FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K062770 |
12/14/2006 |
COPILOT HEALTH MANAGEMENT SYSTEM |
ABBOTT DIABETES CARE INC. |
MARY ROSE |
K062582 |
12/14/2006 |
SUPRACOR BALLOON CATHETER |
ABIOMED, INC. |
ROBERT T.V. KUNG |
K062795 |
12/11/2006 |
MUGARD MUCOADHESIVE ORAL WOUND RINSE |
ACCESS PHARMACEUTICALS, INC |
DAVID NOWOTNIK, PH.D. |
K063460 |
12/07/2006 |
ACUMED CONGRUENT BONE PLATE SYSTEM |
ACUMED LLC |
ED BOEHMER |
K063080 |
12/12/2006 |
TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS |
ADVANCED NEUROMODULATION SYSTEMS |
AMY CLENDENING |
K063127 |
12/22/2006 |
ENTEROCOCCUS FAECALIS PNA FISH |
ADVANDX, INC. |
Amy Aulwes |
K063013 |
12/01/2006 |
PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S |
AEARO COMPANY |
ANN L PHILLIPS |
K063017 |
12/27/2006 |
AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM |
AESCULAP, INC. |
MATTHEW M HULL |
K062217 |
12/13/2006 |
AESKULSKA BETA2-GLYCO-A |
AESKU, INC |
DAVID BELL |
K062951 |
12/12/2006 |
TAP III ANTI-SNORING DEVICE |
AIRWAY MANAGEMENT INC. |
DARREN HENDERSON |
K062971 |
12/18/2006 |
BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS |
Akers Biosciences, Inc. |
BARBARA A BAGBY |
K062371 |
12/04/2006 |
PREVIEW ANTERIOR CERVICAL PLATE SYSTEM |
ALPHASPINE, INC. |
MIKE ENSIGN |
K063379 |
12/11/2006 |
AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220 |
AMEDICA BIOTECH, INC. |
Jeff Chen |
K063015 |
12/20/2006 |
AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150 |
AMEDITECH, INC. |
JOHN WU |
K062794 |
12/07/2006 |
PRN THERMALCARE, MODEL 3000 |
AMERICAN HEALTHCARE PRODUCTS, INC. |
KENT D ELLIS |
K063519 |
12/01/2006 |
DYNAMIC GAS SCAVENGING SYSTEM (DGSS) |
ANESTHETIC GAS RECLAMATION LLC |
JAMES M BERRY |
K062664 |
12/06/2006 |
HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004 |
APEX MEDICAL CORP. |
ALAN CHANG |
K063244 |
12/27/2006 |
ARC SURGICAL BONE REDUCTION SCREW |
ARC SURGICAL LLC. |
ED BOEHMER |
K052719 |
12/05/2006 |
URITEST 10 URINALYSIS REAGENT STRIPS |
ARJ MEDICAL, INC. |
AARON BEHAR |
K062100 |
12/05/2006 |
ARJOWRAP 47/100 AND 47/88 |
ARJO WIGGINS MEDICAL, INC. |
ARTHUR WARD |
K063068 |
12/20/2006 |
FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100 |
ARKRAY USA, INC. |
TOM SPEIKERS |
K063424 |
12/21/2006 |
FILM DIGITZER, MODEL 2908 MAMMO PRO |
ARRAY CORP. |
TAKASHI INAMI |
K063479 |
12/13/2006 |
ARTHREX PUSHLOCK |
ARTHREX, INC. |
ANN WATERHOUSE |
K063538 |
12/01/2006 |
ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD AND WANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
K062692 |
12/13/2006 |
BIS BILATERAL SENSOR |
ASPECT MEDICAL SYSTEMS, INC. |
RENEE GOULD |
K062277 |
12/20/2006 |
ATLANTIS ABUTMENT IN ZIRCONIA FOR NOBEL BIOCARE REPLACE |
ATLANTIS COMPONENTS, INC. |
FRANKLIN UYLEMAN |
K061680 |
12/15/2006 |
ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER |
ATRIUM MEDICAL CORP. |
JOSEPH P DEPAOLO |
K062198 |
12/19/2006 |
SUNSPOTS PRE-GELLED SURFACE ELECTRODES |
AXON SYSTEMS, INC. |
HOWARD BAILIN |
K063194 |
12/04/2006 |
TUFFLEX POLYESTER SUTURE |
AXYA MEDICAL, INC. |
HOWARD L SCHRAYER |
K062714 |
12/15/2006 |
SYNTHETIC VINYL PATIENT EXAM GLOVES, PRE-POWDERED, YELLOW |
BAODING GUANZHONG GLOVE CO., LTD. |
MARY A DOUCETTE |
K062905 |
12/29/2006 |
NIO FUSION 4MP; MDNC 4130 |
BARCOVIEW |
LIEVEN DE WANDEL |
K063331 |
12/19/2006 |
BAUSCH & LOMB NGX MICROSURGICAL SYSTEM |
BAUSCH & LOMB, INC. |
LISA C GRANEY |
K063276 |
12/28/2006 |
CLINITEK ADVANTUS, MODEL 1420 |
BAYER HEALTHCARE, LLC |
NOOR MALKI |
K063301 |
12/08/2006 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) 0.5-64UG/ML |
BECTON, DICKINSON & CO. |
JANINE MATLAK |
K063643 |
12/27/2006 |
MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM |
BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI |
JACKIE BUCKLEY |
K062211 |
12/08/2006 |
BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM |
BIO-RAD LABORATORIES, INC. |
DAVID BHEND |
K062213 |
12/08/2006 |
BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM |
BIO-RAD LABORATORIES, INC. |
DAVID BHEND |
K063400 |
12/01/2006 |
VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0 |
BIO-RAD LABORATORIES, INC. |
JACKIE BUCKLEY |
K063492 |
12/21/2006 |
VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
JOHN TENLLADO |
K062997 |
12/08/2006 |
ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS |
BIOMET MANUFACTURING CORP. |
BECKY EARL |
K060694 |
12/11/2006 |
MODULAR HYBRID GLENOID |
BIOMET MANUFACTURING CORP. |
PATRICIA SANDBORN BERES |
K063398 |
12/05/2006 |
ESA LEADCARE II LEAD CONTROL |
BIONOSTICS, INC. |
RANDY BYRD |
K062819 |
12/04/2006 |
BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY |
BIOPLATE, INC. |
JESUS T FARINAS |
K063343 |
12/13/2006 |
BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM |
BIOPTIGEN, INC. |
RUSSELL PAGANO |
K063505 |
12/12/2006 |
VISUALASE ENVISION SOFTWARE SYSTEM |
BIOTEX, INC. |
MATHEW FOX |
K063237 |
12/08/2006 |
THERACAL LC |
BISCO, INC. |
BENJAMIN LICHTENWALNER |
K063313 |
12/05/2006 |
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM) |
BOSTON SCIENTIFIC CORP. |
DONNA PAGE |
K063493 |
12/21/2006 |
I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) VERSION1.0 |
BOSTON SCIENTIFIC CORP. |
CHRISTINE DUNBAR |
K062750 |
12/04/2006 |
WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030 |
BOSTON SCIENTIFIC CORP. |
ALLYSON BARFORD |
K063028 |
12/12/2006 |
VECTORVISION HIP SR |
BRAINLAB, AG |
RAINER BIRKENBACH |
K063446 |
12/15/2006 |
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 |
C.R. BARD, INC. |
PEGGY KEIFFER |
K063074 |
12/27/2006 |
CANDELA 3630 LASER SYSTEM |
CANDELA CORP. |
JEFFREY ROBERTS |
K063073 |
12/20/2006 |
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS |
CANDELA CORP. |
JEFFERY ROBERTS |
K063072 |
12/20/2006 |
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS: 532 AND 1064 ND:YAG HANDPIECE ACCESSORIES |
CANDELA CORP. |
JEFFERY ROBERTS |
K063308 |
12/04/2006 |
ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200 |
CARBYLAN BIOSURGERY |
ROXANNE DUBOIS |
K051817 |
12/06/2006 |
BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM |
CARDIVA MEDICAL, INC. |
KARIN GASTINEAU |
K062314 |
12/22/2006 |
HORUS LASER KERATOME |
CARL ZEISS MEDITEC AG |
KENT W JONES |
K063087 |
12/11/2006 |
MODIFICATION TO MODEL 750 SERIES MONITOR |
CAS MEDICAL SYSTEMS, INC. |
RON JEFFREY |
K063070 |
12/14/2006 |
APERFIX TIBIAL IMPLANT WITH INSERTER |
CAYENNE MEDICAL, INC. |
Floyd Larson |
K062897 |
12/14/2006 |
C-U2 |
CEFLA S.C.R.L. |
Claude Berthoin |
K062948 |
12/08/2006 |
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B |
CEPHEID |
RUSSEL K ENNS |
K062280 |
12/11/2006 |
OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE |
CEREMED, INC. |
TADEUSZ WELLISZ |
K062922 |
12/13/2006 |
MODIFICATION TO AQUADEX FLEXFLOW SYSTEM |
CHF SOLUTIONS, INC. |
CHRIS SCAVOTTO |
K063579 |
12/14/2006 |
2MP MEDICAL COLOR REFERENCE DISPLAY, MODEL MDC2130-2HC |
CHI LIN TECHNOLOGY CO., LTD. |
JUDY LIN |
K062635 |
12/19/2006 |
MODEL 2200 |
CLARIMEDEX, INC. |
JOHN DUNNING |
K063030 |
12/04/2006 |
COMFORT SCOOTER MODEL LY-EW406 |
COMFORT ORTHOPEDIC CO. LTD. |
Ke-Min Jen |
K063457 |
12/05/2006 |
TRUEHD (1080P) DIGITAL CAMERA SYSTEM |
CONMED LINVATEC |
ELIZABETH PAUL |
K061937 |
12/01/2006 |
COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON |
COOK ENDOSCOPY |
MABEL L HUNTER |
K063619 |
12/20/2006 |
FLIPPER DETACHABLE EMBOLIZATION COILS |
COOK, INC. |
LISA WEBB |
K063254 |
12/07/2006 |
THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM |
CORDIS NEUROVASCULAR, INC. |
