FDA 510(k) Decisions During June, 2004  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K040530 06/25/2004 MEDIA CULTURE SYSTEM INTL., INC. MICHAEL D CECCHI
K041550 06/30/2004 HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE ABBOTT LABORATORIES PATRICIA MELERSKI
K041315 06/10/2004 CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY ACCURAY, INC. ANNE SCHLAGENHAFT
K041165 06/17/2004 FSH MENOPAUSE PREDICTOR TEST ACON LABORATORIES, INC. FRAN WHITE
K041577 06/25/2004 PINNACLE3 RADIATION THERAPY PLANNING SYSTEM ADAC LABORATORIES RANDY VADER
K040817 06/22/2004 POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM ADVANCED UROLOGICAL DEVELOPMENTS GERMAN BORODULIN
K040615 06/01/2004 COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM ADVANCED VASCULAR DYNAMICS HERBERT J SEMLER
K040864 06/17/2004 CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM AESCULAP KATHY A RACOSKY
K040953 06/23/2004 AESKULISA ANA HEP-2 AESKU, INC STANLEY AMMONS
K040712 06/03/2004 AIR SAFETY HEPA, MODEL 3500 AIR SAFETY LTD PAUL DRYDEN
K040874 06/18/2004 RED, WHITE & BLUE ALLESEE ORTHODONTIC APPLIANCES COLLEEN BOSWELL
K041026 06/28/2004 AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S AMBU, INC. SANJAY PARIKH
K040728 06/18/2004 ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND ELVS PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K040674 06/30/2004 IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES ANTHOGYR ERIC GENEVE
K033533 06/24/2004 POWDER FREE LATEX EXAMINATION GLOVES APL INTERNATIONAL INCORPORATED LIMITED LEE SON HONG
K041303 06/18/2004 LED TURBO-PEN APOZA ENTERPRISE CO. LTD. SHIN MIN TEH
K041686 06/30/2004 BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM ARIZANT HEALTHCARE INC. DAVID WESTLIN
K040332 06/16/2004 POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER ARKRAY, INC. HELEN LANDICHO
K041261 06/07/2004 FEMORAL HOOK ARTHROTEK, INC. GARY BAKER
K040604 06/04/2004 INNERVUE DIAGNOSTIC SCOPE SYSTEM ARTHROTEK, INC. KACY ARNOLD
K041158 06/16/2004 ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM ATRION MEDICAL PRODUCTS, INC. DAN CLARK
K033859 06/02/2004 BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY BARCO NV BARCOVIEW FRANK FERGUSON
K041191 06/25/2004 COLLEAGUE VOLUMETRIC INFUSION PUMPS BAXTER HEALTHCARE CORP. JENNIFER M PAINE
K040425 06/14/2004 ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS BAYER HEALTHCARE, LLC KENNETH T EDDS
K040767 06/07/2004 SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT BECKMAN COULTER, INC. ANNETTE HELLIE
K041457 06/28/2004 LIQUICHEK HEMATOLOGY CONTROL (A) BIO-RAD ELIZABETH PLATT
K041444 06/09/2004 BIO-RAD D-10 DUAL PROGRAM BIO-RAD LABORATORIES, INC. JACKIE BUCKLEY
K040030 06/16/2004 BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 BIOCHECK, INC. ROBIN J HELLEN
K040683 06/04/2004 BIODERM SCIENCES WOUND DRESSING BIODERM SCIENCES, INC. EDWARD R GUBISH
K033174 06/30/2004 BMLS03-3 BIOMEDICAL LIFE SYSTEMS, INC. RICHARD SAXON
K040882 06/10/2004 VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442 BIOMERIEUX, INC. SANDRA PERREAND
K040845 06/08/2004 VITEK 2 ESBL TEST BIOMERIEUX, INC. NANCY WEAVER
K040610 06/04/2004 VERSA-DIAL HUMERAL HEAD BIOMET MANUFACTURING, INC. GARY BAKER
K033355 06/30/2004 LACTOSCREW SCREW ANCHOR BIOMET ORTHOPEDICS, INC. MARY L VERSTYNEN
K033489 06/02/2004 AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN BIOMET, INC. PATRICIA SANDBORN BERES
