| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K051790 |
07/01/2005 |
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 4100 |
3M COMPANY |
GINGER CANTOR |
| K051797 |
07/05/2005 |
FUTURE WASH/YPS |
3M ESPE AG DENTAL PRODUCTS |
ANDREAS PETERMANN |
| K052063 |
07/29/2005 |
HUANQIU HEATING LAMP |
A & A MEDICAL SUPPLIES INC |
GEORGE SU |
| K051839 |
07/11/2005 |
FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001 |
ABBOTT DIABETES CARE INC. |
DHRUMA SHAH |
| K051802 |
07/05/2005 |
FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM |
ABBOTT DIABETES CARE INC. |
KIMBERLEY KLINE |
| K051962 |
07/19/2005 |
ULTRA HDL |
ABBOTT LABORATORIES |
LINDA MORRIS |
| K051925 |
07/19/2005 |
CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN |
ACCESS BIO INCORPORATE |
YOUNG HO CHOI |
| K051941 |
07/19/2005 |
CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM |
ACCURAY, INC. |
ANNE SCHLAGENHAFT |
| K052044 |
07/28/2005 |
ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL |
ACMI CORPORATION |
TERRENCE E SULLIVAN |
| K052023 |
07/26/2005 |
CADIMAS VERSION 1.0 |
ALAN PENN & ASSOCIATES., INC. |
ROGER H SCHNEIDER |
| K051852 |
07/19/2005 |
SINGLE AMPLIFIER FOR BOTOX |
ALLERGAN, INC. |
SUSAN O'BRIEN |
| K052062 |
07/29/2005 |
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES |
ALLIANCE MEDICAL CORP. |
MOIRA BARTON |
| K052064 |
07/29/2005 |
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES |
ALLIANCE MEDICAL CORP. |
MOIRA BARTON |
| K052065 |
07/29/2005 |
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES |
ALLIANCE MEDICAL CORP. |
MOIRA BARTON |
| K051830 |
07/06/2005 |
NEURODRIVE SYSTEM |
ALPHA OMEGA LTD. |
SHLOMO PUNDAK |
| K051912 |
07/25/2005 |
COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B |
ALSIUS CORP. |
KENNETH A COLLINS |
| K051903 |
07/13/2005 |
FETALGARD LITE-NIBP, MODEL FGL-NIBP |
ANALOGIC CORPORATION |
JANET KWIATKOWSKI |
| K051779 |
07/01/2005 |
ANDROFLOW - RESPIRATORY RATE MONITOR |
ANDROMED, INC. |
GEORGE PAPAGIANNIS |
| K051793 |
07/01/2005 |
ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CONTAINING GLYCERINE) |
ANSELL HEALTHCARE PRODUCTS, LLC |
CYNTHIA A INGRAM |
| K051831 |
07/07/2005 |
GEMINI SURGICAL CONTROL & DISPLAY SYSTEM |
APPLIED SURGICAL, LLC |
DAVID A ALEXANDER |
| K051795 |
07/05/2005 |
NOMAD DENTAL X-RAY SYSTEM |
ARIBEX, INC. |
D.CLARK TURNER |
| K051820 |
07/05/2005 |
PARALLAX EZFLOW CEMENT DELIVERY SYSTEM |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K051783 |
07/01/2005 |
ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES |
ARTSANA S.P.A. |
LARA N SIMMONS |
| K052022 |
07/27/2005 |
ASAHI PTCA GUIDE WIRE FIELDER |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K051772 |
07/05/2005 |
ASAHI TORNUS SUPPORT CATHETER |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K052047 |
07/29/2005 |
ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101 |
AVENT AMERICA, INC. |
RICHARD MORRONEY |
| K051983 |
07/25/2005 |
MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR |
AXYA MEDICAL, INC. |
HOWARD SCHRAYER |
| K052006 |
07/28/2005 |
POWDER-FREE VINYL EXAM GLOVES |
BAODING GUANZHONG GLOVE CO., LTD. |
MARY ANN DOUCETTE |
| K051902 |
07/13/2005 |
NIO 2MP-21" |
BARCOVIEW |
LIEVEN DE WANDEL |
| K051901 |
07/13/2005 |
NIO 3MP-21" |
BARCOVIEW |
LIEVEN DE WANDEL |
| K051899 |
07/13/2005 |
BD PEN NEEDLE |
BECTON DICKINSON & CO. |
JOHN SCHALAGO |
