |
Julie Broderick |
| K162308 |
08/17/2016 |
Noris Medical MBI-2mm Dental Implant System |
Noris Medical Ltd |
Simha Sibony |
| K162218 |
08/08/2016 |
Pain FreezeÖ, Medium Stream Spray, Model #2101; Pain FreezeÖ, Mist Spray, Model #2102 |
NUANCE MEDICAL, LLC |
MARC LIEBERMAN |
| K162371 |
08/24/2016 |
Pulsaderm ACE-All Blue |
Nutra Luxe MD, LLC |
Gloria Avendano |
| K162313 |
08/18/2016 |
NuVasive Next Generation NVM5 System |
NUVASIVE INCORPORATED |
MARY ADAMS |
| K162138 |
08/01/2016 |
NuVasive CoRoent Small Ti-C System |
NUVASIVE, INCORPORATED |
MICHELLE CHEUNG |
| K162426 |
08/30/2016 |
nva, nvp, and nvt |
NVISION BIOMEDICAL TECHNOLOGIES, LLC |
Diana L. Langham |
| K162361 |
08/23/2016 |
Soft Plug Extended Duration 180 Canalicular Plug |
OASIS MEDICAL, INC. |
JAMES CHRISTENSEN |
| K162217 |
08/08/2016 |
LOYON |
Oculus Innovative Sciences |
Brian W. Martin |
| K162191 |
08/04/2016 |
NAVILAS Laser System |
OD-OS GMBH |
WINFRIED TEIWES |
| K162430 |
08/31/2016 |
UniStrip1 Generic Blood Glucose Test Strips |
OK BIOTECH CO., LTD. |
KE-MIN JEN |
| K162209 |
08/05/2016 |
Sapphire NC Plus |
OrbusNeich Medical, Inc |
John D. Pazienza |
| K162355 |
08/23/2016 |
Raycast MammoRx Carbon Fibre Breast Board |
Orfit Industries NV |
Eddy Marivoet |
| K162307 |
08/17/2016 |
OrthoPediatrics Locking Proximal Femur System Cortical Screws |
ORTHOPEDIATRICS, CORP. |
ADAM CARGILL |
| K162366 |
08/23/2016 |
Omega VL |
OV WORLD CO., LTD |
GEUNG-GYU GANG |
| K162433 |
08/31/2016 |
GCE Zen-O Portable Oxygen Concentrator |
OXUS, INC |
RYAN LENARCIC |
| K162154 |
08/02/2016 |
Pantheon Medical Balanced Plating System |
PANTHEON MEDICAL |
TRAVID BIRD |
| K162241 |
08/10/2016 |
TITAN 3-DÖ Wedge System |
PARAGON 28 |
Frank S. Bono |
| K162198 |
08/05/2016 |
GFS Ultimate |
PARCUS MEDICAL, LLC |
PAUL VAGTS |
| K162233 |
08/08/2016 |
Kurin Blood Culture Collection Set |
Pathway LLC |
Emily Davis |
| K162151 |
08/02/2016 |
PENTAX Medical ENT Video Imaging System |
PENTAX OF AMERICA, INC. |
Krishna Govindarajan |
| K162329 |
08/19/2016 |
CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System |
Philips Healthcare |
Maxs Newberry |
| K162148 |
08/01/2016 |
Allura Xper R9 |
PHILIPS MEDICAL SYSTEMS NETHRLANDS BV |
Jeanette Becker |
| K162418 |
08/30/2016 |
Pioneer Plus Catheter |
PHILIPS VOLCANO |
MARY STANNERS |
| K162376 |
08/24/2016 |
CAAS MR 4D Flow |
PIE MEDICAL IMAGING B.V. |
ANNEMIEK BOUTS |
| K162362 |
08/23/2016 |
PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator |
PMS TIBBI CIHAZLAR TEKNOLOJISI SAN VE TIC AS |
DERYA DIKICI |
| K162282 |
08/15/2016 |
CardioChek Plus Test System, CardioChek Home Test System |
Polymer Technology Systems, Inc. d/b/a PTS Diagnostics |
Margo Enright |
| K162211 |
08/08/2016 |
AccuFit Lateral Plate System |
PRECISION SPINE, INC. |
Michael C. Dawson |
| K162300 |
08/16/2016 |
Reform« POCT System |
PRECISION SPINE, INC. |
MICHAEL C. DAWSON |
| K162240 |
08/09/2016 |
ProMedTek Model C1400 Shortwave Diathermy Device |
PROMEDTEK INC. |
Dan Puchek |
| K162246 |
08/10/2016 |
ProNova SC360 Proton Therapy System |
ProNova Solutions, LLC |
ADAM KUHN |
| K162284 |
08/15/2016 |
