FDA 510(k) Decisions During September, 2004  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K041811 09/10/2004 ABBOTT AXSYM TROPONIN-I ADV ABBOTT LABORATORIES MARGARET PROCHNIAK
K042146 09/17/2004 ROBOCOUCH PATIENT SUPPORT SYSTEM ACCURAY INCORPORATED ANNE SCHLAGENHAFT
K042225 09/10/2004 ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 ACMI CORPORATION TERRENCE E SULLIVAN
K041822 09/16/2004 ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K042151 09/09/2004 ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST ACON LABORATORIES, INC. EDWARD TUNG
K041743 09/09/2004 ACON TRI-FECT DRUG SCREEN TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K041268 09/20/2004 SILVERSITE OR CALGITROL ADRI GEORGE H SCHERR, PH.D.
K042130 09/08/2004 AURA CPAP PATIENT INTERFACE AEIOMED INC. Gary Syring
K041186 09/09/2004 CADDY AFIKIM ELECTRIC VEHICLES AVNER FISHBEIN
K032922 09/22/2004 CLARISSA INFANT NCPAP CANNULA AIRWAYS LTD., INC. RICHARD J LARKIN
K042242 09/15/2004 ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES ALDEN OPTICAL LABS., INC. CHARLES H CREIGHTON
K041734 09/22/2004 AMBU DISPOSABLE ECG ELECTRODE AMBU, INC. SANJAY PARIKH
K042462 09/21/2004 AMERICAN DENTAL IMPLANT AMERICAN DENTAL IMPLANT CORPORATION STEVEN B LOMBARDI
K040392 09/14/2004 TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING AMERICAN I.V. PRODUCTS, INC. GREGORY FALK
K042575 09/30/2004 AMPLIFE DIGITAL CLINICAL THERMOMETER AMPLIFE CORPORATION SUSAN D GOLDSTEIN-FALK
K041279 09/23/2004 IMPLANTEO IMPLANTOLOGY MOTOR ANTHOGYR ERIC GENEVE
K041566 09/08/2004 SONOSURG ULTRASONIC SURGICAL SYSTEM AOMORI OLYMPUS CO., LTD. TINA STEFFANIE-OAK
K041795 09/14/2004 MODIFICATION TO OPTICAL SEPARATOR SYSTEM APPLIED MEDICAL RESOURCES CORP. CHERYL BLAKE
K041965 09/08/2004 ARTHREX HUMERAL FRACTURE PLATES AND SCREWS ARTHREX, INC. SALLY FOUST
K040070 09/21/2004 ARTELON SPACER CMC-1 ARTIMPLANT AB MARIE MARLOW
K041269 09/14/2004 ATRIUM MEDICAL CORPORATION ICAST COVERED STENT ATRIUM MEDICAL CORP. JOSEPH P DE PAOLO
K041866 09/29/2004 ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) AXIS-SHIELD DIAGNOSTICS, LTD. SUSAN LEONARD
K042488 09/30/2004 PERIFIX CATHETER AND CONTIPLEX CATHETER B. BRAUN MEDICAL, INC. AMY SMITH
K042105 09/23/2004 CLIPPER DIAGNOSTIC ELECTRODE CATHETER BARD ELECTROPHYSIOLOGY DEBORAH L HERRINGTON
K042062 09/30/2004 PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE BARD PERIPHERAL VASCULAR, INC. SHARI ALLEN
K042015 09/29/2004 ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE BAYER HEALTHCARE, DIAGNOSTICS DIVISION ANDRES HOLLE
K042251 09/17/2004 BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM BAYER HEALTHCARE, LLC ANDRES HOLLE
K041074 09/17/2004 BD FACSCANTO WITH BD FACSANTO SOFTWARE BD Biosciences KIM FONDA
K042281 09/16/2004 MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY BECKMAN COULTER, INC. BARBARA STEGMEIER
