FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K083672 |
04/13/2009 |
P.D SOFTWARE |
.DECIMAL, INC. |
DANIEL BENNETT |
K090569 |
04/29/2009 |
MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 1292 |
3M COMPANY |
BRYAN BECKER |
K090519 |
04/15/2009 |
VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247 |
3M COMPANY |
KAREN O'MALLEY |
K090460 |
04/14/2009 |
BONOS INJECT |
AAP BIOMATERIALS GMBH |
VOLKER STIRNAL |
K083223 |
04/16/2009 |
RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01 |
ABBOTT DIABETES CARE INC. |
ARUL STERLIN |
K083809 |
04/07/2009 |
CREATININE |
ABBOTT LABORATORIES |
LINDA MORRIS |
K083111 |
04/16/2009 |
IMPELLA 5.0 CATHETER FAMILY |
ABIOMED, INC. |
WILLIAM BOLT |
K090300 |
04/30/2009 |
MODIFICATION TO AUTOFUSER |
ACE MEDICAL US, LLC |
ANDREW LAMBORNE |
K090057 |
04/08/2009 |
ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM |
ACON LABORATORIES CO. |
RICHARD LENART |
K090031 |
04/16/2009 |
ACTHERM INFRARED EAR THERMOMETER, ACT 8000 SERIES; PROBE COVER FOR ACTHERM INFRARED EAR THERMOMETER, MODEL MEDACCU2010 |
ACTHERM, INC. |
RICHARD HSIEH |
K083539 |
04/03/2009 |
INFANT CARDIAC ARRAY |
ADVANCED IMAGING RESEARCH, INC. |
RAVI SRINIVASAN |
K090299 |
04/24/2009 |
BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS |
AESCULAP IMPLANT SYSTEMS |
KATHY A RACOSKY |
K090657 |
04/20/2009 |
MODIFICATION TO: S4 SPINAL SYSTEM |
AESCULAP IMPLANT SYSTEMS |
LISA M BOYLE |
K090138 |
04/24/2009 |
MOBILECARE MONITOR, MODEL 2100 |
AFRAME DIGITAL, INC. |
DARREN REEVES |
K082080 |
04/01/2009 |
ALCO TUBE PLUS |
ALCOTEST QUEBEC |
E.J. Smith |
K083848 |
04/14/2009 |
ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORM |
ALMA LASERS LTD. |
TATIANA EPSTEIN |
K090782 |
04/22/2009 |
NOVEL ALIF SPINAL SPACER SYSTEM |
ALPHATEC SPINE, INC. |
MARY STANNERS |
K090228 |
04/29/2009 |
ROC LUMBAR PLATING SYSTEM |
ALPHATEC SPINE, INC. |
KARLA SCHAFFNER |
K090854 |
04/16/2009 |
ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090 |
AMERICAN BIOLOGICAL TECHNOLOGIES, INC. |
JOHN GROMLEY |
K082333 |
04/02/2009 |
ASAP WOUND DRESSING GEL |
AMERICAN BIOTECH LABS |
JAMES S TURNER |
K090663 |
04/09/2009 |
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS |
AMERICAN MEDICAL SYSTEMS, INC. |
STEPHANIE GEORGE |
K090713 |
04/02/2009 |
ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP |
AMERICAN MEDICAL SYSTEMS, INC. |
DENISE THOMPSON |
K090963 |
04/30/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556 |
ANDON HEALTH CO.,LTD |
LIU YI |
K090043 |
04/09/2009 |
AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9 |
APEX BIOTECHNOLOGY CORP. |
THOMAS Y.S. SHEN |
K083656 |
04/22/2009 |
APEX MEDICAL XT AUTO CPAP 9S-005200 |
APEX MEDICAL CORP. |
ALAN CHANG |
K082325 |
04/21/2009 |
APEXUM ABLATOR |
APEXUM LTD. |
IDAN TOBIS |
K082846 |
04/03/2009 |
APK SPO2 PULSE OXIMETER SENSOR |
APK TECHNOLOGY CO., LTD |
Diana Hong |
K083278 |
04/08/2009 |
AVC A/H5N1 FLU TEST |
ARBOR VITA CORPORTATION |
LINDA ALLISTER |
K082951 |
04/08/2009 |
IMMERSION HYDROBATH |
ARJO HOSPITAL EQUIPMENT AB |
TRACI GIOVENCO |
K083799 |
04/16/2009 |
TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00 |
ARK DIAGNOSTICS,INC |
JOHNNY VALDEZ |
