FDA 510(k) Decisions During December, 2003  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K033392 12/10/2003 IMMEDIATE STABILIZING IMPLANT (ISI) "O" CO., INC. DAVID D DALISE
K031281 12/23/2003 ERGO SRS 3D LINE USA, INC. NADER SALEHI
K032756 12/04/2003 A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533 A-DEC, INC. TOM LOUISELL
K032757 12/10/2003 A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE A-DEC, INC. TOM LOUISELL
K032572 12/03/2003 A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT A-DEC, INC. TOM LOUISELL
K033356 12/30/2003 VERASOFT ES AALBA DENT, INC. VINCENT BENETTI
K031260 12/19/2003 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005 ABBOTT DIABETES CARE INC. DONNA K TEMPLEMAN
K033576 12/04/2003 LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE ABBOTT LABORATORIES PATRICIA MELERSKI
K033537 12/10/2003 SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005 ABBOTT LABORATORIES JOANNA KUSKOWSKI
K033299 12/12/2003 ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K032970 12/08/2003 ACRA-CUT XPRESS 120 ACRA CUT, INC. KENNETH M NICOLL
K033735 12/12/2003 VANTAGE PRO ATTENUATION CORRECTION DEVICE ADAC LABORATORIES CHARLENE BRUMBAUGH
K033429 12/04/2003 LAMITRODE SPINAL CORD STIMULATION LEADS ADVANCED NEUROMODULATION SYSTEMS DANIELLE ALARCON
K032469 12/16/2003 AESKULISA ANA 8PRO AESKU, INC STANLEY AMMONS
K031579 12/19/2003 INSTAREAD LITHIUM SYSTEM AKERS LABORATORIES, INC. ERIKA B AMMIRATI
K032422 12/15/2003 EUSOL-C AL.CHI.MI.A GEORGE MYERS
K032417 12/23/2003 HEPARIN LOCK FLUSH SYRINGE AM2 PAT INC. DUSHYANT PATEL
K031711 12/18/2003 TANGO, MODELS, BP1 AMERICAN BANTEX CORP. TRACY S BEST
K033045 12/23/2003 DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST AMERICAN GREEN DENT. MFG, INC. ANDREW ROWE
K033636 12/31/2003 AMS LARGE PORE POLYPROPYLENE MESH AMERICAN MEDICAL SYSTEMS, INC. ELSA A LINKE
K033076 12/19/2003 LIFESTYLES LIQUID PERSONAL LUBRICANT ANSELL HEALTHCARE, INC. LON D MCILVAIN
K033201 12/02/2003 LA500 BLUE LIGHT APOZA ENTERPRISE CO. LTD. SHIH MIN-TEH
K033637 12/17/2003 MEDICAL IMAGE DIGITIZER, MODEL 2908 ARRAY CORP. TAKASHI INAMI
K030895 12/03/2003 ASEPTICO ENDOPEX V, MODEL AEU-40 ASEPTICO, INC. GRANT RAMALEY
K033256 12/30/2003 ATHENA PELVIC MUSCLE TRAINER II ATHENA FEMININE TECHNOLOGIES, INC. BARBARA SARKIS
K031612 12/11/2003 ALT LASER, MODEL VTR 75 AVICENNA LASER TECHNOLOGY, INC. BRUCE R COREN
K032741 12/16/2003 EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION AXON SYSTEMS, INC. HOWARD BAILIN
K033653 12/17/2003 VENTURI PHACO PACK BAUSCH & LOMB, INC. DENNIS POZZO
K030713 12/19/2003 BAY AREA HYPERSCIENCES BAY AREA HYPERSCIENCES, LLC EDWARD F GOOD
K033380 12/16/2003 BAYER SPECIAL CHEMISTRY CALIBRATORS BAYER DIAGNOSTICS CORP. ANDRES HOLLE