Puritan Fecal Opti-Swab Collection and Transport System |
PURITAN MEDICAL PRODUCTS LLC |
MEHDI KARAMCHI |
| K162372 |
08/24/2016 |
QT Ultrasound Breast Scanner-1 |
QT ULTRASOUND LLC |
ELAINE IUANOW |
| K162196 |
08/05/2016 |
Dell UP3216Q with QUBYX PerfectLum bundle |
QUBYX SOFTWARE TECHNOLOGIES INC. |
MARC LEPPLA |
| K162276 |
08/12/2016 |
SeraQuest Herpes Type 1 Specific IgG |
QUEST INTERNATIONAL, INC |
DAVID J. KIEFER |
| K162304 |
08/17/2016 |
Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets |
QUEST MEDICAL, INC. |
Amy Clendening-Wheeler |
| K162438 |
08/31/2016 |
Sofia Influenza A+B FIA on Sofia 2 |
Quidel Corporation |
Jennifer S. Rial |
| K162274 |
08/12/2016 |
Solana Strep Complete Assay |
Quidel Corporation |
Ronald H Lollar |
| K162275 |
08/12/2016 |
Randox RX Daytona Plus Alkaline Phosphatase (ALP) |
RANDOX LABORATORIES LIMITED |
Pauline Armstrong |
| K162200 |
08/05/2016 |
Randox RX Daytona Plus Magnesium (MG) |
RANDOX LABORATORIES LTD |
PAULINE 0 ARMSTRONG |
| K162131 |
08/01/2016 |
ExSpiron 1Xi |
Respiratory Motion Inc. |
Edwin Rule |
| K162321 |
08/19/2016 |
EasyClip Xpress |
RESTORE SURGICAL LLC dba Instratek |
JEFF SEAVEY |
| K162173 |
08/03/2016 |
Elecsys CYFRA 21-1 CalCheck 5 |
Roche Diagnostics |
Adam Clark |
| K162278 |
08/15/2016 |
Digital Diagnostic Mobile X-ray System |
SAMSUNG ELECTRONICS CO., LTD. |
CHULSIN KIM |
| K162351 |
08/23/2016 |
SeaSpine« Vu aòPODÖ Prime NanoMetalene« Intervertebral Body Fusion Device |
SEASPINE ORTHOPEDICS CORPORATION |
Gina Flores |
| K162281 |
08/15/2016 |
CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) |
SEBIA |
KAREN ANDERSON |
| K162312 |
08/18/2016 |
Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color |
SHEN WEI USA INC. |
CHERYL BAILEY-KROLL |
| K162267 |
08/11/2016 |
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD |
Zhai Pei |
| K162261 |
08/11/2016 |
CERAMAGE UP |
SHOFU DENTAL CORPORATION |
MAURO MALZYNER |
| K162298 |
08/16/2016 |
LOCI Total Vitamin D Total Assay, LOCI VITD CAL |
SIEMENS HEALTHCARE DIAGNOSTICS |
KATHLEEN DRAY-LYONS |
| K162420 |
08/30/2016 |
Sysmex Automated Blood Coagulation Analyzer CS-5100 |
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
PETRA DISSMANN |
| K162399 |
08/26/2016 |
Atellica CH Magnesium (Mg) |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
LAURA J. DUGGAN |
| K162221 |
08/08/2016 |
ACUSON SC2000 Diagnostic Ultrasound System |
Siemens Medical Solutions Inc. Ultrasound Group |
Kevon Kong |
| K162339 |
08/22/2016 |
Scenium |
SIEMENS MEDICAL SOLUTIONS USA, INC |
VERONICA PADHARIA |
| K162302 |
08/17/2016 |
Somatom Confidence « RT Pro |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY MANGUM |
| K162370 |
08/24/2016 |
syngo.via RT Image Suite |
Siemens Medical Solutions USA, Inc. |
Kimberly Mangum |
| K162417 |
08/30/2016 |
Acuson Freestyle Ultrasound System |
Siemens Medical Solutions, Inc. |
Lawrence Engle |
| K162243 |
08/10/2016 |
ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System |
Siemens Medical Solutions, Inc. |
Shelly Pearce |
| K162337 |
08/22/2016 |
Symbia 6.5 |
SIEMENS MEDICAL SOLUTIONS, USA, INC |
Cynthia Busch |