K040611 06/04/2004 MODULAR RADIAL HEAD REPLACEMENT DEVICE BIOMET, INC. PATRICIA SANDBORN BERES
K041331 06/15/2004 BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER BIOPSY SCIENCES, LLC SHARON ROCKWELL
K040437 06/25/2004 TRIAGE PROFILER S.O.B. PANEL BIOSITE INCORPORATED JEFFREY R DAHLEN
K040650 06/03/2004 BONAMATES SERIES BIOTECH ONE, INC. KAREN UYESUGI
K041094 06/17/2004 HSG CATHETER SET BIOTEQUE AMERICA, INC. DENIS DORSEY
K040149 06/03/2004 PSI-TEC PERISTALTIC INFILTRATION PUMP BYRON MEDICAL REGINA S HARRIS
K041546 06/23/2004 DIGITAL FUNDUS CAMERA, MODEL CF-60DSI CANON INC. SHEILA DRISCOLL
K040862 06/30/2004 GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM CARADYNE, LTD. JOHN O'DEA
K041418 06/10/2004 AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER CARDINAL HEALTH LAVENIA FORD
K041180 06/07/2004 QUANTIX OR VESSEL STABILIZER DEVICE CARDIOSONIX, LTD. AHAVA STEIN
K040966 06/02/2004 MODIFICATION TO CAREMATIX WELLNESS SYSTEM CAREMATIX INC. SUKHWANT KHANUJA
K033048 06/01/2004 CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS CAS MEDICAL SYSTEMS, INC. RON JEFFREY
DEN040004 06/25/2004 CELLERATION MIST THERAPY SYSTEM CELLERATION DAVID L BREMSETH
K032378 06/25/2004 CELLERATION MIST THERAPY SYSTEM CELLERATION DAVID L BREMSETH
K031368 06/22/2004 POWDERED LATEX SURGEON'S GLOVES CEPHAS MEDICAL PRIVATE LTD. THANGIAH IMMANUEL
K040579 06/18/2004 CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) CHOLESTECH CORP. THOMAS E WORTHY
K040919 06/01/2004 NUCLEOTOME PROBE SET, MODEL 21200 CLARUS MEDICAL, LLC. TOM BARTHEL
K041130 06/10/2004 CDS HEMATOLOGY CALIBRATOR (CDS CAL) CLINICAL DIAGNOSTIC SOLUTIONS, INC. ANDREW SWANSON
K041518 06/22/2004 CODMAN DURAFORM DURAL GRAFT IMPLANT CODMAN & SHURTLEFF, INC. ELIZABETH DOLAN
K041296 06/10/2004 MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI CODMAN & SHURTLEFF, INC. KATHRYN WUNDER
K041023 06/15/2004 STAY-PUT IMPREGNATED COLTENE/WHALEDENT GMBH & CO. KG HENRY J VOGELSTEIN
K040700 06/21/2004 CONCENTRIC RETRIEVER X5, MODEL 90035; CONCENTRIC RETRIEVER X6, MODEL 90037 CONCENTRIC MEDICAL, INC. KEVIN F MACDONALD
K041146 06/08/2004 CONTROL SOLUTIONS, INC., MODEL CS3102 HVG CONTROL SOLUTIONS, INC. BRETT WALACH
K040413 06/21/2004 CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018" DELIVERY SYSTEM CORDIS EUROPA N.V. KAREN WILK
K040994 06/03/2004 COSMEDENT CORE PASTE COSMEDENT, INC. JAMES L SANDRIK
K041229 06/17/2004 MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL) COSMEDENT, INC. JAMES L SANDRIK
K033743 06/03/2004 COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT COZART BIOSCIENCE LTD. ROBERTO LIDDI
K040933 06/07/2004 ECAT HRRT CTI PET SYSTEMS, INC. M. ALAINE MEDIO
K041569 06/30/2004 CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002 CURELIGHT LTD JONATHAN S KAHN
K040952 06/29/2004 PRELUDE DANVILLE MATERIALS, INC. CRAIG BURNS
K041281 06/07/2004 DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES DATASCOPE CORP. JOANN TAYLOR
K033896 06/16/2004 DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P DEFIBTECH, LLC JOHN L ROGERS
K041335 06/16/2004 PTM SYSTEM DENTSPLY INTERNATIONAL P JEFFERY LEHN
K041372 06/24/2004 SMARTLITE PS PEN-STYLE LED CURING LIGHT DENTSPLY INTERNATIONAL P. JEFFERY LEHN
K041343 06/16/2004 XENO NM LIGHT CURED DENTAL ADHESIVE DENTSPLY INTERNATIONAL P. JEFFERY LEHN
K040906 06/16/2004 CALIBRA CEMENT DENTSPLY INTL. P. JEFFERY LEHN
