FDA 510(k) Decisions During August, 2004  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K041687 08/18/2004 ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR ABBOTT LABORATORIES KENT SMITH
K041685 08/30/2004 ACON MULTI-CLIN DRUG SCREEN TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG, PH.D.
K041946 08/16/2004 ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG, PH.D.
K041604 08/16/2004 MACRO-MICRO DEPTH ELECTRODE AD-TECH MEDICAL INSTRUMENT CORP. GARY SYRING
K042246 08/31/2004 MULTI-DRIP INFUSION CATHETER ADVANCED INFUSION, INC. JAMES CHRISTENSEN
K041316 08/05/2004 ANTIMICROBIAL ALGINATE DRESSING ADVANCED MEDICAL SOLUTIONS LTD. JOHN E GREENHAM
K032742 08/16/2004 SILVER FOAM WOUND DRESSING ADVANCED MEDICAL SOLUTIONS LTD. JOHN GREEN
K040191 08/25/2004 BICONTACT HIP STEM AND FEMORAL HEAD AESCULAP JOYCE KILROY
K041120 08/30/2004 EV APAN DIGITAL, MODEL K1VSM2000 AFP IMAGING CORP. JAMES JOHNSON
K042266 08/31/2004 ACCLAIM AIR TECHNIQUES, INC. JOSEPH CAREY
K041585 08/26/2004 AUTOFUSER AMBULATORY INFUSION PUMP ALGOS, LC ROBERT J BARD
K040819 08/16/2004 TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834 AMERICAN I.V. PRODUCTS, INC. GREGORY FALK
K041948 08/11/2004 SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS AMERICAN MEDICAL SYSTEMS, INC. KRISTYN BENSON
K041057 08/12/2004 FLO-RITE AMERIFLO CORP. MATTHEW THIE
K041434 08/06/2004 C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS ANALOGIC CORP. DONALD J SHERRATT
K040082 08/04/2004 PORE-SI BONE GRAFT SUBSTITUTE APATECH LTD. BARRY SALL
K041711 08/26/2004 ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304 APPLIED MEDICAL RESOURCES CORP. CHERYL BLAKE
K041263 08/03/2004 NEUROGUIDE ANALYSIS SYSTEM APPLIED NEUROSCIENCE INC. ROBERT W THATCHER
K041782 08/16/2004 SEEMOR 5.0 IMAGE DISPLAY PROGRAM AREEDA ASSOC., LTD. JOSEPH AREEDA
K042126 08/27/2004 PICC ARROW INTL., INC. SUZANNE SCHORLE
K041589 08/05/2004 ARTHREX FIBERWIRE WITH SILK ARTHREX, INC. ANN WATERHOUSE
K041531 08/03/2004 ASAHI PTCA GUIDE WIRE CONFIANZA PRO ASAHI INTECC CO., LTD. YOSHI TERAI
K041451 08/25/2004 ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50 ASCENSION ORTHOPEDICS, INC. PETER STRZEPA
K041492 08/09/2004 ASTRA TECH IMPLANTS - DENTAL SYSTEM ASTRA TECH, INC. BRUCE R MANNING
K041748 08/09/2004 AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM) AZOG, INC. AZUBUIKE OGALA
K041683 08/27/2004 B. BRAUN BICARBONATE DIALYSATE B. BRAUN MEDICAL, INC. JENNIFER A PUNG
K041415 08/04/2004 EVA TPN CONTAINER B. BRAUN MEDICAL, INC. AMY SMITH
K041508 08/27/2004 BARCOVIEW CORONIS 5MP HD MEDICAL FLAT PANEL DISPLAY SYSTEM BARCO NV BARCOVIEW FRANK FERGUSON
K041998 08/16/2004 PHACO CHOP NEEDLES BAUSCH & LOMB, INC. DENNIS POZZO
K041428 08/27/2004 ACCUSOL DIALYSIS SOLUTION BAXTER HEALTHCARE CORP. DAVID E CURTIN
K041643 08/18/2004 SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT BECKMAN COULTER, INC. MARY BETH TANG
K042061 08/26/2004 0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE BECTON DICKINSON PETER ZURLO
