FDA 510(k) Applications Received During January, 2005

FDA 510(k) Number Submission Date Device Name Applicant Contact
K053256 11/22/2005 3M TEGADERM SILVER (AG) MESH 3M COMPANY AMY E SHORT
K050159 01/25/2005 MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000 3M COMPANY GINGER CANTOR
K050103 01/18/2005 XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM ABBOTT LABORATORIES ANN E LEONARD
K050050 01/10/2005 ON CALL MULTI-DRUG HOME TEST ACON LABORATORIES, INC. EDWARD TUNG
K053032 11/16/2005 ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000 ACRO BIOTECH LLC. GREGORY LEE
K053035 11/16/2005 ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000 ACRO BIOTECH LLC. GREGORY LEE
K053033 11/16/2005 ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000 ACRO BIOTECH LLC. GREGORY LEE
K053037 11/16/2005 ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100 ACRO BIOTECH LLC. GREGORY LEE
K053034 11/16/2005 ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000 ACRO BIOTECH LLC. GREGORY LEE
K050015 01/04/2005 MODIFIED ACUMEN SHEATH, MODEL TTWO767 ACUMEN MEDICAL, INC. MARYBETH GAMBER
K053094 11/04/2005 ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056 ADVANCED BIO-SURFACES, INC. PHILLIP B JARVI
K053250 11/30/2005 ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT ADVANCED NEUROMODULATION SYSTEMS DANIELLE ALARCON
K053158 11/14/2005 OPTILENE MESH LP AESCULAP, INC. MATTHEW M HULL
K053187 11/15/2005 AMPLATZER NOODLEWIRE GUIDEWIRE AGA MEDICAL CORP. PATRICIA A LAFORET
K053117 11/07/2005 EZ-OX PLUS AIR LIQUIDE HEALTHCARE AMERICA ANGIE BEYER
K050060 01/24/2005 LAGUNA PEDICLE SCREW SYSTEM ALLEZ SPINE, LLC HARTMUT LOCH
K053316 11/29/2005 REPROCESSED COMPRESSION SLEEVES ALLIANCE MEDICAL CORP. MOIRA BARTON
K053257 11/22/2005 PARA-PRO FC50 ALPHA-TEC SYSTEMS, INC. RICHARD WILLIAMS
K050078 01/13/2005 ROC LUMBAR PLATING SYSTEM ALPHATEC/NEXMED ELLEN A YARNALL
K053070 11/01/2005 CONTOUR II SPINAL SYSTEM ALTIVA CORP. JOHN KAPTIAN
K053142 11/09/2005 AMBU MARK IV BABY RESUSCITATOR AMBU A/S SANJAY PARIKH
K053140 11/10/2005 AMBU MARK IV RESUSCITATOR AMBU A/S SANJAY PARIKH
K053175 11/16/2005 AMEDITECH DRUGSMARTCUP AMEDITECH, INC. JOHN WU
K050186 01/28/2005 AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III AMEDITECH, INC. JOHN WU
K050025 01/07/2005 NANOSS BONE VOID FILLER ANGSTROM MEDICA, INC. FLOYD G LARSON
K053138 11/17/2005 MYSET PREGNANCY TEST ANI BIOTECH OY FRAN WHITE
K050104 01/18/2005 APEX MEDICAL MININEB & MINIPLUS APEX MEDICAL CORP. ANAN CHANG
K050236 01/31/2005 FISHVIEW APPLIED SPECTRAL IMAGING, LTD. DAN LAOR
K053119 11/07/2005 DISTAL RADIO-ULNAR JOINT IMPLANT APTIS MEDICAL, LLC. BRYAN BABB
K050077 01/12/2005 SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS ARKRAY, INC. HELEN LANDICHO
K053297 11/25/2005 ARTHROCARE 8000S COBLATOR SURGERY SYSTEM ARTHROCARE CORP. VALERIE DEFIESTA-NG
K053180 11/14/2005 PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K050201 01/28/2005 AEU-14CF EXPENDITION ASEPTICO, INC. GRANT RAMALEY
K050063 01/12/2005 PROSTATE-63 CANCER DIAGNOSTIC TEST ASYMMETRX MARIA MCKEON
K050052 01/10/2005 ATLANTIS ABUTMENT FOR STRAUMANN INTERFACE ATLANTIS COMPONENTS, INC. BETSY A BROWN
K043582 01/04/2005 OCEAN CHEST DRAIN ATRIUM MEDICAL CORP. JOSEPH P DE PAOLO
