FDA 510(k) Applications Received During April, 2004

FDA 510(k) Number Submission Date Device Name Applicant Contact
K040857 04/07/2004 MODIFICATION TO ADPER PROMPT 3M ESPE AG DENTAL PRODUCTS ANDREAS PETERMANN
K040954 04/13/2004 FOX PLUS PTA CATHETER ABBOTT LABORATORIES INC JOANNA KUSKOWSKI
K041140 04/30/2004 ACELL UBM SURGICAL MESH ML AND MLPLUS ACELL, INC PATSY J TRISLER
K040949 04/12/2004 VIADUCT MINISCOPE AND ACCESSORIES ACUEITY, INC. NANCY LINCE
K040883 04/05/2004 EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM ADVANCED STERILIZATION PRODUCTS NEELU MEDHEKAR
K040817 04/01/2004 POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM ADVANCED UROLOGICAL DEVELOPMENTS GERMAN BORODULIN
K040615 04/16/2004 COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM ADVANCED VASCULAR DYNAMICS HERBERT J SEMLER
K040865 04/02/2004 AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER AESCULAP MATTHEW M HULL
K040864 04/02/2004 CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM AESCULAP KATHY A RACOSKY
K040953 04/12/2004 AESKULISA ANA HEP-2 AESKU, INC STANLEY AMMONS
K040874 04/02/2004 RED, WHITE & BLUE ALLESEE ORTHODONTIC APPLIANCES COLLEEN BOSWELL
K041026 04/21/2004 AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S AMBU, INC. SANJAY PARIKH
K040991 04/16/2004 AMBU DISPOSABLE PRESSURE MANOMETER AMBU, INC. SANJAY PARIKH
K041057 04/23/2004 FLO-RITE AMERIFLO CORP. MATTHEW THIE
K040995 04/26/2004 SYNERAD MULTI DIGITAL X-RAY SYSTEM, MODEL AN6150 ANALOGIC CORP. DONALD J SHERRATT
K040671 04/16/2004 EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES ANTHOGYR ERIC GENEVE
K040674 04/16/2004 IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES ANTHOGYR ERIC GENEVE
K041137 04/30/2004 NEWTOM 3G QR-DVT 9000 APERIO SERVICES, LLC K. ROBERT WISNER
K041131 04/30/2004 APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR APPLE MEDICAL CORP. JOHN C PULFORD
K040760 04/08/2004 MODIFICATION TO URETERAL STENT APPLIED MEDICAL RESOURCES CORP. CHERYL BLAKE
K040866 04/08/2004 FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST ARMKEL LLC STEPHEN C KOLAKOWSKY
K040801 04/06/2004 INTRA-AORTIC BALLOON (IAB) ARROW INTL., INC. WILLIAM PAQUIN
K040907 04/07/2004 ARTHREX SMALL FRAGMENT PLATES AND SCREWS ARTHREX, INC. SALLY FOUST
K040913 04/08/2004 NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) BAUSCH & LOMB DAVID THOMAS
K040985 04/15/2004 PUMP CONNECTIVITY INTERFACE BAXTER HEALTHCARE CORP. JENNIFER M PAINE
K041133 04/30/2004 MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER BAYER HEALTHCARE, LLC ANDRES HOLLE
K041074 04/26/2004 BD FACSCANTO WITH BD FACSANTO SOFTWARE BD BIOSCIENCES KIM FONDA
K041071 04/26/2004 BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381 BECTON DICKINSON & CO. JING ZHANG
K041049 04/22/2004 BINAXNOW INFLUENZA A & B TEST BINAX, INC. PAM ANGELL
K041136 04/30/2004 MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTS BIO-LOK INTL., INC. ELAINE DUNCAN
K040872 04/02/2004 VARIANT II HEMOGLOBIN A1C BIO-RAD LABORATORIES, INC. JACKIE BUCKLEY