| K162303 |
08/17/2016 |
REDAPT Sleeved Monolithic Revision Stems |
SMITH & NEPHEW INC. |
KIM PHAN |
| K162129 |
08/01/2016 |
RENASYS-G Gauze Dressing Kits with Soft Port |
Smith & Nephew, Inc. |
Laura Reynolds |
| K162219 |
08/08/2016 |
CADD« Infusion Disposables Portfolio with NRFitÖ connectors |
Smiths Medical ASD, Inc. |
Wendy J. Kivens |
| K162356 |
08/23/2016 |
Vesair Cystoscopic Sheath |
Solace Therapeutics |
William Gruber |
| K162402 |
08/26/2016 |
4CIS« Marlin ACIF Cage System |
SOLCO BIOMEDICAL CO., LTD. |
KIM IL |
| K162306 |
08/17/2016 |
SomnoDent ALPHA |
SomnoMed Inc. |
Kien Nguyen |
| K162215 |
08/08/2016 |
Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae |
SORIN GROUP ITALIA S.R.L |
Luigi Vecchi |
| K162317 |
08/19/2016 |
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 |
| K162162 |
08/02/2016 |
Barrier Supreme Sterilization Wrapper |
Standard Textile Co., Inc. |
Bradley J. Bushman |
| K162222 |
08/08/2016 |
GENflex2 Total Knee System |
StelKast, Inc. |
Dave Stumpo |
| K162413 |
08/29/2016 |
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 |
| K162161 |
08/02/2016 |
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit |
Stimwave Technologies Incorporated |
Elizabeth Greene |
| K162262 |
08/11/2016 |
Tritanium« PL Cage |
STRYKER |
Deirdre Jayko |
| K162310 |
08/17/2016 |
XBraid TT Suture Tape |
Stryker |
Taylor White |
| K162439 |
08/31/2016 |
AxSOS 3 Ti; Stryker Plating System |
STRYKER GMBH |
Irene Bacalocostantis |
| K162341 |
08/22/2016 |
Stryker OrthoMap Precision Knee system |
Stryker Leibinger GmbH & Co. KG |
N/A N/A |
| K162171 |
08/03/2016 |
S4 Screw SystemÖ |
SUBCHONDRAL SOLUTIONS |
SHERYL MCCOY |
| K162165 |
08/03/2016 |
ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump |
SUMMIT MEDICAL PRODUCTS, INC |
LeVoy Haight |
| K162223 |
08/08/2016 |
Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) |
SUPERVISION OPTIMAX SDN BHD |
YAP PEAK GEEH |
| K162359 |
08/23/2016 |
Surefire Guiding Catheter |
Surefire Medical, Inc. |
Lynne Aronson |
| K162125 |
08/01/2016 |
MALUCÖ Total Hip Arthroplasty System |
SurgTech, Inc., |
Xuegong Yu |
| K162163 |
08/02/2016 |
UltraShape System |
SYNERON MEDICAL LTD |
Ruthie Amir |
| K162358 |
08/23/2016 |
T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System |
SYNTHES USA PRODUCTS LLC |
Eugene Bang |
| K162382 |
08/24/2016 |
Smart Dongle Blood Glucose Monitoring System |
TaiDoc Technology Corporation |
Paul Liu |
| K162242 |
08/10/2016 |
Comfort Flo Humidification System |
TELEFLEX MEDICAL, INC |
BRIAN GALL |
| K162396 |
08/26/2016 |
SILK Surgical Suture |
TELEFLEX MEDICAL, INC |
NATALIE HICHAK |
| K162365 |
08/23/2016 |
T-Cuff |
Terumo BCT, Inc. |
Nithya Rajan |
| K162263 |
08/11/2016 |
Optilite Rheumatoid Factor Kit |
THE BINDING SITE GROUP LTD. |
JON LAUDER |
| K162195 |
08/05/2016 |
TSolution One Cup1 Surgical System |
THINK SURGICAL INC. |
IN K. MUN |
| K162258 |
08/11/2016 |
Self Sealing Sterilization Pouches |
Tianchang Jiarui Packaging Material Co., Ltd. |
Zhang Ruiqing |
| K162387 |
08/25/2016 |
U-IGNITE Bladeless Trocar |
TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO.LTD. |
