| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K151144 |
04/29/2015 |
SuPro 100 |
3M DEUTSCHLAND GMBH |
DESI W. SOEGIARTO |
| K150974 |
04/13/2015 |
aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium |
AAP IMPLANTATE AG |
CHRISTIAN ZIETSCH |
| K151014 |
04/16/2015 |
Aura DR 43C-AG flat panel detector |
ABYZR CO., LTD |
JOHN LIM |
| K150873 |
04/01/2015 |
CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System |
ACCURAY INCORPORATED |
Shweta Kaushik |
| K150866 |
04/01/2015 |
SURGISEAL Topical Skin Adhesvie |
ADHEZION BIOMEDICAL, LLC |
TRACY LOFGREN |
| K151056 |
04/20/2015 |
Aesculap T-Space PEEK and XP Spinal System |
AESCULAP IMPLANT SYSTEMS, LLC |
LISA M. BOYLE |
| K151097 |
04/24/2015 |
Active Breathing Coordinator |
AKTINA MEDICAL CORPORATION |
TONY SPACCAROTELLA |
| K150976 |
04/13/2015 |
Collage |
ANATOMAGE INC. |
SEAN XU |
| K150924 |
04/06/2015 |
A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Sut |
ANCHOR INNOVATION MEDICAL (A.I.M.) |
CARY STALNECKER |
| K151112 |
04/28/2015 |
Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design |
ANGIOTECH |
HILARY WELLS |
| K151153 |
04/30/2015 |
Pirouette 018 |
ARRAVASC LIMITED |
MAIREAD MCCAFFREY |
| K151078 |
04/22/2015 |
Arthrex RetroFusion Screw |
ARTHREX, INC. |
DAVID L ROGERS |
| K151103 |
04/24/2015 |
ASAHI Corsair Microcatheter |
ASAHI INTECC CO., LTD. |
YOSHIHIKO FUKUI |
| K150996 |
04/15/2015 |
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip |
ATRICURE, INC. |
Brittany Lowe |
| K151102 |
04/24/2015 |
Bausch + Lomb Injector System |
Bausch & Lomb, Inc. |
Joyce Zhong |
| K150860 |
04/01/2015 |
Nitroglycerin Sets with DUO-VENT Spike |
BAXTER HEALTHCARE CORPORATION |
DHIRAJ BIZZUL |
| K151009 |
04/15/2015 |
Nexus Suture |
BAYLIS MEDICAL COMPANY INC. |
Meghal Khakhar |
| K150953 |
04/09/2015 |
Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC |
BIO COMPRESSION SYSTEMS, INC. |
Barbara J Whitman |
| K151064 |
04/20/2015 |
Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System |
BIOMET SPINE |
Alexandra Beck |
| K150867 |
04/01/2015 |
Affixus Tibial Nailing System |
BIOMET, INC. |
SUZANA OTANO |
| K151040 |
04/20/2015 |
Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer |
BIOMETRIX LTD. |
Zoya Lee |
| K150951 |
04/09/2015 |
aeris Balloon Dialation Catheter |
Bryan Medical , Inc. |
ANDY BLACK |
| K151054 |
04/20/2015 |
Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System |
C2 Therapeutics, Inc. |
Theresa Brandner-Allen |
| K151107 |
04/27/2015 |
CoSense ETCO Monitor |
Capnia Inc |
KRISTEN YEN |
| K151071 |
04/21/2015 |
SmartLinx Vitals Plus Patient Monitoring System |
CAPSULE TECHNOLOGIE SAS |
PETER KELLEY |
| K151116 |
04/27/2015 |
CapLOX II/TowerLOX Pedicle Screw System |
CAPTIVA SPINE |
TAMALA WAMPLER |
| K151010 |
04/15/2015 |
Piccolo Composite Nailing System |
CARBOFIX ORTHOPEDICS LTD. |
YAEL RUBIN |
| K150990 |
04/15/2015 |
ECVUE Mapping System |
CardioInsight Technologies, Inc. |
Christina V Vacca |
| K150929 |
04/06/2015 |
CareView 1500Cw X-ray Flat Panel Detectors |
CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. |
YULING DING |
| K150977 |
04/13/2015 |
Optical Coherence Tomography |
CARL ZEISS MEDITEC INC |
MANDY AMBRECHT |
| K151068 |
04/21/2015 |
SureLock W Suture Anchor |