| K051914 |
07/14/2005 |
GENEROS 80, GENEROS 60 |
BERKELEY ADVANCED BIOMATERIALS, INC. |
FRANCOIS GENIN |
| K052053 |
07/29/2005 |
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK |
BIO-RAD |
SUZANNE S PARSONS |
| K051816 |
07/05/2005 |
LUMIWAVE 1X4 INFRARED THERAPY DEVICE |
BIOCARE SYSTEMS, INC. |
CLAY ANSELMO |
| K051774 |
07/01/2005 |
MBCP |
BIOMATLANTE |
MYRIAM VINCENT |
| K051885 |
07/12/2005 |
MBCP |
BIOMATLANTE |
MYRIAM VINCENT |
| K051849 |
07/07/2005 |
VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
NANCY WEAVER |
| K051843 |
07/07/2005 |
COPELAND EAS HUMERAL RESURFACING HEADS |
BIOMET, INC. |
TRACY BICKEL JOHNSON |
| K051975 |
07/21/2005 |
POROUS COATED DISCOVERY ELBOW |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K051775 |
07/01/2005 |
OSTEOMIMETIC SYNTHETIC BONE MATRIX |
BIOMIMETIC PHARMACEUTICALS INC. |
SANDRA WILLIAMSON |
| K051845 |
07/07/2005 |
THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM |
BIOPLATE, INC. |
JESUS T FARINAS |
| K051787 |
07/01/2005 |
TRIAGE BNP TEST, MODEL 98000XR |
BIOSITE INCORPORATED |
JEFFREY DAHLEN |
| K051985 |
07/25/2005 |
BIOVALVE MINI-JECT NEEDLEFREE INJECTOR |
BIOVALVE TECHNOLOGIES, INC. |
SCOTT HUIE |
| K051999 |
07/25/2005 |
BISCOVER LED |
BISCO, INC. |
BENJAMIN LICHTENWALNER |
| K051951 |
07/22/2005 |
CERAMENT BONE VOID FILLER |
BONE SUPPORT AB |
JEFFREY R SHIDEMAN |
| K051984 |
07/22/2005 |
FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300 |
BOSTON SCIENTIFIC CORP. |
DEBBIE MCINTIRE |
| K051880 |
07/11/2005 |
RIO ASPIRATION CATHETER |
BOSTON SCIENTIFIC CORP. |
CATHERINE A PETERS |
| K052038 |
07/28/2005 |
PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM |
BOSTON SCIENTIFIC CORPORATION |
RENUKA KRISHNAN |
| K051819 |
07/07/2005 |
C CHANGE SOLUTION WARMER |
C CHANGE SURGICAL LLC |
ROBERT KELLY |
| K051991 |
07/22/2005 |
POWERPICC, POLY PER-Q-CATH, 6 FR TL POLY PER-Q-CATH, POWER HOHN AND POWER LINE |
C.R. BARD, INC. |
LYNN M KIRCHOFF |
| K052035 |
07/28/2005 |
CANADY PLASMA PROBES |
CANADY TECHNOLOGY, LLC |
JEROME CANADY |
| K051853 |
07/13/2005 |
CARDIOSTREAM SONOAIM |
CARDIOSTREAM, LLC |
IAN P GORDON |
| K051817 |
07/05/2005 |
BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM |
CARDIVA MEDICAL, INC. |
KARIN GASTINEAU |
| K051789 |
07/01/2005 |
VISANTE OCT |
CARL ZEISS MEDITEC INC |
JUDITH A BRIMACOMBE |
| K051887 |
07/12/2005 |
PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF) |
CARLETON LIFE SUPPORT SYSTEMS INC. |
GARY BYRD |
| K051896 |
07/13/2005 |
MODEL 750E SERIES MONITOR |
CAS MEDICAL SYSTEMS, INC. |
RON JEFFREY |
| K051938 |
07/20/2005 |
TRITON/TRU-TRAC/TX TRACTION DEVICES |
CHATTANOOGA GROUP |
CHERYL BAGWELL |
| K052046 |
07/29/2005 |
BLOOD PRESSURE METER, MODEL CH-432 |
CITIZEN WATCH CO., LTD. |
JOSEPH EDMONDSON |
| K051799 |
07/05/2005 |
DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS |
COEUR, INC. |
DEBRA F MANNING |
| K052041 |
07/29/2005 |
COLLAGEN BONE HEALING PROTECTIVE SHEET |
COLLAGEN MATRIX, INC. |
PEGGY HANSEN |
| K051964 |
07/20/2005 |
POWERNEB |
COMEDICA , INC. |
KRISTA OAKES |
| K051838 |
07/07/2005 |
MODIFIED CONCENTRIC RETRIEVER, MODEL 90039 |
CONCENTRIC MEDICAL, INC. |
JEAN M CAILLOUETTE |
| K052045 |
07/28/2005 |
ACCESS BREAST COIL |
CONFIRMA, INC. |
PATRICIA A MILBANK |
| K052009 |
07/25/2005 |
CONMED SYSTEM MODEL 2450 ELECTROSURGICAL GENERATOR |
CONMED CORPORATION |
PAMELA VETTER |
| K051785 |