TAO FAN |
| K162183 |
08/04/2016 |
Vantage Galan 3T, MRT-3020, V4.0 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K162187 |
08/04/2016 |
Xario 100 Diagnostic Ultrasound System, V5.0 |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K162155 |
08/02/2016 |
Xario 200 Diagnostic Ultrasound System V5.0 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K162256 |
08/11/2016 |
Klassic Femur, Porous, Klassic Tibial Baseplate, Porous |
TOTAL JOINT ORTHOPEDICS, INC. |
CHRIS WEABER |
| K162422 |
08/30/2016 |
Klassic Knee System |
Total Joint Orthopedics, Inc. |
Chris Weaber |
| K162354 |
08/23/2016 |
Sniper Staple System |
TRILLIANT SURGICAL LTD |
Jon Olson |
| K162189 |
08/04/2016 |
ANAXÖ 5.5 Spinal System |
U&I Corporation |
Ji Yea Lee |
| K162334 |
08/22/2016 |
U.S. Laser Worx Patriot 1 family of lasers |
U.S. Laser Worx |
Frank Ford |
| K162415 |
08/29/2016 |
Spectra 9Plus |
Uzinmedicare Company |
Nathan Ahn |
| K162272 |
08/12/2016 |
Fluent inflation device |
VASCULAR SOLUTIONS, INC. |
BEKA VITE |
| K162252 |
08/10/2016 |
FasTouch Fixation System |
VIA SURGICAL LTD. |
OFEK LEVIN |
| K162175 |
08/03/2016 |
Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less |
Viet Glove Corporation |
PHAM NGOC THANH |
| K162393 |
08/26/2016 |
The ViewRay (MRIdian) Linac System |
VIEWRAY INCORPORATED |
SEAN DELANEY |
| K162190 |
08/04/2016 |
Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) |
VILLA SISTEMI MEDICALI S.P.A. |
PAOLO CASAGRANDE SANTIN |
| K162363 |
08/23/2016 |
V30 system, V-Form Handpiece BC Medium applicator |
Viora Ltd. |
Stella Raizelman Perry |
| K162145 |
08/01/2016 |
vRad PACS with Mammography |
Virtual Radiologic Corporation |
Melinda Sewell |
| K162137 |
08/01/2016 |
Fever ScoutÖ Continuous Monitoring thermometer |
VivaLnk Inc. |
Cecilia Xi |
| K162159 |
08/02/2016 |
VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing |
VR Medical Technologies, LLC |
Lee Pan |
| K162188 |
08/04/2016 |
Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) |
VR MEDICAL TECHNOLOGY |
LEE PAN |
| K162340 |
08/22/2016 |
Stomach Tube |
WELL LEAD MEDICAL CO., LTD |
HUANG KAI GEN |
| K162225 |
08/08/2016 |
WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System |
WellDoc, Inc |
Michele Livingston |
| K162343 |
08/22/2016 |
Westmed Gas Sampling Cannula with O2 delivery |
WESTMED, INC. |
DIANA UPP |
| K162142 |
08/01/2016 |
Accessory Irrigation Adapter |
WILSON-COOK MEDICAL, INC. |
THERESA DE PRAT |
| K162328 |
08/19/2016 |
Winner Transfer Wheelchair |
Winner SG Pte Ltd |
Michael Pang |
| K162353 |
08/23/2016 |
MICATM Screw System |
WRIGHT MEDICAL TECHNOLOGY, INC. |
TARA CONRAD |
| K162141 |
08/01/2016 |
Restore PACS |
XIAN WINGSPAN ELECTRONIC TECHNOLOGY CO., LTD. |
Echo Chou |
| K162237 |
08/09/2016 |
XO1 Knee Balancing System |
XPANDORTHO, INC. |
REBECCA K PINE |
| K162206 |
08/05/2016 |
Zavation IBF |
Zavation, LLC |
Lawrence Walker |
| K162259 |
08/11/2016 |
DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
ZIBO DAIYANG PLASTIC COMPANY |
YANG YAN HONG |
| K162429 |
08/30/2016 |
ZipE Knotless Tissue Repair and Attachment Devices |
ZIPTEK, LLC |
William F. Bennett |