K041141 06/16/2004 DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125 DENTSPLY INTL. P. JEFFERY LEHN
K041203 06/02/2004 SUMMIT OCT SPINAL SYSTEM DEPUY SPINE, INC. SHARON STAROWICZ
K040655 06/02/2004 SWIFT ANTERIOR CERVICAL PLATE SYSTEM DEPUY SPINE,INC SHARON STAROWICZ
K040474 06/23/2004 ACCUSOFT DIREX SYSTEMS CORP. LARISA GERSTEIN
K040612 06/17/2004 SKY BONE EXPANDER SYSTEM (SKY SYSTEM) DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. YAEL RUBIN
K033785 06/18/2004 PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE DISCUS DENTAL, INC. VIVIAN LAI
K040443 06/16/2004 DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I DOME IMAGING SYSTEMS, INC. SUSAN HAMANN
K040847 06/17/2004 MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR DRAEGER MEDICAL, INC. GALE E WINARSKY
K040642 06/02/2004 LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA DRAEGET MEDICAL AG & CO. KGAA JAMES J BRENNAN
K040911 06/22/2004 VITALHEAT DYNATHERM MEDICAL, INC. JOHN R KANE
K040729 06/02/2004 SOLARIS D890 THERAPY PROBE DYNATRONICS CORP. RON HATCH
K041198 06/01/2004 NIC36 AMPLIFIER EB NEURO, S.P.A. CARRI GRAHAM
K040908 06/25/2004 EBI DISTAL RADIUS PLATING SYSTEM EBI, L.P. FREDERIC TESTA
K033464 06/22/2004 EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE EDWARDS LIFESCIENCES LLC. JASON SMITH
K041597 06/24/2004 MONOCHROME LCD MONITOR, MODEL RADIFORCE G22 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K034043 06/30/2004 H-FLOW VALVE ELCAM MEDICAL A.C.A.L. TALI HAZAN
K040071 06/03/2004 ENNOBLE DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN ELITE INTERNATIONAL, INC. BOBBY LING
K040220 06/09/2004 MEDICAL AIR COMPRESSOR EVENT MEDICAL LTD ROBBIE WALSH
K040613 06/04/2004 EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS EXACTECH, INC. GARY MILLER
K040755 06/17/2004 EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE EXACTECH, INC. REBECCA ROBERTS
K041280 06/24/2004 HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500 FELTON INTERNATIONAL, INC. JIM STANLEY
K041240 06/02/2004 SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED FERTILITY SOLUTIONS, INC. SUSAN A ROTHMANN, PH.D., HCLD
K040956 06/14/2004 HILUX LEDMAX 3 FIRST MEDICAL INFECTION CONTROL ASSOCIATES, INC. DAVID SMALL
K040941 06/10/2004 CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES) FISHER & PAYKEL HEALTHCARE, LTD. JAMES THOMPSON
K040854 06/30/2004 WEST NILE VIRUS IGM CAPTURE ELISA FOCUS TECHNOLOGIES, INC. MICHAEL J WAGNER
K031939 06/24/2004 BIO-EUROLIG INTERFERENCE SCREW FOURNITURES HOSPITALIERES INDUSTRIE CHRISTINE QUENDEZ
K040048 06/07/2004 FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM FUJINON, INC. JOSEPH M AZARY
K033711 06/03/2004 FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM FUKUDA DENSHI USA, INC. LARRY D WALKER
K041471 06/29/2004 G-BOND GC AMERICA INC. TERRY L JORITZ
K041398 06/25/2004 GC FUSION GC AMERICA, INC. TERRY L JORITZ
K041543 06/22/2004 GE DISCOVERY ST GE HEALTHCARE LARRY A KROGER
K041220 06/15/2004 GE DISCOVERY ST SYSTEM GE MEDICAL SYSTEMS DAVID DUERSTELER
K040458 06/03/2004 MODIFICATION TO DASH 3000/4000 PATIENT MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MELISSA ROBINSON
K040559 06/04/2004 MODIFICATION TO UNITY NETWORK ID GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES DIANA M THORSON
K041476 06/17/2004 GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM GE MEDICAL SYSTEMS, LLC LARRY A KROGER PH.D.
