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 |
K150930 |
04/06/2015 |
Deployable Oxygen Generation System-Smaill (DOGS-S) |
AirSep Corporation |
Peter Weisenborn |
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 |
K151047 |
04/20/2015 |
MTA Repair HP |
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS |
Paulo Sergio Calixto de Oliveria |
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 |
K151092 |
04/23/2015 |
Arthrex Short Suture Anchors |
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 |
K150942 |
04/08/2015 |
Contour Next USB Blood Glucose Monitoring System |
BAYER HEALTHCARE |
JENNIFER L. GREGORY |
K151009 |
04/15/2015 |
Nexus Suture |
BAYLIS MEDICAL COMPANY INC. |
Meghal Khakhar |
K150963 |
04/10/2015 |
AnsCare ChitoClot Pad |
BENQ MATERIALS CORPORATION |
Kenix Chang |
K150953 |
04/09/2015 |
Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC |
BIO COMPRESSION SYSTEMS, INC. |
Barbara J Whitman |
K150876 |
04/01/2015 |
Bead Block |
BIOCOMPATIBLES UK LTD |
PEDRO GARCIA |
DEN150013 |
04/09/2015 |
FilmArray Meningitis/Encephalitis(ME) Panel |
BioFire Diagnostics, LLC |
Kristen J Kanack |
K151019 |
04/16/2015 |
SternaLock« 360 Sternal Closure System |
BIOMET MICROFIXATION |
LAUREN JASPER |
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 |
K150932 |
04/06/2015 |
Sheath Introducer |
BIOTEQUE CORP. |
Simon Lin |
K150997 |
04/15/2015 |
RUBY STAR |
BISON MEDICAL CO., LTD |
SUN-WOO LEE |
K151048 |
04/20/2015 |
CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set |
BRACCO INJENEERING |
MAUD GIORGI |
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 |
K151081 |
04/22/2015 |
MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge |
Cardica, Inc. |
Vee Arya |
K150990 |
04/15/2015 |
ECVUE Mapping System |
CardioInsight Technologies, Inc. |
Christina V Vacca |
K151125 |
04/28/2015 |
AVAflex Vertebral Balloon System |
CAREFUSION |
Joy Greidanus |
K151036 |
04/20/2015 |
Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments |
CAREFUSION 2200 INC. |
JANE WEBER |
K150929 |
04/06/2015 |
CareView 1500Cw X-ray Flat Panel Detectors |
CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. |
YULING DING |
K150977 |
04/13/2015 |
CIRRUS HD-OCT |
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 |
K151062 |
04/20/2015 |
WASTON Metallic Intramedullary Nail System |
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 |
K150902 |
04/03/2015 |
330psi Extension Y-Line with Dual Check Valve |
COEUR, INC. |
Erin Rheinscheld |
K151126 |
04/28/2015 |
Foresight Intracardiac Echocardiography (ICE) System |
Colibri Technologies Inc. |
SAM MOSTAFAVI |
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 |
K150936 |
04/07/2015 |
SureClip |
CONMED CORPORATION |
ANNA D'LIMA |
K150970 |
04/13/2015 |
Coda LP Balloon Catheter |
COOK INCORPORATED |
Chad Schulenburg |
K151018 |
04/16/2015 |
Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette |
COOK INCORPORATED |
Naomi Funkhouser |
K150931 |
04/06/2015 |
MReye Embolization Coils |
Cook Incorporated |
Nozomi Yagi |
K150964 |
04/10/2015 |
MReye Flipper Detachable Embolization Coil and Delivery System |
Cook Incorporated |
Nozomi Yagi |
K151051 |
04/20/2015 |
Universa Soft Ureteral Stents and Stent Sets |
COOK INCORPORATED |
Jamie Ridner |
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 |
K151090 |
04/23/2015 |
CPL Insulin Pen Needle |
CPL CO., LTD. |
CHOI KYOUNG SOO |
K150920 |
04/06/2015 |
truFreeze System |
CSA MEDICAL, INC. |
SHERRIE COVAL-GOLDSMITH |
K150980 |
04/14/2015 |
Venous Assist System |
DAESUNG MAREF CO., LTD. |
JAE-WHA LEE |
K151088 |
04/23/2015 |
DMRC Bulk Fill |
DANVILLE MATERIALS, LLC |
DONG HUA |
K151149 |
04/30/2015 |
Ready-Fit |
DENTEK ORAL CARE, INC. |
LINDA GILES |
K151039 |
04/20/2015 |
ATLANTIS Abutment for NobelActive 3.0 |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
K150862 |
04/01/2015 |
DePuy Actis Duofox Hip Prosthesis |
DEPUY ORTHOPAEDICS, INC. |
CORRENE RAMY |
K150985 |
04/14/2015 |
Medihoney Wound Gel |
DERMA SCIENCES, INC. |