K083007 |
04/08/2009 |
PROWICK |
ARTHREX, INC. |
SALLY FOUST |
K090323 |
04/01/2009 |
REPROCESSED ELECTROPHYSIOLOGY CATHETERS |
ASCENT HEALTHCARE SOLUTIONS |
KATIE BRAY |
K083871 |
04/15/2009 |
ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONE |
ASTRA TECH, INC. |
BETSY A BROWN |
K090130 |
04/02/2009 |
ATMOS S041 WOUND |
ATMOS INC. |
CARL ALLETTO |
K090121 |
04/15/2009 |
PRE-FILLED CATHETER INFLATION SYRINGE |
AVAIL MEDICAL PRODUCTS, INC. |
PATRICIA A GOEREE |
K090905 |
04/27/2009 |
ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE |
B. BRAUN MEDICAL, INC. |
ANGELA J CARAVELLA |
K090603 |
04/22/2009 |
BARCO 5MP MAMMO, MODEL MDMG-5221 |
BARCO NV |
ALBERT XTHONA |
K090732 |
04/20/2009 |
NIO COLOR 3MP AND MDNC-3121 |
BARCO NV |
LIEVEN DE WANDEL |
K082251 |
04/08/2009 |
SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 |
BECKMAN COULTER, INC. |
MARINE BOYAJIAN |
K083466 |
04/03/2009 |
MD2000A VITAL SIGN MONITOR, MODEL MD2000A |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
Diana Hong |
K090873 |
04/10/2009 |
I OPEN 0.5T |
BEIJING WANDONG MEDICAL EQUIPMENT CO., LTD. |
WANG WEIMIN |
K090999 |
04/15/2009 |
BIOCARDIA MORPH SHEATH GUIDE |
BIOCARDIA, INC. |
DAVID SNOW |
K090759 |
04/01/2009 |
BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM |
BIODRAIN MEDICAL, INC. |
CHAD RUWE |
K090003 |
04/02/2009 |
ZETAJET |
BIOJECT, INC. |
KRIS RICHARD |
K083595 |
04/14/2009 |
EZLASE |
BIOLASE TECHNOLOGY, INC. |
IOANA RIZOUI |
K080561 |
04/10/2009 |
VIDAS CA 125 II ASSAY |
BIOMERIEUX, INC. |
SANDRA L PERREAND |
K083779 |
04/03/2009 |
MAK OSS KNEE FEMORAL COMPONENTS |
BIOMET MANUFACTURING CORP. |
PATRICIA S BERES |
K083782 |
04/03/2009 |
REGENEREX PATELLA COMPONENTS |
BIOMET MANUFACTURING CORP. |
SUSAN ALEXANDER |
K082793 |
04/02/2009 |
INTERGRO DBM |
BIOMET SPINE |
KATHLEEN IDEO |
K083674 |
04/01/2009 |
PK-141 PATIENT CABLE |
BIOTRONIK, INC. |
Jon Brumbaugh |
K090607 |
04/22/2009 |
BLUE SKY BIO PLAN, VERSION .38 |
BLUE SKY BIO, LLC |
ALBERT ZICKMANN |
K090297 |
04/14/2009 |
BLUESHINE GOLD SERIES |
BLUESHINE SRL |
CHIARA RICCI |
K083374 |
04/22/2009 |
WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM |
BOSTON SCIENTIFIC CORP. |
Marybeth Gamber |
K083627 |
04/07/2009 |
WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540 |
Boston Scientific Corporation |
Marybeth Gamber |
K083483 |
04/08/2009 |
BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED |
BRAINLAB AG |
MICHAEL HOTTNER |
K083310 |
04/01/2009 |
SPINE & TRAUMA ICT |
BRAINLAB AG |
RAINER BIRKENBACH |
K090743 |
04/03/2009 |
YIELD MINI DOPPLER SYSTEM |
BRONCUS TECHNOLOGIES, INC. |
NANCY ISAAC |
K090853 |
04/07/2009 |
YIELD TISSUE SAMPLER |
BRONCUS TECHNOLOGIES, INC. |
NANCY ISAAC |
K090134 |
04/21/2009 |
INTRAVENOUS POWER INJECTOR EXTENSION SET |
C.R. BARD, INC. |
SCOTT PEASE |
K091017 |
04/29/2009 |
CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001 |
CARDICA, INC. |
KIMBERLEE LEON |
K090872 |
04/21/2009 |
MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM |
CARDICA, INC. |
KIMBERLEE LEON |
K090014 |
04/09/2009 |
CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPE |
CAREMATE MEDICAL DEVICE CO., LTD |
XIAOMING HONG |
K090318 |
