| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K121593 |
03/15/2013 |
3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER RAPID 5 STEAM-PLUS CHALLENGE PACK |
3M COMPANY |
SUZANNE LEUNG |
| K123546 |
03/18/2013 |
3M ATTEST(TM) AUTO-READER |
3M COMPANY |
SUZANNE LEUNG |
| K130157 |
03/19/2013 |
AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET |
AALTO SCIENTIFIC LTD. |
DESSI LYAKOV |
| K123225 |
03/15/2013 |
BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60 |
AAP BIOMATERIALS GMBH & CO. KG |
VOLKER STIRNAL |
| K123081 |
03/07/2013 |
BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40 |
AAP BIOMATERIALS GMBH & CO. KG |
VOLKER STIRNAL |
| K123875 |
03/11/2013 |
AAP RADIUS SET 2.5 |
AAP IMPLANTATE AG |
CHRISTIAN ZIETSCH |
| K130113 |
03/11/2013 |
PICCOLO LACTATE TEST SYSTEM |
ABAXIS, INC. |
Dennis M Bleile |
| K123890 |
03/18/2013 |
ACUMED CANNULATED SCREW SYSTEM |
ACUMED LLC |
KARA BUDOR |
| K130625 |
03/28/2013 |
12MM AND 13MM TIBIAL NAILS |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
ALLYSON PARKS |
| K123939 |
03/12/2013 |
S4 SPINAL SYSTEM |
AESCULAP IMPLANT SYSTEMS, INC. |
LISA M BOYLE |
| K130596 |
03/22/2013 |
CAIMAN SEAL AND CUT TECHNOLOGY |
AESCULAP, INC. |
DENISE ADAMS |
| K122736 |
03/11/2013 |
DX-D IMAGING PACKAGE |
AGFA HEALTHCARE N.V. |
DAVID LEDWIG |
| K123993 |
03/05/2013 |
SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM |
ALPHATEC SPINE, INC. |
TREVOR DENBO |
| K122501 |
03/29/2013 |
AEI DR. TERAUCHI ULTRASONIC TIPS |
AMERICAN EAGLE INSTRUMENTS, INC. |
KRISTEN SCHALLIOL |
| K122098 |
03/21/2013 |
APPS-HEALTH01 |
ANDON HEALTH CO., LTD |
YI LIU |
| K130671 |
03/26/2013 |
VENACURE EVLT NEVERTOUCH PROCEDURE KIT |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K122476 |
03/07/2013 |
LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT |
ANSELL HEALTHCARE PRODUCTS, LLC |
DONNA DI GANGI |
| K122415 |
03/15/2013 |
X-FIX DYNAMIC EXTERNAL DISTRACTOR |
AREX USA LLC |
CHARLES HOKANSON |
| K123618 |
03/24/2013 |
AXERA 2 ACCESS SYSTEM |
ARSTASIS, INC. |
DEBRA COGAN |
| K122469 |
03/08/2013 |
ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K122468 |
03/08/2013 |
ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIO |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K130520 |
03/13/2013 |
CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR |
ASHITAKA FACTORY OF TERUMO CORP. |
EILEEN DORSEY |
| K123139 |
03/28/2013 |
ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES |
ASI MEDICAL, INC. |
JOHN MCPEEK |
| K130142 |
03/15/2013 |
FLIXENE IFG VASCULAR GRAFT |
ATRIUM MEDICAL CORPORATION |
MEGAN MCCAGH, RAC, CTBS |
| K121946 |
03/22/2013 |
AXIS-SHIELD ACVTIVE-B12 |
AXIS-SHIELD DIAGNOSTICS, LTD. |
SIMON JOHN RICHARDS |
| K130245 |
03/01/2013 |
LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO |
BAXTER HEALTHCARE CORP. |
NANETTE HEDDEN |
| K120771 |
03/22/2013 |
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM |
BECKMAN COULTER, INC. |
ERIC GRACE |
| K121655 |
03/20/2013 |
BD ALCOHOL SWAB |
BECTON DICKINSON & CO. |
AVITAL LAKES |
| K123929 |
03/14/2013 |
BEGOPAL+ |
BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO |
HEIKE GUSTKE |
| K130162 |
03/01/2013 |
LIQUID ASSAYED MULTIQUAL PREMIUM |
Bio-Rad Laboratories |
SUZANNE PARSONS |
| K123512 |
03/28/2013 |
BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM |
BIODENTA SWISS AG |
DAVID EILER |
| K123415 |
03/19/2013 |
BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED |
BIODENTA SWISS AG |
DAVID EILER |
| K120089 |
03/13/2013 |
BIOGENESIS IMPLANT SYSTEM |
BIOGENESIS CO., LTD. |
Priscilla Chung |
| K121825 |
03/11/2013 |
CS-MAG II |
BIOMAGNETIK-PARK GMBH |
THOMAS WEBER |
| K123745 |
03/25/2013 |
SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL |
BIOMECANICA INDUSTRIA E COMERICO DE PRODUCTOS ORTO |
TARA CONRAD |
| K122986 |
03/05/2013 |
VIDAS LYME IGG |
BIOMERIEUX SA |
CATHERINE FRITSCH |
| K122770 |
03/28/2013 |
BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831 |
BIOMET MANUFACTURING CORP. |
PATRICIA SANDBORN BERES |
| K122160 |
03/20/2013 |
VANGUARD XP KNEE SYSTEM |
BIOMET MANUFACTURING CORP. |
TRACY BICKEL JOHNSON |
| K123485 |
03/18/2013 |
JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF |
BIOMET SPORTS MEDICINE |
ELIZABETH WRAY |
| K123449 |
03/05/2013 |
BIOMONDE LARVAE |
BIOMONDE (A TRADING NAME OF ZOOBIOTIC LIMITED) |
ROSINA ROBINSON RN, MED, RAC |
| K123411 |
03/07/2013 |
LITTLE ANGELS SWADDLING BLANKET |
BIONIX DEVELOPMENT CORP. |
JAMES HUTTNER |
| K130537 |
03/29/2013 |
BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER |
BIOPSY SCIENCES, LLC |
SHARON ROCKWELL |
| K123837 |
03/05/2013 |
PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER |
BIOSENSE WEBSTER, INC. |
WAYNE R HOHMAN |
| K123228 |
03/08/2013 |
INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B) |
BIOSPACE CORPORATION LIMITED |
DANIEL KAMM |
| K123338 |
03/28/2013 |
BARRICADE EMBOLIZATION COIL SYSTEM |
BLOCKADE MEDICAL |
Rebecca K Pine |
| K130483 |
03/28/2013 |
BOEHRINGER GASTRIC SIZING TUBE |
BOEHRINGER LABORATORIES, LLC |
CHRISTOPHER RADL, ENGINEERING |
| K123765 |
03/19/2013 |
GUIDEZILLA GUIDE EXTENSION CATHETER |
BOSTON SCIENTIFIC |
HOLLY RAMIREZ |
| K130243 |
03/01/2013 |
ILAB ULTRASOUND IMAGING SYSTEM |
BOSTON SCIENTIFIC CORP. |
LORI R SMITH |
| K123589 |
03/19/2013 |
CADWELL DISPOSABLE PROBE HANDLE |
CADWELL |
CHRIS BOLKAN |
| K123186 |
03/14/2013 |
RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31 |
CALGARY SCIENTIFIC, INC. |
KYLE PETERSON |
| K123208 |
03/19/2013 |
DIGITAL RETINAL CAMERA |
CANON, INC.-MEDICAL EQUIPMENT GROUP |
IZUMI MARUO |
| K130124 |
03/14/2013 |
CATALYST II AND III |
CARDIVA MEDICAL, INC. |
MICHAEL A DANIEL |
| K123464 |
03/05/2013 |
CALLISTO EYE |
CARL ZEISS MEDITEC AG |
JUDY BRIMACOMBE |
| K124053 |
03/13/2013 |
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) |
CARTICEPT MEDICAL, INC. |
Tanya Eberle |
| K130307 |
03/04/2013 |
ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE |
CELONOVA BIOSCIENCES, INC. |
NICOLE BARBER |
| K121247 |
03/22/2013 |
ALCO-SCREEN |
CHEMATICS, INC. |
CARL REYNOLDS |
| K123675 |
03/01/2013 |
RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR |
COLOPLAST A/S |
BRIAN SCHMIDT |
| K123914 |
03/05/2013 |
RESTORELLE Y CONTOUR |
COLOPLAST A/S |
TIM CRABTREE |
| K121430 |
03/01/2013 |
EVOLUTION BILIARY STENT SYSTEM |
COOK IRELAND LTD |
Jacinta Kilmartin |
| K122940 |
03/19/2013 |
ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3 |
COOK, INC. |
ELYSIA EASTON |
| K130128 |
03/08/2013 |
TRINITY ACETABULAR SYSTEM |
CORIN MEDICAL |
LUCINDA GERBER |
| K130435 |
03/14/2013 |
VERSAPORT V2 BLADELESS OPTICAL TROCAR |
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H |
SARAH RIZK |
| K123893 |
03/04/2013 |
CURA COLLIMATOR |
CURA MEDICAL TECHNOLOGIES, LLC |
THOMAS H FARIS |
| K123897 |
03/13/2013 |
K SERIES CPAP SYSTEMS |
CURATIVE MEDICAL INC. |
AMY MCKINNEY |
| K123818 |
03/04/2013 |
URSA ANGIOGRAPHIC CATHETER |
CURATIVE MEDICAL TECHNOLOGY, INC. |
AMY MCKINNEY |
| K123407 |
03/29/2013 |
CELLULAZE LASER |
CYNOSURE, INC. |
IRINA KULINETS |
| K123924 |
03/01/2013 |
DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS |
DEPUY ORTHOPAEDICS |
CORRENE RAMY |
| K120014 |
03/14/2013 |
STA- COAG CONTROL (N+ABN) PLUS |
DIAGNOSTICA STAGO, INC. |
KEVIN WYCKOFF |
| K130344 |
03/21/2013 |
DORNIER MEDILAS UROPULSE |
DORNIER MEDTECH AMERICA, INC. |
JOHN HOFFER |
| K123188 |
03/04/2013 |
DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DORNOCH DUO SUCTION CART WITH CL500 LID MODEL UL-DU500, DORNOC |