K041521 06/22/2004 VOLUME VIEWER PLUS GENERAL ELECTRIC MEDICAL SYSTEMS LARRY KRUEGER
K041605 06/30/2004 PRECISION RXI ANALOG X-RAY SYSTEM GENERAL MEDICAL MERATE S.P.A. KEVIN WALLS
K040241 06/25/2004 N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET GENZYME CORP. FRED D LASKY
K040868 06/04/2004 SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH GENZYME CORP. MICHAEL G HALPIN
K040721 06/17/2004 ASSURE ANTERIOR CERVICAL PLATE SYSTEM GLOBUS MEDICAL, INC. KELLY J BAKER
K041341 06/03/2004 GOLDEN SPYDER, MODEL GS-300 GOLDEN TECHNOLOGIES, INC. GENE R KULON
K041188 06/01/2004 GRAND WORK PLASTICS PRODUCTS CO., LTD., SYNTHETIC VINYL PATIENT EXAMINATION GLOVES - POWDERED GRAND WORK PLASTIC PRODUCTS CO., LTD. JAMES CHU
K040681 06/03/2004 SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE GRAND WORK PLASTIC PRODUCTS CO., LTD. JAMES CHU
K041051 06/30/2004 RAICHEM BUN RATE REAGENT (LIQUID) HEMAGEN DIAGNOSTICS, INC. JAMES J MILLER
K041009 06/25/2004 RAICHEM CALCIUM (OCPC) LIQUID REAGENT HEMAGEN DIAGNOSTICS, INC. JAMES J MILLER
K041052 06/30/2004 RAICHEM GLUCOSE UV (LIQUID) HEMAGEN DIAGNOSTICS, INC. JAMES J MILLER
K041234 06/10/2004 HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM HEMOCUE, INC. R.J. SLOMOFF
K041580 06/29/2004 IMAGERAYI HENRY SCHEIN, INC. W. EDWARD JOHANSEN
K041035 06/09/2004 HOFFRICHTER TREND 110 CPAP DEVICE WITH AQUATREND III CPAP HUMIDIFIER ACCESSORY FOR TREND HOFFRICHTER GMBH STEPHEN GORSKI
K040749 06/17/2004 MODULAR REPLACEMENT SYSTEM CEMENTED STEMS HOWMEDICA OSTEONICS CORP MARGARET F CROWE
K040926 06/10/2004 ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000 HUDSON DIAGNOSTIC IMAGING LLC MARTIN E WENDELKEN
K041313 06/18/2004 STABIL-O-GRAPH I.E.M. GMBH GUENTER GINSBERG
K040834 06/03/2004 NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000 IMAGE-GUIDED NEUROLOGICS, INC. DAVID M LEE
K041077 06/25/2004 IMALUX OCT PROBE GUIDE IMALUX CORPORATION STEPHANIE A.S. HARRINGTON
K040407 06/03/2004 QUICKELISA ANTHRAX-PA KIT IMMUNETICS, INC. ANDREW LEVIN
K041402 06/16/2004 MODIFICATION TO OSSEOTITE NT CERTAIN IMPLANTS IMPLANT INNOVATIONS, INC. JEANNETTE G DAILEY
K041590 06/23/2004 AUTODETECT SYRINGE INDIGO ORB, INC. ROBERT CHIN
K041500 06/21/2004 STARPACS ORTHOPEDICS SYSTEM INFINITT CO., LTD. CARL ALLETTO
K040885 06/25/2004 QUANTA LITE GP210 ELISA INOVA DIAGNOSTICS, INC. GARY L NORMAN
K041201 06/03/2004 ULTRACLIP II MR INRAD MELISSA LALOMIA
K040063 06/24/2004 INSPEKTOR PRO INSPEKTOR DENTAL CARE BV ELBERT WALLER
K033776 06/25/2004 INSTEAD INTIMATE LUBRICANT INSTEAD, INC. JOE PIKE
K033984 06/30/2004 STRAUMANN DENTAL IMPLANT SYSTEM INSTITUT STRAUMANN AG LINDA JALBERT
K040860 06/17/2004 INTEGRA BONE FIXATION SYSTEM INTEGRA LIFESCIENCES CORPORATION DONNA R WALLACE
K041581 06/22/2004 COMPACS, VERSION 1.0 INTELLIGENT IMAGES SRL MAURIZIO PAIGGIO
K041048 06/04/2004 POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE INTERNACIONAL FARMACEUTICA, S.A. DE C.V. CAROLANN KOTULA
K040853 06/21/2004 PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101 INTERNATIONAL HOSPITAL SUPPLY CO. ANGELIKA SCHERP
K033819 06/04/2004 INVACARE 3G TARSYS INVACARE CORP. CARROLL MARTIN
K041108 06/22/2004 ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA ISCIENCE SURGICAL CORPORATION JUDY F GORDON