K033379 12/19/2003 BAYER SPECIAL CHEMISTRY CONTROLS BAYER DIAGNOSTICS CORP. ANDRES HOLLE
K031947 12/19/2003 BAYER CLINITEK STATUS ANALYZER BAYER HEALTHCARE, LLC MARY E GRAY
K031560 12/17/2003 BAYER RAPIDLAB 1200 SYSTEM BAYER HEALTHCARE, LLC MARY E GRAY
K032563 12/23/2003 CLINITEST HCG PREGNANCY TEST BAYER HEALTHCARE, LLC MARY GRAY
K031949 12/10/2003 TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 BAYLIS MEDICAL CO., INC. AMANDA HARTLEY
K033781 12/30/2003 BEBIG ISOSEED I-125 BEBIG ISOTOPEN-UND MEDIZINTECHNIK GMBH SVEN LANGER
K033038 12/29/2003 GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688 BECKMAN COULTER, INC. BRENT TABER
K033603 12/19/2003 INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999 BECKMAN COULTER, INC. VALYNDA MACHEN
K033558 12/19/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS BECTON, DICKINSON & CO. BRADFORD SPRING
K033229 12/17/2003 (MULTIPLE LABELS) POWDER-FREE VINYL EXAMINATION GLOVES BERNARD TECHNOLOGIES, INC. MICHAEL D LELAH, PHD
K033366 12/12/2003 LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455 BIO-RAD MARIA ZEBALLOS
K033404 12/12/2003 LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES) BIO-RAD MARIA ZEBALLOS
K033387 12/02/2003 QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 BIO-RAD MARIA ZEBALLOS
K032104 12/12/2003 AMNIOLENS BIO-TISSUE, INC. DAVID J BLOCH
K033398 12/12/2003 LARYNGEAL AUGMENTATION IMPLANT BIOFORM, INC. JAMES MILLER
K032268 12/11/2003 MBCP BIOMATLANTE MYRIAM VINCENT
K033519 12/05/2003 CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET BIOMET, INC. GARY BAKER
K031804 12/18/2003 COMPRESS DISTAL FEMORAL REPLACEMENT BIOMET, INC. GARY BAKER
K033280 12/19/2003 DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM BIOMET, INC. PATRICIA SANDBORN BERES
K030086 12/17/2003 PALACOS R BONE CEMENT WITH GENTAMICIN BIOMET, INC. LONNIE WITHAM
K033383 12/23/2003 TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200 BIOSITE INCORPORATED JEFFREY R DAHLEN, PH.D.
K033613 12/08/2003 MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER BIOTRONIK, INC. JON BRUMBAUGH
K033287 12/19/2003 EXACTRAC GATING BRAINLAB AG RAINER BIRKENBACH
K033829 12/29/2003 BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM, MODEL CRE-2100 BRUNO INDEPENDENT LIVING AIDS, INC. RICHARD KELLER
K033752 12/12/2003 BRUNO ELECTRA-RIDE STAIRWAY ELEVATOR SYSTEM. MODEL SRE-1540 BRUNO INDEPENDENT LIVING AIDS, INC. RICHARD A KELLER
K032029 12/18/2003 BTG SMARTEST GLUCOSE TEST SYSTEM BT MEDICAL DEBBIE CHENG
K033695 12/23/2003 IRRIGATION CHANNEL TUBING, MODEL 100135 BYRNE MEDICAL, INC. J. HARVEY KNAUSS
K033562 12/12/2003 FASTRAC GASTRIC ACCESS PORT KIT C.R. BARD, INC. THOMAS HIRTE, P.E.
