| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K080395 |
08/13/2008 |
SUNIVF DISHES |
INTL., INC. |
MICHAEL D CECCHI |
| K081549 |
08/19/2008 |
RX ACCUNET LP EMBOLIC PROTECTION SYSTEM |
ABBOTT LABORATORIES |
VIRGINIA SINGER |
| K081622 |
08/29/2008 |
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM |
ABBOTT SPINE, INC. |
MARITZA ELIAS |
| K072708 |
08/18/2008 |
ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM |
ABBOTT VASCULAR-VASCULAR SOLUTIONS |
MICHELLE GROSSMAN |
| K073197 |
08/28/2008 |
SILVER ANTIMICROBIAL WOUND GEL |
ADVANCED MEDICAL SOLUTIONS LIMITED |
CLAIRE RYAN |
| K081973 |
08/07/2008 |
METHA SHORT STEM HIP SYSTEM; MODULAR HIP SYSTEM; EXCIA HIP SYSTEM |
AESCULAP IMPLANT SYSTEMS, INC. |
MATTHEW M HULL |
| K080606 |
08/07/2008 |
ALATECH POWDERED LATEX PATIENT EXAMINATION GLOVE |
ALATECH HEALTHCARE, LLC. |
NEIL ANDERSON |
| K080063 |
08/15/2008 |
MASS CASUALTY VENTILATOR, MODEL MCV100 |
ALLIED HEALTHCARE PRODUCTS, INC. |
WAYNE KARCHER |
| K082100 |
08/06/2008 |
ALLTECH ECHOSTAR 1.5 T MR SYSTEM |
ALLTECH MEDICAL SYSTEMS AMERICA, INC. |
JOHN DURAJ |
| K082064 |
08/22/2008 |
RADVISION ET DIAGNOSTIC X-RAY SYSTEM |
ALMANA MEDICAL IMAGING |
DANIEL KAMM |
| K080847 |
08/06/2008 |
RFVISION, MODEL 9.9D |
ALMANA MEDICAL IMAGING |
DANIEL KAMM, P.E |
| K081936 |
08/13/2008 |
SOLEX CATHETER, MODEL SL2593 |
ALSIUS CORP. |
JOHN RIOLO |
| K080872 |
08/19/2008 |
AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ |
AMEDICA BIOTECH, INC. |
Jeff Chen |
| K080749 |
08/04/2008 |
RADIANCE |
AMERICAN ORTHODONTICS |
JEROME H SCHOMBERG |
| K082059 |
08/11/2008 |
ANGIOSCULPT PTA SCORING BALLOON CATHETER |
ANGIOSCORE, INC. |
KIMBERLEY KLINE |
| K080966 |
08/06/2008 |
HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM |
AOTI LTD. |
ROBBIE WALSH |
| K073677 |
08/01/2008 |
SCANSCOPE XT SYSTEM |
APERIO TECHNOLOGIES |
JEFF RYBERG |
| K081853 |
08/18/2008 |
OVERSTITCH ENDOSCOPIC SUTURE SYSTEM |
APOLLO ENDOSURGERY, INC. |
DENNIS MCWILLIAMS |
| K073047 |
08/07/2008 |
APROXI 1100 AND 4000 SERIES DENTAL INLAYS |
APROXI APS |
KIRSTEN RONO |
| K082323 |
08/28/2008 |
ARTHROCARE ARTHROWANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K081752 |
08/06/2008 |
EDGE PACS |
ASHVA TECHNOLOGIES, PVT. LTD |
CARL ALLETTO |
| K072974 |
08/18/2008 |
SURGIMESH XB |
ASPIDE MEDICAL |
HOWARD M HOLSTEIN |
| K073396 |
08/07/2008 |
ANTIMICROBIAL ULTRASITE VALUE, ULTRASITE AG |
B. BRAUN MEDICAL, INC. |
REBECCA STOLARICK |
| K082132 |
08/28/2008 |
BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK |
BAUSCH & LOMB, INC |
NED LUCE |
| K081721 |
08/06/2008 |
TRICOS A RESORBABLE SUBSTITUTE |
BAXTER HEALTHCARE CORP. |
BARBARA K BARBEAU |
| K081289 |
08/04/2008 |
V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE |
BAXTER HEALTHCARE CORP. |
NANETTE HEDDEN |
| K081213 |
08/14/2008 |
BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 |
BD Biosciences |
NOBUKO NAKAJIMA |
| K080634 |
08/11/2008 |
ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495 |
BECKMAN COULTER, INC. |
LYNN WEIST |
| K081526 |
08/14/2008 |
FLOWCARE TLG REAGENT |
BECKMAN COULTER, INC. |
NANCY NADLER |
| K081980 |
08/04/2008 |
KYMCO FORU, MODEL EQ35 |
BESTEAM TECHNOLOGY INC. |
JUNNATA CHANG |
| K081729 |
08/07/2008 |
MODIFICATION TO GFX NERVE ABLATION SYSTEM |