07/01/2005 |
FORMULA 418 BILIARY STENT |
COOK, INC. |
KAREN BRADBURN |
| K052040 |
07/28/2005 |
QUICKSMILE |
COSMETIC DENTAL MATERIALS INC |
ROBERT BOWERS |
| K051916 |
07/15/2005 |
POLAR CATH PERIPHERAL DILATATION SYSTEM |
CRYOVASCULAR SYSTEMS, INC. |
ELAINE APLAON |
| K051911 |
07/14/2005 |
GELITA-SPON |
CURAMEDICAL, BV |
WILLIAM GREENROSE |
| K051922 |
07/15/2005 |
ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6 |
CYNOSURE, INC. |
GEORGE CHO |
| K051910 |
07/14/2005 |
MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER |
D.B.I. AMERICA CORP. |
UBIRACI R FERNANDES |
| K052017 |
07/26/2005 |
CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108 |
DADE BEHRING, INC. |
ANDREA M TASKER |
| K052015 |
07/26/2005 |
DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 |
DADE BEHRING, INC. |
ANDREA M TASKER |
| K051897 |
07/13/2005 |
TRIO MONITOR |
DATASCOPE CORP. |
SUSAN E MANDY |
| K051895 |
07/13/2005 |
GE DATEX-OHMEDA ENGSTROM CARESTATION |
DATEX-OHMEDA, INC. |
DAN KOSEDNAR |
| K051848 |
07/07/2005 |
SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079 |
DAVOL INC., SUB. C.R. BARD, INC. |
LUCINDA L FOX |
| K051960 |
07/22/2005 |
CARDIONAVIGATOR + |
DEL MAR REYNOLDS MEDICAL, LTD. |
GEORGE MYERS |
| K051989 |
07/22/2005 |
GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
DENISE LUCIANO |
| K051786 |
07/01/2005 |
MELIDE FIBEROPTIC LIGHT |
DESIGNS FOR VISION, INC. |
CYNTHIA J M. NOLTE |
| K051757 |
07/07/2005 |
CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 |
DIAGNOSTIC CHEMICALS LTD. |
PENNY WHITE |
| K051996 |
07/25/2005 |
DIOMED DELTA 15, MODEL DELTA 15; DIOMED DELTA 30, MODEL DELTA 30 |
DIOMED, LTD. |
TIM PHIPPS |
| K051776 |
07/01/2005 |
PROTEGE ULTRASONIC INSERT |
DISCUS DENTAL INC. |
SUZANNE RIDGWAY |
| K051825 |
07/05/2005 |
COGNITRACE |
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH |
DANIEL KAMM |
| K051932 |
07/13/2005 |
ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 |
ELEKTA, INC |
PETER STEGAGNO |
| K051860 |
07/12/2005 |
FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 |
EPIMED INTERNATIONAL, INC. |
CHRISTOPHER LAKE |
| K051806 |
07/12/2005 |
CARE FECAL OCCULT BLOOD TEST, MODEL KT313 |
EPITOPE DIAGNOSTICS, INC. |
PING GAO |
| K051837 |
07/06/2005 |
MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100 |
ESAOTE, S.P.A. |
CARRI GRAHAM |
| K051749 |
07/07/2005 |
COBRA SURGICAL SYSTEM |
ESTECH, INC. |
CRAIG COOMBS |
| K051950 |
07/18/2005 |
INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321 |
ETHICON ENDO-SURGERY, INC. |
KIMBERLY SHOEMAKER |
| K051858 |
07/08/2005 |
ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM |
EXACTECH, INC. |
LISA SIMPSON |
| K052000 |
07/27/2005 |
ARCHITECT CA 19-9XR ASSAY |
FUJIREBIO DIAGNOSTICS, INC. |
DIANA L WOLANIUK |
| K051883 |
07/12/2005 |
DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES. |
GE HEALTHCARE |
JOEL KENT |
| K051873 |
07/11/2005 |
DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES |
GE HEALTHCARE |
JOEL C KENT |
| K051967 |
07/20/2005 |
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS |
GE HEALTHCARE |
JOHN L SCHMIDT |
| K051855 |
07/08/2005 |
VENTRI |
GE MEDICAL SYSTEMS F.I. HAIFA |
ELI WERNER |
| K052039 |
07/28/2005 |
GE OEC ALTITUDE |
GE OEC MEDICAL SYSTEMS |
SUSAN SCHMIDT |
| K051721 |
07/13/2005 |
GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM |
GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC. |