CAYENNE MEDICAL, INC |
SHIMA HASHEMIAN |
| K151057 |
04/20/2015 |
WASTON Metallic Bone Plate and Screw Systems |
CHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD |
Jack Lu |
| K150861 |
04/01/2015 |
QBit Series Diagnostic Ultrasound System |
CHISON MEDICAL IMAGING CO., LTD. |
QIFEI LIU |
| K150886 |
04/02/2015 |
Trojan Riviera Personal Lubricant |
CHURCH & DWIGHT CO., INC. |
LISA BURNS |
| K150927 |
04/06/2015 |
Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff |
COLOPLAST A/S |
LEEANNE SWIRIDOW |
| K150935 |
04/07/2015 |
SpeediCath Compact Eve |
COLOPLAST A/S |
Meg Daniel |
| K151037 |
04/20/2015 |
GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle |
CONMED CORPORATION |
NYROBIA FREEMAN |
| K150970 |
04/13/2015 |
Coda LP Balloon Catheter |
COOK INCORPORATED |
Chad Schulenburg |
| K150892 |
04/02/2015 |
CorPath 200 System |
CORINDUS, INC. |
Milind Gramopadhye |
| K150891 |
04/02/2015 |
BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System |
Covidien LLC( Formerly Beacon Endoscopic Corp.) |
Saket Bhatt |
| K150920 |
04/06/2015 |
truFreeze System |
CSA MEDICAL, INC. |
SHERRIE COVAL-GOLDSMITH |
| K151088 |
04/23/2015 |
DMRC Bulk Fill |
DANVILLE MATERIALS, LLC |
DONG HUA |
| K151149 |
04/30/2015 |
Ready-Fit |
DENTEK ORAL CARE, INC. |
LINDA GILES |
| K150862 |
04/01/2015 |
DePuy Actis Duofox Hip Prosthesis |
DEPUY ORTHOPAEDICS, INC. |
CORRENE RAMY |
| K150879 |
04/01/2015 |
LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers |
DiaSorin Inc. |
John Walter |
| K151006 |
04/15/2015 |
EarlySense Central Display Station (CDS) |
EARLYSENSE LTD. |
DALIA ARGAMAN |
| K150949 |
04/08/2015 |
FibroScan |
ECHOSENS |
CELINE FOURNIER |
| K151038 |
04/20/2015 |
EPX-Series Mobile X-ray System |
ECOTRON CO.,LTD |
SANG BONG LEE |
| K150999 |
04/15/2015 |
Acclarix Diagnostic Ultrasound System |
EDAN INSTRUMENTS, INC. |
QUEENA CHEN |
| K150901 |
04/03/2015 |
Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express |
EDAN INSTRUMENTS, INC. |
Queena Chen |
| K150882 |
04/02/2015 |
Edwards Suture Fastening System |
EDWARDS LIFESCIENCES, LLC. |
NINA BROOKE |
| K150906 |
04/03/2015 |
ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh |
EHICON INC. |
SUSAN LIN |
| K151113 |
04/27/2015 |
ELITech Clinical Systems CALCIUM ARSENAZO |
ELITechGroup |
Valerie Gourdon |
| K150907 |
04/03/2015 |
Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra |
Ellipse A/S |
Ole Kofod |
| K150885 |
04/02/2015 |
MAGEC 2 Spinal Bracing and Distraction System |
Ellipse Technologies, Incorporated |
REBECCA SHELBURNE |
| K151131 |
04/28/2015 |
PRECICE Intramedullary Limb Lengthening System |
Ellipse Technologies, Incorporated |
Rebecca Shelburne |
| K151041 |
04/20/2015 |
ERBECRYO 2 Cryosurgical Unit with accessories |
ERBE USA, INC. |
John Tartal |
| K151061 |
04/20/2015 |
Cornea Cold |
EUROBIO |
Marie-Claude Amoureux |
| K150890 |
04/02/2015 |
Exactech Optetrak Logic CC |
EXACTECH, INC. |
PATRICK HUGHES |
| K150883 |
04/02/2015 |
HyaloGYN Vaginal Hydrating Gel |
FIDIA FARMACEUTICI SPA |
Dr. Giuseppina Lo Castro |
| K150900 |
04/03/2015 |
Flexicare Heated Wire Breathing Systems |
FLEXICARE MEDICAL LTD. |
Joel Biddle |
| K150962 |
04/10/2015 |
Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack |
FOCUS DIAGNOSTICS |
SHARON YOUNG |
| K151028 |
04/17/2015 |
LOGIQ e |
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS |
TRACEY ORTIZ |
| K150998 |
04/15/2015 |
HEARTWAY Power Mobility Scooter |
HEARTWAY Medical Products Co., Ltd. |
JEN KE-MIN |
| K150987 |
04/14/2015 |
HEARTWAY Power Mobility Scooter, BRIO S19 |
HEARTWAY Medical Products Co., Ltd. |
JEN KE-MIN |
| K150933 |
04/06/2015 |
iBond Universal & iBond Ceramic Primer |
Heraeus Kulzer LLC, Mitsui Chemicals Group |
Jamie Cleveland |
| K151015 |
04/16/2015 |
ECHELON Oval V 5.0 MRI System |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
| K151132 |
04/28/2015 |
PROBEAT-V |
Hitachi, Ltd.,Health Care Company |
Naoya Nishimura |
| K150925 |
04/06/2015 |
Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set |
Immunalysis Corporation |
Joseph Ginete |
| K150913 |
04/06/2015 |
INCITE ANCHORED CERVICAL INTERBODY DEVICE |
INCITE INNOVATION |
JOHN KIRWAN |
| K150954 |
04/09/2015 |
Elite L Expandable Lumbar Fusion System |
INNOVA SPINAL TECHNOLOGIES, LLC |
ARMANDO VARELA |
| K151146 |
04/29/2015 |
N-Force Fixation System |
INNOVISION, INC. |
KEITH RUSSELL |
| K151027 |
04/17/2015 |
zensor system |
INTELESENS LIMITED |
PATRICIA PEPPER |
| K150965 |
04/10/2015 |
LeForte System II |
Jeil Medical Corporation |
Jieun KIM |
| K150971 |
04/13/2015 |
Zekang Self-adhesive Electrode |
Jiangsu Zekang Medical Technology Co., Ltd |
Doris Dong |
| K151017 |
04/16/2015 |
JMS Harmony A.V. Fistula Needle Set |
JMS NORTH AMERICA CORPORATION |
SHO HOSOKI |
| K151143 |
04/29/2015 |
EndoLIF On-Cage |
JOIMAX GMBH |
Eulodie Tila |
| K151007 |
04/15/2015 |
21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550) |
JVC KENWOOD CORPORATION |
Tsukasa Tashiro |
| K151134 |
04/29/2015 |
21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210) |
JVC KENWOOD CORPORATION |
Tsukasa Tashiro |
| K150983 |
04/14/2015 |
Pyrenees Cervical Plate System |
K2M |
Nancy Giezen |
| K150865 |
04/01/2015 |
Metacross RX PTA Balloon Dilitation Catheter |
Kaneka Corporation |
Toshihiko Motomine |
| K151060 |
04/20/2015 |
Ultrasound System SONIMAGE HS1 |
KONICA MINOLTA, INC. |
Shigeyuki Kojima |
| K151140 |
04/29/2015 |
LnK Lumbar Interbody Fusion Cage System |
L&K BIOMED Co., Ltd |
Yerim An |
| K150878 |
04/01/2015 |
ILUMIEN OPTIS |
LIGHTLAB IMAGING,INC. |
ERDIE DE PERALTA |
| K150903 |
04/03/2015 |
EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural |
MAANSHAN BOND MEDICAL INSTRUMENTS CO., LTD. |
Viva Gu |
| K150928 |
04/06/2015 |
Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides |
MATERIALISE N.V. |
Laurel Berzanskis |
| K151023 |
04/16/2015 |
COMPACT PIEZO LED |
MECTRON SPA |
FRANCO ZUNINO |
| K150986 |
04/14/2015 |
Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants |
MEDDEV CORPORATION |
PATRICK GREY |
| K151117 |
04/27/2015 |
Laparoscope Lens Shield Device |
Medeon Biodesign, Inc |
Greta Chang |
| K150887 |
04/02/2015 |
Para-Fix C&S Medium |
MEDICAL CHEMICAL CORPORATION |
KRIS J KONTIS |
| K151001 |
04/15/2015 |
MUSE System |
MEDIGUS LTD. |
YANIV SAGIE |
| K151000 |
04/15/2015 |
O-Arm O2 Imaging System |
MEDTRONIC INC. |
RISHI SINHA |
| K151128 |
04/28/2015 |
CAPSTONE Spinal System, CLYDESDALE Spinal System |
MEDTRONIC SOFAMOR DANEK USA, INC |
LEE GRANT |