DORNOCH MEDICAL SYSTEMS, INC. |
LARRY SMITH |
| K123776 |
03/08/2013 |
POLARIS 100/200 |
DRAGER MEDICAL GMBH |
BETH ZIS |
| K123370 |
03/13/2013 |
EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA |
EDWARDS LIFESCIENCES, LLC. |
KAREN JONES |
| K123298 |
03/15/2013 |
FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING |
EDWARDS LIFESCIENCES, LLC. |
DANNETTE CROOMS |
| K123303 |
03/22/2013 |
FEMORAL ACCESS VENOUS CANNULAE |
EDWARDS LIFESCIENCES, LLC. |
DANNETTE CROOMS |
| K130336 |
03/28/2013 |
5MP MONOCHROME LCD MONITOR, RADIFORCE GX540 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K123151 |
03/08/2013 |
ENDOSEE MODEL 8000 U-SCOPE |
ENDOSEE CORP |
XIAOLONG(BRUCE) OUYANG |
| K130395 |
03/11/2013 |
STEREOS WORKSTATION |
EOS IMAGING INC. |
JOHN J SMITH |
| K130653 |
03/29/2013 |
ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CU |
ETHICON ENDO-SURGERY, LLC |
CAROL HUBBARD |
| K123212 |
03/08/2013 |
ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS |
ETHICON ENDO-SURGERY, LLC |
LIPING WU |
| K123687 |
03/20/2013 |
OPTETRAK LOGIC POROUS FEMORAL COMPONENT |
EXACTECH, INC. |
PATRICK HUGHES |
| K130283 |
03/07/2013 |
EVRF SYSTEM |
F CARE SYSTEMS NV |
E. J SMITH |
| K122702 |
03/18/2013 |
BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR |
FILLIGENT LIMITED |
KAI DEUSCH |
| K123562 |
03/29/2013 |
FLOWER SMALL AND MEDIUM BONE IMPLANTS |
FLOWER ORTHOPEDICS CORPORATION |
JANICE M HOGAN |
| K123169 |
03/13/2013 |
ORALID |
FORWARD SCIENCE LLC |
BRIAN PIKKULA |
| K120740 |
03/05/2013 |
COLS« FIXATION SYSTEM |
FOURNITURES HOSPITALIERES INDUSTRIE |
PATRICIA DONNARD |
| K130173 |
03/25/2013 |
SONOSITE MAXX SERIES ULTRASOUND SYSTEM |
FUJIFILM SONOSITE,INC. |
SCOTT PAULSON |
| K122206 |
03/21/2013 |
GARAVENTA X3 INCLINED PLATFORM LIFT |
GARAVENTA (CANADA) LTD [DBA GARAVENTA LIFT] |
JAY MANSOUR |
| K123522 |
03/13/2013 |
OPTIMA MR450W |
GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC) |
MICHELLE HUETTNER |
| K122253 |
03/22/2013 |
PROCARE MONITOR B20 |
GE MEDICAL SYSTEMS CHINA CO., LTD. |
ROBERT CASARSA |
| K130155 |
03/01/2013 |
MUSE CARDIOLOGY INFORMATION SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
KRISTIN PABST |
| K123136 |
03/07/2013 |
GENESIS HEALTH RECORD SYSTEM, (GHRS) |
GENESIS HEALTH TECHNOLOGIES |
KATHLEEN JOHNSON |
| K122272 |
03/28/2013 |
CARDIOMEM |
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
SUSAN D GOLDSTEIN-FALK |
| K122071 |
03/12/2013 |
GETINGE 400HC-E / SERIES STEAM STERILIZER |
GETINGE SOURCING LLC |
BARB SMITH |
| K123782 |
03/14/2013 |
PARAGON HIP SYSTEM |
GLOBAL MANUFACTURING TECHNOLOGY |
HOLLACE S RHODES |
| K123783 |
03/14/2013 |
ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS |
GLOBUS MEDICAL, INC. |
SARAH M FITZGERALD |
| K123487 |
03/11/2013 |
GSO GS1 CANNULATED SCREW SYSTEM |
GOLD STANDARD ORTHOPAEDICS, LLC |
DAVID BAUGHMAN |
| K123073 |
03/11/2013 |
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X0 |
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
PATRICK CHOW |
| K130034 |
03/08/2013 |
UNI-PICC |
HEALTH LINE INTERNATIONAL CORPORATION |
NOLA BENSTOG |
| K123587 |
03/22/2013 |
HEINE MINI 3000 LED OPHTHALMOSCOPE |
HEINE OPTOTECHNIK GMBH & CO. KG. |
JOERG ROENNAU |
| K124039 |
03/07/2013 |
HERO GRAFT |
HEMOSHPERE, INC., A CRYOLIFE COMPANY |
LAURIE LYNCH |
| K122494 |
03/27/2013 |
POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT |
HEMOSTASIS, LLC |
BERNARD HORWATH |
| K130141 |
03/22/2013 |
S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
ERIKA B AMMIRATI, RAC, MT (ASCP) |
| K123509 |
03/29/2013 |
SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
| K123108 |
03/15/2013 |
TVC IMAGING SYSTEM MODEL NIRS-MC7-70 |
Infraredx, Inc. |
STEVEN J CHARTIER |
| K123761 |
03/01/2013 |
VITA ENAMIC STAINS |
INNOVATION MEDITECH GMBH |