K033778 12/30/2003 MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT C.R. BARD, INC. FRAN HARRISON
K030834 12/03/2003 CANDELA SMOOTHBEAM LASER SYSTEM CANDELA CORP. LORRAINE C PATROVIC
K033624 12/15/2003 PACS SOFTWARE SOLUTION 2003 CANON U.S.A., INC. SEAN M CURRY
K032835 12/11/2003 H/S CATHETER SET CATHETER RESEARCH, INC. JOHN A STEEN
K031599 12/09/2003 CD LEYCOM PRESSURE/VOLUME CATHETERS CD LEYCOM BV T. LOPES
K033799 12/22/2003 CLINICAL LASETTE P-200 CELL ROBOTICS, INC. LINDA A BLAIR
K033664 12/17/2003 MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM CENTERPULSE ORTHOPEDICS, INC. JEAN ASQUITH
K031116 12/03/2003 VECTRA (INTELECT) EPR ULTRASOUND CHATTANOOGA GROUP MICK DAVIS
K031077 12/11/2003 VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM CHATTANOOGA GROUP CHERYL L BAGWELL
K031689 12/23/2003 DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) CHF SOLUTIONS, INC. AMY PETERSON
K032113 12/23/2003 ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) CHROMA VISION MEDICAL SYSTEMS INC. DAVID DAVIS
K033701 12/15/2003 FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES CIBA VISION CORPORATION ALICIA M PLESNARSKI
K033147 12/30/2003 CLEARTOOTH DIGITAL X-RAY SYSTEM CLEARTOOTH ELECTRONICS, INC. GREG HOLLAND
K033020 12/19/2003 IMPAK ACRYLIC REPAIR RESIN LIQUID CMP INDUSTRIES LLC. WILLIAM REGAN
K033524 12/18/2003 COAPT ENDOTINE CHIN 3.5 DEVICE COAPT SYSTEMS, INC. LORI DONDIEGO
K033641 12/11/2003 SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800 COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K032920 12/16/2003 THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003 COEUR MEDICAL DEBRA F MANNING
K031618 12/18/2003 COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 2 COMFORT ORTHOPEDIC CO. LTD. ERIC H.C. LEE
K033052 12/17/2003 CONDUCTIVE EEG ELECTROLYTE COMPUMEDICS USA, LTD. ELVIRA GARCIA
K032762 12/02/2003 XIO RADIATION TREATMENT PLANNING SYSTEM COMPUTERIZED MEDICAL SYSTEMS, INC. KATHRYN STINSON
K033348 12/15/2003 ZILVER 518 BILIARY STENT COOK, INC. LELAND KEYT
K033394 12/22/2003 CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035" DELIVERY SYSTEM CORDIS CORP. KAREN WILK
K033156 12/09/2003 OB1 OBSTETRICAL DOPPLER D. E. HOKANSON, INC. D. EUGENE HOKANSON
K033487 12/24/2003 STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI DADE BEHRING, INC. GEORGE M PLUMMER
K032955 12/15/2003 AUTOMOVE, MODEL AM800 DANMETER A/S HANNE NIELSEN
K032988 12/03/2003 ELPHA 4 CONTI DANMETER A/S HANNE NIELSEN
K031124 12/04/2003 POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR DATEX-OHMEDA, INC. AL VAN HOUDT
K033705 12/04/2003 BOBCAT PRO SCALER SYSTEM, MODEL G-130 DENTSPLY INTERNATIONAL P. JEFFERY LEHN
K033553 12/02/2003 PFZ PORCELAIN SYSTEM DENTSPLY INTL. P. JEFFERY LEHN
K032659 12/04/2003 DEPUY ASR RESURFACING FEMORAL HEADS DEPUY ORTHOPAEDICS, INC. NATALIE HECK
K033516 12/03/2003 DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS DEPUY ORTHOPAEDICS, INC. TIFFANI D ROGERS
K033234 12/12/2003 IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER DIAGNOSTIC PRODUCTS CORP. EDWARD LEVINE
K033063 12/12/2003 MISSION CONTROLS DIAMOND DIAGNOSTICS, INC. LINDA M STUNDTNER
K033714 12/11/2003 MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING DIDECO S.P.A. BARRY SALL
K032171 12/15/2003 ACCUSOFT DIREX SYSTEMS CORP. LARISA GERSHTEIN
K032358 12/17/2003 B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM) DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. JONANTHAN S KAHN
K033600 12/11/2003 INFINITY GAMMAXL DRAEGER MEDICAL SYSTEMS, INC. PENELOPE H GRECO