K041384 08/03/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME - GRAM NEGATIVE BECTON, DICKINSON & CO. MICHELLE B BANDY
K041572 08/12/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERCILLIN (GN) 0.5-128 UG/ML BECTON, DICKINSON AND CO. MONICA E GIGUERE
K041889 08/19/2004 TRI-OSTETIC BERKELEY ADVANCED BIOMATERIALS, INC. FRANCOIS GENIN
K041049 08/10/2004 BINAXNOW INFLUENZA A & B TEST BINAX, INC. PAM ANGELL
K041089 08/31/2004 OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM BIOMET MANUFACTURING, INC. PATRICIA SANDBORN BERES
K041970 08/03/2004 BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND 10CC/ML BIOTOP TECHNOLOGY CO., LTD. KE-MIN JEN
K041939 08/17/2004 BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS BLACKSTONE MEDICAL, INC. DEAN E CIPORKIN
K041359 08/20/2004 BODY CLOCK STIMPLUS AND STIMPLUS PRO BODY CLOCK HEALTH CARE LTD RASHELLE PRESTON
K041827 08/06/2004 DUALFLEX RX ERCP CANNULA, MODELS 4681, 4682 BOSTON SCIENTIFIC CORP. PAIGE SWEENEY
K032884 08/06/2004 FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH BOSTON SCIENTIFIC EPI DEBBIE MCINTIRE
K041993 08/16/2004 2 CM PERIPHERAL CUTTING BALOON BOSTON SCIENTIFIC IVT RENUKA KRISHNAN
K040368 08/23/2004 VECTORVISION HIP 3.0 BRAINLAB AG RAINER BIRKENBACH
K042036 08/23/2004 AIRGUARD VALVED INTRODUCER C.R. BARD, INC. GLENN NORTON
K041169 08/24/2004 PIESOMETER, MODEL MK-1 CANAMET CANADIAN NATL MEDICAL TECHNOLOGIES, INC. DANIEL KAMM
K040637 08/06/2004 POWERHEART AED G3 PRO CARDIAC SCIENCE, INC. KENNETH OLSON
K040947 08/27/2004 DURASUL BIPOLAR CENTERPULSE ORTHOPEDICS, INC. AUDREY SWEARINGEN
K041898 08/16/2004 CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM CLINIQA CORPORATION CAROL RUGGIERO
K042078 08/27/2004 ENDOTINE FOREHEAD TRIPLE DEVICE COAPT SYSTEMS, INC. LORI DONDIEGO
K033736 08/11/2004 MERCI RETRIEVER, MODELS 90065, 90066 CONCENTRIC MEDICAL, INC. KEVIN F MACDONALD
K040745 08/11/2004 MODIFIED CONCENTRIC RETRIEVER, MODEL 90038 CONCENTRIC MEDICAL, INC. KEVIN F MACDONALD
K041953 08/09/2004 VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART CONMED CORP. IRA DUESLER
K032831 08/31/2004 PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200 CONMED CORPORATION IRA DUESLER
K033843 08/12/2004 SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING COOK, INC. JENNIFER BOSLEY, MBA
K041796 08/03/2004 PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM CORDIS CORPORATION ELENA S JUGO
K041689 08/06/2004 POLYURETHANE BLOOD PRESSURE CUFFS D. E. HOKANSON, INC. D. EUGENE HOKANSON
K041503 08/12/2004 HOVERJACK AIR PATIENT LIFT DEVICE D.T. DAVIS ENTERPRISES LTD. DAVID T DAVIS
K040580 08/26/2004 AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR D.Y. INSTRUMENT, INC. ANNA D LEE
K041438 08/11/2004 ADVANCED D-DIMER ASSAY DADE BEHRING, INC. KATHLEEN DRAYLYONS
K041878 08/16/2004 N LATEX CYSTATIN DADE BEHRING, INC. KATHLEEN A DRAY-LYONS
K032954 08/09/2004 ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80 DANMETER A/S HANNE NIELSEN
K042154 08/31/2004 GE DATEX-OHMEDA AISYS CARESTATION DATEX-OHMEDA, INC. DAN KOSEDNAR, RAC