K032767 06/03/2004 LILY VOLUME METERIC ADMINISTRATION SET, MODELS IB-2111 AND CIB-120ES LILY MEDICAL SUPPLIES CO., LTD. KE-MIN JEN
K041288 06/10/2004 MODIFICATION TO SMARTPIN LINVATEC BIOMATERIALS, INC. TUIJA ANNALA
K041204 06/29/2004 NC SP02 ADAPTER CABLE MASIMO CORP. JAMES J CRONIN
K041332 06/25/2004 JOEY CLAMP OPENING TOOL MATERNUS, INC. RONALD B HICKS
K040484 06/09/2004 MAXO2+, MODEL "A" AND "AE" MAXTEC, INC. GORDON R ROTH
K040659 06/01/2004 MCCUE PLC ENERGIST ULTRA VARIABLE PULSED LIGHT SYSTEM MCCUE PLC STEVEN PEACH
K041179 06/04/2004 MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR MEDEGEN MEDICAL MANUFACTURING SERVICES, INC. TIM TRUITT
K041448 06/16/2004 HEXAPOD RT COUCHTOP MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH SANDOR CSABA ATS
K033118 06/28/2004 BIPRO MODEL SDS-CB200 MEDICAL SOLUTIONS INTERNATIONAL JACK DILLON
K040837 06/17/2004 MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE MEDICEL AG GEORGE MYERS
K040746 06/08/2004 MRA-CMS MEDIS MEDICAL IMAGING SYSTEMS, B.V. J.I. HOLLANDER
K032948 06/25/2004 ELASTIC SKIN LIQUID BANDAGE MEDPAK, LLC JOSEPH G SANT'ANGELO
K040943 06/15/2004 MEDTRONIC PS MEDICAL STRATA VALVE MEDTRONIC NEUROSURGERY JEFF HENDERSON
K041030 06/30/2004 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K041452 06/24/2004 MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K041282 06/10/2004 MODIFICATION TO TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K040869 06/01/2004 EXPORT CATHETER MEDTRONIC VASCULAR FRED L BOUCHER
K040699 06/04/2004 LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS) MEGADYNE MEDICAL PRODUCTS, INC. RONDA MAGNESON
K023956 06/17/2004 THERMOMETER MODELS ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F MESURE TECHNOLOGY CO.,LTD. JOHN CHEN
K040704 06/18/2004 MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLICATOR MICK RADIO-NUCLEAR INSTRUMENTS, INC. FELIX MICK
K040316 06/23/2004 CEDIA BUPRENORPHINE ASSAY MICROGENICS CORP. DAVID CASAL
K040723 06/10/2004 MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE) MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K041200 06/17/2004 THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000 MIGUN MEDICAL INSTRUMENT CO. LTD. EDWARD A KROLL
K040807 06/09/2004 MIS DENTAL IMPLANT SYSTEM MIS - IMPLANT TECHNOLOGIES LTD. MOTTI WEISMAN
K030831 06/15/2004 LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS MODERN MEDICAL EQUIPMENT MFG., LTD. DAVID LOU
K032327 06/15/2004 MODERN MEDICAL BIPOLAR FORCEPS MODERN MEDICAL EQUIPMENT MFG., LTD. DAVID LOU
K040238 06/22/2004 SOFTSEAL HSG CATHETER MODERN MEDICAL EQUIPMENT MFG., LTD. AL MUZZAMMEL
K040663 06/30/2004 TELENABLE EMS SYSTEM MOLEX, INC. EUGENE H DIBBLE
K032836 06/18/2004 M3 MICROKERATOME MORIA S.A. MELANIE RENAUD-SAMIRI
K033512 06/03/2004 PROCYON SPINAL SYSTEM NAS MEDICAL TECHNOLOGIES, INC. MAKOTO NONAKA
K041212 06/09/2004 HOUVA 3 PHOTOTHERAPY SYSTEM NATIONAL BIOLOGICAL CORP. LORETTA MOONEY
K040310 06/17/2004 NOVA FAMILY OF MEDICAL RADIOLOGY DISPLAYS NATIONAL DISPLAY SYSTEMS RON HANSEN
K041347 06/04/2004 MODIFICATION TO EN-BLOC BIOPSY SYSTEM NEOTHERMIA CORP. SHERRIE COVAL-GOLDSMITH
K041542 06/17/2004 CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS NEUSOFT DIGITAL MEDICAL SYSTEMS CO., LTD. WANG ZHIQIANG