ELIZABETH WOLFSEN |
| K122584 |
03/24/2013 |
HEMOSIL READIPLAS TIN |
INSTRUMENTATION LABORATORY CO. |
Jacqueline Emery |
| K122480 |
03/27/2013 |
INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST |
INTERNATIONAL BIOPHYSICS CORPORATION |
H. DAVID SHOCKLEY JR. |
| K121747 |
03/14/2013 |
FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS |
INTERSURGICAL INCORPORATED |
MICHAEL ZALEWSKI |
| K123330 |
03/19/2013 |
IOGYN ENDOSCOPE |
IOGYN, INC. |
Mary J Edwards |
| K121769 |
03/05/2013 |
DENTOCORE / DENTOCORE BODY |
ITENA CLINICAL |
LOUIS- PAUL MARIN |
| K122522 |
03/19/2013 |
DENTOETCH QUICKBOND BOND ACTIVATOR |
ITENA CLINICAL |
LOUIS-PAUL MARIN |
| K124008 |
03/29/2013 |
IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE |
IVOCLAR VIVADENT, AGIN |
DONNA MARIE HARTNETT |
| K121488 |
03/05/2013 |
JMS SAFE WING CATH (SWC) |
JMS NORTH AMERICA CORPORATION |
YOLANDA SMITH |
| K121520 |
03/15/2013 |
ULTRASONIC NEBULIZER (MESH TYPE) |
K-JUMP HEALTH CO., LTD. |
JM LIN |
| K123100 |
03/28/2013 |
INTESS LUMBAR CAGE |
KALITEC DIRECT, LLC |
J D WEBB |
| K123344 |
03/07/2013 |
K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS) |
KAWASUMI LABORATORIES, INC. |
CHRISTINA HENZA |
| K123468 |
03/20/2013 |
DEMI ULTRA |
KERR CORPORATION |
Wendy Garman |
| K123749 |
03/01/2013 |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE |
KOSSAN LATEX INDUSTRIES(M)SDN BHD |
CHO SOW FONG |
| K123665 |
03/25/2013 |
LIFELINES IEEG |
KVIKNA EHF |
YOLANDA SMITH |
| K123219 |
03/18/2013 |
URGOCLEAN ABSORBENT WOUND DRESSING |
LABORATOIRES URGO |
SOPHIE FORTIN |
| K123767 |
03/18/2013 |
LANX FUSION SYSTEM- SA |
LANX, INC. |
Alan Burkholder |
| K124059 |
03/25/2013 |
AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT) |
LAUER MEMBRAN WASSERTECHNIK GMBH |
STEPHAN KRIETEMEYER |
| K123859 |
03/27/2013 |
TBD |
LENSAR, INC. |
SHIRLEY K MCGARVEY |
| K122247 |
03/20/2013 |
LIDCORAPID V2 MONITOR |
LIDCO LTD. |
GREGORY SPELLER |
| K123373 |
03/06/2013 |
NAUTILUS SPINAL SYSTEM |
LIFE SPINE |
RANDY LEWIS |
| K123955 |
03/08/2013 |
QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT |
LIFE TECHNOLOGIES CORPORATION |
DEANNA VELLA |
| K130497 |
03/29/2013 |
D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION |
LINVATEC CORPORATION D/B/A CONMED LINVATEC |
JONATHAN WERNER |
| K123014 |
03/29/2013 |
LITECURE THERAPY SYSTEM MODEL LTS-1500 |
LITECURE, LLC |
LIANG LU |
| K123628 |
03/18/2013 |
STERILE LATEX SURGICAL GLOVE |
LUCENXIA PRESCIENCE AG |
ROBERT HILL |
| K130164 |
03/24/2013 |
FIBERLASE ENDURE CO2 FIBER |
LUMENIS LTD. |
YORAM LEVY |
| K121894 |
03/21/2013 |
XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
LUBNA SYED |
| K121511 |
03/07/2013 |
MACLIN POWER INTRAVASCULAR ADMINISTRATION SET |
MACLIN POWER INC. |
ENRICO BISSON |
| K121933 |
03/14/2013 |
NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM) |
MARVAO MEDICAL DEVICES, LTD. |
Marybeth Gamber |
| K130210 |
03/15/2013 |
MEDELA THOPAZ |
MEDELA AG |
MARKUS BUETLER |
| K123802 |
03/01/2013 |
EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT |
MEDICA CORP. |
Photios Makris |
| K121979 |
03/21/2013 |
PASS OCT SPINAL SYSTEM |
MEDICREA INTERNATIONAL |
LAURA AVIRON-VIOLET |
| K130221 |
03/21/2013 |
HERO II DENTAL IMPLANT SYSTEM, UI DENTAL IMPLANT SYSTEM |
MEDIMECCA CO., LTD. |
Priscilla Chung |
| K122850 |
03/28/2013 |
TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES |
MEDITECH ADVISORS, LLC |
Sharyn Orton |
| K123350 |
03/07/2013 |
ECLIPSE SOFT TISSUE FASTENER |
MEDSHAPE, INC |
JACK C GRIFFIS III |
| K123762 |
03/27/2013 |
DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF |
MEDTRONIC INC. |
CHELSEA PIOSKE |
| K124004 |
03/22/2013 |
NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS |
MEDTRONIC NAVIGATION, INC. |
MICHAEL BLASCO |