CARL KNOBLOCH |
| K051777 |
07/01/2005 |
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE) |
HARTALEGA SDN BHD |
KUAN KAM HON |
| K051778 |
07/01/2005 |
NITRILE POWDERED EXAMINATION GLOVES (BLUE) |
HARTALEGA SDN BHD |
KUAN KAM HON |
| K052007 |
07/25/2005 |
ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE) |
HORIBA ABX |
TIM LAWTON |
| K052052 |
07/29/2005 |
HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5 |
HOSPIRA, INC. |
PATRICIA MELERSKI |
| K051948 |
07/18/2005 |
AVON PATELLO-FEMORAL JOINT PROSTHESIS |
HOWMEDICA OSTEONICS CORP |
VIVIAN KELLY |
| K052037 |
07/28/2005 |
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM |
HOWMEDICA OSTEONICS CORP |
VIVIAN KELLY |
| K051977 |
07/21/2005 |
SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS |
HOWMEDICA OSTEONICS CORP |
KAREN ARIEMMA |
| K052011 |
07/25/2005 |
PILONPLATE WITH ANGULAR STABILITY |
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
AL LIPPINCOTT |
| K051969 |
07/20/2005 |
TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA |
IBL GMBH |
GARY LEHNUS |
| K051980 |
07/27/2005 |
DVT SCANNER |
IMAGING SCIENCES INTL., INC. |
DAVID W COWAN |
| K051978 |
07/21/2005 |
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT |
IMPLEX CORP. |
MARCI HALEVI |
| K051800 |
07/05/2005 |
IN6 SAFETY SYRINGE, MODEL 3ML |
IN6 INCUVESTOR INC. |
JENNIFER REICH |
| K051667 |
07/08/2005 |
EZ-JECT |
INDOLOR, LTD. |
GEORGE J HATTUB |
| K051821 |
07/05/2005 |
INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM |
INION LTD. |
HANNA MARTTILA |
| K051907 |
07/14/2005 |
INNOCOR |
INNOVISION A/S |
RICHARD O WOOD |
| K052059 |
07/29/2005 |
IUI CATHETER, MODEL 9057 |
INNTEC, INC. |
GARY SYRING |
| K051943 |
07/18/2005 |
SUREFLOW SAFETY INFUSION DEVICE |
INTRASAFE MEDICAL, LLC |
SHEPARD G BENTLEY |
| K051917 |
07/15/2005 |
DIVER C.E. CATHETER |
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. |
STEPHANIE K ISGRIGG ROBINSON |
| K051782 |
07/07/2005 |
BLUEPHASE 16I |
IVOCLAR VIVADENT, INC. |
DONNA M HARTNETT |
| K051705 |
07/13/2005 |
IPS E.MAX CAD/IPS E.MAX ZIRCAD |
IVOCLAR VIVADENT, INC. |
DONNA MARIE HARTNETT |
| K051780 |
07/01/2005 |
JETLITE 5000 |
J. MORITA USA, INC. |
HOWARD ROWE |
| K051918 |
07/19/2005 |
RESOLVE OPEN BACK HALO RINGS |
JEROME MEDICAL |
BERNIE TATRO |
| K051814 |
07/05/2005 |
JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET |
JMS NORTH AMERICA CORP. |
CHONG SWEE CHEAU |
| K051900 |
07/13/2005 |
ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR |
JOHNSON & JOHNSON VISION CARE, INC. |
SUSAN MORRIS |
| K051827 |
07/06/2005 |
JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS LAMINOSCOPE/MULTISCOPE |
JOIMAX GMBH |
KARIN GASTINEAU |
| K051972 |
07/22/2005 |
KARL STORZ TRANS-NASAL ESOPHAGOSCOPE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
YVONNE FERNANDEZ |
| K051909 |
07/20/2005 |
DIAGNODENT |
KAVO AMERICA |
DENIEL KAMM |
| K051847 |
07/07/2005 |
KD-768 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR |
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
LIU YI |
| K052095 |
07/25/2005 |
MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
MASAFUMI SAITO |
| K051998 |
07/28/2005 |
REGIUS MODEL 170 DIRECT DIGITIZER |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
MASAFUMI SAITO |
| K051796 |
07/12/2005 |
CLEARFIL TRI-S BOND SINGLE DOSE |
KURARAY MEDICAL KURASHIKI PLANT |