SHARMINI ATHERAY |
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 |
K151137 |
04/29/2015 |
X-VIEW, IMAGEN |
EDLEN IMAGING LLC |
NICK RADACHI |
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 |
K151136 |
04/29/2015 |
HARMONIC HOOK |
ETHICON ENDO-SURGERY, LLC |
MARJORIE MEDINA |
K151061 |
04/20/2015 |
Cornea Cold |
EUROBIO |
Marie-Claude Amoureux |
K150890 |
04/02/2015 |
Exactech Optetrak Logic CC |
EXACTECH, INC. |
PATRICK HUGHES |
K151083 |
04/22/2015 |
BioBridge Collagen Matrix |
Fibralign Corporation |
Greg King |
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 |
K150914 |
04/06/2015 |
Dash-Topic Plus Cream |
Founders Science Group, LLC |
Ronald M Gurge |
K151063 |
04/20/2015 |
Monitor B40 |
GE MEDICAL SYSTEMS CHINA CO., LTD. |
Sun YanLi |
K151028 |
04/17/2015 |
LOGIQ e |
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS |
TRACEY ORTIZ |
K151086 |
04/22/2015 |
ManoScan System |
GIVEN IMAGING LTD. |
HILLA DEBBY |
K150923 |
04/06/2015 |
Breast Pump |
Guangzhou Jinxinbao Electronic Co.,Ltd |
Jiacheng Guo |
K150966 |
04/13/2015 |
HMB32 |
HAEMOPHARM BIOFLUIDS SRL |
GIUSEPPE TOMASINI |
K150893 |
04/02/2015 |
IntelliCuff |
HAMILTON MEDICAL AG |
STEFFEN BODEN |
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 |
K150916 |
04/06/2015 |
HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO |
HemCon Medical Technologies, Inc. |
Jody Oyama |
K150933 |
04/06/2015 |
iBond Universal & iBond Ceramic Primer |
Heraeus Kulzer LLC, Mitsui Chemicals Group |
Jamie Cleveland |
K151127 |
04/28/2015 |
higi Station |
higi SH LLC |
Colin Hill |
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 |
K151133 |
04/28/2015 |
PENTRA XLR |
HORIBA ABX SAS |
Caroline Ferrer |
K151025 |
04/16/2015 |
iHearTest |
IHEAR MEDICAL, INC. |
ANGELA LEE FOREMAN |
K150915 |
04/06/2015 |
SPINAUT-P |
IMEDICOM CO., LTD. |
BONGGU HA |
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 |
K150877 |
04/01/2015 |
ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS |
Instrumentation Laboratory Co. |
Carol Marble |
K151027 |
04/17/2015 |
zensor system |
INTELESENS LIMITED |
PATRICIA PEPPER |
K150965 |
04/10/2015 |
LeForte System II |
Jeil Medical Corporation |
Jieun KIM |
K151074 |
04/22/2015 |
Magnetic Reasonance Imaging System |
JIANGSU MAGSPIN INSTRUMENT CO.,LTD |
LEO LI |
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 |
K151044 |
04/20/2015 |
CLICKLINE Scissor Insert for Single Use |
KARL STORZ Endoscopy America, Inc. |
Winkie Wong |
K150969 |
04/13/2015 |
Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces |
KARL STORZ ENDOSCOPY AMERICA, INC. |
Jennifer Michelle Chambers |
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 |
K150934 |
04/06/2015 |
Powder Free Vinyl Patient Examination Glove (Non?-Sterile) |
LPL (HUI ZHOU) GLOVE |
LEE HONG CHONG |
K151109 |
04/27/2015 |
Lumenis Smart532 Laser System |
LUMENIS, INC. |
Jayce R. McLane |
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 |
K151139 |
04/29/2015 |
EasyMap MAP Catheter |
MedFact Engineering GmbH |
Joerg Reinhardt |
K150887 |
04/02/2015 |
Para-Fix C&S Medium |
MEDICAL CHEMICAL CORPORATION |
KRIS J KONTIS |
K150918 |
04/06/2015 |
PASS OCT Spinal System |
MEDICREA INTERNATIONAL S.A. |
Jean-Denys Marechal |
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 |
K150979 |
04/13/2015 |
CT/MR Compatible M.A.C. Interstitial GYN Template |
Mick Radio-Nuclear Instruments, Inc. |
Chuck Smith |
K150870 |
04/01/2015 |
HydroPearl Microspheres, HydroPearl Microspheres |
MICROVENTION, INC. |
NAOMI GONG |
K150958 |
04/09/2015 |
LifePearl Microshperes |
MicroVention, Inc. |
Naomi Gong |
K150898 |
04/02/2015 |
LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm |
MOLLER MEDICAL GMBH |
JULIANE DRAGON |
K150912 |
04/03/2015 |
Houva-NET Control System |
National Biological Corporation |
Lynn Keller |
K150993 |
04/15/2015 |
NICO TRIOwand |
NICO CORPORATION |
JAY DITTMAN |
K151080 |
04/22/2015 |
Nihon Kohden CSM 1901 Bedside Monitor |
Nihon Kohden |
Tom Bento |
K151141 |
04/29/2015 |