K042195 09/16/2004 SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747 BECKMAN COULTER, INC. KIM WALKER
K040026 09/10/2004 BD FACS 7-COLOR SETUP BEADS BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS CINDY MORROW
K040725 09/10/2004 BD FACSCANTO SYSTEM BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS KIM FONDA
K042301 09/03/2004 PROTENS ELECTRODE BIO PROTECH, INC. E.J. EDWARD
K042335 09/17/2004 ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05 BIO-RAD LABORATORIES, INC. MARIA ZEBALLOS
K042429 09/16/2004 THE PRODIGY SYSTEM DENTAL IMPLANTS BIOHORIZONS IMPLANT SYSTEMS, INC. WINSTON GREER
K041002 09/24/2004 FIDIS CELIAC BIOMEDICAL DIAGNOSTICS S.A. PASCALE LAROCHE
K041982 09/14/2004 VITEK 2 GRAM NEGATIVE ERTAPENEM BIOMERIEUX, INC. Nancy Weaver
K041872 09/08/2004 ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL FEMORAL PEGS BIOMET MANUFACTURING CORP. PATRICIA SANDBORN BERES
K041936 09/08/2004 BIOPRO SUBTALAR IMPLANT BIOPRO, INC. DAVID MRAK
K040591 09/16/2004 DUET SYSTEM BIOVIEW LTD. DORIT WINITZ
K040942 09/15/2004 VST3 BIOWATCH MEDICAL, INC. URSULA E WILSON
K042100 09/20/2004 BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR BLACKSTONE MEDICAL, INC. DEAN CIPORKIN
K041732 09/21/2004 CAVERMAP SURGICAL AID BLUE TORCH MEDICAL TECHNOLOGIES FREDERICK TOBIA
K042065 09/30/2004 WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM BOSTON SCIENTIFIC CORP. KATHLEEN MORAHAN
K041330 09/22/2004 IPLAN! FLOW BRAINLAB AG RAINER BIRKENBACH
K041767 09/30/2004 COOLCUBE COOLPEN BRUCE J. SAND M.D. BRUCE J SAND, M.D.
K042026 09/10/2004 BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004 C.R. BARD, INC. KAREN S GWOZDOWSKI GAUVIN
K040658 09/29/2004 BARDEX I.C. LATEX FOLEY CATHETER C.R. BARD, INC. JOHN C KNORPP
K042085 09/17/2004 CRONO F CANE S.R.L. DANIEL KAMM
K042296 09/20/2004 BIOMARC PRELOADED TISSUE MARKER DEVICE CARBON MEDICAL TECHNOLOGIES, INC. ROBERT W JOHNSON
K042139 09/09/2004 VISULAS YAG III CARL ZEISS MEDITEC AG R. MICHAEL CROMPTON
K033634 09/15/2004 EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED CENTERPULSE ORTHOPEDICS, INC. AUDREY SWEARINGEN
K042142 09/20/2004 CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S CHAD THERAPEUTICS, INC. KEVIN MCCULLOH
K040662 09/08/2004 VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS CHATTANOOGA GROUP CHERYL BAGWELL
K041783 09/28/2004 POLAR WAND CHEK-MED SYSTEMS ROB WHALEN
K041791 09/10/2004 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) CHF SOLUTIONS, INC. AMY PETERSON
K041835 09/28/2004 ENDOTINE MIDFACE B 4.5 DEVICE COAPT SYSTEMS, INC. LORI DONDIEGO
K041868 09/28/2004 VALUPEN,PROFILE CONMED CORPORATION PAMELA VETTER
K040921 09/28/2004 COOLTOUCH, MODEL NS 160 COOLTOUCH, INC. DONALD V JOHNSON
K040549 09/28/2004 COSMED PONY FX COSMED S.R.L. ROBERT SCHIFF
K041655 09/08/2004 BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS) COWELL MEDI CO LTD. DAE KYU CHANG
