FDA 510(k) Decisions During February, 2005  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K043189 02/09/2005 SONALIS, MODEL 2000 3G ULTRASOUND, INC. PAUL SCHNEIDER
K053256 12/16/2005 3M TEGADERM SILVER (AG) MESH 3M COMPANY AMY E SHORT
K050159 02/22/2005 MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000 3M COMPANY GINGER CANTOR
K051041 12/23/2005 INSULIN PUMP ABBOTT DIABETES CARE INC. MARY ROSE
K053330 12/16/2005 ARCHITECT B12 CALIBRATORS ABBOTT LABORATORIES MARGARET PROCHNIAK
K050103 02/16/2005 XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM ABBOTT LABORATORIES ANN E LEONARD
K052744 12/16/2005 C2000 AUTOMATED MANIFOLD KIT ACIST MEDICAL SYSTEMS, INC. A; SAALABI
K042272 02/28/2005 ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) ACON LABORATORIES, INC. EDWARD TUNG, PH.D.
K043507 02/25/2005 ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K050015 02/03/2005 MODIFIED ACUMEN SHEATH, MODEL TTWO767 ACUMEN MEDICAL, INC. Marybeth Gamber
K053250 12/15/2005 ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT ADVANCED NEUROMODULATION SYSTEMS DANIELLE ALARCON
K052087 12/14/2005 BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178 AG INDUSTRIES IAN GORDON
K053440 12/30/2005 AMPLATZER SIZING BALLOON II AGA MEDICAL CORP. AMANDA JOHNSON
K053458 12/22/2005 WEB1000 AGFA CORP. PHIL CUSCUNA
K052023 12/08/2005 CADIMAS VERSION 1.0 ALAN PENN & ASSOCIATES., INC. ROGER H SCHNEIDER
K051101 12/06/2005 VERIFY FLASH INTEGRATOR ALBERT BROWNE LTD. CYNTHIA J M. NOLTE
K043126 02/03/2005 ASSIST HEADER CLEANER ALCAVIS INTERNATIONAL, INC. GARY J MISHKIN
K052340 12/09/2005 DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM ALFA TECH MEDICAL SYSTEMS, LTD. SUSAN D GOLDSTEIN-FALK
K051275 12/09/2005 LAGUNA MONOAXIAL PEDICLE SCREW SYSTEM ALLEZ SPINE, LLC HARTMUT LOCH
K052733 12/22/2005 ALMITECH INC. DENTAL IMPLANT SYSTEM ALMITECH INC. ALEX BREYTMAN
K050078 02/18/2005 ROC LUMBAR PLATING SYSTEM ALPHATEC/NEXMED ELLEN A YARNALL
K053142 12/20/2005 AMBU MARK IV BABY RESUSCITATOR AMBU A/S SANJAY PARIKH
K053140 12/23/2005 AMBU MARK IV RESUSCITATOR AMBU A/S SANJAY PARIKH
K053175 12/08/2005 AMEDITECH DRUGSMARTCUP AMEDITECH, INC. JOHN WU
K051903 12/27/2005 FETALGARD LITE-NIBP, MODEL FGL-NIBP ANALOGIC CORPORATION JANET KWIATKOWSKI
K050025 02/03/2005 NANOSS BONE VOID FILLER ANGSTROM MEDICA, INC. FLOYD G LARSON
K050104 02/16/2005 APEX MEDICAL MININEB & MINIPLUS APEX MEDICAL CORP. ANAN CHANG
K043123 02/10/2005 APEX MODULAR HA HIP STEM APEX SURGICAL, LLC. EDWARD J CHEAL
K053119 12/07/2005 DISTAL RADIO-ULNAR JOINT IMPLANT APTIS MEDICAL, LLC. BRYAN BABB
K050077 02/15/2005 SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS ARKRAY, INC. HELEN LANDICHO
K043284 02/25/2005 ENDOASSIST ARMSTRONG HEALTHCARE LIMITED PATRICK A FINLAY
K052901 12/12/2005 ARTHREX TENSIONLOK ARTHREX, INC. ANN WATERHOUSE
K043145 02/18/2005 BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B ARTHREX, INC. SALLY FOUST
K052776 12/13/2005 TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD ARTHREX, INC. SALLY FOUST