| K151067 |
04/21/2015 |
Ventilation (Tympanostomy) Tubes |
Medtronic Xomed, Inc. |
Michelle Hughes |
| K151110 |
04/27/2015 |
Intersept Filtered Cardiotomy Reservoir |
Medtronic, Inc |
Chelsea L Pioske |
| K151055 |
04/20/2015 |
Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE |
MENTOR WORLDWIDE LLC |
Sarah McManus |
| K151046 |
04/20/2015 |
illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10 |
MERIDIAN BIOSCIENCE, INC. |
STEFANIE JOHNS |
| K150958 |
04/09/2015 |
LifePearl Microshperes |
MicroVention, Inc. |
Naomi Gong |
| K150912 |
04/03/2015 |
Houva-NET Control System |
National Biological Corporation |
Lynn Keller |
| K150993 |
04/15/2015 |
NICO TRIOwand |
NICO CORPORATION |
JAY DITTMAN |
| K151095 |
04/23/2015 |
Circumplast Circumcision Device |
Novadien Healthcare |
Milad Melhem |
| K150874 |
04/01/2015 |
NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) |
NOVO NORDISK INC. |
Poonam Tuliani |
| K150994 |
04/15/2015 |
NuVasive CoRoent Thoracolumbar Implants |
NUVASIVE, INCORPORATED |
CYNTHIA ADAMS |
| K151011 |
04/15/2015 |
VISERA 4K UHD SYSTEM |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K151147 |
04/30/2015 |
STARband, STARlight |
ORTHOMERICA PRODUCTS, INC. |
DAVID C. KERR |
| K151021 |
04/16/2015 |
OsteoMed Cannulated Screw System |
OSTEOMED CORP. |
Blesson Abraham |
| K150946 |
04/08/2015 |
FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm |
OSTIAL CORPORATION |
Jake Wolenberg |
| K150880 |
04/01/2015 |
Tablo Console with Wireless Capability |
Outset Medical |
Nancy Gallo |
| K151150 |
04/30/2015 |
Elements |
PAC-DENT INTERNATIONAL, INC. |
WENYING ZHU |
| K151033 |
04/17/2015 |
Philips Self-Adhesive Electrodes |
PHILIPS CONSUMER LIFESTYLE |
MARTA WALKER |
| K151035 |
04/17/2015 |
PulseRelief |
PHILIPS CONSUMER LIFESTYLE |
Marta Walker |
| K150975 |
04/13/2015 |
Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors |
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
Michael Asmalsky |
| K150872 |
04/01/2015 |
BruxZir Anterior Milling Blanks |
PRISMATIK DENTALCRAFT, INC. |
ARMIN ZEHTABCHI |
| K151079 |
04/22/2015 |
Q2 Intravenous Adminstration Sets and Extension Sets |
QUEST MEDICAL, INC. |
AMY CLENDENING-WHEELER |
| K150868 |
04/01/2015 |
Solana GAS Assay, Solana instrument |
QUIDEL CORPORATION |
RONALD H LOLLAR |
| K150910 |
04/03/2015 |
ACCU-CHEK Connect Diabetes Management App |
ROCHE DIABETES CARE INC. |
CHUNHONG TAO |
| K150955 |
04/09/2015 |
Elecsys Progesterone III Cal Check 5 |
ROCHE DIAGNOSTICS |
ADAM CLARK |
| K151082 |
04/22/2015 |
MicroCross Catheter |
ROXWOOD MEDICAL, INC. |
GRACE LI |
| K150894 |
04/02/2015 |
VIA 21 Microcatheter |
SEQUENT MEDICAL, INC |
Bethany Barrett |
| K150995 |
04/15/2015 |
Electronic Pulse Stimulator |
SHENZHEN JINGKEHUI ELECTRONIC CO., LTD |
PU JIANG |
| K150875 |
04/01/2015 |
iFuse Implant System |
SI-BONE, Inc. |
Roxanne Dubois |
| K150909 |
04/03/2015 |
INTEGO Family and Accesories |
Sirona Dental Systems GMBH |
Thomas Diesch |
| K151045 |
04/20/2015 |
TENEO Dental Treatment Unit and Accessories |
SIRONA DENTAL SYSTEMS GMBH |
THOMAS DIESCH |
| K150939 |
04/07/2015 |
Ensizor Endoscopic Scissors |
SLATER ENDOSCOPY, LLC |
JOHN STARKEY |
| K151118 |
04/27/2015 |
Smith and Nephew Legion Hinge Knee System |
SMITH & NEPHEW |