K041894 09/17/2004 ORTHOFIBER CP MEDICAL MARY ANN GREENAWALT
K042354 09/21/2004 MODIFICATION TO: CRESCO TI IMPLANT CONCEPT CRESCO TI SYSTEMS AB J. BENGTSSON
K042569 09/29/2004 8600 VITAL SIGNS MONITOR CRITICARE SYSTEMS, INC. ALEX KAPLAN
K041890 09/22/2004 CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12 CRYOCOR, INC. JAMI MILLER
K041627 09/03/2004 CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR DAKO A/S DANA OLSEN
K040491 09/10/2004 CHIN-UP STRIP DALE MILLER, INC. - THE CHIN-UP COMPANY DALE MILLER
K042016 09/23/2004 DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER DATASCOPE CORP. PATRICE NAPODA
K040831 09/02/2004 DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 DATEX-OHMEDA, INC. SCOTT LIGHT
K041524 09/20/2004 GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM DATEX-OHMEDA, INC. DAN KOSEDNAR
K042233 09/28/2004 PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE DEPUY MITEK, A JOHNSON & JOHNSON COMPANY RUTH C FORSTADT
K042325 09/08/2004 TROCHANTERIC NAIL SYSTEM DEPUY ORTHOPAEDICS, INC. STEVE KAHN
K041801 09/08/2004 EXPEDIUM MIS SPINE SYSTEM DEPUY SPINE, INC. JENNIFER MOONEY
K041722 09/23/2004 MODIFICATION TO VBR SPINAL SYSTEM DEPUY SPINE, INC. LISA GILMAN
K033164 09/07/2004 ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM DR. LEN'S MEDICAL PRODUCTS LLC JAY MANSOUR
K042003 09/01/2004 INFINITY TRIDENT NMT POD Draeger Medical Systems, Inc. PENELOPE H GRECO
K042276 09/23/2004 D-VAPOR DRAEGER MEDICAL, INC. GALE E WINARSKY
K042313 09/09/2004 INTEGRADWEB MPR/MIP DYNAMIC IMAGING INC. CARL ALLETTO
K042159 09/24/2004 KODAK COLOR MEDICAL IMAGER 1000 EASTMAN KODAK COMPANY STEPHEN SLAVENS
K042158 09/24/2004 KODAK MEDICAL IMAGER 300 EASTMAN KODAK COMPANY STEPHEN SLAVENS
K042237 09/16/2004 EBI PERIARTICULAR PLATING SYSTEM EBI, L.P. PETER ALLAN
K040903 09/02/2004 CADENCE, MODELS 2001 AND 2002 EDAN INSTRUMENTS, INC. WILLIAM STERN
K041739 09/29/2004 EDWARDS E360 SURGICAL ABLATION DEVICE EDWARDS LIFESCIENCES, LLC. ELIZABETH MORAN
K042456 09/23/2004 MODIFICATION TO LYSUS INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K041522 09/14/2004 FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS ELEKON INDUSTRIES U.S.A., INC. KRISTA OAKES
K041647 09/02/2004 FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE) ELEKON INDUSTRIES U.S.A., INC. KRISTA OAKES
K042269 09/08/2004 LEKSELL GAMMAPLAN 4C WITH MULTIVIEW ELEKTA INSTRUMENT AB ANDERS SKOGLUND
K042008 09/03/2004 ULTRAVISUAL EMAGEON UV, INC. INGER COUTURE
K041638 09/02/2004 TARGETSCAN BIOPSY KIT ENVISIONEERING, LLC. TOM KAPPEL
K041637 09/01/2004 TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM ENVISIONEERING, LLC. TOM KAPPEL
K041639 09/02/2004 TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM ENVISIONEERING, LLC. TOM KAPPEL
K041442 09/14/2004 EP-4 CLINICAL STIMUTATOR EP MEDSYSTEMS JAMES E KUHN JR.