K050194 01/27/2005 AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES AXON SYSTEMS, INC. HOWARD BAILIN
K050147 01/24/2005 TRELLIS-8 PERIPHERAL INFUSION SYSTEM BACCHUS VASCULAR, INC. MAUREEN BENSING
K050049 01/10/2005 DYNAFLO BYPASS GRAFT BARD PERIPHERAL VASCULAR, INC. GLENN NORTON
K053124 11/15/2005 BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES BAUSCH & LOMB INCORPORATED LISA GRANEY
K050157 01/26/2005 MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS BAUSCH & LOMB, INC. LISA GRANEY
K053082 11/02/2005 BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6 BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K050202 01/28/2005 CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS BECKMAN COULTER, INC. BRENT TABER
K050057 01/11/2005 COULTER LH 750 HEMATOLOGY ANALYZER BECKMAN COULTER, INC. STAN SUGRUE
K053090 11/02/2005 DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR BECKMAN COULTER, INC. ERI HIRUMI
K050119 01/18/2005 PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT BECKMAN COULTER, INC. KIM WALKER
K050062 01/11/2005 GEMIFLOXACIN, 5UG BBL SENSI-DISC BECTON DICKINSON & CO. BRADFORD SPRING
K050191 01/27/2005 MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE BECTON DICKINSON & CO. CARTER NAVARRO
K050207 01/28/2005 BD POSIFLOW POSITIVE DISPLACEMENT VALVE BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. LESLIE WOOD
K050089 01/14/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN-SULBACTAM (GP) 2-32 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K053241 11/18/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN GP 1-32 G/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K053213 11/16/2005 BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM BERKELEY ADVANCED BIOMATERIALS, INC. FRANCOIS GENIN
K053126 11/10/2005 BINAXNOW INFLUENZA A & B TEST BINAX, INC. ANGELA DRYSDALE
K050170 01/26/2005 FORTOSS VITAL BONE GRAFT SUBSTITUTE BIOCOMPOSITES LTD. SIMON FITZER
K050135 01/21/2005 K-C HEMOSTATIC BIOPSY SYSTEM BIOENGINEERING CONSULTANTS LTD. WILLIAM R KRAUSE
K053099 11/03/2005 BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS BIOHORIZONS IMPLANT SYSTEMS, INC. WINSTON GREER
K053152 11/10/2005 BIOHORIZONS SINGLE-STAGE IMPLANT BIOHORIZONS IMPLANT SYSTEMS, INC. WINSTON GREER
K050182 01/27/2005 Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM BIOMEDIX, INC. JUDY S CHEN
K050002 01/03/2005 VITEK 2 COMPACT BIOMERIEUX, INC. NANCY WEAVER
K053097 11/03/2005 VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN BIOMERIEUX, INC. NANCY WEAVER
K050075 01/12/2005 VITEK 2 GRAM POSITIVE DAPTOMYCIN BIOMERIEUX, INC. JOLYN TENLLADO
K050076 01/12/2005 VITEK 2 GRAM POSITIVE ERTAPENEM BIOMERIEUX, INC. JOLYN TENLLADO
K053186 11/14/2005 VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC. NANCY WEAVER
K050028 01/06/2005 MAESTRO CARPAL HEMIARTHROPLASTY BIOMET MANUFACTURING, INC. PATRICIA SANDBORN BERES
K053299 11/25/2005 REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT BIOMET MANUFACTURING, INC. PATRICIA S BERES
K050210 01/28/2005 DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES BIOMET, INC. LONNIE WITHAM
K050124 01/19/2005 POROUS COATED ACETABULAR COMPONENTS BIOMET, INC. PATRICIA BERES
