FDA 510(k) Decisions During February, 2006  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K060117 02/22/2006 BOVIE BUTTON REMOTE HAND SWITCH AARON MEDICAL INDUSTRIES RICHARD A KOZLOFF
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
K052732 02/24/2006 ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P ABRACAIR, INC. DAVID CHANGARIS
K062795 12/11/2006 MUGARD MUCOADHESIVE ORAL WOUND RINSE ACCESS PHARMACEUTICALS, INC DAVID NOWOTNIK, PH.D.
K053032 02/09/2006 ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000 ACRO BIOTECH LLC. GREGORY LEE
K063460 12/07/2006 ACUMED CONGRUENT BONE PLATE SYSTEM ACUMED LLC ED BOEHMER
K053094 02/06/2006 ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056 ADVANCED BIO-SURFACES, INC. PHILLIP B JARVI
K053473 02/03/2006 MAESTRO MDTL LASER SYSTEM ADVANCED MEDICAL TECHNOLOGIES, INC. M. JOYCE HEINRICH
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
K053389 02/15/2006 AESCULAP STERILCONTAINER SYSTEM AESCULAP, INC. MATTHEW M HULL
K063017 12/27/2006 AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM AESCULAP, INC. MATTHEW M HULL
K053390 02/06/2006 COLUMBUS (CR) TOTAL KNEE SYSTEM AESCULAP, INC. KATHY A RACOSKY
K060152 02/03/2006 MODIFICATION TO S4 SPINAL SYSTEM AESCULAP, INC. Lisa Boyle
K062217 12/13/2006 AESKULSKA BETA2-GLYCO-A AESKU, INC DAVID BELL
K052439 02/07/2006 AESKULISA GLIA A AND AESKULISA GLIA G AESKU.DIAGNOSTICS STANLEY AMMONS
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
K060091 02/17/2006 ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES ALLIANCE MEDICAL CORP. MOIRA BARTON
K053316 02/13/2006 REPROCESSED COMPRESSION SLEEVES ALLIANCE MEDICAL CORP. MOIRA BARTON
K060049 02/24/2006 REPROCESSED COMPRESSION SLEEVES ALLIANCE MEDICAL CORP. MOIRA BARTON
K062371 12/04/2006 PREVIEW ANTERIOR CERVICAL PLATE SYSTEM ALPHASPINE, INC. MIKE ENSIGN
K051636 02/17/2006 CAMLOG DENTAL IMPLANT ABUTMENTS, HEALING CAPS, AND ACCESSORIES ALTATEC GMBH TINA STEFFANIE-OAK
K053070 02/13/2006 CONTOUR II SPINAL SYSTEM ALTIVA CORP. JOHN KAPTIAN
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
K051525 02/17/2006 ARX SPINAL SYSTEM AMEDICA CORP. ROBERT M WOLFARTH
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
K053371 02/03/2006 AMS MALE TRANSOBTURATOR SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC. FRANK B FREEDMAN
K060150 02/23/2006 SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM ANDANTE MEDICAL DEVICES LTD. DORIT WINITZ
K063519 12/01/2006 DYNAMIC GAS SCAVENGING SYSTEM (DGSS) ANESTHETIC GAS RECLAMATION LLC JAMES M BERRY
K053103 02/01/2006 INTERFACE APEX DENTAL MATERIALS, INC. CHRIS KULTON
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
K053461 02/03/2006 EZLOC FEMORAL FIXATION DEVICE ARTHROTEK, INC. SUSAN ALEXANDER
K060019 02/17/2006 ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM) ARTRON LABORATORIES, INC. JERRY ZHENG
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
K053512 02/16/2006 HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310 BAXTER HEALTHCARE CORP. DAVID E CURTIN
K063276 12/28/2006 CLINITEK ADVANTUS, MODEL 1420 BAYER HEALTHCARE, LLC NOOR MALKI
K060130 02/13/2006 IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT BECKMAN COULTER, INC. ANNETTE HELLIE
K060256 02/27/2006 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM BECKMAN COULTER, INC. MARY BETH TANG
K063301 12/08/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) 0.5-64UG/ML BECTON, DICKINSON & CO. JANINE MATLAK
K060042 02/14/2006 LANDLEX, MODEL P100X BESTEAM TECHNOLOGY INC. JEFF CHANG
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
K053099 02/14/2006 BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS BIOHORIZONS IMPLANT SYSTEMS, INC. WINSTON GREER
K053595 02/28/2006 CURAY CUSTOM SEED ARRAY BIOLUCENT, INC. SHERYL HIGGINS
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
K060131 02/15/2006 OSS-BODIES PROXIMAL TIBIAL SLEEVE BIOMET MANUFACTURING CORP. TRACY BICKEL JOHNSON
K052089 02/17/2006 XR-SERIES BI-METRIC FEMORAL COMPONENTS BIOMET MANUFACTURING, INC. PATRICIA SANDBORN-BERES