K041021 09/16/2004 RF INTRODUCTION CANNULA EPIMED INTERNATIONAL, INC. CHRISTOPHER B LAKE
K041139 09/30/2004 ERCHONIA EML LASER ERCHONIA MEDICAL, INC. Kevin Walls
K021096 09/08/2004 X-SIZER CATHETER SYSTEM EV3 CORPORATION JILL MUNSINGER
K041906 09/10/2004 EXACTECH 12/14 TOTAL HIP SYSTEM EXACTECH, INC. GARY J MILLER
K042223 09/16/2004 XLTEK CONNEX IP HEADBOX, MODEL 1054 EXCEL TECH. LTD. NICOLE LANDREVILLE
K041829 09/07/2004 FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUCTS FOCUS MEDICAL, LLC. JOHN LEE
K041792 09/24/2004 FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211 FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR EILINSFELD
K041206 09/15/2004 EPITOME SYSTEM GEBAUER MEDIZINTECHNIK GMBH KIMBERLEY DONEY
K042257 09/08/2004 DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION GENERAL ELECTRIC CO. DAVID DUERSTELER
K042030 09/16/2004 HYPROCURE SUBTALAR IMPLANT SYSTEM GRAHAM MEDICAL TECHNOLOGIES, L.L.C. MICHAEL GRAHAM
K041079 09/28/2004 GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103 GUAN HONG ENTERPRISE CO., LTD. JENNIFER REICH
K041237 09/08/2004 ECHOSAMPLER GYNETICS MEDICAL PRODUCTS NV GRACE HOLLAND
K041285 09/10/2004 GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) GYRUS MEDICAL LTD. ANDREW DZIMITROWICZ
K041502 09/01/2004 THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY HAEMOSCOPE CORP. ELI COHEN
K042059 09/30/2004 SHOULDER FIXATION SYSTEM HAND INNOVATIONS, INC. AL WEISENBORN
K041694 09/13/2004 DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETER HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., JI BO
K041692 09/13/2004 INFRARED EAR THERMOMETER, ET-100 SERIES HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., JI BO
K042042 09/21/2004 ULTRASOUND CAPTURE SYSTEM HEARTLAB, INC. RICHARD PETROCELLI
K042088 09/02/2004 SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301 HEARTSINE TECHNOLOGIES, INC. WILLIAM J SMIRLES
K042199 09/08/2004 TRANSLUX POWER BLUE HERAEUS KULZER GMBH CHERYL V ZIMMERMAN
K042428 09/17/2004 SCEPTREP3 PET/CT HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUGLASS THISTLETHWAITE
K042033 09/29/2004 HOVEROUND POWER WHEELCHAIR, MODEL HD700 HOVEROUND CORP. TONY DIGIOVANNI
K041591 09/23/2004 SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS HOWMEDICA OSTEONICS CORP KAREN ARIEMMA
K041706 09/08/2004 HOFFMANN II FOOT RING HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K042019 09/24/2004 HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K041709 09/08/2004 NUMELOCK II SYSTEM HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K042020 09/15/2004 SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA) HUTCHINSON TECHNOLOGY, INC. THOMAS A DOLD
K041867 09/10/2004 HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N HYGIA HEALTH SERVICES, INC. TRACY WOOD COMAS
K041349 09/24/2004 LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM IBL GMBH Gary Lehnus
K042507 09/27/2004 UBIPACS ICM CO., LTD. CARL ALLETTO
K042182 09/01/2004 Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432 ICU MEDICAL, INC. DALE FAIRCHILD
K042041 09/17/2004 XPLORER 1600 IMAGING DYNAMICS COMPANY LIMITED ROBIN WINSOR
K040630 09/30/2004 TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ IMPLEX CORP. MARCI HALEVI
K042289 09/15/2004 MDI ORTHO IMTEC CORP. J. BRAD VANCE
K041405 09/02/2004 ASPIRATION PUMP, MODEL IMD-020 INDUSTRIAL & MEDICAL DESIGN, INC. YEVGENIY KUKLIN
K041837 09/24/2004 INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED INNOLATEX SDN. BHD ELI J CARTER
K042267 09/30/2004 INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP INOVEL LLC WILLIAM WAWRZYNIAK
K042341 09/20/2004 ULTRACLIP II US INRAD MELISSA LALOMIA
K041905 09/28/2004 HEMOSIL CALIBRATION PLASMA INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K042192 09/02/2004 LOW FLOW OSV II HYDROCEPHALUS VALVE INTEGRA NEUROSCIENCES IMPLANTS S.A. JUDITH E O'GRADY