SATOSHI YAMAGUCHI |
| K051812 |
07/26/2005 |
TGO SPRAY |
LABORATOIRES CARILENE S.A.S. |
EMALEE MURPHY |
| K051926 |
07/19/2005 |
LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP |
LIMERICK, INC. |
PAUL KRUMM |
| K051944 |
07/18/2005 |
FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES |
LUMENIS, INC. |
KAREN L BAKER |
| K051946 |
07/19/2005 |
MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM |
MEDARTIS, INC. |
FLOYD G LARSON |
| K051930 |
07/13/2005 |
DRUG ACCESS SPIKE |
MEDEGEN MEDICAL MANUFACTURING SERVICES |
SALVADORE F PALOMARES |
| K051939 |
07/18/2005 |
MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR |
MEDEGEN MEDICAL MANUFACTURING SYSTEM |
TIM TRUITT |
| K051809 |
07/05/2005 |
EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM |
MEDICAL INSIGHT A/S |
GARY J ALLSEBROOK |
| K051422 |
07/19/2005 |
DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE |
MEDISIM LTD. |
AHAVA STEIN |
| K051875 |
07/11/2005 |
BIOFLEX PRESCRIPTION SYSTEM AND RELATED TREATMENT HEADS |
MEDITECH INTERNATIONAL, INC. |
RICHARD KEEN |
| K052057 |
07/29/2005 |
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR |
MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. |
SHERRI POCOCK |
| K051773 |
07/05/2005 |
MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS |
MEDTRONIC INC.,NEUROLOGICAL DIVISION |
PAULA CORDERO |
| K052054 |
07/29/2005 |
TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K051846 |
07/08/2005 |
7F SHERPA NX GUIDE CATHETER |
MEDTRONIC VASCULAR |
FRED L BOUCHER |
| K051965 |
07/20/2005 |
OSTEOBRIDGE IDSF INTRAMEDULLARY DIAPHYSEAL SEGMENTAL DEFECT FIXATION ROD SYSTEM |
MERETE MEDICAL GMBH |
CARL KNOBLOCH |
| K051990 |
07/27/2005 |
ECHELON MICRO CATHETER |
MICRO THERAPEUTICS, INC. |
MARILYN R POURAZAR |
| K051836 |
07/12/2005 |
SKELITE RESORBABLE CEMENT RESTRICTOR |
MILLENIUM BIOLOGIX, INC. |
ROBERT SCHIFF |
| K051872 |
07/19/2005 |
MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011 |
MK-DENT GMBH |
MARTINA GUNDEROTH |
| K051958 |
07/19/2005 |
MP RAPIDOXY TEST STRIP, MODEL 07RD-7073 |
MP BIOMEDICALS, LLC. |
ROBIN J HELLEN |
| K051963 |
07/25/2005 |
BE-CERTAIN PREGNANCY TEST |
NATUREPLEX, LLC |
VICTOR J SANTOS |
| K051869 |
07/11/2005 |
NEOBLUE COZY LED PHOTOTHERAPY SYSTEM |
NATUS MEDICAL, INC. |
LUANNE NG |
| K051828 |
07/06/2005 |
NIPRO SUREFUSER AMBULATORY INFUSION PUMP |
NIPRO MEDICAL CORPORATION |
KAELYN HADLEY |
| K051835 |
07/08/2005 |
NPAC MULTI-USE EAR THERMOMETER, MODELS TP 700,TP 702 |
NORM PACIFIC AUTOMATION CORP. |
CHI-CHU WU CHEN |
| K051959 |
07/18/2005 |
NV CORMED SOLAS SPINAL SYSTEM |
NV CORMED |
CARL KNOBLOCH |
| K051889 |
07/12/2005 |
CAREVENT CA AND DRA |
O-TWO MEDICAL TECHNOLOGIES, INC. |
AMMAR AL-DOJAILY |
| K051794 |
07/01/2005 |
GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS |
OFFICE OF THE SURGEON GENERAL, U.S. ARMY |
DIANE ULLMAN |
| K051886 |
07/12/2005 |
OLYMPUS CHOLEDOCHOSCOPE, MODEL XCHF-BP160F |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K051945 |
07/18/2005 |
MIOT PLATING SYSTEM |
ORTHOFIX SRL |
CANDACE F CEDERMAN |
| K051798 |
07/11/2005 |
OSTEOMED ORTHODONTIC ANCHOR PLATING SYSTEM |
OSTEOMED L.P. |
DAWN T HOLDERMAN |
| K051781 |
07/07/2005 |
GRAFTCAGE TLX |
OSTEOTECH, INC. |
CHRISTOPHER TALBOT |
| K051876 |
07/11/2005 |
MULTIWAVE XR |
PACIFIC QUANTUM INSTRUMENTS, INC. |
GENNADY L NIKOLAENKO |
| K052048 |
07/29/2005 |
ACCORDION |
PERCUTANEOUS SYSTEMS, INCORPORATED |