K042022 08/12/2004 E-TAC EX-1000 ELECTROCARDIOGRAPHIC EVENT RECORDER DATRIX, INC. DBA OF JON BARRON, INC. LAURA M LUHMANN
K041458 08/24/2004 MARE DENTAL OPERATIVE UNIT DENIMED ELECTRONICA S.H. GEORGE ECHEVERRI
K042178 08/30/2004 ORTHODONTIC CERAMIC BRACKETS DENTSPLY INTL. P. JEFFERY LEHN
K041806 08/03/2004 PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE; AND PASSING NEEDLE WITH ETHIBOND LOOP DEPUY MITEK, A JOHNSON & JOHNSON COMPANY RUTH C FORSTADT
K041205 08/17/2004 EXPEDIUM ANTERIOR SPINE SYSTEM DEPUY SPINE, INC. JENNIFER MOONEY
K041666 08/17/2004 DC-ACETA/SAL CONTROLS DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K040703 08/26/2004 URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS DIRUI INDUSTRIAL CO., LTD. JOSEPH F LUDFORD
K041960 08/30/2004 COMPOSITE/COMPOMER REPAIR KIT DMG USA, INC. PAMELA PAPINEAU
K040380 08/31/2004 DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420 DOLPHIN MEDICAL INC. JON WERNER
K041935 08/16/2004 DR SYSTEMS PACS, RELEASE 6.1 DR. SYSTEMS, INC. KIMBERLY J MEADE
K042086 08/31/2004 FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM DRAEGER MEDICAL, INC. MICHAEL A KELHART
K041956 08/09/2004 EMG - ESSENTIAL GAS MODULE, MODEL M1013A DRAEGET MEDICAL AG & CO. KGAA JAMES J BRENNAN
K041915 08/04/2004 HEMO-DOP DWL ELEKTRONISCHE SYSTEME GMBH GEROLD WIDENHORN
K033918 08/16/2004 EBI LACTOSORB GRAFT CONTAINMENT SYSTEM EBI, L.P. JON CAPAROTTA
K041629 08/06/2004 LYSUS INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K033399 08/04/2004 GEODESIC EEG SYSTEM SERIES 100 ELECTRICAL GEODESICS, INCORPORATED ROBERT S MCQUATE
K041264 08/10/2004 ELEKTA OY ELEKTA NEUROMAG OY BIRGITTA FAGERSTROM
K040314 08/12/2004 HEALICOLL ENCOLL CORP. SUBRAMANIAN GUNASEKARAN
K042017 08/26/2004 BAHA DIVINO ENTIFIC MEDICAL SYSTEMS, INC. CONSTANCE G BUNDY
K041034 08/31/2004 SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL) ENTRACARE, LLC GRACE HOLLAND
K041843 08/24/2004 PENCIL POINT NEEDLE EPIMED INTERNATIONAL, INC. CHRIS LAKE
K040108 08/17/2004 OPUE-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN EST INTERNATIONAL CORPORATION ELIZABETH DENG
K042204 08/23/2004 MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT EV3 INC GLEN D SMYTHE
K040358 08/06/2004 XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 EXCEL TECH. LTD. CAMERON MAHON
K042150 08/27/2004 XLTEK TREX MODEL#10309 EXCEL TECH. LTD. NICOLE LANDREVILLE
K041900 08/31/2004 HC604 CPAP HUMIDIFIER FISHER & PAYKEL HEALTHCARE, LTD. JAMES THOMPSON
K041192 08/12/2004 ARCHITECT STAT TROPONIN-I IMMUNOASSAY FISHER DIAGNOSTICS JOSEFINA INFANTAS
K041400 08/24/2004 FORTIFIER DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LF-01 FORTIFIER INTERNATIONAL CO., LTD. KE-MIN JEN
K041456 08/25/2004 SNAP-OFF SCREWS FOURNITURES HOSPITALIERES INDUSTRIE CHRISTINE QUENDEZ
K041509 08/26/2004 ANKYLOS DENTAL IMPLANT SYSTEM FRIADENT GMBH CAROL PATTERSON
K042023 08/25/2004 FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER FUJIFILM MEDICAL SYSTEM U.S.A., INC. FRANK GIANELLI
K041990 08/06/2004 FUJI MEDICAL CR CONSOLE, MODEL FLASH IIP FUJIFILM MEDICAL SYSTEM U.S.A., INC. FRANK GIANELLI