K033635 12/03/2003 MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM EBI, L.P. FREDERIC TESTA
K033250 12/30/2003 EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR EDWARDS LIFESCIENCES, LLC. JASON SMITH
K032900 12/04/2003 LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS EDWARDS LIFESCIENCES, LLC. DAUN PUTNAM
K033795 12/19/2003 PLASMACURE BXE EELE LABORATORIES, LLC ROBERT GRASMAN
K033206 12/18/2003 EPW FOLDABLE POWER WHEELCHAIR, EPW-03 EMG TECHNOLOGY CO., LTD. JEN KE-MIN
K023683 12/01/2003 MULTI-STRAP FULL FACE MASK ENGINEERED MEDICAL SYSTEMS PAUL DRYDEN
K031267 12/23/2003 STERICHEK BICARB PH REAGENT STRIPS ENVIRONMENTAL TEST SYSTEMS, INC. DAVID A MORRIS
K033138 12/02/2003 CAP3 BONE SUBSTITUTE MATERIAL ETEX CORP. PAMELA W ADAMS
K033269 12/10/2003 ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD ETHICON ENDO-SURGERY, INC. GEORGIA C ABERNATHY
K033568 12/08/2003 GYNECARE TVT OBTURATOR SYSTEM ETHICON, INC. SEAN O'BRYAN
K033746 12/18/2003 MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE ETHICON, INC. REY LIBROJO
K033544 12/10/2003 ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607 EVERYWAY MEDICAL INSTRUMENTS CO., LTD. JAY MANSOUR
K031818 12/03/2003 FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE FACILAI ENTERPRISES LTD. KE-MIN JEN
K032208 12/09/2003 MONA LISA ASPIRATION NEEDLE FERTILITY TECHNOLOGY RESOURCES, INC. CONSTANCE W STURGEON
K031649 12/05/2003 SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES FINK ENGINEERING PTY LTD W.T. WORKMAN
K033510 12/03/2003 MODIFICATION TO TELEGRAPH HUMERAL NAIL FOURNITURES HOSPITALIERES INDUSTRIE CHRISTINE QUENDEZ
K033542 12/05/2003 EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE GALT MEDICAL CORP. DAVID CATLIN
K033874 12/30/2003 MYOLIGHT GE MEDICAL SYSTEMS F.I. HAIFA LAURENCE BIGIO
K033672 12/18/2003 MODIFICATION TO UNITY NETWORK ID GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES DIANA M THORSON
K033400 12/04/2003 SENO ADVANTAGE GE MEDICAL SYSTEMS W-400 LARRY A KROGER, PH.D.
K032720 12/10/2003 GEM-STIM TENS, MODELS GM3XY AND GM3AXY GEMORE TECHNOLOGY CO., LTD. BODEN S.P. LAI
K032994 12/16/2003 GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING) GEMORE TECHNOLOGY CO., LTD. BODEN S.P. LAI
K032719 12/10/2003 GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING) GEMORE TECHNOLOGY CO., LTD. BODEN S.P. LAI
K032554 12/31/2003 GEN-PROBE APTIMA COMBO 2 ASSAY GEN-PROBE, INC. ALAN MADERAZO
K032194 12/24/2003 TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS GEN-PROBE, INC. WAYNE A KVETKOSKY
K033360 12/23/2003 DIAZYME LITHIUM ENZYMATIC ASSAY KIT GENERAL ATOMICS CHONG YUAN
K033867 12/19/2003 GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS GENERAL ELECTRIC CO. LARRY A KROGER
K033478 12/29/2003 VACUETTE QUICKSHIELD SAFETY TUBE HOLDER GREINER BIO-ONE VACUETTE NORTH AMERICA JUDI SMITH
K033161 12/18/2003 VISU-LOCK 5MM CLIP APPLIER GYRX, LLC CORY EDWARDS
K033054 12/16/2003 HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP HARVARD CLINICAL TECHNOLOGY ERIC J FLACHBART
K032127 12/30/2003 HEMEDEX FIXATION DEVICE HEMEDEX INCORPORATED DEBBIE IAMPIETRO
K033665 12/30/2003 VENUS FLOW HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K033629 12/22/2003 VERSYO.BOND HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K032855 12/10/2003 STRYKER SPINE MAPS SYSTEM HOWMEDICA OSTEONICS KAREN ARIEMMA
K032829 12/10/2003 SCORPIO LOW PROFILE TIBIAL TRAY HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K032821 12/05/2003 HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF HYGIA HEALTH SERVICES, INC. TRACY W COMAS
K021692 12/04/2003 CLC2000 CATHETER PATENCY DEVICE ICU MEDICAL, INC. ALISON D BURCAR