K053635 02/21/2006 MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM BIONIME CORPORATION SUSAN D GOLDSTEIN-FALK
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
K053329 02/15/2006 KORLEX-GR GINGIVAL RETRACTION PASTE BIOTECH ONE, INC. KAREN UYESUGI
K063505 12/12/2006 VISUALASE ENVISION SOFTWARE SYSTEM BIOTEX, INC. MATHEW FOX
K063237 12/08/2006 THERACAL LC BISCO, INC. BENJAMIN LICHTENWALNER
K052608 02/01/2006 TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS) BL HEALTHCARE, INC. MICHAEL MATHUR
K060350 02/24/2006 CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM BLACKSTONE MEDICAL, INC. WHITNEY G TURNING
K060283 02/22/2006 TRANSET SYSTEM BONUTTI RESEARCH, INC. PATRICK BALSMANN
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
K053500 02/03/2006 FRAMELESS RADIOSURGERY COMPONENTS BRAINLAB AG RAINER BIRKENBACH
K052966 02/13/2006 CI KNEE, CI MI TKR BRAINLAB, AG RAINER BIRKENBACH
K053127 02/09/2006 IPLAN BRAINLAB, AG RAINER BIRKENBACH
K063028 12/12/2006 VECTORVISION HIP SR BRAINLAB, AG RAINER BIRKENBACH
K050086 02/17/2006 BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING BRENNEN MEDICAL, INC. KENNETH B HERLAND
K063446 12/15/2006 CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 C.R. BARD, INC. PEGGY KEIFFER
K060004 02/22/2006 CALDERA MESH CALDERA MEDICAL, INC. MARLA KENGEN
K053424 02/22/2006 POPMESH CALDERA MEDICAL, INC. MARLA KENGEN
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
K052125 02/08/2006 CARBONAID GAS DIFFUSER CARDIA INNOVATION AB JEFFREY R SHIDEMAN
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
K053301 02/03/2006 CEDARA I-RESPONSE CEDARA PET/CT CEDARA SOFTWARE CORP. CAROL NAKAGAWA
K062897 12/14/2006 C-U2 CEFLA S.C.R.L. Claude Berthoin
K060159 02/03/2006 INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET CENTERS FOR DISEASE CONTROL AND PREVENTION HYE-JOO KIM
DEN060008 02/03/2006 INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET CENTERS FOR DISEASE CONTROL AND PREVENTION HYE-JOO KIM
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
K053223 02/24/2006 TRITON/TRU-TRAC/TX/TRITON DTS TRACTION CHATTANOOGA GROUP MICHAEL TREAS
K050757 02/23/2006 FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIVE PROFESSIONAL LIQUID BANDAGE CHEMENCE MEDICAL INC. SCOTT LEAL
K060008 02/02/2006 AQUADEX FLEXFLOW SYSTEM CHF SOLUTIONS, INC. CHRIS SCAVOTTO
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
K053376 02/16/2006 CHUNG CHENG FAR INFRARED RAY HEALTHFUL LAMP (OR MEDICAL FIR RADIATOR), MODEL CH-8810 CHUNG CHENG ELECTRIC HEATING CO., LTD. JENNIFER REICH
K050828 02/28/2006 TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM CHURCH & DWIGHT CO., INC. STEPHEN C KOLAKOWSKY
K051175 02/17/2006 CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION CIVENT COMMUNICATIONS LTD RUDI LOKITS
K062635 12/19/2006 MODEL 2200 CLARIMEDEX, INC. JOHN DUNNING
K060268 02/24/2006 PEDIATRIC URINARY CATHETER CLAY KENNARD CLAY KENNARD
K052591 02/09/2006 NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT CLINICAL DATA, INC. ISRAEL M STEIN
K053260 02/22/2006 OSSIX -PLUS COLBAR LIFESCIENCE LTD. JONATHAN S KAHAN
K063030 12/04/2006 COMFORT SCOOTER MODEL LY-EW406 COMFORT ORTHOPEDIC CO. LTD. Ke-Min Jen
K053561 02/23/2006 BIO-MINI REVO SUTURE ANCHOR CONMED LINVATEC ELIZABETH PAUL
K063457 12/05/2006 TRUEHD (1080P) DIGITAL CAMERA SYSTEM CONMED LINVATEC ELIZABETH PAUL
K052448 02/23/2006 POCKET BREATHALYZER. CONNECTABLES CONNECTABLES, LLC PHILLIP H CORSE
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
K060174 02/17/2006 SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM COOK, INC. EVANGELINE D LOH
K063254 12/07/2006 THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM CORDIS NEUROVASCULAR, INC. Amarilys Machado
K052696 02/03/2006 COVACLEARAG COLLAGEN WITH SILVER ANTIMICROBIAL GEL SHEET DRESSING COVALON TECHNOLOGIES LTD. JACQUES LEMMETTI
K051288 02/03/2006 VIELLE LUBRICANT CST MEDICAL LIMITED Christian Smith
K053608 02/13/2006 CYNOSURE PHOTOGENICA V-STAR LASER CYNOSURE, INC. GEORGE CHO
K053421 02/01/2006 YAG MIR FAMILY LASER CYNOSURE, INC. GEORGE CHO