Amarilys Machado |
K063206 |
12/28/2006 |
DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH |
DADE BEHRING, INC. |
KATHLEEN DRAY- LYONS |
K063366 |
12/08/2006 |
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH SYNERCID (0.12-2UG/ML 5DILUTION BREAKPOINT SEQUENCE |
DADE BEHRING, INC. |
ROBERT EUSEBIO |
K062924 |
12/26/2006 |
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK |
DADE BEHRING, INC. |
PAMELA A JURGA |
K063365 |
12/08/2006 |
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML LONG DILUTION SEQUENCE |
DADE BEHRING, INC. |
ROBERT EUSEBIO |
K062710 |
12/08/2006 |
GE DATEX-OHMEDA ENGSTROM CARESTATION |
DATEX-OHMEDA, INC. |
DAN KOSEDNAR |
K063478 |
12/15/2006 |
VERSALOK ANCHOR WITH FREE STRANDS OF ORTHOCORD SUTURE (210808), ETHIBOND SUTURE (210809), AND PANACRYL SUTURE (210810) |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
RUTH C FOSTADT |
K062426 |
12/15/2006 |
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS |
DEPUY ORTHOPAEDICS, INC. |
ANNE M SCHULER |
K062814 |
12/15/2006 |
PIPELINE II ACCESS SYSTEM |
DEPUY SPINE, INC. |
SHARON STAROWICZ |
K063045 |
12/05/2006 |
IMMULITE 2000, IMMULITE 2500 VANCOMYCIN |
DIAGNOSTIC PRODUCTS CORP. |
DEBORAH L MORRIS |
K063057 |
12/22/2006 |
IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP |
DIAGNOSTIC PRODUCTS CORPORATION |
DEBORAH L MORRIS |
K061805 |
12/06/2006 |
STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM |
DIAGNOSTICA STAGO, INC. |
LAURA WORFOLK |
K062674 |
12/01/2006 |
MISSION TRINITY B |
DIAMOND DIAGNOSTICS, INC. |
RANDOLPH QUINN |
K063482 |
12/14/2006 |
CROSSPLAN / ACCUSOFT-XL V.4.04 |
DIREX SYSTEMS CORP. |
LARISA GERSHTEIN |
K061466 |
12/04/2006 |
INTIMOL |
DLC LABORATORIES, INC. |
JUAN MANZUR |
K062364 |
12/06/2006 |
I-SCOPE 200 |
DONGJIN MEDICAL CO., LTD |
MIN-KANG KIM |
K060988 |
12/06/2006 |
TOTAL AND HEMI SHOULDER SYSTEM |
DVO EXTREMITY SOLUTIONS, LLC |
DINA WEISSMAN |
K063469 |
12/01/2006 |
MEDICAN ALPHA |
EASTERN MEDIKIT LTD. |
RAJEEV ASRI |
K062508 |
12/05/2006 |
NEUROWAVE MICRO-INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
K063414 |
12/12/2006 |
MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38 |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
K063182 |
12/21/2006 |
ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX |
ENPATH MEDICAL, INC. |
JAMES JENKINS |
K061533 |
12/11/2006 |
PROCEED VENTRAL PATCH |
ETHICON, INC. |
BRYAN A LISA |
K062045 |
12/04/2006 |
EDIA ANTI-CCP |
EURO-DIAGNOSTICA AB |
ANNIKA ANDERSSON |
K063213 |
12/05/2006 |
EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES |
EVER LIGHT PLASTIC PRODUCTS CO., LTD. |
KATHY LIU |
K063214 |
12/08/2006 |
EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES |
EVER LIGHT PLASTIC PRODUCTS CO., LTD. |
KATHY LIU |
K063215 |
12/08/2006 |
EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES |
EVER LIGHT PLASTIC PRODUCTS CO., LTD. |
KATHY LIU |
K063036 |
12/22/2006 |
OPUS HC482 DIRECT NASAL MASK |
FISHER & PAYKEL HEALTHCARE, LTD. |
JAYANTI KARANDIKAR |
K062324 |
12/06/2006 |
MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN |
GE HEALTHCARE |
JOEL KENT |
K063628 |
12/26/2006 |
CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY |
GE HEALTHCARE INTEGRATED IT SOLUTIONS |
KAREN M LUNDE |
K063224 |
12/22/2006 |
GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL |
GENTRIS CORPORATION |
DEBORAH N KLOOS |
K062836 |
12/19/2006 |
CITADEL ANTERIOR LUMBAR PLATE SYSTEM |
GLOBUS MEDICAL INC. |
KELLY J BAKER |
K063374 |
12/06/2006 |
NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE |
Grace Medical, Inc. |
JEFF COBB |
K062950 |
12/21/2006 |
POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE) |
HARTALEGA SDN BHD |
KUAN K HON |
K062383 |
12/21/2006 |
UNISYN HA PLASMA MODULAR HIP |
HAYES MEDICAL, INC. |