K040813 06/08/2004 NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022 NICHOLS INSTITUTE DIAGNOSTICS JIMMY WONG
K040395 06/01/2004 CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES NIHON KOHDEN AMERICA, INC. SERRAH NAMINI
K041156 06/09/2004 AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001 NONIN MEDICAL, INC. JOHN R DALPEE
K040589 06/03/2004 MODIFICATION TO AVANT 9600 PULSE OXIMETER NONIN MEDICAL, INC. JOHN R DALPEE
K040753 06/10/2004 R-TEST EVOLUTION 3 NOVACOR DOMINIQUE GRENIER
K041306 06/10/2004 NUMED PTS X SIZING BALLOON CATHETER NUMED, INC. NICHELLE LAFLESH
K040830 06/18/2004 PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS NUMED, INC. NICHELLE R LAFLESH
K030195 06/17/2004 BBP BONE SUBSTITUTES OCT, USA, INC. KEVIN WALLS
K040689 06/10/2004 EYE SPHERE IMPLANTS OCULO PLASTIK, INC. JEAN-FRANCOIS DRETTE
K040900 06/15/2004 S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR OPTICAL CONNECTION, INC. GAROLD L EDWARDS
K040654 06/04/2004 SENSILASE PAD 3000 OPTICAL SENSORS, INC. GARY SYRING
K041440 06/25/2004 OPUS MAGNUM ANCHOR WITH INSERTER OPUS MEDICAL, INC. LAURA N KASPEROWICZ
K041370 06/24/2004 LIFESTENT LP SDS BILIARY ENDOPROSTHESIS ORBUS MEDICAL TECHNOLOGIES JIM CLOSSICK
K041322 06/17/2004 VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS ORTHO-CLINICAL DIAGNOSTICS, INC. SARAH PARSONS
K040850 06/24/2004 TSY SHOULDER PLATE IMPLANT ORTHOPEDIC SCIENCES, INC FLOYD G LARSON
K041369 06/22/2004 NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017 ORTHOSOFT, INC. CHRISTOPHER MCLEAN
K040661 06/09/2004 RADENT PROPHY PASTE PASCAL CO., INC. VINCENT M TENTARELLI
K041214 06/07/2004 PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. LINDA K DILLON
K041395 06/09/2004 EG-3630UR PENTAX PRECISION INSTRUMENT CORP. PAUL SILVA
K041397 06/09/2004 EG-3830UT PENTAX PRECISION INSTRUMENT CORP. PAUL SILVA
K041396 06/09/2004 FG-36UX FIBER ULTRASOUND GASTROSCOPE PENTAX PRECISION INSTRUMENT CORP. PAUL SILVA
K041401 06/04/2004 MODIFICATION TO M2376A DEVICELINK SYSTEM PHILIPS MEDICAL SYSTEMS HERBERT VAN DYK
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K040391 06/02/2004 TOTAL BILIRUBIN REAGENT SET POINTE SCIENTIFIC, INC. RON JAMISON
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K040364 06/30/2004 MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH POREX SURGICAL, INC. HOWARD MERCER
K040720 06/03/2004 SURGASSIST COMPUTER MEDIATED LINEAR CUTTER DIGITAL LOADING UNITS, 30 MM, 55 MM, 75 MM POWER MEDICAL INTERVENTIONS, INC. BARBARA J WHITMAN
K040987 06/18/2004 CRYOCHECK CLOT C PRECISION BIOLOGIC INC. STEPHEN L DUFF
K033402 06/30/2004 PORTABLE SLEEP DATA RECORDER (PSDR) PRO-TECH SERVICES, INC. NEIL SHELLER
K040791 06/03/2004 POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) PT. SMART GLOVE INDONESIA FOO KHON PU
K040790 06/03/2004 MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS PULMONETIC SYSTEMS, INC. ROBERT C SAMEC
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K040257 06/14/2004 QUEST DIAGNOSTICS HAIRCHECK-DT (THC) QUEST DIAGNOSTICS, INC. PATRICK CARPENTER
K041380 06/08/2004 IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR R2 TECHNOLOGY, INC. KATHY O'SHAUGHNESSY
K033884 06/09/2004 RANDOX AMIKACIN RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