K050100 01/18/2005 RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER BIONOSTICS, INC. KATHY STORRO
K053312 11/28/2005 EASYMATE BLOOD GLUCOSE MONITORING SYSTEM BIOPTIK TECHNOLOGY, INC. ERIC LUO
K050217 01/31/2005 FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING) BIOSENSE WEBSTER, INC. WAYNE R HOHMAN
K053194 11/17/2005 NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE BIOSENSE WEBSTER, INC. SIGI CARON
K050037 01/07/2005 TRIAGE TOX DRUG SCREEN CONTROLS BIOSITE INCORPORATED JEFFREY R DAHLEN
K053087 11/03/2005 VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM BIOTEX, INC. ASHOK GOWDA
K053268 11/23/2005 PVS 2000 SYNCHRO2 GUIDEWIRE BOSTON SCIENTIFIC - PRECISION VASCULAR RICK GAYKOWSKI
K050120 01/28/2005 EASY CORE BIOPSY SYSTEM II BOSTON SCIENTIFIC CORP. MICHELLE M BERRY
K053128 11/08/2005 SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE BOSTON SCIENTIFIC CORP. NICHOLAS CONDAKES
K053118 11/07/2005 STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX BOSTON SCIENTIFIC CORP. MAUREEN MARY MONTBRIAND
K053116 11/07/2005 STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX BOSTON SCIENTIFIC CORP. MAUREEN MARY MONTBRIAND
K053164 11/14/2005 IPLAN FLOW BRAINLAB AG RAINER BIRKENBACH
K053159 11/14/2005 VECTORVISION SPINE BRAINLAB AG RAINER BIRKENBACH
K053127 11/10/2005 IPLAN BRAINLAB, AG RAINER BIRKENBACH
K050192 01/27/2005 BRC SOFTWARE PRODUCT BRC OPERATIONS PTY LIMITED CARRI GRAHAM
K050086 01/13/2005 BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING BRENNEN MEDICAL, INC. KENNETH B HERLAND
K053065 11/01/2005 FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS) BRYAN KEROPIAN DDS BRYAN KEROPIAN
K050006 01/04/2005 BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO C.R. BARD, INC. DEBORAH L HERRINGTON
K050185 01/27/2005 POWERHOHN AND POWERLINE CATHETERS C.R. BARD, INC. CHRLES MORREALE
K050153 01/24/2005 SPIRIT, MODEL HAS CAIRE, INC. DAN CHLAN
K053221 11/23/2005 CDMX-H CAMSIGHT CO., INC. JAY CHOI
K053089 11/02/2005 ASCENT PIT & FISSURE SEALANT CAO GROUP, INC. ROBERT K LARSEN
K053062 11/03/2005 CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2 CARDIARC LTD. JONATHAN KAHN
K050115 01/18/2005 BLOOD HAND PUMP ADMINISTRATION SET CARDINAL HEALTH, ALARIS PRODUCTS STACY L LEWIS
K053303 11/28/2005 CARDIOCOM COMMANDER III CARDIOCOM LLC DANIEL KAMM
K053304 11/28/2005 COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM CARDIOCOM LLC DANIEL KAMM
K053263 11/22/2005 CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003 CARDIONET, INC JACK GAIKWAD
K053301 11/28/2005 CEDARA I-RESPONSE CEDARA PET/CT CEDARA SOFTWARE CORP. CAROL NAKAGAWA
K050129 01/24/2005 CELLERATION MIST THERAPY SYSTEM 5.1 CELLERATION, INC. DAVID BREMSETH
K053223 11/18/2005 TRITON/TRU-TRAC/TX/TRITON DTS TRACTION CHATTANOOGA GROUP MICHAEL TREAS
K050167 01/26/2005 CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE CHISON MEDICAL IMAGING CO., LTD. MO RUOLI
K050065 01/14/2005 FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES CIBA VISION CORPORATION PENNY NORTHCUTT, RAC
K050213 01/31/2005 FRESHLOOK ONE-DAY COLOR CONTACT LENS CIBA VISION CORPORATION ANGELA L BUNN
K053156 11/14/2005 MINI-WRIGHT DIGITAL, MODEL 3120001 CLEMENT CLARKE INTL., LTD. PHILIP HALLYBONE