04/06/2009 |
CARESTREAM DRX-1 SYSTEM |
CARESTREAM HEALTH, INC. |
CHRISTINE EHMANN |
K090013 |
04/21/2009 |
CHEMPAQ XBC ANALYZER |
CHEMPAQ A/S |
LONE HOFFENSETS |
K083216 |
04/14/2009 |
CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES |
CIBA VISION CORPORATION |
MARTINA HEIM |
K082038 |
04/28/2009 |
CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V |
CLARUS MEDICAL, LLC. |
THOMAS BARTHEL |
K083554 |
04/21/2009 |
CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3 |
CLINIQA CORPORATION |
DAWN GAST |
K090217 |
04/23/2009 |
BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070 |
COLOPLAST A/S |
SURESH GHAL |
K083351 |
04/24/2009 |
PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P |
COMDEK INDUSTRIAL CORP. |
Y.S. KUO |
K083482 |
04/02/2009 |
COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET |
COOK VASCULAR INC. |
JIM FERGUSON, JR. |
K090822 |
04/27/2009 |
ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER |
COOK, INC. |
NATHAN SIMON |
K090624 |
04/02/2009 |
COOK MREYE EMBOLIZATION COILS |
COOK, INC. |
SUSANNE GALIN |
K090303 |
04/30/2009 |
XTEND-ST NUCLEUS REMOVAL SYSTEM, MODEL 9004 |
CORESPINE TECHNOLOGIES, LLC |
BRITT K NORTON |
K091084 |
04/29/2009 |
MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS |
COTTON HIGH TECH SL |
ELENA GOMEZ |
K090352 |
04/03/2009 |
TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES |
COVIDIEN |
TED KUHN |
K083350 |
04/21/2009 |
TENS/NMES/FES STIMULATING ELECTRODE |
COVIDIEN LP |
WEI ZHAO |
K083519 |
04/10/2009 |
AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS |
COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES |
FRANK GIANELLI |
K083693 |
04/02/2009 |
PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840 |
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC. |
KIM BLOOM |
K090049 |
04/20/2009 |
ATLAS IMPLANT SYSTEM- MINI PLUS |
COWELLMEDI CO., LTD |
JUNG BAE BANG |
K090618 |
04/14/2009 |
CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C |
CYNOSURE, INC. |
GEORGE CHO |
K083586 |
04/29/2009 |
I-FIX SYSTEM |
DENTIS CO. LTD. |
JUNG BAE BANG |
K083841 |
04/14/2009 |
ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
K090669 |
04/03/2009 |
RIGIDFIX BIOCRYL CROSS PIN KITS |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
ZHENG LIU |
K090799 |
04/22/2009 |
MODIFICATION TO EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
FRANK JURCZAK |
K090695 |
04/23/2009 |
DINKLER SURGICAL SKULL CLAMP, MODEL 0308 |
DINKLER SURGICAL DEVICES, INC. |
CHARLES E DINKLER III |
K090171 |
04/30/2009 |
COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D |
E-WOO TECHNOLOGY |
VINCENT LEE |
K083623 |
04/15/2009 |
CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100 |
EDWARDS LIFESCIENCES, LLC. |
ERICA WALTERS |
K083191 |
04/10/2009 |
DETLOGIX ANNULOPLASTY RING, MODEL: 5100 |
EDWARDS LIFESCIENCES, LLC. |
MARTIN A KAUFMAN |
K090064 |
04/09/2009 |
EMINENT SPINE INTERBODY FUSION SYSTEM |
EMINENT SPINE |
DAVE FREEHILL |
K083381 |
04/15/2009 |
EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) |
EUROIMMUN US INC |
KATHRYN KOHL |
K082130 |
04/07/2009 |
EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG) |
EUROIMMUN US INC |