BIOFORM MEDICAL, INC. |
LORI HAYS |
| K081896 |
08/20/2008 |
BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH |
BIOGENICS, INC. |
LOU JONES |
| K080685 |
08/15/2008 |
HIPLOC COMPRESSION HIP SCREW |
BIOMET MANUFACTURING, INC. |
BECKY EARL |
| K081636 |
08/07/2008 |
PEEK-OPTIMA ALIF SPACER |
BIOMET SPINE |
VIVIAN KELLY |
| K082175 |
08/13/2008 |
MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION |
BIOPLATE, INC. |
JESUS T FARINAS |
| K081149 |
08/05/2008 |
BIOPRO GO-EZ SCREW |
BIOPRO, INC. |
DAVID MRAK |
| K080529 |
08/29/2008 |
STEREOS WORKSTATION |
BIOSPACE MED |
JOHN J SMITH |
| K081849 |
08/28/2008 |
BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE |
BLACKSTONE MEDICAL, INC. |
WHITNEY G TORNING |
| K081550 |
08/28/2008 |
BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO |
BONART CO. LTD. |
ERIC L ONG |
| K080761 |
08/25/2008 |
BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES |
BONART CO. LTD. |
ERIC L ONG |
| K081275 |
08/27/2008 |
BOSTON SCIENTIFIC SURGICAL MESH |
BOSTON SCIENTIFIC CORP. |
JANET A MCGRATH |
| K081021 |
08/08/2008 |
KINETIX GUIDEWIRE, PLUS GUIDEWIRE |
BOSTON SCIENTIFIC CORP. |
CHRISTINE THOMAS |
| K081048 |
08/22/2008 |
PINNACLE PELVIC FLOOR REPAIR KIT II |
BOSTON SCIENTIFIC CORP. |
MICHELLE BARRY |
| K082306 |
08/28/2008 |
POWERLOC CLEAR SAFETY INFUSION SET |
C.R. BARD, INC. |
HENRY BOLAND |
| K082173 |
08/26/2008 |
Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S |
CARDIAC SCIENCE CORPORATION |
BEVERLY MAGRANE |
| K081464 |
08/28/2008 |
STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES |
Cardinal Health |
STEVE TAMSETT |
| K081837 |
08/13/2008 |
AVEA VENTILATOR |
CARDINAL HEALTH 207, INC. |
ANDRE VON MULLER |
| K081944 |
08/14/2008 |
MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM |
CARDIO SYSTEMS, INC. |
DAVID D BROOKE |
| K082191 |
08/19/2008 |
CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080 |
CARDIOMEMS INC |
GRACE POWERS |
| K080276 |
08/04/2008 |
SELF-ADHESIVE ELECTRODES |
CATHAY HEALTHCARE EQUIPMENT MANUFACTURING, INC |
BRANDON CHOI |
| K073334 |
08/22/2008 |
OHMNISCAN NG |
CHRISTINE VALMY INC |
PETER DEHAYDU |
| K081017 |
08/04/2008 |
TEMPLATE AND COUNTER-FIT |
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. |
JEANETTE SMITH |
| K081606 |
08/28/2008 |
BAHA INTENSO |
COCHLEAR AMERICAS |
SEAN BUNDY |
| K080298 |
08/05/2008 |
DERMABIOSAFE |
COMPLETE PRODUCT RESOURCES |
JOHN WALSH |
| K080799 |
08/07/2008 |
ATLAS-BASED AUTOSEGMENTATION |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
KATHRYN STINSON |
| K082034 |
08/15/2008 |
MODIFICATION TO MERCI RETRIEVER |
CONCENTRIC MEDICAL, INC. |
LARAINE PANGELINA |
| K081337 |
08/08/2008 |
APPROACH CTO WIRE GUIDE |
COOK INCORPORATED |
KAREN BRADBURN |
| K080737 |
08/08/2008 |
MIRAFLEX HIGH FLOW MICROCATHETER |
COOK, INC. |
NATHAN SIMON |
| K080037 |
08/01/2008 |
MODIFICATION TO ZILVER 635 BILIARY STENT |
COOK, INC. |
STEPHANIE ROBERTS |
| K082143 |
08/25/2008 |
MICRO GUIDE CATHETER XP |
CORDIS CORP. |
KAREN WILK |
| K081237 |
08/25/2008 |
CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT |
CRAFTMASTER CONTOUR EQUIPMENT, INC. |
STUART R GOLDMAN |
| K081762 |
08/27/2008 |
CURBELL PATIENT MONITORING CABLES |
CURBELL ELECTRONICS INC. |
Kevin Walls |
| K080530 |