| K123351 |
03/19/2013 |
AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE |
MEDTRONIC PERFUSION SYSTEMS |
JULIA A NELSON |
| K122037 |
03/22/2013 |
ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST |
MEDTRONIC SOFAMOR DANEK, INC. |
BECKY RONNER |
| K122513 |
03/06/2013 |
CLEARED UNDER GRAFTON II EDBM |
MEDTRONIC SOFAMOR DANEK, INC. |
KELLY ANGLIN |
| K123870 |
03/27/2013 |
XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM |
MEGAGEN IMPLANT CO., LTD. |
APRIL LEE |
| K122362 |
03/26/2013 |
SMART-WELL INCUBATOR |
MESA LABORATORIES, INC. |
JOLE WILSON |
| K122016 |
03/01/2013 |
REXTAR, REXTAR LCD |
META BIOMED, INC. |
BLIX WINSTON |
| K130229 |
03/20/2013 |
PALM BLADDER SCANNER |
MIANYANG MEIKE ELECTRONIC EQUIPMENT CO., LTD. |
HELEN NAN |
| K122806 |
03/08/2013 |
IMAGE WORKS PANOURA |
MIC INTERNATIONAL |
IZUMI MARUO |
| K124007 |
03/07/2013 |
SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY |
MICRO THERAPEUTICS, INC D/B/A: EV3 INC |
ANALIA STAUBLY |
| K124029 |
03/27/2013 |
MICROLINE FLEXIBLE LIGATING SHEARS |
MICROLINE SURGICAL, INC |
DEAN CIPORKIN |
| K123624 |
03/28/2013 |
OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM |
MIMOSA ACOUSTICS, INC. |
PATRICIA S JENG |
| K130393 |
03/20/2013 |
MIRADA RTX |
MIRADA MEDICAL LTD. |
GWILYM OWEN |
| K123980 |
03/05/2013 |
SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES |
MISONIX, INC. |
RONALD MANNA |
| K123556 |
03/22/2013 |
MORTARA SURVEYOR PATIENT MONITOR |
MORTARA INSTRUMENT, INC. |
AMY YANG |
| K122456 |
03/22/2013 |
MRII CRAINIAL DRILL |
MRI INTERVENTIONS, INC. |
E.F. WADDELL |
| K113717 |
03/05/2013 |
ULTRASONIC SCALER |
NAKANISHI, INC. |
DIANE RUTHERFORD |
| K130609 |
03/21/2013 |
VEEDA 100% COTTON MENSTRUAL TAMPON |
NATURALENA BRANDS, INC. |
JOSH ELLIS |
| K123272 |
03/28/2013 |
1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM |
NEOCOIL, LLC |
KATIE GONZALEZ |
| K130228 |
03/20/2013 |
SUITEHEART |
NEOSOFT, LLC |
JACKIE SCHWABE |
| K123554 |
03/07/2013 |
SHUNTCHECK |
NEURODX DEVELOPMENT LLC |
FREDERICK J FRITZ |
| K121285 |
03/08/2013 |
ORAVAN OSA |
NEW JERSEY SNORING SOLUTIONS |
DEBORAH STEIN |
| K121622 |
03/14/2013 |
NIDEK RS-3000 |
NIDEK CO., LTD. |
LENA SATTLER |
| K123642 |
03/29/2013 |
MUSCLE STIMULATION SYSTEM |
NIVEUS MEDICAL, INC. |
CINDY DOMECUS, R.A.C. (US & EU) |
| K123976 |
03/26/2013 |
NOBELCLINICIAN |
NOBEL BIOCARE AB |
PHUONG NGUYEN |
| K122602 |
03/13/2013 |
NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMS |
NOBEL BIOCARE AB |
PHUONG NGUYEN SON |
| K123013 |
03/22/2013 |
ENDOSCOPIC INTRODUCER |
NOVADAQ TECHNOLOGIES, INC. |
TIM VERSPAGEN |
| K130413 |
03/21/2013 |
PINPOINTE FOOTLASER |
NUVOLASE, INC. |
KATHY MAYNOR |
| K130234 |
03/13/2013 |
NUVON VITALS CHARTING SYSTEM |
NUVON, INC. |
JONATHAN S KAHAN |
| K123395 |
03/07/2013 |
NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS |
NXSTAGE MEDICAL, INC. |
MARY LOU STROUMBOS |
| K123365 |
03/01/2013 |
OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190 |
OLYMPUS MEDICAL SYSTEMS CORP. |
SHERI L MUSGNUNG |
| K123498 |
03/21/2013 |
BP652N (HEM-6300-Z) |
OMRON HEALTHCARE, INC. |
PAUL DRYDEN |
| K123118 |
03/26/2013 |
INSIGNIA DIGICAST |
ORMCO CORP. |
Wendy Garman |
| K123416 |
03/13/2013 |
INSIGNIA WITH ITERO |
ORMCO CORP. |
Wendy Garman |
| K123426 |
03/01/2013 |
MEDICVOD, MEDICAST, MEDISHOW, MEDISEARCH, CENTRAL STORAGE SYSTEM - CSS |
ORPHEUS MEDICAL, LTD. |
CLAY ANSELMO |
| K123457 |
03/22/2013 |
BALANCED KNEE SYSTEM HIGH FLEX PS |
ORTHO DEVELOPMENT CORP. |
TOM HAUETER |
| K130176 |
03/28/2013 |
FIREBIRD SPINAL FIXATION SYSTEM |
ORTHOFIX |
JACKI GEREN |
| K113164 |
03/11/2013 |
DISCOVERY TMAX MANUAL WHEELCHAIR |
OTTO BOCK HEALTHCARE, LP |
WILLIAM KABITZ |
| K122560 |
03/26/2013 |
VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1 |