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K041366 06/08/2004 IPACS ORTHO REAL TIME IMAGE INC. CARL ALLETTO
K040617 06/15/2004 RELIANT LASER SYSTEM II RELIANT TECHNOLOGIES, INC. HEATHER TANNER
K040944 06/03/2004 RESCONTROL II RESMED LTD. DAVID D'CRUZ
K033276 06/07/2004 VPAP III ST-A RESMED LTD. DAVID D'CRUZ
K041412 06/18/2004 ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000 RESPIRONICS CALIFORNIA, INC. MARY FUNK
K041450 06/18/2004 MODIFICATION TO NICO WITH MARS, MODEL 7300 RESPIRONICS NOVAMETRIX, INC. KEVIN MADER
K040187 06/21/2004 MEDICINAL LEECHES RICARIMPEX SAS BRIGITTE LATRILLE
K033477 06/10/2004 HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT ROCHESTER MEDICAL CORP. ROB ANGLIN
K041385 06/07/2004 MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM SCHICK TECHNOLOGIES, INC. DANIEL MICHAELI
K040747 06/17/2004 ALADYN RIGID SPINE PLATE SCIENT'X J.D. WEBB
K032983 06/01/2004 SENSITIVE SKIN ANTIBACTERIAL BANDAGES SCIVOLUTION, INC. ARTHUR WARD
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K040687 06/25/2004 ONEDOSE PATIENT DOSIMETRY SYSTEM SICEL TECHNOLOGIES INC TAMMY B CARREA
K041319 06/07/2004 SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. ISKRA MRAKOVIC
K040675 06/10/2004 AXIOM ARTIS U SIEMENS MEDICAL SYSTEMS, INC. DEBRA PEACOCK
K040950 06/21/2004 ALOCLAIR ORAL GEL SINCLAIR PHARMACEUTICALS, LTD. MICHAEL KILLEEN
K040680 06/14/2004 CONTOUR HA COATED RECONSTRUCTION RING SMITH & NEPHEW, INC. JOHN REABE
K040789 06/04/2004 DURABRAID SUTURE SMITH & NEPHEW, INC. BILL MCCALLUM
K033552 06/10/2004 JAX-TCP SMITH & NEPHEW, INC. KIM P KELLY
K041216 06/07/2004 SMITH & NEPHEW ULTRABRAID SUTURE SMITH & NEPHEW, INC. DENISE LIMA
K041455 06/10/2004 SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM SONOSCAPE COMPANY LIMITED BOB LEIKER
K041050 06/15/2004 DIGORA OPTIME (OR DIGORA ONTIME) SOREDEX PALODEX GROUP OY KAI LANER
K033303 06/24/2004 WAFER SYSTEM SPINE WAVE, INC. RONALD K SMITH
K041017 06/25/2004 SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK SPS MEDICAL SUPPLY CORP. GARY J SOCOLA
K032412 06/10/2004 RE-USEABLE MICROSTAAR INJECTOR, MSI-S STAAR SURGICAL CO. JASON K LYON
K041383 06/14/2004 STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 AND 1100C-230 STELLARTECH RESEARCH CORP. GARY A SEEGER
K041307 06/14/2004 MODIFICATION TO STRYKER XCEL ANCHOR SYSTEM STRYKER ENDOSCOPY MELISSA MURPHY
K041305 06/14/2004 STRYKER BIOZIP SUTURE ANCHOR SYSTEM STRYKER ENDOSCOPY MELISSA MURPHY
K041310 06/14/2004 STRYKER WEDGE SUTURE ANCHOR SYSTEM STRYKER ENDOSCOPY MELISSA MURPHY
K041040 06/16/2004 VARELISA MPO ANCA, MODEL 17648/17696 SWEDEN DIAGNOSTICS (GERMANY) GMBH MICHAEL LINSS
K041022 06/17/2004 NEUROQ - PET DP SYNTERMED, INC. KENNETH F VAN TRAIN
K040777 06/18/2004 LCP RADIAL HEAD PLATING SYSTEM SYNTHES (USA) LISA M BOYLE
K040701 06/15/2004 SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS SYNTHES (USA) SHERI L MUSGNUNG
K033868 06/21/2004 SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS SYNTHES (USA) LISA M BOYLE
K041107 06/18/2004 TAIDOC CHECK TAIDOC TECHNOLOGY CORPORATION SHU-MEI WU
K040748 06/02/2004 ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM TAKARA BELMONT USA, INC. ROBERT SCHIFF