08/15/2008 |
MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE |
CUTERA, INC. |
KATHY MAYNOR |
| K072950 |
08/22/2008 |
CYGNUS 12 LEAD ECG MODULE |
CYGNUS, LLC |
NARCIS NAYDENOV |
| K081844 |
08/29/2008 |
GE DATEX-OHMEDA AVANCE |
DATEX-OHMEDA, INC. |
ADRIENNE LENZ |
| K082239 |
08/29/2008 |
DEPUY C-STEM AMT |
DEPUY ORTHOPAEDICS, INC. |
RHONDA MYER |
| K080990 |
08/08/2008 |
DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER |
DEPUY ORTHOPAEDICS, INC. |
DAWN SINCLAIR |
| K081546 |
08/26/2008 |
SMALL BONE LOCKING PLATING SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K081432 |
08/29/2008 |
HEALOS II BONE GRAFT SUBSTITUTE |
DEPUY SPINE, INC. |
HANDE TUFAN |
| K073427 |
08/20/2008 |
MEDILAS D FAMILY LASERS |
DORNIER MEDTECH AMERICA, INC. |
THERON GOBER |
| K081405 |
08/21/2008 |
XERACEM |
DOXA DENTAL AB |
JONATHAN KAHAN |
| K081847 |
08/21/2008 |
PICASSO MASTER, ECT AND MASTER 3D |
E-WOO TECHNOLOGY |
DAVE KIM |
| K081899 |
08/21/2008 |
ANYRAY PORTABLE X-RAY SYSTEM |
E-WOO TECHNOLOGY CO., LTD. |
DAVE KIM |
| K082341 |
08/29/2008 |
DSA 2000EX |
EIGEN LLC |
ANIMESH KHEMKA |
| K082122 |
08/29/2008 |
MLCI2 |
ELEKTA LTD. |
PATRICK T HULL |
| K081652 |
08/28/2008 |
CLAROS NANO DENTAL LASER SYSTEM |
ELEXXION AG |
HOLGER ERNST |
| K073682 |
08/08/2008 |
EMBLETTA GOLD |
EMBLA SYSTEMS, INC. |
ROBERT G SCHUEPPERT |
| K081679 |
08/20/2008 |
REVELATION HIP STEM, MODELS, 427-01, 427-02; LINEAR HIP STEM, MODELS 425-00, 425-05 |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K080102 |
08/20/2008 |
TQ SOLO AND SOLO PRO AND LS50 ACCESSORY AND MR4 MULTI RADIANCE THERAPY SYSTEM |
ESCADA INTERNATIONAL, INC. |
Kevin Walls |
| K081934 |
08/29/2008 |
EXTREMITY MEDICAL COMPRESSION SCREW |
EXTREMITY MEDICAL LLC |
JAMY GANNOE |
| K073579 |
08/18/2008 |
DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN |
FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESEL |
NEIL R ARMSTRONG |
| K082041 |
08/01/2008 |
FIATLUX VISUALIZE |
FIATLUX IMAGING INC. |
|
| K073381 |
08/04/2008 |
PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M |
FOCUS DIAGNOSTICS, INC. |
CONSTANCE BRIDGES |
| K072293 |
08/06/2008 |
FOSSA URETERAL OPEN STENTS |
FOSSA MEDICAL, INC. |
GLORIA KOLB |
| K080273 |
08/08/2008 |
AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION |
FUJIREBIO DIAGNOSTICS TEXAS, INC. |
JOHN GORMLEY |
| K081915 |
08/08/2008 |
FDTX GLUCOSE CONTROL SOLUTION |
FUJIREBIO DIAGNOSTICS TEXAS, INC. |
JOHN GORMLEY |
| K081891 |
08/29/2008 |
FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR |
FUKUDA DENSHI USA, INC. |
SUSAN D GOLDSTEIN-FALK |
| K081393 |
08/21/2008 |
ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW |
G & H WIRE CO. |
CARRI GRAHAM |
| K082318 |
08/25/2008 |
CENTRICITY PACS IW |
GE HEALTHCARE DYNAMIC IMAGING SOLUTIONS |
JILLIAN M REED |
| K081941 |
08/07/2008 |
NAVIGATOR APPLICATIONS SUITE |
GE HEALTHCARE FINLAND OY |
ADRIENNE LENZ |
| K082185 |
08/15/2008 |
GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2 |
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA |
NICOLE LANDREVILLE |
| K081921 |
08/06/2008 |
GE VIVID E9 ULTRASOUND |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K081875 |
08/20/2008 |
GENTIAN CYSTATIN C IMMUNOASSAY |
GENTIAN AS |
ERIC S GRUFF |
| K081200 |
08/08/2008 |