K050111 01/18/2005 SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG COBE CARDIOVASCULAR, INC. EDWARD E NEWTON
K053107 11/04/2005 CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD CODMAN & SHURTLEFF, INC. SUSAN KAGAN
K053260 11/22/2005 OSSIX -PLUS COLBAR LIFESCIENCE LTD. JONATHAN S KAHAN
K050013 01/03/2005 RETRACTOFOAM COLTENE/WHALEDENT AG HENRY J VOGELSTEIN
K050046 01/10/2005 REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S COMPEX TECHNOLOGIES, INC. BRIAN J EDWARDS
K052687 11/21/2005 CONFORMIS, INC. TOTAL KNEE REPAIR SYSTEM CONFORMIS, INC. PATRICK HESS
K050161 01/25/2005 SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY CONMED ELECTROSURGERY PAMELA VETTER
K050084 01/13/2005 COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT; COSMAN MEDICAL, INC. MICHAEL ARNOLD
K050177 01/26/2005 COLACTIVE COLLAGEN WOUND DRESSING COVALON TECHNOLOGIES, INC. PAUL L GUILBAUD
K053201 11/23/2005 CURAE'LASE CL1000 IR LASER SYSTEM CURAE'LASE INC. M. JOYCE HEINRICH
K050069 01/12/2005 CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT CUTERA, INC. KATHY MAYNOR
K050047 01/10/2005 CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY CUTERA, INC. KATHY MAYNOR
K053155 11/14/2005 VIMPLANT CYBERMED, INC. SONG NAK CHOI
K050165 01/25/2005 MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100 CYDEN LIMITED MICHAEL NOEL KIERNAN
K050080 01/13/2005 CYNOSUREA ECLILITE AND ECLILITE U CYNOSURE, INC. GEORGE CHO
K053157 11/14/2005 AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A DADE BEHRING, INC. VICTOR M CARRIO
K053104 11/04/2005 DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR DADE BEHRING, INC. ANDREA M TASKER
K053109 11/04/2005 DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE DADE BEHRING, INC. ANDREA M TASKER
K053108 11/04/2005 DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108 DADE BEHRING, INC. YUK-TING LEWIS
K043545 01/04/2005 MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML) DADE BEHRING, INC. CYNTHIA VAN DUKER
K050043 01/10/2005 MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN DADE BEHRING, INC. CYNTHIA VAN DUKER
K053072 11/01/2005 N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN DADE BEHRING, INC. KATHLEEN A DRAY-LYONS
K053073 11/01/2005 N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN DADE BEHRING, INC. KATHLEEN A DRAY-LYONS
K053074 11/01/2005 N ANTISERA TO HUMAN CERULOPLASMIN DADE BEHRING, INC. KATHLEEN A DRAY-LYONS
K053075 11/01/2005 N ANTISERA TO HUMAN TRANSFERRIN DADE BEHRING, INC. KATHLEEN A DRAY-LYONS
K043589 01/03/2005 MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K050055 01/11/2005 GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM DATEX-OHMEDA, INC. DAN KOSEDNAR
K053083 11/02/2005 DATRIX CARDIO WIFI ELECTROCARDIOGRAPH DATRIX LINDA GLUCKMAN
K050098 01/18/2005 DDAT OMT DDAT(UK) LTD PETER LIOYD
K052989 11/07/2005 DP240 240 HOUR DOPPLER PROBE DELTEX MEDICAL LAWRENCE BROOKFIELD
K050208 01/28/2005 FRIADENT ESTHETICAP DENTSPLY INTERNATIONAL HELEN LEWIS
K053167 11/14/2005 BIOPURE MTAD ROOT CANAL CLEANSER DENTSPLY INTL., INC. HELEN LEWIS
K053095 11/10/2005 HONEY ALGINATE DRESSING DERMA SCIENCES CANADA, INC. SHARMINI ATHERAY