K043248 02/16/2005 TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS ARTHREX, INC. SALLY FOUST
K053297 12/06/2005 ARTHROCARE 8000S COBLATOR SURGERY SYSTEM ARTHROCARE CORP. VALERIE DEFIESTA-NG
K053447 12/27/2005 ARTHROCARE PERC-D SPINEWAND ARTHROCARE CORP. VALERIE DEFIESTA-NG
K050313 02/24/2005 BIS SRS (SEMI-RESUABLE SENSOR) ASPECT MEDICAL SYSTEMS, INC. CHRISTINE VOZELLA
K050063 02/09/2005 PROSTATE-63 CANCER DIAGNOSTIC TEST ASYMMETRX MARIA MCKEON
K052845 12/16/2005 B-CARE POWDERED LATEX EXAMINATION GLOVES B-CARE INDUSTRIES CO., LTD. Kevin Walls
K050147 02/03/2005 TRELLIS-8 PERIPHERAL INFUSION SYSTEM BACCHUS VASCULAR, INC. MAUREEN BENSING
K052772 12/20/2005 BARRIERPLUS GOLD ORTHO POWDER-FREE SYNTHETIC POLYISOPRENE ORTHOPEDIC SURGICAL GLOVES BARRIERMED GLOVE CO. VICTOR J RAGUCCI
K042808 02/08/2005 ADVIA IMS CARBAMAZEPINE METHOD BAYER HEALTHCARE, LLC ANDRES HOLLE
K042807 02/08/2005 ADVIA IMS VALPROIC ACID METHOD BAYER HEALTHCARE, LLC ANDRES HOLLE
K051693 12/07/2005 MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM BAYER HEALTHCARE, LLC ANDREA HOLLE
K053020 12/30/2005 TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM BAYER HEALTHCARE, LLC ANDRES HOLLE
K052503 12/14/2005 TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM BAYER HEALTHCARE, LLC ANDRES HOLLE
K052307 12/16/2005 BEAMER PAINLOW INFRARED LIGHT TREATMENT SYSTEM BEAMLINE CORPORATION DAVID R BALZER
K042110 02/25/2005 BEAMCATH BEAMPOINT AB CONSTANCE BUNDY
K050202 02/09/2005 CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS BECKMAN COULTER, INC. BRENT TABER
K050057 02/10/2005 COULTER LH 750 HEMATOLOGY ANALYZER BECKMAN COULTER, INC. STAN SUGRUE
K053090 12/16/2005 DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR BECKMAN COULTER, INC. ERI HIRUMI
K050062 02/10/2005 GEMIFLOXACIN, 5UG BBL SENSI-DISC BECTON DICKINSON & CO. BRADFORD SPRING
K050191 02/22/2005 MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE BECTON DICKINSON & CO. CARTER NAVARRO
K050089 02/28/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN-SULBACTAM (GP) 2-32 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K053241 12/22/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN GP 1-32 G/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K043423 02/01/2005 MODEL SC-3008 SEQUENTIAL CIRCULATOR BIO COMPRESSION SYSTEMS, INC. RON MOTHERWELL
K053011 12/14/2005 PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20 BIO PROTECH, INC. E.J. Smith
K043584 02/08/2005 LIQUICHEK BNP CONTROL BIO-RAD LABORATORIES, INC. SUZANNE S PARSONS
K042553 02/17/2005 BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER BIOCARDIA, INC. DANIEL C ROSENMAN
K053152 12/02/2005 BIOHORIZONS SINGLE-STAGE IMPLANT BIOHORIZONS IMPLANT SYSTEMS, INC. WINSTON GREER
K051030 12/23/2005 COAG-A-MATE MTX III BIOMERIEUX, INC. JOHN CUSACK
K050002 02/17/2005 VITEK 2 COMPACT BIOMERIEUX, INC. Nancy Weaver
K053097 12/14/2005 VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN BIOMERIEUX, INC. Nancy Weaver
K050075 02/28/2005 VITEK 2 GRAM POSITIVE DAPTOMYCIN BIOMERIEUX, INC. JOLYN TENLLADO