DENTAL PORCELAIN (GLASS POWDER), TOP-CERAM T-1, T1, T2, T3, T4 |
GLOBAL TOP, INC. |
CLAUDE YANG |
| K082028 |
08/08/2008 |
LASERPEEL SOFT-MET MODIFIED ERBIUM LASER |
GLOBAL USA DISTRIBUTION, LLC. |
MATT MAKOUSKY |
| K081315 |
08/11/2008 |
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (PINK, BLACK, GREY, AND BLUE PEPPERMENT) |
GX CORPORATION SDN BHD |
FOO K PU |
| K082054 |
08/06/2008 |
GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AND DUAL FOOTSWITCH CONNECTOR CABLE, MODEL 710003 |
GYRUS ACMI, INC. |
TERRENCE E SULLIVAN |
| K081766 |
08/08/2008 |
PKS OMNI INSTRUMENT |
GYRUS-ACMI L.P. |
LORRAINE CALZETTA |
| K082075 |
08/15/2008 |
HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER |
HANSEN MEDICAL, INC. |
KATE WHITIN |
| K081159 |
08/08/2008 |
HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 SERIES |
HARVARD MEDICAL DEVICES LTD. |
PAUL AYLETT |
| K072486 |
08/06/2008 |
MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC |
HEMCON MEDICAL TECHNOLOGIES, INC. |
KEVIN HAWKINS |
| K081745 |
08/12/2008 |
ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLEWAITE |
| K080710 |
08/13/2008 |
TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81 |
HOME DIAGNOSTICS, INC. |
KAREN DEVINCENT |
| K080641 |
08/19/2008 |
TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81 |
HOME DIAGNOSTICS, INC. |
KAREN DEVINCENT |
| K073158 |
08/27/2008 |
SCULPTURE 2.94 ER:YAG SYSTEM |
HOYA CONBIO, INC |
LIZA BURNS |
| K082009 |
08/22/2008 |
HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS |
HSINER CO., LTD. |
TOM SHANKS |
| K082025 |
08/13/2008 |
BODY-JET |
HUMAN MED AG |
INGE MATTHIESEN |
| K081361 |
08/28/2008 |
CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX |
ICU MEDICAL INC |
TRACY BEST |
| K080554 |
08/27/2008 |
INAREX, MODEL 2D-LX |
INAREX CORPORATION |
BRANDON CHOI |
| K073664 |
08/08/2008 |
FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER |
INJECTIMED, INC. |
RICHARD G HUNTER |
| K080809 |
08/11/2008 |
IEC MEDSIGHT AND MEDBRIGHT |
INNOVATIVE ENDOSCOPY COMPONENTS, LLC. |
GERALD GOIFITZER |
| K080484 |
08/06/2008 |
INOMAX DS (DELIVERY SYSTEM), MODEL 10003 |
INO THERAPEUTICS |
DAVID TRUEBLOOD |
| K081691 |
08/28/2008 |
INOMAX DS (DELIVERY SYSTEM) |
INO THERAPEUTICS LLC |
DAVID TRUEBLOOD |
| K081651 |
08/08/2008 |
INSTRUMED RONGEUR |
INSTRUMED INTERNATIONAL, INC. |
MICHAEL MASSONG |
| K081459 |
08/13/2008 |
CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM |
INTEGRA RADIONICS, INC. |
KEVIN J O'CONNELL |
| K072629 |
08/06/2008 |
DIGIMATCH ROBODOC SURGICAL SYSTEM |
INTEGRATED SURGICAL SYSTEMS, INC. |
RUSS HIBBERT |
| K073112 |
08/01/2008 |
DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253 |
INTUITIVE SURGICAL, INC. |
MICHAEL H YRAMATEGUI |
| K071687 |
08/07/2008 |
FAMILI OF IRIDEX IQ LASER SYSTEMS |
IRIDEX CORP. |
DAVID BUZAWA |
| K082061 |
08/19/2008 |
INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER |
IRVINE BIOMEDICAL, INC. |
JEANETTE HENDRICKSON |
| K081982 |
08/14/2008 |
WATCH-PAT 200S-2 (WP200S-2) |
ITAMAR MEDICAL |
JONATHAN S KAHAN |
| K081247 |
08/25/2008 |
TM-400 |
ITO CO., LTD. |
KENNETH L BLOCK |
| K081657 |
08/20/2008 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW) |
JIANGSU CUREGUARD GLOVE CO., LTD. |
CHU XIAOAN |
| K082288 |