ALLISON CHAN |
| K151105 |
04/24/2015 |
Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteorap |
Smith & Nephew, Inc. |
Katherine Marcaccio |
| K150981 |
04/14/2015 |
SMV Scientific Bone Screws |
SMV Scientific |
Nephi Zufelt |
| K150941 |
04/08/2015 |
Somnowell Mandibular Advancement Appliance (MAA) |
Somnowell Ltd. |
Simon Ash |
| K151053 |
04/20/2015 |
PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner |
SOPRO - ACTEON GROUP |
PHILIPPE BOYER |
| K150895 |
04/02/2015 |
SPEC Model M16 |
Source Production and Equipment Co.,Inc. |
Kelly Richardt |
| K151020 |
04/16/2015 |
Rampart-T Interbody Fusion System |
Spineology, Inc. |
Tim Crabtree |
| K151101 |
04/24/2015 |
Lotus Series 4 Ultrasonic Surgical System & Accessories |
SRA DEVELOPMENTS, LTD. |
Alan Chivers |
| K150968 |
04/13/2015 |
TRU Dental Implant System |
Sterngold Dental, LLC |
Maria Rao |
| K150899 |
04/03/2015 |
Straumann CARES Titanium Alloy (TAN) Abutment |
STRAUMANN USA, LLC |
Christopher Klaczyk |
| K150938 |
04/07/2015 |
Straumann« Dental Implant System ? Roxolid« SLA Implants |
STRAUMANN USA, LLC |
CHRISTOPHER KLACZYK |
| K151076 |
04/22/2015 |
MicroTaper Needle Introducer Set |
Summit Access, LLC |
Fred Piazza |
| K150959 |
04/10/2015 |
Sutter Bipolar Forceps-Calvian |
SUTTER MEDIZINTECHNIK GMBH |
BERT SUTTER |
| K151100 |
04/24/2015 |
U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System |
TAIDOC TECHNOLOGY CORPORATION |
C.W. CHEN |
| K150824 |
04/01/2015 |
TD-Wand |
TDM SURGITECH, INC |
MICHAEL WEBER |
| K150973 |
04/13/2015 |
NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested for Use with Chemotherapy Drugs |
TERANG NUSA SND BHD |
ROBERT HILL |
| K150919 |
04/06/2015 |
ArgenZ Esthetic Plus |
THE ARGEN CORPORATION |
CRAIG JOLICOEUR |
| K150871 |
04/01/2015 |
ForeFoot STP System |
TORNIER, INC. |
BRIAN HOCKETT |
| K150897 |
04/02/2015 |
Tosama 100% Cotton Menstrual Tampon |
TOSAMA D.O.O. |
Marjetka Kralj Kuncic |
| K151091 |
04/23/2015 |
Vitrea Software Toshiba Package, VSTP-001A |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K150967 |
04/13/2015 |
XIDF-AWS801, Angio Workstation, V6.10 |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K151087 |
04/23/2015 |
CS 8100SC, CS8100SC Access |
TROPHY |
MARIE-PIERRE LABAT-CAMY |
| K151151 |
04/30/2015 |
U & U Intravascular Administration Set |
U & U Medical Technology Co., Ltd |
Xuebo Wang |
| K151094 |
04/23/2015 |
Mosaic Universal Composite |
ULTRADENT PRODUCTS, INC. |
KAREN KAKUNES |
| K151115 |
04/27/2015 |
MR Core Software |
Vital Images, Inc |
Parthiv Shah |
| K151013 |
04/15/2015 |
Vitaphone Tele ECG Loop Recorder |
Vitasystems GmbH |
Michael Rothhaar |
| K151145 |
04/29/2015 |
2.4mm X 127 cm Phoenix Atherectomy Deflecting System |
Volcano AtheroMed, Inc. |
JEAN CHANG |
| K151008 |
04/15/2015 |
LINK« MEGASYSTEM-C« |
Waldemar Link GmbH & Co. KG |
Helmut D Link |
| K151142 |
04/29/2015 |
IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
BETINA KISTNER |
| K151031 |
04/17/2015 |
Virage OCT Spinal Fixation System |
ZIMMER SPINE, INC |
DONNA M. SEMLAK |
| K150896 |
04/02/2015 |
Vitality Spinal Fixation System |
ZIMMER SPINE, INC. |
DONNA M. SEMLAK |
| K150889 |
04/02/2015 |
Suture Wires and Wire Loops |
ZIMMER, INC. |
PATRICK MCCULLAGH |