K053111 11/04/2005 STA-CEPHASCREEN KIT DIAGNOSTICA STAGO, INC. JIM BARROW
K050152 01/24/2005 PALM PRO PREMIUM, MODEL 6PF1 & PALM PRO, MODEL 6PF2, LATEX EXAM GLOVE DIPPED PRODUCTS (THAILAND) LTD IAN P GORDON
K050091 01/14/2005 TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE) DIREX SYSTEMS CORP. LARISA GERSTEIN
K053204 11/16/2005 INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A DRAEGER MEDICAL AG & CO. KGAA MONICA FERRANTE
K053176 11/16/2005 DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797 DUCKWORTH & KENT, LTD. MARTIN LOCK
K053114 11/07/2005 SILVERFIL DUNIA PERWIRA MANUFACTURING SDN. BHD. NARESH SANCHANA
K053285 11/25/2005 MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM DURTECH SYSTEM CORP. ADA LIN
K053284 11/25/2005 MAGBODY DT-600 DURTECH SYSTEM CORP. ADA LIN
K050118 01/18/2005 EBI TROCHANTERIC NAIL SYSTEM EBI, L.P. FREDERIC TESTA
K053248 11/21/2005 SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL ELECTROMED, INC. CHET SIEVERT
K050035 01/07/2005 ELEKTA NEUROMAG WITH MAXWELL FILTER ELEKTA NEUROMAG OY LOUISE LINDBLAD
K050070 01/12/2005 K-LASER, MODELS 3,4,4D,6D ELTECH, S.R.L. RICHARD ALBRIGHT
K053281 11/25/2005 EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE) EMAGEON INC. INGER L HANSON
K043520 01/13/2005 EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR EMG TECHNOLOGY CO., LTD. LEONARD FRIER
K053267 11/23/2005 ENDIUS ATAVI SYSTEM ENDIUS, INC. CHRISTINE KUNTZ-NASSIF
K053100 11/08/2005 ESTECH COBRA BIPOLAR SYSTEM ENDOSCOPIC TECHNOLOGIES, INC. CRAIG COOMBS
K050188 01/27/2005 EPIGUARD EPISAFE MEDICAL DEVICES, LTD. GEORGE J HATTUB
K053078 11/02/2005 ERGOSELECT 100 K/P, ERGOSELECT 200 K/P ERGOLINE GMBH HAIKO BELL
K053021 11/03/2005 ESTECH CLEARVIEW MV ATRIAL DEPRESSOR ESTECH, INC. CRAIG COOMBS
K050032 01/11/2005 EUROMED SURESKIN III WITH SILVER WOUND DRESSINGS EUROMED, INC. MARY MCNAMARA-CULLINANE
K053195 11/15/2005 SPIDERX EMBOLIC PROTECTION DEVICE EV3 INC. BRENDA JOHNSON
K053058 11/03/2005 XLTEK NEUROPATH, MODEL PK1070 EXCEL TECH. LTD. NICOLE LANDREVILLE
K053120 11/07/2005 STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES EXCELSIOR MEDICAL CORP. RUBEN MARTINEZ
K050067 01/12/2005 FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS FIRST QUALITY HYGIENIC, INC. ROBERT J STAAB, PH.D.
K050134 01/24/2005 ICC INSULIN SAFEPRO SAFETY SYRINGE FORMOSA MEDICAL DEVICES, INC. C. Y. LIN
K053139 11/09/2005 FOTONA QX ND:YAG/KTP LASER SYSTEM FOTONA D.D. STOJAN TROST
K043553 01/19/2005 SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300 FOX HOLLOW TECHNOLOGIES MELISSA MURPHY
K050059 01/18/2005 G-LIGHT GC AMERICA, INC. TERRY JORITZ
K053121 11/07/2005 TRAM MODULE GE HEALTHCARE JOEL KENT
K050093 01/14/2005 MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES RONALD N BLASKI
K050178 01/26/2005 HBA1C ENZYMATIC ASSAY GENERAL ATOMICS HUAN TRAN
K050126 01/19/2005 GE LOGIQ TWIN GENERAL ELECTRIC CO. ALLEN SCHUH
K050007 01/04/2005 PHICAL TEST GENOVA DIAGNOSTICS PATRICK HANAWAY
K050195 01/27/2005 V-BAG WITH GBS COATING GISH BIOMEDICAL, INC. J. HARVEY KNAUSS
K050144 01/24/2005 PRISMATIK CERAMIC GLIDEWELL LABORATORIES KEITH D ALLRED
K050027 01/06/2005 LAPAROCISION SCOPE CONTROLLER SYSTEM GMP/COMPANIES, INC. RALPH JUGO