PAN-AMERICA HYPERBARICS, INC. |
WILLIAM M GATES, RRT |
| K130206 |
03/20/2013 |
PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS |
PENTAX OF AMERICA, INC. |
KRISHNA GOVINDARAJAN |
| K130247 |
03/20/2013 |
PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS |
PENTAX OF AMERICA, INC. |
KRISHNA GOVINDARAJAN |
| K121864 |
03/12/2013 |
PERKINELMER 226 SAMPLE COLLECTION DEVICES |
PERKINELMER, INC. |
KAY A TAYLOR |
| K121156 |
03/13/2013 |
AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES |
PHADIA AB |
MARTIN MANN |
| K130091 |
03/13/2013 |
PULMOSAL |
PHARMACARIBE |
PAUL DRYDEN |
| K130153 |
03/12/2013 |
HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST |
PHILIPS MEDICAL SYSTEMS |
MARK PUOPOLO |
| K120815 |
03/06/2013 |
INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE |
PHILIPS MEDICAL SYSTEMS |
PETER SCHIPELLITI |
| K121772 |
03/21/2013 |
ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1 |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
FRANS JACOBS |
| K113636 |
03/08/2013 |
BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE) |
PHILOSYS CO. LTD. |
LINDA CHAN |
| K130351 |
03/14/2013 |
NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER |
PIVOT MEDICAL INC. |
Jon Cook |
| K122907 |
03/14/2013 |
FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER |
POLYMED THERAPEUTICS, INC |
TERRI WALLACE |
| K122634 |
03/12/2013 |
IODOFOAM IODOPHOR FOAM DRESSING |
PROGRESSIVE WOUNDCARE TECHNOLOGIES, LLC |
MASON DIAMOND |
| K122744 |
03/28/2013 |
PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER |
PROSPERA CORPORATION |
LEON E JEW |
| K130223 |
03/29/2013 |
RMGI FILL |
PULPDENT CORPORATION |
KENNETH J BERK |
| K123725 |
03/08/2013 |
FASTPACK CONTROL KIT |
Qualigen, Inc. |
Michael Poirier |
| K123998 |
03/08/2013 |
QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY |
QUIDEL CORP. |
Ronald H Lollar |
| K122189 |
03/08/2013 |
QUIDEL MOLECULAR RSV + HMPV ASSAY |
QUIDEL CORP. |
Ronald H Lollar |
| K123984 |
03/28/2013 |
QUANTIEN MEASUREMENT SYSTEM |
RADI MEDICAL SYSTEMS AB |
ANNA-LISA TIENSUU |
| K130415 |
03/26/2013 |
HIGH METABOLITE QUALICHECK |
RADIOMETER MEDICAL APS |
Martin Gabler |
| K130236 |
03/15/2013 |
RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3 |
RADIOMETER MEDICAL APS |
Martin Gabler |
| K122918 |
03/15/2013 |
RAYSCAN A-EXPERT |
RAY CO., LTD |
ANDREW PAENG |
| K122981 |
03/12/2013 |
RAYSCAN A-EXPERT 3D |
RAY CO., LTD |
ANDREW PAENG |
| K123345 |
03/12/2013 |
DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA |
RAYENCE CO., LTD |
DAVE KIM |
| K123805 |
03/20/2013 |
E-Z CHEK BLOOD LEAK TEST STRIPS |
REPROCESSING PRODUCTS CORP. |
TED WILLIAMS |
| K123557 |
03/14/2013 |
EASYCARE ONLINE |
RESMED LTD. |
JIM CASSI |
| K123511 |
03/21/2013 |
S9 VPAP TX |
RESMED LTD. |
JIM CASSI |
| K123789 |
03/29/2013 |
SWIFT FX NANO |
RESMED LTD. |
JIM CASSI |
| K122847 |
03/06/2013 |
KANGAROO NASAL MASK |
RESPIRONICS INC. |
MICHELLE BRINKER |
| K113042 |
03/08/2013 |
REVOIS IMPLANT SYSTEM |
RIEMSER ARZNEIMITTEL AG |
James M Clinton |
| K130138 |
03/15/2013 |
SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM |
ROCHE DIAGNOSTICS CORP. |
Justin Davis |
| K123356 |
03/05/2013 |
FORTIVA PORCINE DERMIS |
RTI BIOLOGICS, INC. |
ESTHER CARBON |
| K123743 |
03/26/2013 |
ULTRASAFE PLUS PASSIVE NEEDLE GUARD |
SAFETY SYRINGES, INC. |
SUZANNE RICHARDSON |
| K123694 |
03/07/2013 |
SAM JUNCTIONAL TOURNIQUET |
SAM MEDICAL PRODUCTS |
JACK N MCCUTCHEON |
| K123606 |
03/01/2013 |
CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE |
SCION MEDICAL TECHNOLOGIES LLC |
JOSEPH OSTENDORF |
| K123477 |
03/19/2013 |
VIA MICROCATHETER, VIA PLUS MICROCATHETER |
SEQUENT MEDICAL, INC |
MELANIE PARRAVI |
| K113727 |
03/21/2013 |
SHENZHEN MED-LINK PULSE OXIMETER PROBE |