THOMAS LAWSON |
| K051759 |
07/01/2005 |
FLEXI-LITE, MODEL FL-V1.2 |
PERFORMANCE HYPERBARICS |
SPENCER FELDMAN |
| K052049 |
07/29/2005 |
PHILIPS 12-LEAD ALGORITHM |
PHILIPS MEDICAL SYSTEMS |
SONGHUA ZHANG |
| K052013 |
07/26/2005 |
ACHIEVA 1.5T & INERA 1.5T FAMILY |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
LYNN T HARMER |
| K051874 |
07/14/2005 |
SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET |
PHYSIOMETRIX, INC. |
DAWN E FRAZER |
| K051844 |
07/07/2005 |
EQUATOR PLUS ACETABULAR CUP SYSTEM |
PORTLAND ORTHOPAEDICS PTY. LTD. |
ELAINE DUNCAN |
| K051866 |
07/14/2005 |
PREMIER TEMPORARY CEMENT |
PREMIER DENTAL PRODUCTS CO. |
VINCE D'ALESSANDRO |
| K051851 |
07/21/2005 |
AVISO OPHTHALMIC ULTRASOUND SYSTEM |
QUANTEL MEDICAL |
GEORGE MYERS |
| K052005 |
07/25/2005 |
R&R EXTERNAL FIXATION SYSTEM |
R&R MEDICAL, INC. |
J.D. WEBB |
| K051968 |
07/20/2005 |
ABL8X7 FLEX |
RADIOMETER MEDICAL APS |
LENE MEINECHE MARNAES |
| K051928 |
07/18/2005 |
AUTOCHECK6+ |
RADIOMETER MEDICAL APS |
LENE M MARNAES |
| K051947 |
07/18/2005 |
RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE |
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP |
KEVIN J O'CONNELL |
| K052002 |
07/25/2005 |
IRON STANDARD |
ROCHE DIAGNOSTICS CORP. |
CORINA HARPER |
| K051890 |
07/12/2005 |
ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K051888 |
07/12/2005 |
TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013 |
SCANTIBODIES LABORATORY, INC. |
MICHAEL NORDSTROM |
| K051810 |
07/05/2005 |
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014 |
SCANTIBODIES LABORATORY, INC. |
MICHAEL NORDSTROM |
| K051952 |
07/18/2005 |
EUGENONE |
SCIENTIFIC PHARMACEUTICALS, INC. |
JAN A ORLOWSKI |
| K051942 |
07/15/2005 |
MALIBU SPINAL SYSTEM |
SEASPINE, INC. |
DIANA SMITH |
| K051804 |
07/05/2005 |
ABL80 FLEX ANALYZER |
SENDX MEDICAL, INC. |
DOREEN E MILFORD |
| K052016 |
07/26/2005 |
NON-STERILE POWDER FREE MULTICOLOR - RED, BLUE, PURPLE AND YELLOW LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING |
SGMP CO., LTD. |
JANNA P TUCKER |
| K051924 |
07/15/2005 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE, YELLOW) |
SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., |
CHU XIAOAN |
| K051935 |
07/15/2005 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) |
SHIJIAZHUANG WONDER PLASTIC CO., LTD. |
CHU XIAOAN |
| K051923 |
07/15/2005 |
POWDERED VINYL PATIENT EXAMINATION GLOVES WHITE (NON-COLORED) |
SHIJIAZHUANG WONDER PLASTIC CO., LTD. |
CHU XIAOAN |
| K051913 |
07/15/2005 |
POWDERED LATEX PATIENT EXAMINATION GLOVES |
SHINEMOUND ENTERPRISE, INC. |
HUAN-CHUNG LI |
| K051818 |
07/05/2005 |
BEAUTIFIL FLOW |
SHOFU DENTAL CORP. |
DAVID P MORAIS |
| K052033 |
07/27/2005 |
VINTAGE ZR |
SHOFU DENTAL CORP. |
DAVID P MORAIS |
| K052029 |
07/27/2005 |
SYNGO CIRCULATION |
SIEMENS AG, MEDICAL SOLUTIONS |
RUEDIGER KOERNER |
| K052021 |
07/29/2005 |
V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ISKRA MRAKOVIC |
| K051859 |
07/08/2005 |
SISTEMA DE IMPLANTE NACIONAL (S.I.N.); DENTAL IMPLANT SYSTEM |
SIN SISTEMA DE IMPLANTE NACIONAL LTDA |
FLOYD G LARSON |
| K051940 |
07/20/2005 |
CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA |
SIS LTD. SURGICAL INSTRUMENT SYSTEMS |
KEVIN WALLS |
| K051784 |
07/01/2005 |
OSTEOVATION CMF BONE VOID FILLER |
SKELETAL KINETICS, LLC |
DURAN YETKINLER |
| K052055 |
07/29/2005 |
SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200 |
SMISSON-CARTLEDGE BIOMEDICAL LLC |
JULIE STEPHENS |
| K051735 |
07/06/2005 |
PERI-LOC LOCKING BONE PLATES AND LOCKING BONE SCREWS FOR THE UPPER EXTREMITY |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K051956 |
07/19/2005 |
DR. OPPEL ST-501 |
SOMETECH INCORPORATED |
YOUNG-SOO SEOL |
| K052042 |
07/28/2005 |
SONOSCAPE SSI-1000/SSI-5000 ULTRASOUND TRANSDUCERS |
SONOSCAPE COMPANY LIMITED |
BOB LEIKER |
| K052001 |
07/27/2005 |
MODEL SR-115 PORTABLE X-RAY SYSTEM |
SOURCE-RAY, INC. |
RAY MANEZ |
| K051840 |
07/07/2005 |
ENSITE VERISMO SOFTWARE |
ST. JUDE MEDICAL |
KAREN MCKELVEY |
| K051976 |
07/22/2005 |
PROVEN REVISION MODULAR TIBIAL TRAY |
STELKAST COMPANY |
DONALD A STEVENS |
| K051957 |
07/15/2005 |
REPROCESSED EXTERNAL FIXATION DEVICE |
STERILEMED INC. |
THOMAS A DOLD |
| K051953 |
07/18/2005 |
EVERSTICK A&O |
STICK TECH LTD. |
WILLIAM M TROETEL |
| K051871 |
07/12/2005 |
STOMA BONE SCREW |
STORZ AM MARK GMBH |
FRANZ MENEAN |
| K051973 |
07/21/2005 |
MODIFICATION TO: XIA STAINLESS STEEL SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
| K051921 |
07/15/2005 |
THE EDGE DETECTOR, MODEL 1118 |
SUN NUCLEAR CORP. |
NOEL M DOWNEY |
| K051904 |
07/13/2005 |
ALL PURPOSE CUFF, MODEL 222APC |
SUNTECH MEDICAL, INC. |
DAVID GALLICK |
| K051988 |
07/22/2005 |
OXY-SERVE II OXYGEN CONSERVING REGULATOR |
SUPERIOR PRODUCTS, INC. |
RONALD JOHNSTON |
| K051933 |
07/13/2005 |
EXPASYL POWER APPLICATOR |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K051879 |
07/11/2005 |
SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS |
SYNTHES (USA) |
KATHY ANDERSON |
| K051986 |
07/22/2005 |
SYNTHES 4.5 MM LCP STRAIGHT RECONSTRUCTION PLATES |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K051936 |
07/18/2005 |
CLEVER CHECK TD-3215/DR. T TD-3216 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEMS |
TAIDOC TECHNOLOGY CORPORATION |
SHU-MEI WU |
| K051854 |
07/08/2005 |
CLEVER CHEK TD-4225, MODEL TD-4225 |
TAIDOC TECHNOLOGY CORPORATION |
SHU-MEI WU |
| K051929 |
07/13/2005 |
GIARDIA/CRYPTOSPORIDIUM CHEK |
TECHLAB, INC. |
DAVID M LYRLY |
| K051927 |
07/18/2005 |
TECHLAB ASCA-CHEK |
TECHLAB, INC. |
DAVID M LYERLY |
| K051766 |
07/07/2005 |
ORTHOMEND |
TEI BIOSCIENCES INC. |
KENNETH JAMES |
| K051997 |
07/25/2005 |
CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
GARRY A COURTNEY |
| K051865 |
07/11/2005 |
TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR |
TERUMO MEDICAL CORP. |
BARBARA SMITH |
| K052034 |
07/29/2005 |
TERUMO SYRINGE WITH/WITHOUT NEEDLE |
TERUMO MEDICAL CORP. |
BARBARA SMITH |
| K051915 |
07/18/2005 |
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K051993 |
07/25/2005 |
LMA FASTRACH ETT SINGLE USE |
THE LARYNGEAL MASK CO.,LTD. |
FOSTER BOOP |
| K051864 |
07/13/2005 |
MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00 |
THE MAGSTIM COMPANY LTD. |
ANTHONY THOMAS |
| K052056 |
07/29/2005 |
DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM |
THERMO-ELECTRON CORP. |
MELITA LAMBIRIS |
| K051824 |
07/05/2005 |
INVADER UGT1A1 MOLECULAR ASSAY |
THIRD WAVE TECHNOLOGIES, INC. |
SAM RUA |
| K051808 |
07/08/2005 |
ESTELITE FLOW QUICK |
TOKUYAMA DENTAL CORPORATION |
KEITH A BARRITT |
| K051833 |
07/06/2005 |
TSX-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP CT SCANNER |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINGS |
| K051856 |