KATHRYN KOHL |
K090728 |
04/16/2009 |
HYPERGLIDE OCCLUSION BALLOON SYSTEM |
EV3 INC. |
JASON K LYON |
K083793 |
04/27/2009 |
STEERABLE GUIDE CATHETER |
EVALVE INC |
KARUNA VELUSAMY |
K090764 |
04/21/2009 |
NOVATION CFS PRESS-FIT AND CEMENTED STEMS |
EXACTECH, INC. |
TARA R PATTERSON |
K083508 |
04/28/2009 |
SWABCAP |
EXCELSIOR MEDICAL CORP. |
ROSHANA AHMED |
K090801 |
04/08/2009 |
ELECTRONIC HOUSE CALL |
EXPRESS MD SOLUTIONS, LLC |
CHRIS DOHERTY |
K082934 |
04/23/2009 |
EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM |
EXTREMITY MEDICAL LLC |
JAMY GANNOE |
K083889 |
04/23/2009 |
FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY |
FOTONA D.D. |
STOJAN TROST |
K090116 |
04/22/2009 |
FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15 |
FUJINON, INC. |
MASAYUKI OOYATSU |
K090892 |
04/30/2009 |
GE DATEX-OHMEDA S/5 ADU CARESTATION |
GE HEALTHCARE FINLAND OY |
ADRIENNE LENZ |
K083098 |
04/01/2009 |
NAVIGATOR APPLICATIONS SUITE |
GE HEALTHCARE FINLAND OY |
ADRIENNE LENZ |
K090702 |
04/15/2009 |
MODIFICATION TO DASH 2500 PATIENT MONITOR |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
DAVID WAHLIG |
K090638 |
04/29/2009 |
GENADYNE A4-XLR8 WOUND VACUUM SYSTEM |
GENADYNE BIOTECHNOLOGIES, INC. |
CHIEN-MING GOH |
K083509 |
04/24/2009 |
LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA |
GENX INTL., INC. |
MICHAEL D CECCHI |
K072500 |
04/21/2009 |
ONE STEP HCG URINE/SERUM TEST |
Guangzhou Wondfo Biotech Co., Ltd. |
HOWARD MANN |
K090814 |
04/20/2009 |
MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 |
GYRUS ACMI, INC. |
GRAHAM A.L. BAILLIE |
K090249 |
04/03/2009 |
MODIFICATION TO: MICRO-INDUCTION 1000 SYSTEM |
HARBINGER MEDICAL, INC. |
HAROLD HOIUM |
K090237 |
04/17/2009 |
HG II FIXTURE SYSTEM |
HIOSSEN INC. |
MINJOO KIM |
K083534 |
04/13/2009 |
LIFEBED NETWORK PATIENT VIGILANCE SYSTEM |
HOANA MEDICAL, INC. |
NANCY GERTLAR |
K090074 |
04/22/2009 |
HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS |
HYGIA HEALTH SERVICES, INC. |
JEROME JAMES |
K090189 |
04/10/2009 |
ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE |
ICU MEDICAL, INC |
TRACY BEST |
K082806 |
04/06/2009 |
SPINNING SPIROS, MODEL CH-2000 |
ICU MEDICAL, INC |
TRACY BEST |
K083215 |
04/08/2009 |
INCISIVE FAMILY OF INPULSE ND:YAG LASERS |
INCISIVE, LLC. |
ANN WORDEN |
K090506 |
04/20/2009 |
MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114 |
INTEGRA LIFESCIENCES CORPORATION |
HELDER A SOUSA |
K082470 |
04/03/2009 |
SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA |
INTER-MED, INC. |
GEORGE HORVAT |
K083861 |
04/09/2009 |
TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE |
INTERACOUSTICS AS |
HANNE NIELSEN |
K090192 |
04/24/2009 |
BILI BLUE F20T12/BBY AND F40T12/BBY |
INTERLECTRIC CORP. |
KEN C FRAZIER |
K090070 |
04/22/2009 |
INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM |
INVUITY, INC. |
KIT CARIQUITAN |
K083058 |
04/15/2009 |
IBA PROTON THERAPY SYSTEM - PROTEUS 235 |
ION BEAM APPLICATIONS S.A. |
JOHN B REISS |
K090087 |
04/07/2009 |
MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM |
IRADIMED CORPORATION |
FRANCIS X CASEY |
K083590 |
04/17/2009 |
ISKRA MEDICAL GREEN IRF PRESTIGE |