K050024 01/05/2005 ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS GUANGZHOU WONDFO BIOTECH CO., LTD. HOWARD K MANN
K050071 01/19/2005 MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE H.B.M. USA CO.,INC. GORDON X HU
K050214 01/31/2005 NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) HARTALEGA SDN BHD KUAN EU JIN
K050215 01/31/2005 NITRILE POWDERED EXAMINATION GLOVES (WHITE) HARTALEGA SDN BHD KUAN EU JIN
K050107 01/19/2005 HARVARD 2 SYRINGE PUMP, MODEL 2001-001 HARVARD CLINICAL TECHNOLOGY ERIC J FLACHBART
K050169 01/26/2005 HL 200 ELECTRONIC STETHOSCOPE HEALTH & LIFE CO., LTD. JENNIFER REICH
K050053 01/26/2005 HEMORAM/AGGRAM ANALYZER HELENA LABORATORIES PATRICIA FRANKS
K053253 11/23/2005 HEMOCUE ALBUMIN 201 ANALYZING SYSTEM HEMOCUE AB ALLAN WHITE
K050085 01/13/2005 OSTEOPAL V HERAEUS KULZER GMBH CHRISTIAN TUCHSCHERER
K053258 11/22/2005 EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER HITACHI MEDICAL CORP. DOUG THISTLETHWAITE
K053309 11/28/2005 ALTAIRE INTERVENTIONAL MR PACKAGE HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K053148 11/10/2005 CXR16 HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K053280 11/28/2005 PROBEAT HITACHI, LTD., POWER SYSTEMS GROUP JONATHAN KAHAN
K053308 11/29/2005 ABX MICROS CRP 200, OPTION IM HORIBA ABX TIM LAWTON
K050048 01/10/2005 HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP VIVIAN KELLY
K053198 11/16/2005 SIMPLEX P SPEEDSET BONE CEMENT HOWMEDICA OSTEONICS CORP TIFFANI D ROGERS
K050138 01/21/2005 MODIFICATION TO: RESTORATION MODULAR SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K053178 11/17/2005 SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS HU-FRIEDY MFG. CO.,INC. KEITH DUNN
K053298 11/25/2005 ALPHASPHERE ORBITAL IMPLANT HYDRON PTY LIMITED JUDY F GORDON
K053079 11/02/2005 ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001 HYPOGUARD USA, INC. BRUCE A MACFARLANE
K053110 11/04/2005 I-STAT CHEM8 + CARTRIDGE I-STAT CORPORATION PAUL VANDERWERF
K053106 11/04/2005 TEGO, MODEL D1000 ICU MEDICAL, INC. DALE FAIRCHILD
K050083 01/14/2005 BLOOD-PRESSURE METER, BPW120 IDT TECHNOLOGY LIMITED LEON LEONG
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K053135 11/08/2005 SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER SYSMEX AMERICA, INC. NINA GAMPERLING
K053251 11/21/2005 TECHDEVICE GUIDEWIRE TECHDEVICE CORPORATION LEIGH HAYWARD
K050097 01/14/2005 TECHNO-SCOPE VISUAL STETHOSCOPE TECHTRADE LLC ARTHUR M HOROWITZ
K050128 01/26/2005 VITALWARE VMS TELEVITAL, INC. GRACE BARTOO
K053141 11/15/2005 NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800 THE MAGSTIM COMPANY LTD. CHRIS LEWIS
K050058 01/19/2005 THEKEN REVEAL VBR SYSTEM THEKEN SURGICAL,LLC RANDY THEKEN
K053228 11/21/2005 THERIGRAFT TCP PUTTY BONE VOID FILLER THERICS, LLC SUNIL SAINI
K053266 11/23/2005 MYOTRAC INFINITI THOUGHT TECHNOLOGY LTD. SURESH SUGIRTHARAJA
K050114 01/19/2005 SUPERCATH Z3V TOGO MEDIKIT CO., LTD. KOZO NAGAYAMAB
K050012 01/03/2005 VENTANA IMAGE ANALYSIS SYSTEM TRIPATH IMAGING, INC. BRYAN TUCKER
K050116 01/18/2005 UNIQSAFE ROTATABLE, RETRACTABLE SAFETY SYRINGES UNIQSAFE BIOMEDITECH CO., LTD. JENNIFER REICH
K053245 11/23/2005 GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER URESIL, LLC MATTHEW MAHON