K042277 09/29/2004 SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM INTEGRA NEUROSCIENCES, LTD. NIKKI HINTON
K040915 09/22/2004 MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M INVIVO RESEARCH, INC. NEIL BATTISTE
K040209 09/20/2004 IRIS MEDICAL IQ 810 PHOTOCOAGULATOR IRIDEX CORP. JOHN JOSSY
K041930 09/10/2004 VARILITE LASER SYSTEM IRIDEX CORPORATION JOHN JOSSY
K041991 09/16/2004 ASPIREX - BONE MARROW ASPIRATE KIT ISOTIS ORTHOBIOLOGICS, INC PAUL DONER
K042056 09/30/2004 AZ ULTRASONIC SYSTEM J. MORITA USA, INC. HOWARD ROWE
K041914 09/27/2004 PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER KENDALL JIM WELSH
K041923 09/08/2004 BIOBLANKET KENSEY NASH CORP. DEBORAH RACIOPPI
K032878 09/20/2004 KUNG SHIN, HMEF SK203 KUNG SHIN PLASTICS CO., LTD. JEN KE-MIN
K042338 09/16/2004 CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE LAKE REGION MFG., INC. KAREN MORTENSEN
K042364 09/30/2004 PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES LAMONT MEDICAL INC Gary Syring
K041883 09/07/2004 SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21 LEONHARD LANG GMBH ELAINE DUNCAN
K041535 09/16/2004 LSC LIFESTAND COMPACT LIFESTAND CAROLANN KOTULA
K032991 09/14/2004 LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX LIGHT AGE, INC. THOMAS C HAUCK
K042295 09/16/2004 SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020 LINVATEC BIOMATERIALS, LTD. TUIJA ANNALA
K042261 09/20/2004 MACROPORE PURICEL LIPOPLASTY SYSTEM MACROPORE BIOSURGERY, INC. KENNETH K KLEINHENZ
K033026 09/03/2004 MALLARD MODEL 3000 ANESTHESIA MACHINE MALLARD MEDICAL, INC. ROBERT M PEARSON
K041902 09/22/2004 MANTRA ELECTRODE MANTRA INTL. (HK) LTD. ROBERT B SPERTELL
K041520 09/03/2004 MANTRA TENS MODEL NT3 MANTRA INTL. (HK) LTD. ROBERT B SPERTELL
K042346 09/20/2004 LNCS OXIMETRY SENSORS MASIMO CORPORATION JAMES J CRONIN
K031788 09/02/2004 PATHFINDER MASSIE RESEARCH LABORATORIES, INC. N.A. (BERT) MASSIE
K041904 09/07/2004 COMPASS F10 SYSTEM MEDCARE FLAGA BERGLIND HALLGRIMSDOTTIR
K041724 09/28/2004 COMPASS M10 SYSTEM MEDCARE FLAGA BERGLIND HALLGRIMSDOTTIR
K033570 09/16/2004 MEDCOMP T-3 MEDCOMP JEAN CALLOW
K041964 09/14/2004 MEDIAID REUSABLE FINGER CLIP SPO2 SENSORS AND DISPOSABLE NON-ADHESIVE SENSORS AND ADHESIVE SPO2 SENSORS MEDIAID INC. KRISTA OAKES
K042464 09/30/2004 V-CORE FULL CORE BREAST BIOPSY INSTRUMENT MEDICAL DEVICE TECHNOLOGIES, INC. NICOHL WILDING
K042311 09/09/2004 PACSPARTNER MEDICAL STANDARD CO., LTD. CARL ALLETTO
K041621 09/13/2004 LITEPORT LP100 SURGICAL ILLUMINATOR MEDICAL VISION INDUSTRIES, INC. DAVID SCHLERF
K042198 09/24/2004 PS MEDICAL NEUROSURGICAL IMPLANTS MEDTRONIC NEUROSURGERY JEFFREY HENDERSON
K041830 09/29/2004 MAGELLAN RATIO DISPENSER KIT MEDTRONIC PERFUSION SYSTEMS BRUCE BACKLUND
K041862 09/15/2004 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K041777 09/03/2004 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K042167 09/08/2004 MODIFICATION TO: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K042235 09/17/2004 ORION ANTERIOR CERVICAL PLATING SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K042194 09/15/2004 ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY MEDTRONIC VASCULAR LYNN JENSEN
K040812 09/02/2004 DETECT SURGICAL PACING AND MAPPING TOOL MEDTRONIC VASCULAR EDWARD VALDEZ
K042190 09/07/2004 MODEL 6416 TEMPORARY PACING LEAD SYSTEM MEDTRONIC VASCULAR PAULA CORDERO
K041381 09/10/2004 MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT MEDTRONIC XOMED, INC. DAVID S DODD
K042013 09/08/2004 DIGITAL CLINICAL THERMOMETER, MODELS ST-8A3C AND ST-8A3F MESURE TECHNOLOGY CO.,LTD. JOHN CHEN
K042187 09/02/2004 ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90 MICRO THERAPEUTICS, INC. MARILYN R POURAZAR
K040213 09/22/2004 MHLX7EC TRANSDUCER MICROHELIX, INC. CHARLES HOTTINGER
K041435 09/29/2004 THE STRIPPER PGD MID-ATLANTIC DIAGNOSTICS, INC. SUSAN J BUSH
K041805 09/21/2004 MICROSCOPE SYSTEM MIRAS MIRROR IMAGING SOLUTIONS, LTD. DORIT WINITZ PH.D.