ISKRA MEDICAL, D.O.O. |
MOJCA VALJAVEC |
K090701 |
04/29/2009 |
EMPRESS DIRECT |
IVOCLAR VIVADENT, INC. |
DONNA M HARTNETT |
K082698 |
04/21/2009 |
ALEUTIAN IBF SYSTEM |
K2M, INC. |
RICHARD WOODS |
K090292 |
04/03/2009 |
PREMISE MODIFIED |
KERR CORP. |
Wendy Garman |
K083815 |
04/20/2009 |
LANX FUSION SYSTEM |
LANX, INC. |
Alan Burkholder |
K083581 |
04/07/2009 |
LANX SPINAL FIXATION SYSTEM |
LANX, INC. |
ANDREW LAMBORNE |
K090316 |
04/07/2009 |
MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEM |
LANX, INC. |
ANDREW LAMBORNE |
K083203 |
04/28/2009 |
HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM |
LASEROPTEK CO. LTD. |
PHILLIP CHEON |
K090186 |
04/10/2009 |
CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES |
LINVATEC CORP. |
JOY LOVETT |
K090475 |
04/16/2009 |
VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402 |
MAINE STANDARDS CO. |
HOLLY CRESSMAN |
K090147 |
04/22/2009 |
BLOOD MONITORING UNIT, MODEL BMU 40 |
MAQUET CARDIOPULMONARY AG |
ANASTASIA MUELLER |
K083794 |
04/21/2009 |
MECC SET WITH BIOLINE COATING |
MAQUET CARDIOPULMONARY AG |
KATRIN SCHWENKGLENKS |
K083622 |
04/02/2009 |
LNCS OXIMETRY SENSORS |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
K090411 |
04/07/2009 |
FREEDOM METAL BACKED TIBIAL COMPONENT |
MAXX ORTHOPEDICS, INC. |
MARY MCNAMARA-CULLINANE |
K083116 |
04/07/2009 |
VERSAFIT CUP DOUBLE MOBILITY SYSTEM |
MEDACTA INTERNATIONAL, SA |
NATALIE J KENNEL |
K090053 |
04/23/2009 |
APTUS 2.0 RADIAL HEAD SYSTEM |
MEDARTIS AG |
KEVIN THOMAS |
K090714 |
04/17/2009 |
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
MELISA LANSKY |
K090063 |
04/22/2009 |
MERETE LOCKING BONE PLATE SYSTEM |
MERETE MEDICAL, INC. |
JORG MIETZNER |
K090148 |
04/13/2009 |
PROGUIDE CHRONIC DIALYSIS CATHETER |
MERIT MEDICAL SYSTEMS, INC. |
SUSAN CHRISTENSEN |
K090357 |
04/10/2009 |
HYDROFRAME (HES) |
MICROVENTION, INC. |
FLORIN TRUUVERT |
K083659 |
04/16/2009 |
SILVER WOUND PAD |
MILLIKEN & CO. |
MARY MCNAMARA-CULLINANE |
K081527 |
04/01/2009 |
LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT |
MILLIPORE CORPORATION |
ALISHA VU |
K083467 |
04/23/2009 |
REBOUND HRDV |
MINNESOTA MEDICAL DEVELOPMENT, INC. |
STEVE NUSS |
K090809 |
04/28/2009 |
MPS ACACIA POWER INJECTABLE INFUSION SET |
MPS ACACIA |
FERGIE FERGUSON |
K083112 |
04/29/2009 |
PRIMADO |
NAKANISHI, INC. |
KEITH A BARRITT |
K090218 |
04/15/2009 |
MD213MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR MODEL, L218TJ |
NEC DISPLAY SOLUTIONS, LTD. |
ANGUS HSU |
K090215 |
04/15/2009 |
MD213MG 21.3 DIAGNOSTIC IMAGING LCD MONITOR - L218TL |
NEC DISPLAY SOLUTIONS, LTD. |
ANGUS HSU |
K082223 |
04/21/2009 |
NEUTROLUMENPN SYSTEM, MODEL 1000 |
NEUROLUMEN, LLC |
SHELLY HENRY |
K090178 |
04/24/2009 |
ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8 |
NEUSOFT POSITRON MEDICAL SYSTEMS CO., LTD |
SUN YAN |
K090731 |
04/15/2009 |
NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD |
NovaBone Products, LLC |
DAVID M GAISSER |
K090176 |
04/27/2009 |
NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM |
NUVASIVE, INC. |
HAN FAN |
K090697 |
04/16/2009 |
MODIFICATION TO: GIRAFFE AND PANDA WARMER |
OHMEDA MEDICAL |
AGATA SMIEJA |