K053290 11/25/2005 COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES VALLEYLAB CHARLES M COPPERBERG
K053310 11/28/2005 VASCON ROAMER MICROCATHETER VASCON LLC STEPHEN F VADAS
K050133 01/21/2005 D-STAT RADIAL HEMOSTATIC BAND VASCULAR SOLUTIONS, INC. LINDA BUSKLEIN
K053054 11/04/2005 THROMBIX 3X3 HEMOSTATIC PAD VASCULAR SOLUTIONS, INC. LINDA BUSKLEIN
K050146 01/24/2005 VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY VASCULAR SOLUTIONS, INC. LINDA BUSKLEIN
K050021 01/05/2005 VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT VASCULAR SOLUTIONS, INC. LINDA BUSKLEIN
K053270 11/23/2005 IVENT 201 VERSAMED MEDICAL SYSTEMS, INC. JERRY KORTEN
K053183 11/15/2005 JIVE X SOFTWARE VISUS TECHNOLOGY TRANSFER GMBH STEPHEN NEUSHUL
K053162 11/15/2005 DEXTROSCOPE & DEXTROBEAM VOLUME INTERACTIONS PTE LTD R. FAREETH
K052881 11/07/2005 VYGON LATEX FREE BIONECTOR VYGON CORP. COURTNEY SMITH
K053202 11/16/2005 GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL W.L. GORE & ASSOCIATES MICHAEL IVEY
K053200 11/16/2005 GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL W.L. GORE & ASSOCIATES,INC MICHAEL IVEY
K053132 11/09/2005 WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 WAKO CHEMICALS, USA, INC. LORI CREASY
K053131 11/09/2005 WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 WAKO CHEMICALS, USA, INC. LORI CREASY
K053169 11/18/2005 RM3 RENAL PRESERVATION SYSTEM WATERS INSTRUMENTS, INC. DAVE SCHOLLMAN
K050218 01/31/2005 WAVELIGHT SINON WAVELIGHT LASER TECHNOLOGIE AG MANFRED DRAX
K050074 01/12/2005 12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200 WELCH ALLYN, INC. CHRISTOPHER KLACZYKN
K053136 11/10/2005 5TH METATARSAL FRACTURE SCREW WRIGHT MEDICAL TECHNOLOGY, INC. WESLEY L REED
K053319 11/30/2005 ALLOMATRIX CUSTOM WRIGHT MEDICAL TECHNOLOGY, INC. BRIAN YOUNG
K050042 01/07/2005 WU'S 4-WHEELED NEO SCOOTER, WT-XL4 WU'S TECH CO., LTD. JEN KE-MIN
K050010 01/03/2005 WU'S POWERED WHEELCHAIR, MAMBO 36X WU'S TECH CO., LTD. JEN KE-MIN
K050011 01/03/2005 WU'S POWERED WHEELCHAIR, MAMBO F 120 WU'S TECH CO., LTD. JEN KE-MIN
K050137 01/24/2005 TEMPTOUCH DERMAL THERMOMETER XILAS MEDICAL, INC. RUBEN G ZAMORANO
K053321 11/30/2005 LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER XODUS MEDICAL, INC. CRAIG KAFOREY
K050154 01/24/2005 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) ZIBO ZHUANGYUAN PLASTIC & RUBBER CO., LTD. CHEN YUHONG
K050155 01/24/2005 POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) ZIBO ZHUANGYUAN PLASTIC & RUBBER CO., LTD. CHEN YUHONG
K053274 11/23/2005 ANATOMICAL SHOULDER INVERSE/REVERSE ZIMMER GMBH DALENE T BINKLEY
K050101 01/18/2005 THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10 ZIMMER TRABECULAR ROBERT A POGGIE
K053189 11/15/2005 COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES ZIMMER, INC. LAURA D WILLIAMS
K050105 01/18/2005 NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERS ZIMMER, INC. BRANDON HIPSHER
K053226 11/17/2005 ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED CATHETER AND FLOW SPLITTER ZIMMER, INC. CINDY J DICKEY
K050121 01/19/2005 ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM, MODEL 2357 & 2359 ZIMMER, INC. NOAH BARTSCH


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