08/19/2008 |
HAIDA HD21 |
JIANGYIN EAST CHINA MEDICAL TECHNOLOGY CO., LTD. |
JUNNATA CHANG |
| K082274 |
08/19/2008 |
HAIDA MODEL HD11 MANUAL WHEELCHAIR |
JIANGYIN EAST CHINA MEDICAL TECHNOLOGY CO., LTD. |
JUNNATA CHANG |
| K080259 |
08/20/2008 |
JMEA CANNULATED BONE SCREW SYSTEM |
JMEA CORPORATION |
SAM SON |
| K080040 |
08/25/2008 |
ORTHO ALL-FLEX DIAPHRAGM |
JOHNSON & JOHNSON PRODUTOS PROFISSIONAIS LTDA. |
WILLIAM GREENROSE |
| K081695 |
08/12/2008 |
DMC COMPOSITE |
KERR CORP. |
Wendy Garman |
| K082157 |
08/06/2008 |
KETTOSIL AND SILGINAT |
KETTENBACH GMBH & CO KG |
MICHAELA ZINKE |
| K081215 |
08/26/2008 |
VOLUMINA |
KJAYA MEDICAL, LLC |
KOVALAN MUNIANDY |
| K081708 |
08/26/2008 |
TAXI ENDOSCOPIC GUIDEWIRE |
LAKE REGION MFG., INC. |
DEEP PAL |
| K082194 |
08/28/2008 |
LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002 |
LAURIMED LLC |
NANCY LINCE |
| K082067 |
08/22/2008 |
MSC LIPID CONTROL |
MAINE STANDARDS CO. |
HOLLY CRESSMAN |
| K082218 |
08/13/2008 |
MAX ADJUSTING INSTRUMENT |
MANNA OMNI INTERNATIONAL INC. |
STEPHEN TSAI |
| K081672 |
08/15/2008 |
C-INSIGHT |
MAZOR SURGICAL TECHNOLOGIES LTD. |
AHAVA STEIN |
| K071961 |
08/25/2008 |
MESACUP MODELS BP180 AND BP230 ELISA KITS |
MBL INTERNATIONAL CORPORATION |
DANIEL KAMM |
| K080544 |
08/14/2008 |
UNASSIGNED |
MEDCOMP |
JEAN CALLOW |
| K081457 |
08/08/2008 |
ATRILAZE LASER ABLATION SYSTEM |
MEDICALCV, INC. |
KIRK S HONOUR |
| K081559 |
08/28/2008 |
GENESIS |
MEDISISS |
BRANDI JAMES |
| K080899 |
08/07/2008 |
ARCTIC BLAST INTRAVENOUS FLUID CHILLER |
MEDIVANCE, INC. |
LYNNE ARONSON |
| K081516 |
08/26/2008 |
MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT |
MEDSOURCE INTERNATIONAL, LLC. |
|
| K073523 |
08/01/2008 |
INTERCEPTOR PLUS CORONARY FILTER SYSTEMS |
MEDTRONIC INC. |
COLLEEN MULLINS |
| K081804 |
08/05/2008 |
PIONEER PLUS CATHETER |
MEDTRONIC INC. |
CATHERINE PRIESTLEY |
| K082127 |
08/27/2008 |
STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635 |
MEDTRONIC NEUROSURGERY |
JEFFREY HENDERSON |
| K081038 |
08/15/2008 |
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM |
MEDTRONIC SOFAMOR DANEK |
CHRIS MCKEE |
| K082112 |
08/27/2008 |
T2 XVBR SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
MELISA LANSKY |
| K081302 |
08/15/2008 |
RESCUE EXTERNAL IMPLANT SYSTEM |
MEGAGEN IMPLANT CO., LTD |
JUNG B BANG |
| K080303 |
08/05/2008 |
EZ REGULAR |
MEINNTECH CO., LTD. |
DANIEL KAMM |
| K081465 |
08/19/2008 |
AXIUM DETACHABLE COIL SYSTEM |
MICRO THERAPEUTICS, INC. |
NEELU MEDHEKAR |
| K080861 |
08/27/2008 |
MICRUS ASCENT OCCLUSION BALLOON CATHETER |
MICRUS ENDOVASCULAR CORPORATION |
PATRICK LEE |
| K081180 |
08/26/2008 |
SKINSENSE POLYISOPRENE UNDERGLOVE |
MOLNLYCKE HEALTH CARE US, LLC |
STEVEN DOWDLEY |
| K080405 |
08/28/2008 |
SYGNAL DBM |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
NANCY BENNEWITZ JOY |
| K081075 |
08/22/2008 |
PAINSHIELD MD |
NANO VIBRONIX LTD. |
ELI ORBACH |
| K080546 |
08/29/2008 |
NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A |
NIHON KOHDEN AMERICA, INC. |
JACK COGGAN |
| K082373 |
08/29/2008 |
NORAS MR-BI320-PA 3T |
NORAS MRI PRODUCTS GMBH |
PATRICIA KRAPF |
| K081191 |
08/07/2008 |
TCM ENDO 20 |
NOUVAG AG |
ERICH FORSTER |
| K081939 |
08/12/2008 |
OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY |
OMNIGUIDE, INC. |
DOUGLAS W WOODRUFF |
| K082099 |
08/21/2008 |
VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905 |
Ortho-Clinical Diagnostics, Inc. |
MARLENE A HANNA |
| K073685 |
08/29/2008 |
OTA COLLAGEN BIOMATERIAL |
OSSEOUS TECHNOLOGIES OF AMERICA |
DAVID J COLLETTE |
| K081876 |
08/01/2008 |
OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING |
OSTEOMED L.P. |
ALMA RELJA |
| K082186 |
08/29/2008 |
MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
BRIAN CLEARY |
| K081887 |
08/29/2008 |
LUTE-IT II VENEER CEMENT, MODEL NO6 |
PENTRON CLINICAL TECHNOLOGIES |
GREG MOREAU |
| K072213 |
08/29/2008 |
PERIMETRICS PERIOMETER |
PERIMETRICS, INC. |
ALBERT REGO |
| K081983 |
08/22/2008 |
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00 |
PHILIPS MEDICAL SYSTEMS |
CLAIRE ARAKAKI |
| K081937 |
08/29/2008 |
PICOSAT II AND M3002A MULTIMEASUREMENT AND M1020B PLUG-IN MODULES SPO2 PULSE OXIMETRY MODULE |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
JENS-PETER SEHER |
| K081558 |
08/25/2008 |
PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN GILBERT |
| K081699 |
08/29/2008 |
PLANMECA SOVEREIGN |
PLANMECA USA, INC. |
BOB PIENKOWSKI |
| K081232 |
08/06/2008 |
TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES |
PRAXIM |
ANNIE POLLIER |
| K080432 |
08/08/2008 |
MAPERSOL |
PRESERVATION SOLUTIONS, INC. |
NEIL BURRIS |
| K081633 |
08/11/2008 |
PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS |
PRIMED MEDICAL PRODUCTS INC. |
RAYMOND G MARUSYK |
| K081388 |
08/21/2008 |
GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM |
PRONIA MEDICAL SYSTEM, LLC |
CYNTHIA J.M. NOLTE |
| K081488 |
08/28/2008 |
POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE |
PT. MAJA AGUNG LATEXINDO |
EMMY TJOENG |
| K082182 |
08/15/2008 |
AP 34 MULTI-THERAPY INFUSION PUMP |
Q-CORE, LTD |
ASHER KASSEL |
| K071023 |
08/28/2008 |
REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C |
REACH SURGICAL, INC |
RICH GRANT |
| K081756 |
08/07/2008 |
OCULAR RESPONSE ANALYZER |
REICHERT INC. |
SANDRA BROWN |
| K082197 |
08/22/2008 |
RHYTEC, INC., PORTRAIT PSR |
RHYTEC INCORPORATED |
Robert Zoletti |
| K081535 |
08/14/2008 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR |
RICH MOUNTAIN MEDICAL PRODUCTS, INC. |
MICHELLE SHIH |
| K080643 |
08/22/2008 |
ELECSYS ANTI-TSHR CALCHECK |
Roche Diagnostics |
STEPHANIE GREEMAN |
| K082043 |
08/01/2008 |
CARRIAZO-PENDULAR MICROKERATOME |
SCHWIND EYE-TECH-SOLUTIONS GMBH & CO. KG |
ROLF SCHWIND |
| K081085 |
08/01/2008 |
STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS |
SENORX, INC. |
EBEN GORDON |
| K080364 |
08/11/2008 |
FINDRWIRZ GUIDE WIRE SYSTEM |
SENTREHEART INC. |
LINDA GUTHRIE |
| K081508 |
08/27/2008 |
HG OXYGEN CONCENTRATOR, MODELS HG5-W & HG5-WN |
SHENYANG CANTA MEDICAL TECH CO., LTD. |
Diana Hong |
| K081859 |
08/04/2008 |
MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM |
SICEL TECHNOLOGIES, INC. |
SUZANNE SCHWALLER |
| K081182 |
08/08/2008 |
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBLE CLINDAMYCIN |
SIEMENS |
LIBBY WARRINER |
| K080167 |
08/08/2008 |
ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS |
SIEMENS HEALTHCARE DIAGNOSTICS |
PHILIP LIU |
| K081731 |
08/29/2008 |
DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32 |
SIEMENS HEALTHCARE DIAGNOSTICS |
VICTOR M CARRIO |
| K081319 |
08/04/2008 |
DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56 |
Siemens Healthcare Diagnostics Inc. |
GEORGE M PLUMMER |
| K082030 |
08/22/2008 |
DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 |
Siemens Healthcare Diagnostics Inc. |
YUK-TING LEWIS |
| K081992 |
08/05/2008 |
DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108 |
Siemens Healthcare Diagnostics Inc. |
YUK-TING LEWIS |
| K081299 |
08/08/2008 |
DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA |
Siemens Healthcare Diagnostics Inc. |
RADAMES RIESGO |
| K081722 |
08/22/2008 |
YSIO |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
GARY JOHNSON |
| K081903 |
08/26/2008 |
XIOS PLUS WALL-MODULE |
SIRONA DENTAL SYSTEMS GMBH |
FRITZ KOLLE |
| K081511 |
08/26/2008 |
2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S |
SMITH & NEPHEW, INC. |
JANICE HASELTON |
| K081566 |
08/21/2008 |
SMITH & NEPHEW OXINIUM DH FEMORAL HEADS |
SMITH & NEPHEW, INC. |
JASON SELLS |
| K081086 |
08/13/2008 |
PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.0 |
SMITHS MEDICAL ASD, INC. |
JOHN TULLETT |
| K081126 |
08/13/2008 |
PARIETEX COMPOSITE MONO PM MESH |
SOFRADIM PRODUCTION |
SHARON ALEXANDER |
| K082098 |
08/25/2008 |
SONOSITE MAXX SERIES ULTRASOUND SYSTEM |
SONOSITE,INC. |
CHRISTOPHER J HARTZOG |
| K082045 |
08/01/2008 |
MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 |
SPACELABS MEDICAL INC. |
TIM DAVIS |
| K081968 |
08/05/2008 |
MODIFICATION TO LUCENT |
SPINAL ELEMENTS, INC. |
KERRI DIMARTINO |
| K081051 |
08/07/2008 |
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE |
SPINE VIEW, INC. |
ROY CHIN |
| K082304 |
08/27/2008 |
ROLL-X GUIDEWIRE |
ST. JUDE MEDICAL |
JEFF STURM |
| K081365 |
08/15/2008 |
SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR |
ST. JUDE MEDICAL |
ELIZABETH E NEELY |
| K080637 |
08/12/2008 |
POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS |
STEREOTAXIS, INC. |
DENNIS POZZO |
| K081342 |
08/13/2008 |
REPROCESSED EXTERNAL FIXATION ACCESSORIES |
STERILMED, INC. |
JOSHUA CLARIN |
| K081586 |
08/18/2008 |
REPROCESSED EXTERNAL FIXATION DEVICE |
STERILMED, INC. |
JOSHUA CLARIN |
| K081600 |
08/22/2008 |
STERIS RESERT XL TEST STRIP |
STERIS Corporation |
JOHN SCOVILLE |
| K080136 |
08/15/2008 |
INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105 |
STERITEC PRODUCTS, INC. |
LINDA NELSON |
| K073633 |
08/26/2008 |
STRYKER ESSX MICRODEBRIDER SYSTEM |
STRYKER IRELAND LTD., INSTRUMENTS DIVISION |
COLETTE O'CONNOR |
| K081468 |
08/25/2008 |
DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES |
SUNRISE MEDICAL |
JOSEPH E OLSAVSKY |
| K081476 |
08/08/2008 |
SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE |
SURGICAL CONCEPT DESIGNS |
CHRISTOPHER SCOTT |
| K082148 |
08/11/2008 |
SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSION |
SYNTHES (USA) |
JILL R SHERMAN |
| K081610 |
08/29/2008 |
SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER |
SYSMEX AMERICA, INC. |
NINA GAMPERLING |
| K081445 |
08/11/2008 |
FORA COMFORTSCAN EAR THERMOMETER, MODELS TD-1261A; TD-1261B |
TaiDoc Technology Corporation |
Yuhua Chen |
| K081957 |
08/05/2008 |
U-RIGHT TD-4247 BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