LUKE ROSE |
K063612 |
12/29/2006 |
MODIFICATION TO HEALTH BUDDY APPLIANCE |
HEALTH HERO NETWORK, INC. |
ROBIN BUSH |
K052465 |
12/12/2006 |
REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351 |
HEARTSINE TECHNOLOGIES, INC. |
GEORGE BRDLIK |
K061879 |
12/15/2006 |
SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM |
HEMODIAGNOSTICA, LLC |
Bruno Borganti |
K063062 |
12/01/2006 |
HKBOND 2006 |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
K063034 |
12/14/2006 |
AIR-FLEX WITH AUTO-DISTRACTION |
HILL LABORATORIES CO. |
BRADY ALLER |
K063513 |
12/12/2006 |
ECHELON MR-RCC-150 CARDIAC COIL |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUGLAS J THISTLEWAITE |
K063518 |
12/21/2006 |
HI VISION 900 DIAGNOSTIC ULTRASOUND SCANNER |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
K063180 |
12/11/2006 |
ISECURE SYRINGE CARTRIDGE HOLDER |
HOSPIRA, INC. |
DIANE RENNPFERD |
K063239 |
12/11/2006 |
LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526 |
HOSPIRA, INC. |
DIANE RENNPFERD |
K063616 |
12/20/2006 |
TRIDENT II ACETABULAR SYSTEM |
HOWMEDICA OSTEONICS CORP |
MANAL MORCOS |
K063225 |
12/27/2006 |
METAIZEAU NAILING SYSTEM |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
K062845 |
12/13/2006 |
MODULAR REPLACEMENT ELBOW SYSTEM |
HOWMEDICA OSTEONICS CORP. |
FRANCISCO HARO |
K063112 |
12/01/2006 |
REVLITE Q-SWITCHED ND:YAG LASER |
HOYA CONBIO, INC |
DONNA K TEMPLEMAN |
K063166 |
12/22/2006 |
I.T.S. PELVIC RECONSTRUCTION SYSTEM |
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
AL LIPPINCOTT |
K062626 |
12/20/2006 |
CORTISOL ELISA |
IBL-HAMBURG GMBH |
VICTOR HERBST |
K063474 |
12/22/2006 |
ELECTRIC POWERED WHEELCHAIR MODEL-MINI (P14) |
IMC-HEARTWAY, LLC |
MICHAEL CHEN |
K063392 |
12/12/2006 |
IMCO-STAT |
IMCO TECHNOLOGIES |
MARK L SCHWARTZ |
K062891 |
12/14/2006 |
PROTON THERAPY SYSTEM |
INDIANA UNIVERSITY CYCLOTRON FACILITY |
JONATHAN S KAHAN |
K061902 |
12/08/2006 |
COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1 |
INDITHERM MEDICAL |
M.W. (ANDY) ANDERSON |
K062151 |
12/22/2006 |
BOX PEEK VBR SYSTEM |
INNOVASIS, INC. |
WARREN M DANSIE |
K062707 |
12/08/2006 |
RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPE |
INNOVATIVE ENDOSCOPY COMPONENTS, LLC. |
GERALD GOIGITZER |
K061901 |
12/14/2006 |
INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003 |
INO THERAPEUTICS |
FREDERICK MONTGOMERY |
K062708 |
12/13/2006 |
QUANTA LITE CELIAC DGP SCREEN |
INOVA DIAGNOSTICS, INC. |
DONNA L GUSTAFSON |
K061841 |
12/22/2006 |
QUANTA LITE INTRINSIC FACTOR ELISA |
INOVA DIAGNOSTICS, INC. |
GARY L NORMAN |
K063020 |
12/14/2006 |
INTAI BONE PLATE AND BONE SCREW SYSTEM; INTAI DHS/DCS PLATE SYSTEM |
INTAI TECHNOLOGY INC. |
PIEWEN LIN |
K062353 |
12/20/2006 |
MOZAIK BONE REGENERATION MATRIX - PUTTY |
INTEGRA LIFESCIENCES CORPORATION |
DIANA M BORDON |
K063230 |
12/21/2006 |
INTEGRA RADIONICS IMAGEFUSION 3 |
INTEGRA RADIONICS, INC. |
KEVIN J O'CONNELL |
K063402 |
12/11/2006 |
WICK ELECTRODE, MODEL M019260 |
INTELLIGENT HEARING SYSTEMS |
EDWARD MISKIEL |
K063484 |
12/22/2006 |
PATIENT DATA HANDLER & DEVICES (PDH&D) |
INTERMED ADVISORS, INC. |
CHRISTINA VULLO |
K063220 |
12/01/2006 |
DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000 |
INTUITIVE SURGICAL, INC. |
MICHAEL H YRAMATEGUI |
K061889 |
12/12/2006 |
BIOSTAR OIA SHIGATOX |
INVERNESS MEDICAL-BIOSTAR INC. |
ROBIN C HART |
K062880 |
12/22/2006 |
SUBDERMAL WIRE ELECTRODE, MODEL SWE |
IVES EEG SOLUTIONS, INC. |
JOHN R IVES |
K062602 |
12/11/2006 |
BAND-AID(R) BRAND LIQUID BANDAGE |
JOHNSON & JOHNSON CONSUMER COMPANIES, INC. |
MICHELLE R TURK |
K063426 |
12/13/2006 |
V.A.C. ATS LARGE (1000 ML) CANISTER WITH GEL, MODELS M6275093/5, M6275093/10 |
KCI USA, INC. |
VERONIQUE SMITH |
K062965 |
12/22/2006 |
CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM |
KOSSAN LATEX INDUSTRIES (M) SDN. BHD. |
JAMES F LOGAN |
K063640 |
12/18/2006 |
KOWA SL-15 |
KOWA CO. LTD. |
SATOHIKO TAKANASHI |
K063228 |
12/08/2006 |
SURFACE COAT |
KURARAY AMERICA, INC. |
KOJI NISHIDA |
K061656 |
12/15/2006 |
LASER-D68 |
LASER PAIN CLINICS LP |
HOLLY WRIGHT |
K062719 |
12/01/2006 |
GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES |
LASERSCOPE |
PAUL HARDIMAN |
K061462 |
12/15/2006 |
BF+ (PH) |
LDR SPINE USA |
EDWARD E NEWTON |
K062811 |
12/20/2006 |
DPILOG, MODEL DPC-512 |
LIFE OUTCOMES, INC. |
CHARLES M HART |
K061726 |
12/04/2006 |
LSC, MODEL 3 |
LIFESTAND |
STEFANIE D BANKSTON |
K063025 |
12/01/2006 |
LINA POWERBLADE, MODEL 5005,5005-E,5005-C,5005-150,5000-C-150,5005-E-C-150,5005-420,5005-C-420,5005-E-420,5005-E-C-420, |
LINA MEDICAL APS |
WALT BRITTLE |
K063140 |
12/29/2006 |
RAINBOW ADHESIVE CO-OXIMETRY SENSORS |
MASIMO CORPORATION |
JAMES J CRONIN |
K061484 |
12/07/2006 |
MODIFICATION TO: SMITHWICK CAROTID SHUNT |
MCPHERSON ENTERPRISES, INC. |
WILLIAM MCPHERSON |
K063580 |
12/14/2006 |
SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON CO., LTD. |
KYUNG-AM SHIM |
K062969 |
12/14/2006 |
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
K063119 |
12/22/2006 |
LIFEPAK 20 DEFIBRILLATOR/ MONITOR |
MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. |
MICHELLE ACKERMANN |
K062821 |
12/19/2006 |
U-CLIP DEVICE |
MEDTRONIC NEUROSURGERY |
JEFFREY HENDERSON |
K060794 |
12/18/2006 |
PROGENIX DBM PUTTY AND PASTE |
MEDTRONIC SOFAMOR DANEK |
EDWARD S CHIN |
K062986 |
12/08/2006 |
MEDTRONIC GRAFT DELIVERY SYRINGE |
MEDTRONIC SOFAMOR DANEK USA, INC. |
EDWARD S CHIN |
K062879 |
12/22/2006 |
TRAVERSE OCT SPINAL FIXATION SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
ED CHIN |
K062752 |
12/07/2006 |
MERCATOR MICROSYRINGE II INFUSION CATHETER |
MERCATOR MEDSYSTEMS, INC. |
KIRK SEWARD |
K062355 |
12/27/2006 |
ENA CEM |
MICERIUM S.P.A. |
EUGENIO MICELI |
K062367 |
12/08/2006 |
MINISCREWS ANCHORING SYSTEM, M.A.S. |
MICERIUM S.P.A. |
EUGENIO MICELI |
K063381 |
12/22/2006 |
CT COMPATIBLE F/S/D APPLICATORS |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
FLEIX MICK |
K063382 |
12/26/2006 |
HDR CT COMPATIBLE SPLIT RING APPLICATOR |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
FELIX MICK |
K061283 |
12/14/2006 |
PULMOLIFE |
MICRO MEDICAL, LTD. |
GLEN HILLSLEY |
K062867 |
12/06/2006 |
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JC1 |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
K061615 |
12/22/2006 |
INTERDRY TEXTILE WITH SILVER |
MILLIKEN CHEMICAL |
MARY MCNAMARA-CULLINANE |
K061033 |
12/12/2006 |
MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS) |
MILTEX, INC. |
CHARLES WEAVER |
K062524 |
12/15/2006 |
OCTAX LASER SHOT SYSTEM |
MINITUBE OF AMERICA, INC |
FREDERICK KIKKERS |
K061875 |
12/11/2006 |
MINISPIR; SPIROLAB III |
MIR MEDICAL INTL. RESEARCH SRL |
SIMON FOWLER |
K061712 |
12/01/2006 |
SPIROBANK II |
MIR MEDICAL INTL. RESEARCH SRL |
SIMON FOWLER |
K062847 |
12/20/2006 |
BIOGEL ECLIPSE INDICATOR UNDERGLOVE |
MOLNLYCKE HEALTH CARE US, LLC |
STEVEN DOWDLEY |
K060852 |
12/26/2006 |
MOONCUP |
MOONCUP LIMITED |
SU HARDY |
K053218 |
12/28/2006 |
DBX DEMINERALIZED BONE MATRIX PUTTY/PASTE/MIX |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
NANCY BENNEWITZ |
K061774 |
12/13/2006 |
NFIX II PEDICLE SCREW SYSTEM |
N SPINE, INC. |
R. STEPHEN REITZLER |
K062539 |
12/01/2006 |
NCONTACT COAGULATION SYSTEM KIT |
NCONTACT SURGICAL, INC. |
JANE RICUPERO |
K063012 |
12/01/2006 |
NCONTACT COAGULATION SYSTEM KIT, MODEL CSK |
NCONTACT SURGICAL, INC. |
JANE RICUPERO |
K062533 |
12/22/2006 |
BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524 |
NEUROVIRTUAL USA, INC. |
EDUARDO FARIA |