K050076 02/18/2005 VITEK 2 GRAM POSITIVE ERTAPENEM BIOMERIEUX, INC. JOLYN TENLLADO
K053186 12/01/2005 VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC. Nancy Weaver
K043371 02/03/2005 BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER BIOMERIX CORPORATION CHRISTINA L KICHULA
K052888 12/06/2005 POROUS TITANIUM ACETABULAR AUGMENTS BIOMET MANUFACTURING CORP. ALLISON KOSKEY
K043100 02/17/2005 BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS BIOMET, INC. GARY BAKER
K043505 02/09/2005 DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM BIOMET, INC. GARY BAKER
K052990 12/16/2005 STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM BIOMET, INC. LESTER F PADILLA
K042757 02/11/2005 VANGUARD SSK KNEE SYSTEM BIOMET, INC. GARY BAKER
K043598 12/16/2005 FC 1400 FETAL MONITOR BIONET CO., LTD. SUN-YOUNG JEONG
K043597 12/16/2005 FC 700 FETAL MONITOR BIONET CO., LTD. SUN-YOUNG JEONG
K052625 12/05/2005 BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 BIONICARE MEDICAL TECHNOLOGIES, INC. KENT HOFFMAN
K050100 02/25/2005 RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER BIONOSTICS, INC. KATHY STORRO
K043242 02/28/2005 TRIAGE TOX DRUG SCREEN BIOSITE INCORPORATED JEFFREY R DAHLEN
K052646 12/16/2005 BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20 BIOSPACE CORPORATION LIMITED DANIEL KAMM
K033862 02/14/2005 BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK BIOTEQUE CORP. WILLIAM LEE
K052289 12/13/2005 DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE BIOWAVE CORPORATION MARY MCNAMARA-CULLINANE
K051513 12/07/2005 BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER BIPORE, INC. KEITH PALUCH
K043168 02/01/2005 BISCOVER LV BISCO, INC. BENJAMIN LICHTENWALNER
K042804 02/01/2005 TESCERA OPAQUER POWDER/SCULPTING RESIN BISCO, INC. BENJAMIN LICHTENWALNER
K043338 02/18/2005 BLAKSTONE LAMINOPLASTY FIXATION SYSTEM BLACKSTONE MEDICAL, INC. DEAN CIPORKIN
K052799 12/16/2005 MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM BONUTTI RESEARCH, INC. PATRICK BALSMANN
K050120 02/08/2005 EASY CORE BIOPSY SYSTEM II BOSTON SCIENTIFIC CORP. MICHELLE M BERRY
K053118 12/16/2005 STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX BOSTON SCIENTIFIC CORP. MAUREEN MARY MONTBRIAND
K053116 12/16/2005 STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX BOSTON SCIENTIFIC CORP. MAUREEN MARY MONTBRIAND
K042513 02/10/2005 VECTORVISION OSTEOTOMY BRAINLAB AG RAINER BIRKENBACH
K052779 12/20/2005 BRECOMP BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT MARKUS DENK
K052781 12/09/2005 BREFORMANCE BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT MARKUS DENK
K052780 12/21/2005 DENTAPLAST HOT, MODEL 16-XXX BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT MARKUS DENK
K052862 12/30/2005 FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE) BRYAN KEROPIAN DDS BRYAN KEROPIAN
K043246 02/02/2005 BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS C.R. BARD, INC. JOHN C KNORPP
K043251 02/09/2005 CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B CANDELA CORP. LORRAINE CALZETTA