K033242 12/31/2003 KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS) IMAGING THERAPEUTICS, INC. LYNDALL ERB
K032571 12/24/2003 IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA IMMCO DIAGNOSTICS, INC. KEVIN LAWSON
K032251 12/19/2003 IMMUNETECH TOTAL IGE SYSTEM IMMUNETECH CORPORATION VIVIANNE NOETZEL
K033602 12/16/2003 INSORB ABSORBABLE STAPLE, MODEL SP-B20 INCISIVE SURGICAL, INC. JIM PETERSON
K033631 12/15/2003 MODIFICATION TO COATEST FACTOR VIII INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K032663 12/19/2003 QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2 INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K031373 12/19/2003 IXL DIABETES MANAGEMENT SYSTEM INSULET CORP. A. ARTHUR RANKIS
K033698 12/17/2003 CONTOUR-FLEX VALVE AND SHUNT SYSTEM INTEGRA NEUROSCIENCES IMPLANTS S.A. JUDITH E O'GRADY
K033040 12/17/2003 PHOENIX INFANT RADIANT WARMER, MODEL 100NWS INTERNATIONAL HOSPITAL SUPPLY CO. DAGMAR MASER
K031322 12/23/2003 INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS INTRA-LOCK INTERNATIONAL JEFFERY SAKOFF
K033708 12/11/2003 MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K033192 12/22/2003 RH-950 IOMED, INC. CURTIS JENSEN
K032887 12/19/2003 PHENOL RED STOCK SOLUTION IRVINE SCIENTIFIC SALES CO., INC. WENDELL LEE
K032779 12/17/2003 MODIFICATION TO: NUCAMMA RX IS2 RESEARCH, INC. VICTOR WOODBURN
K033520 12/05/2003 BLUEPHASE IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K032643 12/02/2003 JUSTWIN SCOOTER, JS-3013 JOY RIDE TECH CO., LTD. JEN KE-MIN
K032645 12/02/2003 JUSTWIN SCOOTER, JS-3014 JOY RIDE TECH CO., LTD. JEN KE-MIN
K033166 12/12/2003 KACEY INSULIN SYRINGE KACEY, INC. CHARLES F NEILSON, PHD
K032950 12/19/2003 GEM INSET PATELLAR COMPONENT KINAMED, INC. VINEET SARIN
K033267 12/22/2003 EPRICORD KURARAY MEDICAL INC. SATOSHI YAMAGUCHI
K033916 12/30/2003 GRI-BAG, GRI-BAG AP LABORATORIOS GRIFOLS, S.A. SEBASTIAN GASCON
K033682 12/17/2003 SET GRI-FILL 2.0-1 WAY; 2.0-2 WAYS; LUER CONNECTION TUBE LABORATORIOS GRIFOLS, S.A. SEBASTIAN GASCON
K033758 12/19/2003 HYDROPHILIC GUIDEWIRE LAKE REGION MFG., INC. KAREN MORTENSEN
K033159 12/19/2003 LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05 LEMAITRE VASCULAR, INC. BRIAN K KEOGH
K033094 12/19/2003 ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT) LIN-ZHI INTERNATIONAL, INC. CHENG-I LIN
K033804 12/31/2003 BIOANCHOR WITH DISPOSABLE DRIVER LINVATEC CORP. LAURA D KREJCI
K033748 12/15/2003 TRIDENT RESECTION ABLATOR LINVATEC CORP. LAURA D KREJCI
K033657 12/19/2003 MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V LIVING DATA TECHNOLOGIES CORPORATION SUSAN D GOLDSTEIN-FALK
K033202 12/03/2003 ADVANTAGE PADDLE LIVINGSTON PRODUCTS, INC. DANIEL KAMM
K033298 12/12/2003 SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS MASIMO CORP. JAMES J CRONIN
K032968 12/02/2003 TRSANSDERM IONTO SYSTEM MATTIOLI ENGINEERING CORP. MELISSA MAHALL
K032735 12/03/2003 SPECTRA QT: Q-SWITCHED ND: YAG LASER SYSTEM MAX ENGINEERING LTD. MAUREEN O'CONNELL
K033666 12/17/2003 HEMADERM MEDAFOR, INC. JENNIFER A MAY
K033412 12/30/2003 MEDICLUNG, RELEASE 1 MEDICSIGHT CAROL MACDONALD
K032928 12/19/2003 MEDIPHYSICS PAIN TREATMENT SYSTEM, MODEL 1 MEDIPHYSICS PAIN CENTERS OF AMERICA JAMES ROGERS
K032362 12/04/2003 UP-GRADE FOREHEAD THERMOMETER MEDISIM LTD. DALIA GIVONY
K033906 12/24/2003 PORTASCAN BLADDER SCANNER, MODEL PA00146 MEDIWATCH PLC ANDREW HOPKINS
K032810 12/05/2003 DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE MEDTRONIC HEART VALVES JULIE SHERMAN
K033322 12/15/2003 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD W TREHARNE