Yuhua Chen |
| K081390 |
08/12/2008 |
BIOACTIF OSTEOTRANS INTERFENCE SCREW |
TAKIRON CO., LTD |
KUNIHIRO HATA |
| K080603 |
08/05/2008 |
HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED |
TE ME NA SAS |
ARTHUR WARD |
| K080873 |
08/28/2008 |
OPACITY + BONE CEMENT |
TEKNIMED SA |
J.D. WEBB |
| K080833 |
08/07/2008 |
LOVE GUARD MALE LATEX CONDOM |
TIANJIN HUMAN-CARE LATEX CORPORATION |
SIMON LI |
| K082005 |
08/25/2008 |
MODIFICATION TO HI-ART TREATMENT SYSTEM |
TOMOTHERAPY INCORPORATED |
ROBERT BOVY |
| K082119 |
08/12/2008 |
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K082244 |
08/21/2008 |
PCA-8000A, MARK 11, PET / CT SYSTEM |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K073432 |
08/13/2008 |
TRAUSON BONE PLATE |
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD. |
Diana Hong |
| K080448 |
08/28/2008 |
CENTURION PROTECTIVE RESTRAINT, SCR SERIES |
TRI-STATE HOSPITAL SUPPLY CORP. |
MATTHEW K PRICE |
| K081510 |
08/04/2008 |
TIGER CANNULATED SCREW SYSTEM |
TRILLIANT SURGICAL LTD |
J. D WEBB |
| K080189 |
08/15/2008 |
TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXX |
TRIMLINE MEDICAL PRODUCTS CORP. |
NANCY SKOCYPEC |
| K073444 |
08/18/2008 |
TRITON MEIDCAL TMED IV-SET |
TRITON MEDICAL, LLC |
IAN P GORDON |
| K080926 |
08/12/2008 |
AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER |
TRUDELL MEDICAL INTL. |
DARRYL FISCHER |
| K081726 |
08/26/2008 |
TYSONBIO LINK HEALTH MANAGEMENT SYSTEM |
TYSON BIORESEARCH, INC. |
WEN-HAI TSAI |
| K080930 |
08/07/2008 |
MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS |
U-SYSTEM, INC. |
LISA SCOTT |
| K080935 |
08/06/2008 |
SONIX MDP ULTRASOUND SCANNER |
UltraSonix Medical Corporation |
ALAN REMFRY |
| K082204 |
08/13/2008 |
SERIES SY DISPOSABLE ELECTROSURGICAL PAD |
VENTLAB CORP. |
CHRISTINA NORRIS |
| K080983 |
08/07/2008 |
PROVENT NASAL CANNULA |
VENTUS MEDICAL, INC. |
CINDY DOMECUS |
| K081757 |
08/15/2008 |
VERISTA IMAGING ISOCAM II GAMMA CAMERA |
VERISTA IMAGING INC. |
SUSAN D GOLDSTEIN-FALK |
| K080510 |
08/20/2008 |
VIP PULMONARY FUNCTION SYSTEM |
VIASYS HEALTHCARE GMBH |
THOMAS RUST |
| K081942 |
08/12/2008 |
NEUROCATH AG |
VYGON NEURO |
COURTNEY SMITH |
| K082356 |
08/28/2008 |
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE |
W. L. GORE & ASSOCIATES, INC. |
ALICIA HEMPHILL |
| K071649 |
08/07/2008 |
NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B |
WALLAC OY |
CINDY LLOYD |
| K073352 |
08/11/2008 |
WEBERNEEDLE BASIC LASER |
WEBER MEDICAL GMBH |
JURGEN HERMANN |
| K081951 |
08/15/2008 |
ANEROID SPHYGMOMANOMETER, MODEL KT-A01 |
WENZHOU KINDCARE IMPORT & EXPORT CO., LTD |
CHARLIE MACK |
| K082294 |
08/22/2008 |
WESTAR SERIES DENTAL UNITS |
WESTAR MEDICAL PRODUCTS, INC. |
RUTH HALLER |
| K080533 |
08/11/2008 |
WINCO MODEL POWER SERIES LIFT CHAIR |
WINCO, INC. |
JIM ANKOVIAK |
| K081141 |
08/29/2008 |
COMBOCARE 2000 |
XANACARE TECHNOLOGIES, LLC |
ROBERT N CLARK |
| DEN080007 |
08/26/2008 |
ALLOMAP MOLECULAR EXPRESSION TESTING |
XDX |
ROSE ROMEO |
| K081647 |
08/12/2008 |
ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS |
XODUS MEDICAL, INC. |
BRENDA NIEL |
| K073499 |
08/07/2008 |
VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES |
ZIMMER, INC. |
ERIC S PITTMAN |