K042177 08/27/2004 MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES LISA M BAUMHARDT
K042053 08/26/2004 INNOVA 4100, INNOVA 3100 GE MEDICAL SYSTEMS, INC. LARRY A KROGER
K041932 08/18/2004 OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM GE OEC MEDICAL SYSTEMS, INC. JEFF WAGNER
K041931 08/26/2004 OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION GE OEC MEDICAL SYSTEMS, INC. JEFF WAGNER
K041563 08/27/2004 OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS GLAXOSMITHKLINE CONSUMER HEALTHCARE, L.P. ANTHONY G AMITRANO
K041945 08/20/2004 POWDER-FREE BLUE VINYL EXAM GLOVES GLORMED INTL., INC. JANNA P TUCKER
K042218 08/31/2004 ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM GUIDANT CORP. LARAINE PANGELINA
K041762 08/06/2004 FINISHING WIRE SUPPORTRAK GUIDANT CORPORATION JENNIFER TANG
K041981 08/20/2004 GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-2004 GUIDANT CORPORATION M. LAURIE WONG
K040996 08/20/2004 RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM GYRUS ENT L.L.C. ALICIA E FARAGE
K041504 08/06/2004 HEMAMYST SURGICAL APPLICATOR SYSTEM, MODEL H-AS01 HAEMACURE CORP. ELAINE WHITMORE
K040307 08/12/2004 "HANSON SCAR ADE" HANSON MEDICAL, INC. ERIK HANSON
K042265 08/31/2004 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR MODEL# HL888 HEALTH & LIFE CO., LTD. PAUL HUNG
K042273 08/31/2004 MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY HEALTH HERO NETWORK, INC. GEOFFREY J CLAPP
K040741 08/19/2004 ULTRASOUND LOCALIZATION SYSTEM ULS 0142 HMT HIGH MEDICAL TECHNOLOGIES AG TRISH LANDRY
K041266 08/11/2004 PEDIATRIC REFERENCE DATABASE HOLOGIC, INC. ANA RANDALL
K041555 08/09/2004 SECURVIEW DX SOFTCOPY WORKSTATION HOLOGIC, INC. RICHARD FOLLETT
K042080 08/19/2004 TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM HOME DIAGNOSTICS, INC. KAREN DEVINCENT
K040799 08/18/2004 HOMMED GENESIS PATIENT MONITOR SYSTEM WITH OPTIONS HOMMED LLC. TOMMIE J MORGAN
K040651 08/10/2004 HOMMED SENTRY IIIB-F PATIENT MONITOR SYSTEM HOMMED LLC. TOMMIE J MORGAN
K042081 08/24/2004 PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE HOSPIRA, INC. TOM KOZMA
K040734 08/25/2004 MODIFICATION TO RESTORATION MODULAR SYSTEM HOWMEDICA OSTEONICS CORP. GINNY STAMBERGER
K041710 08/03/2004 VERSAWAVE DENTAL ER:YAG LASER SYSTEM HOYA CONBIO JIM GREEN
K041721 08/05/2004 LVI AESTHETIC LASER HOYA PHOTONICS, INC. JIM GREEN
K040798 08/04/2004 HES ULTRASONIC THERAPY APPLIANCE HWANG SUN ENTERPRISE CO., LTD. RICHARD C LANZILLOTTO
K040710 08/11/2004 TEGO NEEDLE FREE ACCESS ACCESS DEVICE ICU MEDICAL, INC. DALE FAIRCHILD
K041517 08/05/2004 INFUSIONCATH, MODELS VI0020, VI20024, VI0028, VI0032, VI0036, VI0040, VI0044 ID LLC MARIO ARBESU
K041728 08/11/2004 HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE IMMUNOSTICS, INC. JEFFREY FLEISHMAN
K031714 08/16/2004 INION TRINION BIODEGRADABLE MENISCUS SCREW INION LTD. HANNA MARTTILA
K041947 08/16/2004 I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND INNOVATIVE IMAGING, INC. CYNTHIA KENDALL
K041650 08/16/2004 MICRO PRIME INNOVX MEDICAL, INC. ELAINE DUNCAN