K053031 12/07/2005 EXTENDSURE HBFASC CONTROL CANTEBURY SCIENTIFIC LTD. MAURICE OWEN
K053089 12/20/2005 ASCENT PIT & FISSURE SEALANT CAO GROUP, INC. ROBERT K LARSEN
K053395 12/23/2005 BP PRO BLOOD PRESSURE MONITOR CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K052790 12/23/2005 SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD CARDINAL HEALTH, ALARIS PRODUCTS STACY L LEWIS
K050230 02/16/2005 TURBO TEMP TRIO CARDINAL HEALTH, ALARIS PRODUCTS STACY L LEWIS
K053303 12/30/2005 CARDIOCOM COMMANDER III CARDIOCOM LLC DANIEL KAMM
K053304 12/30/2005 COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM CARDIOCOM LLC DANIEL KAMM
K043575 02/24/2005 DERMILLUME, MODEL PRO1000 CARE ELECTRONICS, INC. THOMAS MOODY
K043222 02/14/2005 VISCUCAM C DIGITAL CAMERA CARL ZEISS MEDITEC AG R. MICHAEL CROMPTON
K051257 12/22/2005 ADULT CEREBRAL OXIMETER, MODEL 2040 CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K051896 12/16/2005 MODEL 750E SERIES MONITOR CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K052725 12/28/2005 PROTECTOR NEEDLE SHEATH PROP CERTOL INTERNATIONAL, LLC LEWIS WARD
K050758 12/22/2005 CHEMPAQ XBC ANALYZER CHEMPAQ A/S JONATHAN S KAHAN
K050167 02/08/2005 CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE CHISON MEDICAL IMAGING CO., LTD. MO RUOLI
K052963 12/05/2005 MEDIQ VERSION 1.0 CLARIO MEDICAL IMAGING, INC. PATRICIA A MILBANK
K050013 02/09/2005 RETRACTOFOAM COLTENE/WHALEDENT AG HENRY J VOGELSTEIN
K051964 12/01/2005 POWERNEB COMEDICA , INC. KRISTA OAKES
K050161 02/03/2005 SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY CONMED ELECTROSURGERY PAMELA VETTER
K052539 12/09/2005 COOK FORMULA 418 BILIARY STENT SYSTEM COOK, INC. KAREN BRADBURN
K052841 12/08/2005 MIRA-FLEX 18 MICROCATHETER COOK, INC. THALIA BRINE
K052560 12/06/2005 BIOFINITY (COMFILCON A) SOFT CONTACT LENS COOPERVISION, INC. JACK P DOUGLAS
K043605 02/04/2005 INSCOPE 3-STAGE BALLOON DILATOR CORDIS EUROPA, N.V. HARM HOVINGA
K053197 12/15/2005 TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION CORDIS NEUROVASCULAR, INC. Amarilys Machado
K052263 12/16/2005 MULTIPLE (TOOTH DESENSITIZER) COSMEDENT, INC. JAMES L SANDRIK
K053201 12/09/2005 CURAE'LASE CL1000 IR LASER SYSTEM CURAE'LASE INC. M. JOYCE HEINRICH
K051911 12/06/2005 GELITA-SPON CURAMEDICAL, BV WILLIAM GREENROSE
K052135 12/20/2005 CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER CYBERSONICS, INC. WILLIAM A STOLL
K053157 12/09/2005 AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A DADE BEHRING, INC. VICTOR M CARRIO
K053104 12/23/2005 DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR DADE BEHRING, INC. ANDREA M TASKER
K053109 12/23/2005 DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE DADE BEHRING, INC. ANDREA M TASKER
K043545 02/17/2005 MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML) DADE BEHRING, INC. CYNTHIA VAN DUKER
K042735 02/15/2005 N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) DADE BEHRING, INC. KATHLEEN A DRAY-LYONS
K043476 02/15/2005 STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT DADE BEHRING, INC. GEORGE M PLUMMER