K063095 |
12/22/2006 |
HUMERUS LOCKING PLATING SYSTEM |
NEWCLIP TECHNICS |
J.D. WEBB |
K063221 |
12/12/2006 |
MEDWEB ADVANCED 3D WEB PACS |
NEXSYS ELECTRONICS, INC. |
GARY J ALLSEBROOK |
K062551 |
12/15/2006 |
NEXUS IRRIGATION TUBING SET |
NEXUS MEDICAL, LLC |
ANITA SMITH |
K062115 |
12/27/2006 |
CARBON DIOXIDE MONITOR, MODEL OLG-2800A |
NIHON KOHDEN AMERICA, INC. |
SERRAH NAMINI |
K062936 |
12/19/2006 |
NOBELPERFECT CONICAL CONNECTION |
NOBEL BIOCARE AB |
PHUONG NGUYEN SON |
K062566 |
12/06/2006 |
NOBELREPLACE TAPERED CONICAL CONNECTION |
NOBEL BIOCARE USA LLC |
HERBERT CRANE |
K063274 |
12/12/2006 |
ACCULOC BREAST LOCALIZATION SYSTEM |
NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC. |
LEE MYERS |
K063153 |
12/07/2006 |
NOVAPACS |
NOVARAD CORP. |
PAUL SHUMWAY |
K062517 |
12/22/2006 |
ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
K062760 |
12/11/2006 |
ORI F6T DRY ECG MONITORING ELECTRODE |
ORBITAL RESEARCH INC. |
AARON ROOD |
K062856 |
12/13/2006 |
TF ROTARY NICKEL TITANIUM FILE |
ORMCO CORP. |
COLLEEN BOSWELL |
K062838 |
12/19/2006 |
VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303 |
ORTHO-CLINICAL DIAGNOSTICS |
CHARLOTTE BAKER |
K062285 |
12/22/2006 |
VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV |
Ortho-Clinical Diagnostics, Inc. |
Darlene J Phillips |
K063591 |
12/15/2006 |
VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208 |
Ortho-Clinical Diagnostics, Inc. |
MICHAEL M BYRNE |
K062460 |
12/15/2006 |
VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND III |
Ortho-Clinical Diagnostics, Inc. |
MARLENE A HANNA |
K063164 |
12/28/2006 |
VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV |
Ortho-Clinical Diagnostics, Inc. |
MICHAEL M BYRNE |
K063143 |
12/26/2006 |
VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS |
Ortho-Clinical Diagnostics, Inc. |
CHARLOTTE BAKER |
K063395 |
12/22/2006 |
O&P BIVALVE CRANIAL MOLDING HELMET |
ORTHOTIC & PROSTHETIC LAB, INC. |
THOMAS L MALONE |
K062502 |
12/15/2006 |
OSSPRAY CLEANING COMPOUND |
OSPRAY, LTD. |
CARMELINA G ALLIS |
K060839 |
12/07/2006 |
ABC HAIR REMOVAL SYSTEM |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
Sharon Timberlake |
K061436 |
12/06/2006 |
PALOMAR Q-YAG 5 ND:YAG LASER SYSTEM |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
SHARON L TIMBERLAKE |
K062518 |
12/04/2006 |
CELERITY |
PARKELL, INC. |
NELSON J GENDUSA |
K061350 |
12/22/2006 |
LITHODIAMOND ULTRA |
PCK ELECTRONIC INDUSTRY & TRADE CO., LTD. |
JONATHAN KAHAN |
K062947 |
12/14/2006 |
HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES |
PENG LIM ENTERPRISE CO., LTD. |
Ke-Min Jen |
K052298 |
12/12/2006 |
CYSTOGLIDE INTRODUCER SHEATH |
PERCUTANEOUS SYSTEMS, INCORPORATED |
THOMAS LAWSON |
K062796 |
12/08/2006 |
K-Y BRAND INTRIGUE |
PERSONAL PRODUCTS CO. |
NADER FOTOUHI |
K062787 |
12/29/2006 |
ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01 |
PHADIA US INC. |
MARTIN R MANN |
K062583 |
12/26/2006 |
ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01 |
PHADIA US INC. |
MARTIN R MANN |
K060792 |
12/01/2006 |
ILLUMIMED |
PHOTOACTIF, LLC |
JEREMY SHELLMAN |
K063009 |
12/27/2006 |
FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES) |
PRAESIDIA S.R.L. |
GEORGE HAAR |
K062709 |
12/06/2006 |
POWDER FREE LATEX EXAMINATION GLOVES, BLACK |
PT. MAJA AGUNG LATEXINDO |
EMMY TJOENG |
K062929 |
12/18/2006 |
QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA |
QUEST DIAGNOSTICS, INC. |
LIUMING YU |
K062769 |
12/04/2006 |
PRESSUREWIRE CERTUS, MODELS 12006 AND 12306 |
RADI MEDICAL SYSTEMS AB |
MATS GRANLUND |
K063229 |
12/19/2006 |
REST ASSURED NITE PROTECTOR |
RANIR LLC |
CHRISTOPHER PREDKO |
K062612 |
12/13/2006 |
RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04 |
RAYNER SURGICAL INC |
MARK MULLANEY |