K081770 |
04/02/2009 |
BLACK WIDOW ANTERIOR BUTTRESS PLATE |
OMNI SURGICAL, L.P. |
JOSHUA KAUFMAN |
K072732 |
04/15/2009 |
ORTHO T. CRUZI ELISA TEST SYSTEM |
Ortho-Clinical Diagnostics, Inc. |
ANDREA J CASPER |
K091121 |
04/28/2009 |
ORTHOSTAT |
ORTHOCON, INC. |
KENNETH A COLLINS |
K090666 |
04/24/2009 |
PEDIPLATES |
ORTHOPEDIATRICS, CORP. |
GARY BARNETT |
K083012 |
04/09/2009 |
PAPCONE |
OTTO BOCK PUR LIFE SCIENCE GMBH |
CHRISTIAN SCHULTE |
K080950 |
04/02/2009 |
STIWELL MED4 |
OTTO BOCK, AUSTRIA GMBH |
WILLIAM F JACKSON |
K090631 |
04/16/2009 |
PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN G QUASS |
K082759 |
04/10/2009 |
ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY |
PHADIA US INC. |
MARTIN R MANN |
K090808 |
04/03/2009 |
PINNACLE3 SMARTARC |
PHILIPS MEDICAL SYSTEMS, INC. |
JILL KAEDER |
K083284 |
04/08/2009 |
PIEZOSURGERY MEDICAL |
PIEZOSURGERY SRL |
ROGER GRAY |
K090222 |
04/28/2009 |
PIONEER LUMBAR PLATE SYSTEM |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN M GILBERT |
K090253 |
04/08/2009 |
ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001 |
POSSIS MEDICAL, INC. |
Doug Atkins |
K083695 |
04/28/2009 |
TRAXODENT |
PREMIER DENTAL PRODUCTS CO. |
VINCENT D'ALESSANDRO |
K090805 |
04/03/2009 |
V10, THREE WHEEL SCOOTER, MODEL SC610V, V10, THREE WHEEL SCOOTER, MODEL SC610VPS, V10, FOUR WHEEL SCOOTER, MODEL SC710 |
PRIDE MOBILITY PRODUCTS CORP. |
THOMAS J SCHAPPERT |
K090239 |
04/16/2009 |
PROGASTRO CD ASSAY |
PRODESSE, INC. |
KRISTINE SCHRAUFNAGEL |
K090464 |
04/23/2009 |
BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE |
PT MAHAKARYA INTI BUANA |
AZMAN ISMAIL |
K083931 |
04/27/2009 |
SYNTHETIC POWDER-FREE EXAM VINYL GLOVES, YELLOW/WHITE |
QUANTUM CO., LTD. |
LIJUAN WANG |
K090585 |
04/02/2009 |
NEOSALUS CREAM |
QUINNOVA PHARMACEUTICALS |
SHAHBAZ KHAN |
K082091 |
04/15/2009 |
TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00 |
REAMETRIX INC. |
STEVE KUNITAKE |
K082782 |
04/02/2009 |
REPLICATION MEDICAL VESSEL GUARD |
REPLICATION MEDICAL INC |
MARCOS VELEZ-DURAN |
K090244 |
04/13/2009 |
SWIFT FX |
RESMED LTD. |
DAVID D'CRUZ |
K083901 |
04/15/2009 |
NAVI ROOT |
S-DENTI CO., LTD. |
Kevin Walls |
K080243 |
04/07/2009 |
PORTABLE OXYGEN UNIT SCA900 |
SAN CHEONG CO. LTD. |
JUNG BAE BANG |
K090059 |
04/30/2009 |
IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM |
SASET (CHENGDU) INC. |
DONG CHYUAN LIN |
K082309 |
04/09/2009 |
CAMBRIA |
SEASPINE, INC. |
JEFF BRITTAN |
K082085 |
04/17/2009 |
CAPILLARYS IMMUNOTYPING, MODEL 2100 |
SEBIA |
KAREN ANDERSON |
K082388 |
04/14/2009 |
MINICAP IMMUNOTYPING, MODEL: 2300 |
SEBIA |
KAREN ANDERSON |
K083349 |
04/10/2009 |
BLOOD TRANSFUSION SET |
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS |
Diana Hong |
K090131 |
04/27/2009 |
DS N95 SURGICAL MASKS AND FLAT SURGICAL |
SHANGHAI DASHENG HEALTH PRODUCTS |
MAGGIE ZHONG |
K090912 |
04/15/2009 |
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900 |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
TAN CHUANBIN |
K083386 |
04/02/2009 |
ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL) |
SIEMENS HEALTHCARE DIAGNOSTICS |
CAROL BIANCA |
K090236 |
04/27/2009 |
DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 |
SIEMENS HEALTHCARE DIAGNOSTICS |
JANET M FOSE |
K090594 |
04/29/2009 |
DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID |
SIEMENS HEALTHCARE DIAGNOSTICS |
KATHLEEN A DRAY-LYONS |
K090038 |
04/28/2009 |
SYNGO BREVIS |
SIEMENS MEDICAL SOLUTIONS USA INC. |
JUDITH CAMPBELL |
K083524 |
04/01/2009 |
SYNGO DUAL ENERGY WITH EXTENDED FUNATIONALLY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CORRINE MCLEOD |
K083569 |
04/01/2009 |
SURGYBONE |
SILFRADENT S.R.L. |
CLAUDE D BERTHOIN |
K082679 |
04/07/2009 |
LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X |
SINTEA BIOTECH, INC. |
DANIELLE WERNIKOWSKI |
K082479 |
04/24/2009 |
SKLAR SURGICAL GOWN |
SKLAR CORP. |
NATALYA VALERIO |
K083787 |
04/15/2009 |
BCI WW1000 PULSE OXIMETER, MODEL WW1000 |
SMITHS MEDICAL PM, INC. |
DONALD ALEXANDER |
K083705 |
04/09/2009 |
BCI WW1020 PULSE OXIMETER, MODEL WW1020 |
SMITHS MEDICAL PM, INC. |
DONALD ALEXANDER |
K090205 |
04/28/2009 |
BCI WW1021 PC APPLICATION |
SMITHS MEDICAL PM, INC. |
DONALD ALEXANDER |
K081166 |
04/03/2009 |
LIGHTSTREAM LOW LEVEL LASER |
SOLICA CORPORATION |
CARLA WINSLOW |
K082327 |
04/03/2009 |
INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C |
SOMANETICS CORP. |
RONALD A WIDMAN |
K082796 |
04/01/2009 |
SOPRO 184 CAMERA |
SOPRO |
RICK ROSATI |
K090366 |
04/22/2009 |
SPEC MODEL M-31 |
SOURCE PRODUCTION & EQUIPMENT CO., INC. |
JOHN J MUNRO |
K090556 |
04/30/2009 |
SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE |
SPACELABS HEALTHCARE MEDICAL EQUIPMENT (SUZHOU) CO |
THOMAS KROENKE |
K090376 |
04/01/2009 |
SPINESMITH CYNCH SPINAL SYSTEM |
SPINE SMITH PARTNERS L.P. |
ROBERT JONES |
K090278 |
04/15/2009 |
ENSPIRE DEBRIDER SYSTEM |
SPINE VIEW, INC. |
SANDRA SUNDELL |
K090022 |
04/20/2009 |
PARADIS VASO SHIELD |
SPINEMEDICA, LLC |
SALLY THORSEN |
K090163 |
04/01/2009 |
STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 |
ST. JUDE MEDICAL |
GEENA GEORGE |
K091137 |
04/22/2009 |
ULTIMUM/ENGAGE/ENGAGE TR |
ST. JUDE MEDICAL |
LINH PHAM |
K090166 |
04/22/2009 |
AVS ANTERIOR LARGE PEEK SPACERS |
STRYKER CORP. |
VIKKI M O'CONNOR |
K090816 |
04/24/2009 |
STRYKER SPINE AVS PL PEEK SPACERS |
STRYKER CORP. |
VIKKI M O'CONNOR |
K083393 |
04/01/2009 |
XIA 3 SPINAL SYSTEM |
STRYKER SPINE |
CURTIS TRUESDALE |
K091087 |
04/22/2009 |
MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE |
SURGICAL DEVICES, TYCO HEALTHCARE GROUP LP |
JENNIFER BRENNAN |
K091011 |
04/22/2009 |
PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) |
SURGICAL TECHNOLOGY LABORATORIES, INC ("STL") |
MATHEW FAIRFAX |
K090839 |
04/24/2009 |
MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTS |
SYNTEC SCIENTIFIC CORP. |
CAROL CHANG |
K090047 |
04/01/2009 |
SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM |
SYNTHES (USA) |
KARL J NITTINGER |
K082649 |
04/30/2009 |
SYNTHES 90 DEGREE SCREWDRIVER |
SYNTHES (USA) |
ANDREA M TASKER |
K083096 |
04/17/2009 |
LATARJET CORTICAL SCREW SET |
T.A.G. MEDICAL PRODUCTS |
GEORGE J HATTUB |
K090185 |
04/24/2009 |
CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM; ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
SOPHIE LIN |
K083630 |