K041002 04/19/2004 FIDIS CELIAC BIOMEDICAL DIAGNOSTICS S.A. PASCALE LAROCHE
K040824 04/09/2004 INTERFERENTIAL STIMULATOR, MODEL BMLS03-6 BIOMEDICAL LIFE SYSTEMS, INC. GARY BUSSETT
K040882 04/05/2004 VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442 BIOMERIEUX, INC. SANDRA PERREAND
K040845 04/01/2004 VITEK 2 ESBL TEST BIOMERIEUX, INC. NANCY WEAVER
K041089 04/26/2004 OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM BIOMET MANUFACTURING, INC. PATRICIA SANDBORN BERES
K041046 04/22/2004 MAXIM ACCEL (VANGUARD) PS+ BEARINGS BIOMET, INC. TRACY J BICKEL
K041094 04/27/2004 HSG CATHETER SET BIOTEQUE AMERICA, INC. DENIS DORSEY
K040942 04/12/2004 VST3 BIOWATCH MEDICAL, INC. URSULA E WILSON
K040787 04/01/2004 MODIFICATION TO SURGICAL MESH POLYMERIC BOSTON SCIENTIFIC DONNA M GARDNER
K040776 04/02/2004 ATLANTIS SR, MODEL C4020; ATLANTIS SR PLUS, MODEL 35975 BOSTON SCIENTIFIC CORP. ROBERT Z PHILLIPS
K040893 04/06/2004 EASY CORE BIOPSY SYSTEM BOSTON SCIENTIFIC CORP. CHRISTINE M CAMERON
K040867 04/02/2004 PERIVAC KIT, MODELS 4304, 4305, 4314, 4315 BOSTON SCIENTIFIC CORP. RONALD C ALLEN
K040887 04/14/2004 B-R-A-H-M-S PCT LIA BRAHMS AKTIENGESELLSCHAFT MELISSA MAHALL
K040931 04/26/2004 PATXFER RT BRAINLAB, AG RAINER BIRKENBACH
K041088 04/26/2004 TRIFUSION, MODEL 0609190/0659350 C.R. BARD, INC. LYNN M KIRCHOFF
K040986 04/27/2004 CADWELL LIMB MOVEMENT MODULE CADWELL LABORATORIES, INC. CHRIS BOLKAN
K040932 04/27/2004 EASYNET BODY POSITION MODULE CADWELL LABORATORIES, INC. CHRIS BOLKAN
K040957 04/14/2004 NOA III ENTERAL NUTRITION PUMP CAESAREA MEDICAL ELECTRONICS LTD. GALI TZURY
K040862 04/02/2004 GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM CARADYNE, LTD. JOHN O'DEA
K040966 04/14/2004 MODIFICATION TO CAREMATIX WELLNESS SYSTEM CAREMATIX INC. SUKHWANT KHANUJA
DEN040004 04/29/2004 CELLERATION MIST THERAPY SYSTEM CELLERATION DAVID L BREMSETH
K040947 04/12/2004 DURASUL BIPOLAR CENTERPULSE ORTHOPEDICS, INC. AUDREY SWEARINGEN
K041060 04/23/2004 E-Z LUBRICATING JELLY CHESTER LABS, INC. JOHN B ARMSTRONG
K040910 04/08/2004 INFANT INCUBATOR, MODEL CHS-I1000 CHOONGWAE MEDICAL CORP. RONALD D ARKIN
K040919 04/08/2004 NUCLEOTOME PROBE SET, MODEL 21200 CLARUS MEDICAL, LLC. TOM BARTHEL
K040927 04/09/2004 LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS CLINIQA CORPORATION CAROL RUGGIERO
K040849 04/01/2004 MENTAMOVE COLE & ASSOCIATES RICHARD O WOOD
K040888 04/06/2004 DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE COLLAGEN MATRIX, INC. PEGGY HANSEN
K041098 04/27/2004 COOL TEMP NATURAL COLTENE AG STEPHAN KAGI
K041023 04/20/2004 STAY-PUT IMPREGNATED COLTENE/WHALEDENT GMBH & CO. KG HENRY J VOGELSTEIN
K041020 04/20/2004 CADSTREAM VERSION 3.1 CONFIRMA, INC. PATRICIA A MILBANK
K041062 04/23/2004 INTRAUTERINE VENOGRAM NEEDLE SET COOK UROLOGICAL, INC. CINDY RUMPLE
K041044 04/26/2004 CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET COOK, INC. JENNIFER BOSLEY
K040921 04/13/2004 COOLTOUCH, MODEL NS 160 COOLTOUCH, INC. DONALD V JOHNSON
K040994 04/16/2004 COSMEDENT CORE PASTE COSMEDENT, INC. JAMES L SANDRIK