K041409 08/20/2004 MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799 INOMED GMBH ANDERS SKOGLUND
K040928 08/27/2004 EXPANDABLE PEEK VBR IMPLANT INTERPORE CROSS INTL. WENDY SPIELBERGER
K041973 08/16/2004 MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K041562 08/09/2004 CRYOTIP IRVINE SCIENTIFIC SALES CO., INC. WENDELL LEE
K031813 08/20/2004 OSSATURA DENTAL ISOTIS NV MARY MCNAMARA-CULLINANE
K041433 08/19/2004 BRIGHT GOLD XH IVOCLAR VIVADENT, INC. ANDERJEET GULATI
K032975 08/16/2004 JMS BLOOD TUBING SETS JMS NORTH AMERICA CORP. SWEE CHEAU
K040476 08/26/2004 STORZ MODULITH, MODEL SLX-F2 KARL STORZ ENDOSCOPY-AMERICA, INC. RENATE A MACLAREN
K041677 08/05/2004 KARMA SCOOTER, MODEL KS-747.2 KARMA MEDICAL PRODUCTS CO., LTD. JEN KE-MIN
K041123 08/26/2004 RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG01477/FG01703 KERBEROS PROXIMAL SOLUTIONS, INC. TOM MASON
K041334 08/11/2004 ALCOMATE, MODEL CA2000 KHN SOLUTIONS, LLC DANIEL KAMM
K041461 08/16/2004 KMI DISTAL VOLAR RADIUS PLATE SYSTEM KINETIKOS MEDICAL, INC. JOHN G SPAMPINATO
K042066 08/25/2004 KLSA MARTIN HAND DISTRACTOR KLS-MARTIN L.P. JENNIFER DAMATO
K041378 08/02/2004 BIO 60 KODENT, INC. DAE KYU CHANG
K041262 08/13/2004 DURALITE-GL LASER SCIENTIFIC JOHN CROWNOVER
K040562 08/31/2004 LIFECLINIC, MODEL 2400 LIFECLINIC INTERNATIONAL, INC. GEORGE MYERS
K032291 08/24/2004 TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM LINDE MEDICAL SENSORS AG JEAN-PIERRE PALMA
K041485 08/02/2004 MARPAC MESSENGER MODEL #501 MARPAC, INC. EVELYN TRUJILLO
K041778 08/31/2004 REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T MAXI-AIDS, INC. ELLIOT ZARETSKY
K040315 08/27/2004 MYOHEALTH CLENCHING INHIBITOR MCI-MYOHEALTH SYSTEMS DAVID BALDING
K041974 08/24/2004 MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER MED2000 S.R.L. SUSAN D GOLDSTEIN-FALK
K041194 08/16/2004 ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H MEDICAL ANALYSIS SYSTEMS, INC. MARY THORSNESS
K041419 08/26/2004 LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM MEDICAL ENERGY, INC. DAVID P LEWING
K041780 08/11/2004 NEW BRID MEDICAL IMAGING SOLUTIONS, INC. NANCY BUTCHER
K033685 08/03/2004 NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000 MEDICALCV, INC. DENNY STEGER
K041527 08/19/2004 AARHUS ANCHORAGE SYSTEM MEDICON, E.G. COLLEEN BOSWELL
K041980 08/06/2004 MSI S-500L RF GENERATOR MEDSPHERE INTERNATIONAL, INC ERIC KAO
K041197 08/09/2004 MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K042025 08/25/2004 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K041244 08/12/2004 POLYGRAM NET BIOFEEDBACK APPLICATION MEDTRONIC VASCULAR JULIE GOODE
K041985 08/12/2004 XPS CURVED BUR MEDTRONIC XOMED, INC. MARTIN D SARGENT
K041840 08/20/2004 MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM MEDX, INC. FLOYD R ROWAN
K041445 08/13/2004 IMMUNOCARD STAT! RSV MODEL #750630 MERIDIAN BIOSCIENCE, INC. SUSAN ROLIH
K041003 08/20/2004 IMMUNOCARD TOXINS A & B, MODEL 712050 MERIDIAN BIOSCIENCE, INC. SUSAN ROLIH
K041846 08/26/2004 SABRESOURCE DRAPE MINRAD, INC. JOHN MCNEIRNEY