07/08/2005 |
TRANS1 FACET SCREWS |
TRANS1 INCORPORATED |
ROBERT L SHERIDAN |
| K051931 |
07/13/2005 |
AXCEL |
TRI DENTAL INNOVATORS |
LINDA NGUYEN |
| K052043 |
07/28/2005 |
3.8MM CS FACET COMPRESSION DEVICE |
TRIAGE MEDICAL, INC. |
GAYLE HIROTA |
| K051949 |
07/15/2005 |
4.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LSPW-45-3040 |
TRIAGE MEDICAL, INC. |
GAYLE HIROTA |
| K051805 |
07/08/2005 |
KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE |
TYCO HEALTHCARE/KENDALL |
BRIDGET GARDNER |
| K051971 |
07/22/2005 |
OPTIMA SPINAL SYSTEM |
U&I CORP. |
BETTY LIM |
| K051651 |
07/05/2005 |
G4, MODEL IGM-0004 |
U. S. DIAGNOSTICS, INC. |
EDWARD LETKO |
| K051813 |
07/13/2005 |
ULTRAPACS |
ULTRARAD CORPORATION |
CARL ALLETTO |
| K052025 |
07/27/2005 |
URGENT PC NEUROMODULATION SYSTEM |
UROPLASTY, INC. |
MICHAEL MORRELL |
| K051905 |
07/14/2005 |
UROPLASTY RIGID ENDOSCOPIC NEEDLE |
UROPLASTY, INC. |
MICHAEL MORRELL |
| K051919 |
07/15/2005 |
MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE |
USGI MEDICAL |
MARY LOU MOONEY |
| K052004 |
07/25/2005 |
VASCON NEUROPATH GUIDING CATHETER |
VASCON LLC |
ROBERTA D GOODE |
| K051815 |
07/05/2005 |
MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM |
VERTEBRON, INC. |
LUIS NESPRIDO |
| K051992 |
07/22/2005 |
POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM |
VIDACARE CORPORATION |
GRACE HOLLAND |
| K052003 |
07/25/2005 |
VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40) |
VNUS MEDICAL TECHNOLOGIES, INC. |
SAM NANAVATI |
| K051867 |
07/11/2005 |
GRANDIO |
VOCO GMBH |
GERALD W SHIPPS |
| K051868 |
07/11/2005 |
GRANDIO FLOW |
VOCO GMBH |
GERALD W SHIPPS |
| K051920 |
07/20/2005 |
VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001 |
VOLCANO CORPORATION |
MICHELLE J BADAL |
| K051690 |
07/05/2005 |
VYGON NUTRILINE CATHETERS |
VYGON CORP. |
COURTNEY SMITH |
| K051841 |
07/08/2005 |
WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST |
W.H.P.M., INC. |
FRAN WHITE |
| K051826 |
07/07/2005 |
BETACONE HIP PROSTHESIS SYSTEM |
WALDEMAR LINK GMBH & CO. KG |
JANICE M HOGAN |
| K051857 |
07/08/2005 |
VEO MULTIGAS MONITOR FOR POCKET PC, MODEL 400221 |
WEISSBURG ASSOCIATES |
DAVID WEISSBURG |
| K052051 |
07/29/2005 |
OMNI SPHINCTEROTOME |
WILSON-COOK MEDICAL, INC. |
MARGE WALLS-WALKER |
| K051961 |
07/19/2005 |
WWMED, MODEL 401 |
WONG WAY CORPORATION |
RICHARD KEEN |
| K051966 |
07/20/2005 |
FIRST CHECK MULTI DRUG CUP 7 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY |
WORLDWIDE MEDICAL LLC |
KEVIN J GADAWSKI |
| K051908 |
07/14/2005 |
CHARLOTTE COMPRESSION PLATE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
WESLEY L REED |
| K051884 |
07/12/2005 |
CHARLOTTE SMALL MTP FUSION PLATE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
WESLEY L REED |
| K052026 |
07/27/2005 |
LINEAGE A-CLASS POLY LINER |
WRIGHT MEDICAL TECHNOLOGY, INC. |
THERESA LEISTER |
| K051995 |
07/25/2005 |
PROFEMUR RENAISSANCE HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
THERESA LEISTER |
| K051863 |
07/08/2005 |
AMLUCK, YA HORNG |
YA HORNG ELECTRONIC CO., LTD. |
JEN KE-MIN |
| K051862 |
07/08/2005 |
PC COMPATIBLE BLOOD PRESSURE MONITOR, MODEL AK-4000TU, BP-410U, BP-410R; AUTOMATIC DIGITAL WRIST BLOOD PRESS. MONITOR. |
YA HORNG ELECTRONIC CO., LTD. |
JEN KEN-MIN |
| K051955 |
07/19/2005 |
QUICKCLOT ACS - ACCELERATED CLOTTING SPONGE |
Z-MEDICA CORPORATION |
ROBERT V PACKARD |