K043589 02/14/2005 MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K052303 12/16/2005 READMYHEART, MODEL RMH2.0 DAILYCARE BIOMEDICAL INC DANIEL J. H. CHANG
K042884 02/15/2005 DAKOCYTOMATION ER/PR PHARMDX KIT DAKOCYTOMATION CALIFORNIA, INC. TIFFANY D ALMEROTH
K052688 12/12/2005 ELLIPSE FLEX PPT, MODEL 9ESF7255 DANISH DERMATOLOGIC DEVELOPMENT A/S OLE KOFOD
K043255 02/24/2005 ELLIPSE LIGHT SPT DANISH DERMATOLOGIC DEVELOPMENT A/S OLE KOFOD
K043572 02/22/2005 COMPATIBILITY ECG TRUNK CABLES DATEX-OHMEDA JOEL C KENT
K043551 02/18/2005 DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND ACCESSORIES DATEX-OHMEDA JOEL KENT
K050055 02/04/2005 GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM DATEX-OHMEDA, INC. DAN KOSEDNAR
K050386 02/23/2005 PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM DENTSPLY INTERNATIONAL HELEN LEWIS
K053167 12/08/2005 BIOPURE MTAD ROOT CANAL CLEANSER DENTSPLY INTL., INC. HELEN LEWIS
K052840 12/16/2005 IGI-SYSTEM DENX ADVANCED DENTAL SYSTEMS RACHEL WEISSBROD
K042992 02/11/2005 CORAIL AMT HIP PROSTHESIS DEPUY ORTHOPAEDICS, INC. NANCY S FRIDDLE
K043308 02/16/2005 MODIFICATION TO: HEALOS BONE GRAFT MATERIAL DEPUY SPINE, INC. SHARON STAROWICZ
K041390 02/09/2005 DIAMOND MEDISTIM DIAMOND SYSTEMS USA, INC. DONNA LOPE
K051714 12/07/2005 TOTAL BILE ACIDS ASSAY, MODEL DZ042A DIAZYME LABORATORIES HUAN TRAN
K043323 02/01/2005 D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR DIDECO S.R.L. BARRY SALL
K050152 02/07/2005 PALM PRO PREMIUM, MODEL 6PF1 & PALM PRO, MODEL 6PF2, LATEX EXAM GLOVE DIPPED PRODUCTS (THAILAND) LTD IAN P GORDON
K051487 12/22/2005 DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE DOCTOR'S RESEARCH GROUP, INC. MAHMUD AHMED
K043461 02/28/2005 CUSTODIOL DR. FRANZ KOHLER CHEMIE GMBH T. WHIT ATHEY
K042904 02/18/2005 INFINITY KAPPA XLT Draeger Medical Systems, Inc. PENELOPE H GRECO
K043439 02/18/2005 INFINITY MODULAR MONITORS WITH VF5 MODIFICATIONS (DELTA/KAPPA/DELTA XL/VISTA XL/GAMMA X XL AND SC 7000/8000/9000XL Draeger Medical Systems, Inc. PENELOPE H GRECO
K051733 12/07/2005 ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL DRG INTL., INC. Gary Lehnus
K052445 12/05/2005 DUOPROSS NEEDLE DUOPROSS MEDITECH CORPORATION FRANK FERGUSON
K042500 02/22/2005 DUOPROSS SYRINGES DUOPROSS MEDITECH CORPORATION FRANK FREGUSON
K052743 12/22/2005 DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 DYNAREX CORP. JAMES HURLMAN
K052343 12/07/2005 E-SAN BLUETOOTH CRADLE E-SAN LIMITED KRISTIN M ZIELINSKI
K053008 12/27/2005 E-Z-EM ENDOSCOPIC CO2 REGULATOR E-Z-EM, INC. ROBERT WILLIAMS
K050921 12/12/2005 EASYSTIM NMS-28 EASYMED INSTRUMENT CO., LTD. JEFFERY WU
K050118 02/16/2005 EBI TROCHANTERIC NAIL SYSTEM EBI, L.P. FREDERIC TESTA
K053404 12/21/2005 LIFESTENT FLEXSTART BILIARY STENT SYSTEM EDWARDS LIFESCIENCES, LLC. KEVIN DRISKO
K053016 12/30/2005 WIRELESS PHYSIOLOGIC MONITORING SYSTEM EDWARDS LIFESCIENCES, LLC. DIANE PETERSON
K043233 02/01/2005 GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL EFRATGO, LTD. HI TECH BIO-SURGICAL GEORGE J HATTUB