K042103 08/16/2004 NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL MRI DEVICES CORPORATION TOM SCHUBERT
K041573 08/25/2004 NANMA VACUUM PUMP PROXZEK MODEL 2M9498S NANMA MFG CO., LTD. YOLANDA SMITH
K041320 08/12/2004 MODIFICATION TO NC-STAT NEUROMETRIX, INC. JOSEPH F BURKE
K033580 08/05/2004 NEXFLEX TOTAL HIP SYSTEM NEXMED, INC. ELLEN A YARNALL
K041845 08/24/2004 NEXUS PAV LUER LOCK DEVICE, MODEL NIS-4 NEXUS MEDICAL, LLC AL BOEDEKER
K041661 08/26/2004 NOBEL BIOCARE ENDOSSEOUS IMPLANTS NOBEL BIOCARE UAS INC ELIZABETH J MASON
K041876 08/20/2004 NOBELDIRECT OD IMPLANT NOBEL BIOCARE UAS INC ELIZABETH J MASON
K033587 08/05/2004 SILVERSEAL NOBLE FIBER TECHNOLOGIES PATRICIA DAVIDSON
K041901 08/31/2004 SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER NORTHEAST MONITORING, INC. JOSEPH AZARY
K041613 08/25/2004 NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE NOVABONE PRODUCTS, LLC DAVID M GAISSER
K041371 08/23/2004 BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN NOVAMIN TECHNOLOGY, INC. DAVID C GREENSPAN
K040343 08/03/2004 TEMP F NOVOCOL, INC. STEVE RUDOLPH
K041933 08/18/2004 MICROSELECTRON PDR NUCLETRON CORP. LISA DIMMICK
K040717 08/12/2004 NUNC IVF MULTIDISH 4 WELLS NUNCLON NUNC A/S HENRIK KVISTGAARD
K041447 08/16/2004 NUVASIVE ANTERIOR CERVICAL PLATE SYSTEM NUVASIVE, INC. LAETITIA BERNARD
K042045 08/27/2004 NXSTAGE PUREFLOW-B SOLUTION NXSTAGE MEDICAL, INC. NORMA LEMAY
K041668 08/19/2004 OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT OLYMPUS AMERICA INC. BEV HARDING
K042140 08/18/2004 OLYMPUS BF TYPE UC160-OL8 OLYMPUS CORPORATION TINA STEFFANIE-OAK
K033222 08/02/2004 OLYMPUS STERILIZATION TRAYS OLYMPUS WINTER & IBE GMBH TINA STEFFANIE-OAK
K041720 08/25/2004 VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II ORTHO-CLINICAL DIAGNOSTICS, INC. MARLENE A HANNA
K041799 08/25/2004 VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS ORTHO-CLINICAL DIAGNOSTICS, INC. CAREY MAYO
K041616 08/25/2004 BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID ORTHOS (UK) LIMITED ALAN RORKE
K041809 08/06/2004 PERMANENT PACING LEAD, MODEL PY2 OSCOR INC. MILA DOSKOCIL
K033707 08/16/2004 POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX OSTEOBIOLOGICS, INC. GABRIELE G NIEDERAUER, PH.D.
K041231 08/10/2004 WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M PANBIO LIMITED CRAIG BREADMORE
K041776 08/03/2004 PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. LINDA K DILLON
K041393 08/17/2004 FASSIER-DUVAL TELSCOPIC IM SYSTEM PEGA MEDICAL INC. ARIEL R DUJOVNE
K041076 08/09/2004 DELTA T PENLON LTD. ALAN GREEN
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K042014 08/06/2004 DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400 SEIN ELECTRONICS CO., LTD. JAY MANSOUR
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K041657 08/30/2004 THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT THERMO ELECTRON CORPORATION BOLA NICHOLSON
K041873 08/25/2004 AEQUALIS REVERSED SHOULDER PROSTHESIS TORNIER MIREILLE LEMERY
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