K063750 |
12/20/2006 |
XCEL 255 SLIT LAMP |
REICHERT INC. |
SANDRA BROWN |
K061737 |
12/18/2006 |
LOSS OF RESISTANCE SYRINGE |
ROBERT BUSSE & CO., INC. |
MUHAMAD ANSARI |
K063543 |
12/22/2006 |
COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226 |
ROCHE DIAGNOSTICS CORP. |
CORINA HARPER |
K062001 |
12/07/2006 |
ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS |
ROSTAM LTD. |
ROBERT J STAAB |
K063497 |
12/19/2006 |
MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM |
SCANDIUS BIOMEDICAL, INC. |
RALPH ZIMMERMAN |
K063499 |
12/19/2006 |
MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM |
SCANDIUS BIOMEDICAL, INC. |
RALPH ZIMMERMAN |
K052509 |
12/11/2006 |
M-BOLUS EMBOLIC MICROSPHERES |
SCION CARDIO-VASCULAR, INC. |
SUZANA OTANO-LATA |
K063334 |
12/08/2006 |
SHANGHAI GANGHAI MODEL GIKO 1400 |
SHANGHAI GANGKAI PURIFYING PRODUCTS CO., LTD. |
JOSEPH Z ZDROK |
K062676 |
12/14/2006 |
RUIKE, MODEL 3331 |
SHANGHAI RUIKE SPORTS GOODS CO., LTD. |
JUNNATA CHANG |
K062645 |
12/19/2006 |
RUIKE, MODEL 3431 |
SHANGHAI RUIKE SPORTS GOODS CO., LTD. |
JUNNATA CHANG |
K063500 |
12/06/2006 |
DC-6 DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN GOLDSTEIN-FALK |
K063055 |
12/21/2006 |
VS-800 VITAL SIGNS MONITOR |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
K061082 |
12/18/2006 |
MOBIS SPINAL IMPLANT |
SIGNUS MEDIZINTECHNIK GMBH |
TRACY L GRAY |
K063160 |
12/22/2006 |
ALLERGEAZE PATCH TEST CHAMBERS |
SMART PRACTICE |
KIM SULLIVAN |
K063253 |
12/12/2006 |
RCHIVE PACS |
SOBHA RENAISSANCE INFORMATION TECHNOLOGY PVT LTD |
CARL ALLETTO |
K063459 |
12/26/2006 |
CRANEX NOVUS |
SOREDEX PALODEX GROUP OY |
KAI LANER |
K063136 |
12/19/2006 |
NEEDLELESS SLING |
SPECIALITIES REMEEX INTERNATIONAL, S.L. |
JEFFREY R SHIDEMAN |
K061578 |
12/26/2006 |
SSP VERTEBRAL BODY REPLACEMENT |
SPECIALTY SPINE PRODUCTS, LLC |
FLOYD G LARSON |
K062513 |
12/22/2006 |
APEX SPINE SYSTEM |
SPINECRAFT, INC. |
AMI AKALLAL-ASAAD |
K062435 |
12/05/2006 |
REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS |
SPIRE BIOMEDICAL, INC. |
SHEKHAR NIMKAR |
K062333 |
12/14/2006 |
LAIMAD |
STEVEN LAMBERG, D.D.S |
JONATHAN S KAHAN |
K060795 |
12/18/2006 |
SOMNOFIT |
STRATEGIC COUNSEL SARL |
JOHN DENNIS |
K063218 |
12/14/2006 |
E-CHECK (XE) |
Streck |
KERRIE OETTER |
K062640 |
12/14/2006 |
STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000 |
STRYKER INSTRUMENTS |
BECKEY DITTY |
K063428 |
12/11/2006 |
XIA STAINLESS STEEL SPINAL SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
K063600 |
12/19/2006 |
VISTA AVS |
SUMMIT DOPPLER SYSTEMS, INC. |
KEN JARRELL |
K063485 |
12/01/2006 |
LOGIC LAPAROSCOPIC SCISSORS |
SURGICAL INNOVATIONS PLC |
STUART MORAN |
K062265 |
12/26/2006 |
CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM |
SWISS MEDICAL CARE S.A. |
ROBERT AROMANDO |
K063116 |
12/05/2006 |
DEMETRON A.2 |
SYBRON DENTAL SPECIALTIES |
COLLEEN BOSWELL |
K062915 |
12/06/2006 |
VERITAS COLLAGEN MATRIX |
SYNOVIS SURGICAL INNOVATIONS |
CYNTHIA LAMARUCCIOLA |
K063049 |
12/18/2006 |
SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM |
SYNTHES (USA) |
DEBORAH L JACKSON |
K062652 |
12/28/2006 |
INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR |
TANITA CORPORATION OF AMERICA |
BETH MACKEY |
K063613 |
12/26/2006 |
MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE |
TERUMO MEDICAL CORP. |
SANDI HARTKA |
K061227 |
12/20/2006 |
HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER |
THE HYMED GROUP CORP. |
ANITA PETITO |
K060851 |
12/22/2006 |
SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE PAK 2 IV WARMER AND THE THERMAL SAC PRESSURE INFUSER |
THE SMITHWORKS COMPANY |
PATRICIA A MILBANK |
K063551 |
12/22/2006 |
AEQUALIS HUMERAL PLATE |
TORNIER |
Mireille Lemery |
K062661 |
12/22/2006 |