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. |
RHONDA ALEXANDER |
| K121981 |
03/21/2013 |
ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY |
SIEMENS HEALTHCARE DIAGNOSTICS |
PHILIP LIU |
| K123677 |
03/07/2013 |
DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) |
SIEMENS HEALTHCARE DIAGNOSTICS |
ROSE T MARINELLI |
| K122534 |
03/14/2013 |
IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL |
Siemens Healthcare Diagnostics Inc. |
Garo Mimaryan |
| K130276 |
03/22/2013 |
DIMENSION EXL WITH LM SYSTEM |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
PAMELA A JURGA |
| K123933 |
03/14/2013 |
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
Elisabeth Warriner |
| K130619 |
03/21/2013 |
ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHELLY PEARCE |
| K123812 |
03/01/2013 |
COHERENCE RT THERAPIST CONNECT WORKSPACE, V2.3, ARIA CONNECTIVITY OPTION FOR SIEMENS NON-IMAGING SYSTEMS, ARIA CONNECTIV |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CHRISTINE DUNBAR |
| K130262 |
03/01/2013 |
MAGNETOM ESSENZA WITH SYNGO MR D14 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NADIA SOOKDEO |
| K123584 |
03/12/2013 |
SYNGO, CT BONE READING |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY MANGUM |
| K130754 |
03/25/2013 |
ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS, INC. |
PATRICK LYNCH |
| K123952 |
03/20/2013 |
CEREC BLOCS C IN |
SIRONA DENTAL SYSTEMS GMBH |
FRITZ KOLLE |
| K123070 |
03/15/2013 |
GALILEOS FAMILY |
SIRONA DENTAL SYSTEMS GMBH |
FRITZ KOLLE |
| K120354 |
03/21/2013 |
BETA-TCP GRANULES |
SKELETAL KINETICS, LLC |
CHRISTINE KUO |
| K123161 |
03/14/2013 |
SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE |
SMARTGUARD, INC. |
SHELLY GARG |
| K121904 |
03/11/2013 |
GYNECOLOGY STERILIZATION TRAY |
SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
JANICE HASELTON |
| K122059 |
03/18/2013 |
ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS |
SMITH & NEPHEW, INC. |
KARIN DESJARDINS |
| K123948 |
03/14/2013 |
CHINA NAILS AND ACCESSORIES |
SMITH & NEPHEW, INC. |
JASON SELLS |
| K122220 |
03/19/2013 |
ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS AND IRREGULAR COR ENI-EYE SH SOFT K TORIC S |
SOFLEX LIMITED |
Kevin Walls |
| K121685 |
03/12/2013 |
SOPROCARE |
SOPRO |
RICK ROSATI |
| K130433 |
03/20/2013 |
INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR, INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATE |
SORIN GROUP ITALIA S.R.L. |
SCOTT LIGHT |
| K130112 |
03/21/2013 |
CAPNO MODULE, 92517 |
SPACELABS HEALTHCARE |
THOMAS KROENKE |
| K130396 |
03/25/2013 |
RAMPART O AND RAMPART P |
SPINEOLOGY, INC. |
BRYAN BECKER |
| K123652 |
03/22/2013 |
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE |
SPINEOLOGY, INC. |
BRYAN BECKER |
| K130252 |
03/20/2013 |
CPS AIM UNIVERSAL SLITTABLE INNER CATHETER |
ST. JUDE MEDICAL |
COLLEEN CANAN |
| K130257 |
03/20/2013 |
CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER |
ST. JUDE MEDICAL |
COLLEEN CANAN |
| K123484 |
03/29/2013 |
SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT (HYDROPHILIC) CONTACT LENS |
ST. SHINE OPTICAL CO., LTD. |
ELLA LEE |
| K122113 |
03/12/2013 |
MEMORY METAL STAPLES, EASYCLIP |
STRYKER CORP. |
ESTELA CELI |
| K123178 |
03/28/2013 |
STRYKER VENOM ELECTRODES AND CANNULAE |
STRYKER INSTRUMENTS, INSTRUMENTS DIV. |
CHRISTINA MCKEE |
| K123964 |
03/28/2013 |
AXSOS 3 TI LOCKING PLATE SYSTEM |
Stryker Trauma AG |
ESTELA CELI |
| K123403 |
03/20/2013 |
AXSOS PROXIMAL LATERAL TIBIA LONG PLATES |
Stryker Trauma AG |
ESTELA CELI |
| K130116 |
03/05/2013 |
SUPERIOR LATERAL VARIAX CLAVICLE PLATE |
Stryker Trauma AG |
ESTELA CELI |
| K130009 |
03/22/2013 |
VARIAX 2 COMPRESSION PLATING SYSTEM |
Stryker Trauma AG |
ESTELA CELI |
| K121743 |
03/28/2013 |
EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN |
SUNMED LLC |
WU TINGJIE |
| K123335 |
03/21/2013 |
SUNRAY FETAL MONITOR |
SUNRAY MEDICAL APPARATUS CO., LTD. |
SABRINA WEI |
| K122306 |
03/08/2013 |
SYNOVIS COLLAGEN MATRIX (TBD) |
SYNOVIS SURGICAL INNOVATIONS |
JODI JORGENSON |
| K122060 |
03/21/2013 |
CLEVER TD-7001NEBULIZER |
TaiDoc Technology Corporation |
PINJUNG CHEN |
| K122221 |
03/29/2013 |
NEXUS IR30 NON-CONTACT INFRARED FOREHEAD THERMOMETER |
TaiDoc Technology Corporation |
PINJUNG CHEN |
| K122412 |
03/13/2013 |
VISIOFOCUS |
TECNIMED S.R.L. |
Claude Berthoin |
| K122175 |
03/28/2013 |
MENDEC SPINE HV, MENDEC SPINE HV SYSTEM |
TECRES SPA |
CHRISTINE BRAUER, PH.D. |
| K123640 |
03/20/2013 |
TX1 TISSUE REMOVAL SYSTEM |
TENEX HEALTH |
DAVID SALZBERG |
| K130359 |
03/13/2013 |
CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
SUZANNE GRENIER |
| K130333 |
03/13/2013 |
CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
SUZANNE GRENIER |
| K130280 |
03/13/2013 |
CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR |
TERUMO Corporation |
GARRY A COURTNEY, MBA, RAC |
| K130493 |
03/13/2013 |
CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR |
TERUMO Corporation |
GARRY A COURTNEY, MBA, RAC |
| K122590 |
03/01/2013 |
RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE |
Terumo Medical Corporation |
STACY A KLUESNER, MS, RAC |
| K113823 |
03/27/2013 |
HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT |
THE BINDING SITE GROUP LTD |
JILL CONSTANTINE |
| K123832 |
03/20/2013 |
OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME |
THE ORTHOPAEDIC IMPLANT COMPANY (OIC) |
ITAI NEMOVICHER |
| K123472 |
03/05/2013 |
CIMVA UNIVERSAL |
THERAPEUTIC MONITORING SYSTEMS (TMS), INC. |
CRAIG J COOMBS |
| K123889 |
03/04/2013 |
ACLEARA, THERACLEAR |
THERAVANT CORPORATION |
Marcy Moore |
| K123819 |
03/05/2013 |
MULTIPLE NAME |
TOP CALIBRE SDN BHD |
ROSNITA MAODIN |
| K120001 |
03/01/2013 |
UNIGOLD GIARDIA |
TRINITY BIOTECH |
LUPE KAGAN |
| K123614 |
03/11/2013 |
SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) |
TRUDELL MEDICAL INTL. |
DARRYL FISCHER |
| K123717 |
03/04/2013 |
UCENTUM |
ULRICH GMBH & CO. KG |
HANS STOVER |
| K130251 |
03/13/2013 |
ESOPHAGUS BOUGIE SET |
VARIAN MEDICAL SYSTEMS, INC. |
PETER J CORONADO |
| K123815 |
03/11/2013 |
SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE |
VARIAN MEDICAL SYSTEMS, INC. |
PETER J CORONADO |
| K123220 |
03/01/2013 |
VERTEX THERMOSENS RIGID |
VERTEX-DENTAL B.V. |
MASON DIAMOND |
| K121823 |
03/27/2013 |
CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC |
WESCOR, INC. |
DAWN T PERDUE |
| K122955 |
03/01/2013 |
DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM |
WRIGHT HEALTH GROUP LTD. |
STEPHEN T MLCOCH |
| K122218 |
03/21/2013 |
ADVANCE TOTAL KNEE SYSTEM-PATELLA |
WRIGHT MEDICAL TECHNOLOGY, INC. |
Danielle Mueller |
| K123059 |
03/04/2013 |
INBONE ( I AND II) TOTAL ANKLE SYSTEMS |
WRIGHT MEDICAL TECHNOLOGY, INC. |
RYAN BORMANN |
| K113871 |
03/25/2013 |
PRO-DENSE BONE GRAFT SUBSTITUTE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SAMIR IBRAHIM |
| K123702 |
03/11/2013 |
SILEX SACROILIAC JOINT FUSION SYSTEM |
X-SPINE SYSTEMS, INC. |
DAVID KIRSCHMAN, M.D. |
| K130468 |
03/19/2013 |
ORBIT INFUSION SET |
YPSOMED AG |
BENJAMIN REINMANN |
| K120782 |
03/20/2013 |
INTERVENTIONAL HEMOSTATIC BANDAGE |
Z-MEDICA CORPORATION |
SHEILA WALLIN |
| K123780 |
03/01/2013 |
TRANSTEK BLOOD PRESSURE MONITOR |
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
LEO WANG |
| K123392 |
03/04/2013 |
AVENIR MULLER STEM |
ZIMMER GMBH |
KAREN O'LEARY |
| K123602 |
03/01/2013 |
TM ARDIS INTERBODY SYSTEM INSERTER |
ZIMMER TRABECULAR METAL TECHNOLOGY |
JUDITH ROSEN |
| K123862 |
03/12/2013 |
ZIMMER NEXEL TOTAL ELBOW |
ZIMMER, INC. |
JOANNA L SURMA |