K033790 06/03/2004 THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES TECNIMED S.R.L. CAROLANN KOTULA
K040135 06/21/2004 THERMAGE THERMACOOL SYSTEM THERMAGE, INC. PAMELA M BUCKMAN
K041199 06/01/2004 MEDI-PUMP ASPIRATOR, MODEL 1615 THOMAS INDUSTRIES DANIEL PFISTER
K040713 06/01/2004 MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM THOMAS MEDICAL PRODUCTS, INC. TIM STOUDT
K041557 06/25/2004 MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W THOMSON & NIELSEN ELECTRONICS, LTD. MARY HERBERT
K034053 06/24/2004 TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030 & TMS-3040 TIARA MEDICAL SYSTEMS, INC. GEOFFREY SLEEPER
K041339 06/17/2004 AEQUALIS SHOULDER SYSTEM TORNIER MIREILLE LEMERY
K041499 06/10/2004 SSA-770A, APLIO VERSION 5.5 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K040695 06/07/2004 21,3-INCH (54CM) MONOCHROME LCD MONITOR ME213L (MDL2108A) TOTOKU ELECTRIC CO., LTD MIKIO HASEGAWA
K040697 06/10/2004 21.3-INCH (54CM) COLOR LCD MONITOR CCL212 (CDL2107A) TOTOKU ELECTRIC CO., LTD MIKIO HASEGAWA
K032438 06/30/2004 MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE TYCO HEALTHCARE DAVID OLSON
K040511 06/28/2004 SCD EXPRESS PORTABLE COMPRESSION SYSTEM TYCO HEALTHCARE/KENDALL BRIDGET GARDNER
K041404 06/08/2004 CLEARBLUE EASY EASY READ PREGNANCY TEST UNIPATH LTD. LOUISE ROBERTS
K040494 06/23/2004 CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144 UNITED STATES ENDOSCOPY GROUP, INC. GRETCHEN Y COHEN
K040836 06/10/2004 DISPOSABLE OVERTUBE UNITED STATES ENDOSCOPY GROUP, INC. GRETCHEN Y COHEN
K041545 06/30/2004 CONTACT DETACH UNOMEDICAL A/S JOHN M LINDSKOG
K041487 06/17/2004 QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT USA INSTRUMENTS, INC. JAMES WRENN
K040333 06/07/2004 VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR WITHOUT VISORS, TIES AND EARLOOPS VALUMAX INTL., INC. JANET JIA
K033960 06/15/2004 OLINDA/EXM VANDERBILT UNIVERSITY MICHAEL STABIN
K040730 06/18/2004 VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP VASCULAR SOLUTIONS, INC. DEBORAH L NEYMARK
K040726 06/03/2004 VENTLAB NASAL CPAP CANNULA VENTLAB CORP. ROBERT M KELLY
K040898 06/28/2004 CELLSEARCH EPITHELIAL CELL CONTROL KIT VERIDEX, LLC DEBRA J RASMUSSEN
K040171 06/08/2004 MICRODERM, MODEL/VERSION 3.5 VISIOMED AG JOHN GREENBAUM
K041309 06/30/2004 IMASK TM VITAL SIGNS, INC. THOMAS DIELMANN
K040638 06/07/2004 VNUS RADIOFREQUENCY GENERATOR, MODEL RFG2 VNUS MEDICAL TECHNOLOGIES, INC. SAM NANAVATI
K041134 06/02/2004 COMBOMAP PRESSURE AND FLOW SYSTEM VOLCANO THERAPEUTICS, INC. LORRY W HUFFMAN
K040657 06/10/2004 BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80 VYGON S A LAETITIA BERNARD
K041124 06/07/2004 IRRIGATION TUBING SET 2.2M AND 3.8M W&H DENTALWERK BURMOOS RALF BENDA
K041308 06/28/2004 REMOTENURSE PATIENT MONITORING SYSTEM WEBVMC, LLC JAY MANSOUR
K040800 06/25/2004 WILOSN-COOK BILIARY DILATION BALLOON WILSON-COOK MEDICAL, INC. MARGE WALLS-WALKER
K040794 06/10/2004 INCUBATOR CAPE WRAPPED IN COMFORT JANE GETSLA
K041425 06/25/2004 CONSERVE PLUS REVISION SHELL AND CONSERVE PLUS THICK SHELL WRIGHT MEDICAL TECHNOLOGY, INC. KATIE LOGEROT
K040967 06/16/2004 DISPOSABLE POWDER FREE VINYL EXAMINATION GLOVES ZI BO HONG WANG PLASTIC & RUBBER PRODUCTS CO. LTD. HUAN-CHUNG LI


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