AEQUALIS RESURFACING HEAD |
TORNIER |
Mireille Lemery |
K063200 |
12/07/2006 |
20.1-INCH (51CM) COLOR LCD MONITOR CDL2010A (CCL204) |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
K063199 |
12/04/2006 |
21.3-INCH (54CM) COLOR LCD MONITOR CDL2120A (CCL252I2) |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
K062841 |
12/20/2006 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
K062577 |
12/15/2006 |
V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC |
TZ MEDICAL, INC. |
MADALYN DUNCAN |
K063416 |
12/07/2006 |
LUXVISION SLIT LAMP |
U.S. OPHTHALMIC LLC |
AL WEISENBORN |
K060416 |
12/26/2006 |
OBELISC VERTEBRAL BODY REPLACEMENT DEVICE |
ULRICH GMBH & CO. KG |
IAN P GORDON |
K063703 |
12/21/2006 |
CITRIC ACID 20% SOLUTION, MODEL 329 |
ULTRADENT PRODUCTS, INC. |
COREY JASEPH |
K063557 |
12/12/2006 |
PEAK BOND, MODEL 5133 |
ULTRADENT PRODUCTS, INC. |
DIANE ROGERS |
K063558 |
12/14/2006 |
PEAK SE, MODEL 5135 |
ULTRADENT PRODUCTS, INC. |
DIANE ROGERS |
K062791 |
12/11/2006 |
USI DENTAL SCALER, 25XXX SERIES |
ULTRASONIC SERVICES INC. |
JAMES FEINE |
K060346 |
12/22/2006 |
ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM |
ULTRAZONIX DNT AB |
JEFFREY R SHIDEMAN |
K062788 |
12/28/2006 |
COLLIMATOR, MODEL M-38 |
UMI INTERNATIONAL |
KWANG C JUNG |
K061676 |
12/27/2006 |
RIGIDOMETER, MODEL DIR-4U |
UROAN 21 |
ANABEL ROSSELLO |
K062785 |
12/26/2006 |
LTD POLYAXIAL FIXATION SYSTEM |
US SPINE |
RICHARD JANSEN |
K061276 |
12/06/2006 |
G-PROX ENDOSCOPIC GRASPER |
USGI MEDICAL |
MARY LOU MOONEY |
K063270 |
12/14/2006 |
RPM RESPIRATORY GATING SYSTEM |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
K063371 |
12/14/2006 |
PRONTO V3 EXTRACTION CATHETER, MODEL 5003 |
VASCULAR SOLUTIONS, INC. |
JULIE TAPPER |
K062013 |
12/14/2006 |
CELLSEARCH CIRCULATING TUMOR CELL KIT |
VERIDEX, LLC |
DEBRA J RASMUSSEN |
K062956 |
12/05/2006 |
EZ-MIO, EZ-IO DISTAL TIBIA |
VIDACARE CORPORATION |
GRACE HOLLAND |
K063142 |
12/08/2006 |
MANUAL PD-IO; POWERED PD-IO |
VIDACARE CORPORATION |
GRACE HOLLAND |
K063262 |
12/26/2006 |
AMX4-50 AND AMX4-31 MOBILE DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS |
VIRTUAL IMAGING |
DANIEL KAMM |
K062555 |
12/27/2006 |
EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G |
VISGENEER, INC. |
Ke-Min Jen |
K063337 |
12/12/2006 |
OPAL-RAD |
VIZTEK, INC. |
CARL ALLETTO |
K062345 |
12/15/2006 |
CERAMIC BOND |
VOCO GMBH |
MICHAEL SUES |
K062380 |
12/14/2006 |
FLOSIMPLE ARTHROSCOPY PUMP A120 |
W.O.M. WORLD OF MEDICINE AG |
SUSANNE RAAB |
K062940 |
12/22/2006 |
BONE INJECTION GUN (B.I.G.) |
WAISMED LTD. |
JONATHAN S KAHAN |
K063506 |
12/18/2006 |
LORENZ STERNAL CLOSURE SYSTEM |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
K062842 |
12/04/2006 |
TWIST DRILL |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
K063419 |
12/04/2006 |
MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 ) |
WELCH ALLYN PROTOCOL, INC. |
JEFFREY WAGNER |
K063547 |
12/21/2006 |
CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM |
WITT BIOMEDICAL CORP |
JAMES LUKER |
K062960 |
12/01/2006 |
CONSERVE FEMORAL RESURFACING COMPONENT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
THERESA LEISTER |
K061844 |
12/06/2006 |
DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MATT PAUL |
K062038 |
12/19/2006 |
X-STEN MILD TOOL KIT, MODEL MTK-0001 |
X-STEN CORP. |
TIMOTHY M REEVES |
K063657 |
12/12/2006 |
VASCUTRAK PTA DILATION CATHETER |
YMED INC. |
THOMAS SCHROEDER |
K061461 |
12/20/2006 |
MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 00.65-8026-010-05 |
ZIMMER, INC. |
PATRICIA JENKS |
K063602 |
12/21/2006 |
AUTOPULSE RESUSCITATION SYSTEM MODEL100 |
ZOLL CIRCULATION |
MARK PERKINS |
K062177 |
12/13/2006 |
ZOLL E SERIES WITH REAL CPR HELP |
ZOLL MEDICAL CORPORATION |
SEAN REYNOLDS |