K033495 12/03/2003 MODIFICATION TO EQUATION FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K032222 12/05/2003 IMMUNOCARDSTAT HPSA MERIDIAN BIOSCIENCE, INC. SUSAN ROLIH
K033082 12/03/2003 9 SECOND DIGITAL THERMOMETER, MODEL BT-S09 METATECH CO., LTD. GUENTER GINSBERG
K033847 12/23/2003 A1CNOW FOR HOME AND PROFESSIONAL USE METRIKA, INC. ERIKA AMMIRATI
K031102 12/01/2003 MICROLAB SPIROMETER MICRO DIRECT, INC. DAVID R STASZAK
K033836 12/30/2003 HYDROCOIL EMBOLIC SYSTEM (HES) MICROVENTION, INC. VINCENT CUTARELLI
K032690 12/09/2003 MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM MISONIX, INC. RONALD R MANNA
K032841 12/10/2003 MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR MOOR INSTRUMENTS LTD. DAVID BOGGETT
K030485 12/03/2003 NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR NEWMEDICAL TECHNOLOGY, INC. HAITHAM MATLOUB
K032902 12/15/2003 SUBTALAR ARTHRORISIS IMPLANT NEXA ORTHOPEDICS, INC. LOUISE M FOCHT
K033046 12/23/2003 SUBTALAR PEG IMPLANT NEXA ORTHOPEDICS, INC. LOUISE M FOCHT
K031733 12/04/2003 NON-CONTACT TONOMETER, MODEL NT-4000 NIDEK, INC. CAROL PATTERSON
K031968 12/22/2003 CERABIEN ZR NORITAKE CO., INC. IVAN J WASSERMAN
K032309 12/04/2003 NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY NOVELENS, INC. RICHARD E LIPPMAN
K033317 12/30/2003 SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070 OPUS MEDICAL, INC. LAURA N KASPEROWICZ
K032812 12/08/2003 ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT ORTHOVITA, INC. DAVID J MCILHENNY
K032288 12/19/2003 VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL ORTHOVITA, INC. GINA M NAGVAJARA
K023414 12/05/2003 MIDA ALGORITHM REV. B ORTIVUS AB KENNETH EKLUND
K032729 12/03/2003 Z-SERIES MODULAR TOTAL HIP SYSTEM OSTEOIMPLANT TECHNOLOGY, INC. SAM SON
K033230 12/12/2003 TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA PARALLAX MEDICAL, INC. LINDA PAUL
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K033306 12/15/2003 PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS ROCHE DIAGNOSTICS CORP. KERWIN KAUFMAN
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K032980 12/18/2003 AMI REPROCESSED MULTIPLE CLIP APPLIERS VANGUARD MEDICAL CONCEPTS, INC. MARK ALDANA
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K033339 12/30/2003 ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY VARIAN MEDICAL SYSTEMS, INC. VY TRAN
K033343 12/23/2003 TRILOGY RADIOTHERAPY DELIVERY SYSTEM VARIAN MEDICAL SYSTEMS, INC. VY TRAN
K023023 12/04/2003 LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACCESS CANNILA VASCA, INC. NAMA DODDI
K031812 12/12/2003 TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03 VASCULAR CONTROL SYSTEMS, INC AL MEMMOLO
K033709 12/18/2003 VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE VASCULAR SOLUTIONS, INC. GREGORY W SACHS
K032763 12/19/2003 VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER VASCULAR SOLUTIONS, INC. GREGORY SACHS
K032102 12/12/2003 VERTELINK KOBRA SPINAL FIXATION SYSTEM VERTELINK CORPORATION GREG HOLLAND
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K033137 12/08/2003 POTENS + WADA, INC. GAIL RODRICK-HIGHBERG
K033740 12/15/2003 LORENZ STERNAL CLOSURE SYSTEM WALTER LORENZ SURGICAL, INC. KIM REED
K033857 12/19/2003 T-TECH DIGITAL, MODEL WL-22XXA SERIES WELL-LIFE HEALTHCARE, INC. JENNY HSIAH
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K033203 12/19/2003 WILSON-COOK TRI-TOME SELECT PLUS WILSON-COOK MEDICAL, INC. MARGE WALLS-WALKER
K033529 12/03/2003 TIE-IN TRAPEZIUM WRIGHT MEDICAL TECHNOLOGY, INC. KATIE LOGEROT
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