Cronus HP - High Pressure Peripheral Balloon Catheter |
NIPRO MEDICAL CORPORATION |
JESSICA OSWALD-MCLEOD |
K150956 |
04/09/2015 |
PINPOINT Endoscopic Fluorescence Imaging System |
NOVADAQ TECHNOLOGIES, INC. |
TIM VERSPAGEN |
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 |
K151123 |
04/28/2015 |
Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film |
Pac-Dent International, Inc. |
Wenying Zhu |
K150960 |
04/10/2015 |
WoundPro Negative Pressure Wound Therapy System |
PENSAR MEDICAL LLC |
BRIAN GUTHRIE |
K151029 |
04/17/2015 |
Phadia Prime |
PHADIA AB |
Anna-Lisa Tiensuu |
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 |
K151050 |
04/20/2015 |
Pacifier Activated Lullaby (PAL«) |
Power Medical Devices, LLC |
Patricia Palmer |
K150872 |
04/01/2015 |
BruxZir Anterior Milling Blanks |
PRISMATIK DENTALCRAFT, INC. |
ARMIN ZEHTABCHI |
K151154 |
04/30/2015 |
FIBERGRAFT BG Morsels |
PROSIDYAN INC. |
CHARANPREET S BAGGA |
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 |
K151070 |
04/21/2015 |
Sonishield 100 Antimicrobial Ultrasound Gel |
Quotient Medical |
David Okamoto |
K151120 |
04/27/2015 |
Simple T Pediatric Nasal Mask |
RESPIRONICS, INC. |
SHAYLEE MASILUNAS |
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 |
K151152 |
04/30/2015 |
ImplantMax Software |
SATURN IMAGING INC. |
BEENDER YANG |
K151004 |
04/15/2015 |
PULLUP« Adjustable Juxtacortical Fixation Device |
SBM SCIENCES FOR BIO MATERIALS |
DENIS CLEMENT |
K150894 |
04/02/2015 |
VIA 21 Microcatheter |
SEQUENT MEDICAL, INC |
Bethany Barrett |
K150888 |
04/02/2015 |
Shape-HF Cardiopulmonary Testing System |
SHAPE MEDICAL SYSTEMS, INC |
BERNARD HORWATH |
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 |
K150908 |
04/03/2015 |
XM-01 Electronic Automatic Blood Pressure Monitor |
Sky Innovation Technology ( Shanghai) Limited |
Charles Shen |
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 |
K151072 |
04/21/2015 |
Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit |
Solo-Dex, Inc. |
Siddarth Desai |
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 |
K151069 |
04/21/2015 |
SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle |
SPECTRA MEDICAL DEVICES, INC. |
Agustin Turriza |
K151104 |
04/24/2015 |
OTELO LL |
SPINEART |
Franck Pennesi |
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 |
K151114 |
04/27/2015 |
Medismart ( Latex Surgeon?s Gloves powdered ) and Medismart + (Latex Surgeon?s Gloves Powder Free, Polymer coated with protein |
ST.MARYS RUBBERS PVT. LTD. |
Srinivasan. S |
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 |
K151024 |
04/16/2015 |
Finger Type Pulse Oximeter |
TAIDOC TECHNOLOGY CORPORATION |
C. W. CHEN |
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 |
K151075 |
04/22/2015 |
BR-ABVS Viewer 1.0 |
TAIHAO MEDICAL INC. |
HSIN HUNG(SIMON) LAI |
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 |
K151034 |
04/17/2015 |
PainKARE |
TrioWave Technologies |
Huiyou Zhu |
K151135 |
04/29/2015 |
MODEL 621/624 BIOMAGNETOMETER |
TRISTAN TECHNOLOGIES, INC |
KEVIN PRATT |
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 |
K151022 |
04/16/2015 |
Intraluminal Applicator Set |
VARIAN MEDICAL SYSTEMS, INC. |
PETER J. CORONADO |
K150869 |
04/01/2015 |
Checkme Pro Health Monitor |
Viatom Technology Co., Ltd. |
Zhou Saixin |
K150992 |
04/15/2015 |
Vios Monitoring System |
VIOS MEDICAL, INC. |
MEGAN GRAHAM |
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 |
K150961 |
04/10/2015 |
EmbryoSlide Culture Dish |
VITROLIFE A/S |
BELINDA DUEHOLM |
K150950 |
04/08/2015 |
FreezeKit Cleave , ThawKit Cleave |
VITROLIFE SWEDEN AB |
Brett Sonet Glazar |
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 |
K151084 |
04/22/2015 |
Well Lead Ureteral Access Sheath |
WELL LEAD MEDICAL CO. LTD |
HUANG KAI GEN |
K151142 |
04/29/2015 |
IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
BETINA KISTNER |
K150921 |
04/06/2015 |
Orbit Infusion Set |
YPSOMED AG |
STEPHAN AFFOLTER |
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 |