K041028 04/21/2004 CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL CROWN DELTA CORP. MARK P KONOPKA
K040933 04/09/2004 ECAT HRRT CTI PET SYSTEMS, INC. M. ALAINE MEDIO
K041095 04/27/2004 PHOTOSILK PULSED LIGHT SYSTEM CYNOSURE, INC. GEORGE CHO
K041080 04/27/2004 SURGICAL DRAPE KIT - D.I.R.R.A. SRL D.I.R.R.A. S.R.L. ELISABETTA BACCHI
K040952 04/12/2004 PRELUDE DANVILLE MATERIALS, INC. CRAIG BURNS
K040906 04/07/2004 CALIBRA CEMENT DENTSPLY INTL. P. JEFFERY LEHN
K041141 04/30/2004 DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125 DENTSPLY INTL. P. JEFFERY LEHN
K040895 04/06/2004 INTEGRITY TEMPORARY CEMENT DENTSPLY INTL. P. JEFFERY LEHN
K041064 04/23/2004 BIOKNOTLESS RC ANCHOR DEPUY MITEK ALLYSON BARFORD
K041065 04/23/2004 PANALOK RC LOOP ANCHOR DEPUY MITEK ALLYSON BARFORD
K041117 04/29/2004 PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732 DEPUY MITEK ALLYSON BARFORD
K041116 04/29/2004 SUPER QUICKANCHOR PLUS DEPUY MITEK ALLYSON BARFORD
K041075 04/26/2004 FASTIN RC ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON COMPANY KAREN SYLVIA
K041115 04/29/2004 GII QUICKANCHOR PLUS DEPUY MITEK, A JOHNSON & JOHNSON COMPANY ALLYSON BARFORD
K040827 04/02/2004 PANALOK LOOP ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON COMPANY ALLYSON BARFORD
K041069 04/26/2004 SPIRALOK ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON COMPANY KAREN SYLVIA
K041135 04/30/2004 VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES DEPUY MITEK, A JOHNSON & JOHNSON COMPANY RUTH C FORSTADT
K041119 04/29/2004 EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. SHARON STAROWICZ
K041085 04/26/2004 LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY DEPUY, INC. TIFFANI ROGERS
K041059 04/23/2004 EPI-MAX DERMAGENICS, INC. STEVE MONROE
K041014 04/20/2004 TSH-CTK-3 IRMA DIASORIN, INC. DAVID M IKEDA
K041061 04/23/2004 D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS DIDECO S.P.A. BARRY SALL
K040939 04/12/2004 SKY BONE EXPANDER SYSTEM (SKY SYSTEM) DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. YAEL RUBIN
K041018 04/20/2004 DRG SOFTRELEASE DOCTOR'S RESEARCH GROUP, INC. EDWARD H GOLDMAN
K041087 04/26/2004 INFINITY GAMMA DRAEGER MEDICAL SYSTEMS, INC. PENELOPE H GRECO
K040945 04/12/2004 MODIFICATION TO INFINITY EXPLORER DRAEGER MEDICAL SYSTEMS, INC. PENELOPE H GRECO
K040847 04/01/2004 MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR DRAEGER MEDICAL, INC. GALE E WINARSKY
K040911 04/08/2004 VITALHEAT DYNATHERM MEDICAL, INC. JOHN R KANE
K040908 04/07/2004 EBI DISTAL RADIUS PLATING SYSTEM EBI, L.P. FREDERIC TESTA
K040935 04/09/2004 EBI XFIX DFS SYSTEM EBI, L.P. FREDERIC TESTA
K040903 04/07/2004 CADENCE, MODELS 2001 AND 2002 EDAN INSTRUMENTS, INC. WILLIAM STERN
K040982 04/15/2004 COLOR LCD MONITOR, MODEL RADIFORCE R12 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K040979 04/15/2004 ELEKTA MICRODRIVE, MODEL 916716 ELEKTA INSTRUMENT AB ANDERS SKOGLUND
K040909 04/08/2004 SONO TT ULTRASONIC FLOWCOMPUTER EM-TEC GMBH ANDREAS KNABE