K053108 02/16/2006 DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108 DADE BEHRING, INC. YUK-TING LEWIS
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
K053576 02/07/2006 DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR DADE BEHRING, INC. GEORGE M PLUMMER
K060090 02/27/2006 DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE DADE BEHRING, INC. LORRAINE H PIESTRAK
K053061 02/06/2006 EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY DADE BEHRING, INC. YUK-TING LEWIS
K060088 02/03/2006 MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - AMPICILLIN DADE BEHRING, INC. ROBERT C EUSEBIO
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
K053504 02/24/2006 MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.12-16 UG/ML) 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
K052731 02/01/2006 KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLES DAXIN LI YINGCHAO XIAO
K052823 02/21/2006 IMPLANTIUM ABUTMENTS DENTIUM, INC. KLAAS BESSELING
K060293 02/17/2006 TEMPORARY CROWN AND BRIDGE MATERIAL DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
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
K052546 02/03/2006 AEGIS ANTERIOR LUMBAR PLATE SYSTEM DEPUY SPINE, INC. SHARON STAROWICZ
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
K053533 02/03/2006 IMMULITE/IMMULITE 1000 TURBO INTACT PTH DIAGNOSTIC PRODUCTS CORPORATION 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
K052499 02/08/2006 DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS DIASORIN S.P.A. MARI A MEYER
K053566 02/15/2006 MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A DIAZYME LABORATORIES HUAN TRAN
K063482 12/14/2006 CROSSPLAN / ACCUSOFT-XL V.4.04 DIREX SYSTEMS CORP. LARISA GERSHTEIN
K052705 02/21/2006 DART-12 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
K053204 02/03/2006 INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A DRAEGER MEDICAL AG & CO. KGAA MONICA FERRANTE
K053484 02/22/2006 INFINITY GAMMA / GAMMAXL, INFINITY VISTA Draeger Medical Systems, Inc. KAREN A LORIO
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
K060079 02/08/2006 KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM EASTMAN KODAK COMPANY RAVI NABAR
K060055 02/07/2006 KODAK PACS EASTMAN KODAK COMPANY CAROLYN L WAGNER
K053609 02/28/2006 PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR EDWARDS LIFESCIENCES, LLC. DIANE PETERSON
K060084 02/07/2006 MODIFICATION TO: LYSUS INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K062508 12/05/2006 NEUROWAVE MICRO-INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K052241 02/24/2006 DISC-FX SYSTEM ELLMAN INTERNATIONAL, INC. JOAN CARTER
K063414 12/12/2006 MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38 ENCORE MEDICAL, L.P. TEFFANY HUTTO
K060279 02/28/2006 CRYOCARE CS SURGICAL SYSTEM ENDOCARE, INC. ALDEN KAY
K063182 12/21/2006 ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX ENPATH MEDICAL, INC. JAMES JENKINS
K053429 02/08/2006 ADVANCED UROLOGICAL CATHETER ENTRACARE, LLC AL BOEDEKER
K060046 02/27/2006 DERMASTREAM ENZYSURGE, LTD. GEORGE J HATTUB
K053318 02/17/2006 RX EPIDURAL NEEDLE EPIMED INTERNATIONAL, INC. CHRISTOPHER LAKE
K060183 02/16/2006 ERBE APC INTEGRATED FILTER PROBES; ERBE APC INTEGRATED FILTER PROBE ADAPTER ERBE USA, INC. JOHN TARTAL
K060170 02/16/2006 ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS ERBE USA, INC. JULIE STEPHENS
K061533 12/11/2006 PROCEED VENTRAL PATCH ETHICON, INC. BRYAN A LISA
K062045 12/04/2006 EDIA ANTI-CCP EURO-DIAGNOSTICA AB ANNIKA ANDERSSON
K051489 02/16/2006 EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM EUROIMMUN US LLC KATHRYN KOHL
K052659 02/17/2006 SPIDERX EMBOLIC PROTECTION DEVICE EV3 INC GLEN D SMYTHE
K053493 02/22/2006 BERRY FRUITY TEETHER EVENFLO COMPANY, INC. RUBEN D COLMENARES
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
K060107 02/06/2006 MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS EXACTECH, INC. MARITZA ELIAS
K050806 02/08/2006 OPTECURE EXACTECH, INC. REBECCA S ROBERTS
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