K042755 02/10/2005 MONOCHROME LCD MONITOR, RADIFORCE G51 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K053432 12/30/2005 EKOS MICRO-INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K053248 12/01/2005 SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL ELECTROMED, INC. CHET SIEVERT
K053281 12/07/2005 EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE) EMAGEON INC. INGER L HANSON
K043446 02/04/2005 EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER EMMEBI SRL MARJORIE BUSH
K052320 12/30/2005 ENCORE CLP OFFSET TOTAL HIP SYSTEM ENCORE MEDICAL CORPORATION SAM SON
K050347 02/25/2005 MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM ENDOCARE, INC. EBEN GORDON
K053100 12/19/2005 ESTECH COBRA BIPOLAR SYSTEM ENDOSCOPIC TECHNOLOGIES, INC. CRAIG COOMBS
K043463 02/11/2005 ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS ENVITEC-WISMAR GMBH STEPHEN GORSKI
K043257 02/03/2005 REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM EP TECHNOLOGIES, INC. TODD G BRILL
K050326 02/28/2005 7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350 ESAOTE, S.P.A. CARRI GRAHAM
K052081 12/16/2005 REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA ESTECH, INC. CRAIG COOMBS
K052233 12/13/2005 TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM ETVIEW LTD. YORAM LEVY
K052133 12/12/2005 IMMUNOSCAN RA ANTI-CCP TEST SYSTEM EURODIAGNOSTICA WILLIAM L BOTELER JR.
K052787 12/27/2005 ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMATCH 12/14 L-SERIES CEMENTED FEMORAL STEMS (SIZE 1-5) EXACTECH, INC. MARITZA ELIAS
K051858 12/01/2005 ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM EXACTECH, INC. Lisa Simpson
K053120 12/09/2005 STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES EXCELSIOR MEDICAL CORP. RUBEN MARTINEZ
K042308 02/17/2005 SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018; SHEATH-IN-SHEATH CATHETER, 6 FR., MODEL S00019 FACILE MEDICAL, INC. ALBERT REGO
K051294 12/21/2005 FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 FEMSPEC L.L.C. CARL YOUNGMANN
K031660 02/22/2005 FERRIS POLYMEM STERILE BREAST PAD FERRIS MFG. CORP. THEODORE R THORSEN
K052115 12/29/2005 FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY FIRST CHECK DIAGNOSTICS LLC KEVIN J GADAWSKI
K050067 02/01/2005 FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS FIRST QUALITY HYGIENIC, INC. ROBERT J STAAB, PH.D.
K041224 02/03/2005 FOOTHILLS SURGICAL DRAPES FOOTHILLS INDUSTRIES, INC. JOY SHUFORD
K043553 02/18/2005 SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300 FOX HOLLOW TECHNOLOGIES MELISSA MURPHY
K052531 12/14/2005 FU HONG INDUSTRIES LIMITED SOOTHER TEETHER FU HONG INDUSTRIES LTD. Kevin Walls
K043407 02/11/2005 INF 4160, MODEL D-FJ27F FUJI DYNAMICS LIMITED ANTHONY AH YIN SHUM
K052889 12/20/2005 VITROS CA 19-9 FUJIREBIO DIAGNOSTICS, INC. DIANA L WOLANIUK
K050363 02/17/2005 FUKUDA DENSHI MODEL UF-850XTD FUKUDA DENSHI USA, INC. LARRY D WALKER
K043525 02/09/2005 CATHETER INTRODUCER GALT MEDICAL CORP. DAVID CATLIN
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