04/23/2009 |
CLUE MEDICAL AND CLUE MEDICAL BASIC |
TELOVITAL GMBH TELEMEDIZIN |
CHERITA JAMES |
K090878 |
04/03/2009 |
MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING) |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
CHRISTINA THOMAS |
K083834 |
04/17/2009 |
TERUMO PALL AL6X ARTERIAL FILTER |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
EILEEN DORSEY |
K082997 |
04/15/2009 |
TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER |
TERUMO MEDICAL CORP. |
EILEEN DORSEY |
K090465 |
04/08/2009 |
DIGDOP ULTRASOUND SYSTEM |
THE NEWMAN GROUP, LLC |
SPENCER NEWMAN |
K083714 |
04/15/2009 |
ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD) |
TITAN SPINE, LLC |
RICHARD JANSEN |
K080978 |
04/23/2009 |
WALGREEN'S PERSONAL LUBRICATING JELLY |
TOPCO SALES |
LORELEI CHAVEZ |
K090065 |
04/09/2009 |
AEROCHAMBER MINI VENTILATION CHAMBER |
TRUDELL MEDICAL INTL. |
DARRYL FISCHER |
K090886 |
04/15/2009 |
RTX 3371 |
TUNSTALL HEALTHCARE |
NIELS OLE ANDERSON |
K090355 |
04/29/2009 |
OPAL SEAL |
ULTRADENT PRODUCTS, INC. |
DIANE ROGERS |
K083820 |
04/01/2009 |
VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C |
VASOMEDICAL, INC. |
MELISSA PURPURA |
K090398 |
04/03/2009 |
PROVENT PROFESSIONAL SLEEP APNEA THERAPY |
VENTUS MEDICAL, INC. |
MARY ROSE |
K090992 |
04/21/2009 |
WELL-PASTE |
VERICOM CO., LTD. |
JAY HWANG |
K082634 |
04/07/2009 |
VERTIGONE BPPV GOGGLE |
VERTIGONE, INC. |
JAYE THOMPSON |
K090350 |
04/10/2009 |
EXTREME 4X4-X8 POWER WHEELCHAIR |
VESTIL MANUFACTURING CORP. |
RICK MICHAEL |
K083910 |
04/15/2009 |
VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW, STANDALONE VIEWER |
VIDISTAR, LLC |
CRAIG WALKER |
K090679 |
04/17/2009 |
VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM |
VIOPTIX, INC. |
GRACE HOLLAND |
K081922 |
04/16/2009 |
AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT |
WALLAC OY |
KATRIINA SUONPAA |
K090327 |
04/03/2009 |
POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE |
WEAR SAFE (MALAYSIA) SDN. BHD. |
S.H. TAN |
K082065 |
04/10/2009 |
WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP |
WELL-LIFE HEALTHCARE LIMITED |
PAUL DRYDEN |
K082908 |
04/24/2009 |
NOVAGUARD, MODEL 3611001 |
WEST PHARMACEUTICAL SERVICES, INC. |
ARI Y SOBEL |
K082363 |
04/29/2009 |
COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS |
WILLIAM A. COOK AUSTRALIA PTY, LTD. |
GUS TADDEO |
K090140 |
04/03/2009 |
GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER |
WILLIAM COOK EUROPE APS |
MOLLY BUSENBARK |
K083512 |
04/22/2009 |
FLUID-FILLED TEETHER |
WILTEC INDUSTRIES LTD. |
Kevin Walls |
K083637 |
04/20/2009 |
CALIX SPINAL IMPLANT SYSTEM |
X-SPINE SYSTEMS, INC. |
DAVID KIRSCHMAN |
K090778 |
04/28/2009 |
MTA PROTECTIVE SHEET |
XYLOS CORPORATION |
JOYCE ELKINS |
K090058 |
04/22/2009 |
YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-700, BP-700T, BP700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB |
YA HORNG ELECTRONIC CO., LTD. |
JEN KE-MIN |
K090620 |
04/08/2009 |
QUIKCLOT INTEVENTIONAL, MODEL P/N 182 |
Z-MEDICA CORPORATION |
RONALD E PETERSON |
K090723 |
04/07/2009 |
HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5, |
ZIMMER DENTAL INC. |
WILLIAM FISHER |