K033543 09/17/2004 NARCOTREND, MODEL COMPACT 4.0 MT MONITORTECHNIK GMBH & CO. KG FRIEDMUND WIELAND
K040143 09/13/2004 MONORAIL NATS CORP. RICHARD LANZILLOTTO
K042170 09/07/2004 EN-BLOC BIOPSY SYSTEM MODEL#777-110,777-001,777-002,777-006,777-301,777-302,777-115,777-120 NEOTHERMIA CORPORATION SHERRIE COVAL-GOLDSMITH
K041786 09/08/2004 CALCAMEA PLATE NEWDEAL S.A. NORMA F ESTRIN
K041082 09/07/2004 NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER NEWPORT MEDICAL INSTRUMENTS, INC. RICHARD WATERS
K041844 09/03/2004 ALL SAFE HUBER SAFETY INFUSION SETS NEXUS MEDICAL, LLC AL BOEDEKER
K041779 09/21/2004 NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L NIPRO MEDICAL CORP. KAELYN B HADLEY
K041751 09/16/2004 COMPRESSION ANASTOMOSIS CLIP (CAC) NITI MEDICAL TECHNOLOGIES LTD. ORLY MAOR
K042113 09/14/2004 ZOE FLUID STATUS MONITOR NONINVASIVE MEDICAL TECHNOLOGIES, LLC. ALDEN KAY
K041560 09/28/2004 FLO-ASSISTANT NORTHGATE TECHNOLOGIES, INC. CASEY KUREK
K040858 09/02/2004 ORALIEF THERAPY FOR SENSITIVE TEETH NOVAMIN TECHNOLOGY, INC. DAVID C GREENSPAN
K041705 09/01/2004 RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2 OMNISONICS MEDICAL TECHNOLOGIES ANNE M KULIS
K042202 09/10/2004 TEMPTELLER - HIGH SPEED DIGITAL THERMOMETERS, MODELS DT-302, DT-312, DT-412, DT-502 ORIENTAL SYSTEM TECHNOLOGY, INC. SUSAN D GOLDSTEIN-FALK
K042442 09/24/2004 QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE ORION DIAGNOSTICA OY ANNIKKA RANTAMA
K041764 09/09/2004 THE VITROS 5,1 FS CHEMISTRY SYSTEM ORTHO-CLINICAL DIAGNOSTICS CAREY A MAYO
K042303 09/27/2004 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS ORTHO-CLINICAL DIAGNOSTICS SARAH GLOVER
K041863 09/20/2004 VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS Ortho-Clinical Diagnostics, Inc. MARLENE A HANNA
K042310 09/16/2004 ORTHO-PRO CANNULATED BONE SCREWS ORTHO-PRO LLC J.D. WEBB
K040493 09/03/2004 OUTOLOGOUS SPINAL FIXATION SYSTEM ORTHOPEDIC SCIENCES, INC FLOYD G LARSON
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K033132 09/02/2004 STRYKER SWITCHPOINT INFINITY STRYKER COMMUNICATIONS CORP. NATHAN WOODCOCK
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K041911 09/08/2004 SYNTHES (USA) LCP CURVED PLATES SYNTHES (USA) LISA M BOYLE
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K041909 09/23/2004 VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP) VASCULAR SOLUTIONS, INC. SARA L COON
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K041491 09/20/2004 ZEWA MFM-007 BLOOD PRESSURE MONITOR ZEWA, INC. THOMAS ZEINDLER
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