K041066 04/26/2004 ENCORE REVERSE SHOULDER PROSTHESIS ENCORE MEDICAL, L.P. DEBBIE DE LOS SANTOS
K041034 04/26/2004 SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL) ENTRACARE, LLC GRACE HOLLAND
K041139 04/30/2004 ERCHONIA EML LASER ERCHONIA MEDICAL, INC. KEVIN WALLS
K040877 04/05/2004 ARTOSCAN C ESAOTE S.P.A. CARRI GRAHAM
K040889 04/05/2004 EXACTECH OPTETRAK UNICONDYLAR KNEE EXACTECH, INC. GARY MILLER
K040914 04/12/2004 POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAINER FOR OPHTHALMICS EXERO PRODUCTS, INC. MARTIN DALSING
K040871 04/02/2004 FACEMASTER FACIAL TONING SYSTEM FACEMASTER OF BEVERLY HILLS, INC. JIM ENGLAND
K040941 04/12/2004 CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES) FISHER & PAYKEL HEALTHCARE, LTD. JAMES THOMPSON
K040854 04/06/2004 WEST NILE VIRUS IGM CAPTURE ELISA FOCUS TECHNOLOGIES, INC. MICHAEL J WAGNER
K041042 04/22/2004 SPLIT SEPTUM INJECTION SITES FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR EILINSFELD
K040946 04/12/2004 ANKYLOS DENTAL IMPLANT SYSTEM FRIADENT GMBH CAROL PATTERSON
K041005 04/19/2004 GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS GAMBRO RENAL PRODUCTS THOMAS B DOWELL
K041039 04/22/2004 FERTELL MALE FERTILITY TEST GENOSIS LTD. SHARON A SEGAL
K040868 04/05/2004 SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH GENZYME CORP. MICHAEL G HALPIN
K041025 04/21/2004 BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED GOLDEN TECHNOLOGIES, INC. GENE R KULON
K040881 04/06/2004 METACRYL GREAT LAKES ORTHODONTICS, LTD. MARK LAUREN
K041079 04/26/2004 GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103 GUAN HONG ENTERPRISE CO., LTD. JENNIFER REICH
K040996 04/16/2004 RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM GYRUS ENT L.L.C. ALICIA E FARAGE
K041081 04/27/2004 FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES HAND INNOVATIONS, INC. AL WEISENBORN
K040896 04/09/2004 MODIFICATION TO ENCOMPASS HEARTLAB, INC. RICHARD PETROCELLI
K041067 04/30/2004 HEARTSINE SAMARITAN PAD HEARTSINE TECHNOLOGIES, INC. WILLIAM J SMIRLES
K041013 04/20/2004 SUILE OINTMENT WOUND DRESSING HEDONIST BIOCHEMICAL TECHNOLOGIES CO., LTD. ERIC LUO, PH.D.
K041051 04/19/2004 RAICHEM BUN RATE REAGENT (LIQUID) HEMAGEN DIAGNOSTICS, INC. JAMES J MILLER
K041009 04/19/2004 RAICHEM CALCIUM (OCPC) LIQUID REAGENT HEMAGEN DIAGNOSTICS, INC. JAMES J MILLER
K041052 04/19/2004 RAICHEM GLUCOSE UV (LIQUID) HEMAGEN DIAGNOSTICS, INC. JAMES J MILLER
K040859 04/23/2004 HERACERAM PRESS HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K040902 04/07/2004 HITACHI PRESTO HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUGLAS THISTLETHWAITE
K040741 04/02/2004 ULTRASOUND LOCALIZATION SYSTEM ULS 0142 HMT HIGH MEDICAL TECHNOLOGIES AG TRISH LANDRY
K041035 04/21/2004 HOFFRICHTER TREND 110 CPAP DEVICE WITH AQUATREND III CPAP HUMIDIFIER ACCESSORY FOR TREND HOFFRICHTER GMBH STEPHEN GORSKI
K040884 04/06/2004 LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM HOLOGIC, INC. GAIL YAEKER-DAUNIS
K040964 04/14/2004 SCORPIO TOTAL KNEE SYSTEM - POSTERIOR STABILIZED TIBIAL INSERTS HOWMEDICA OSTEONICS CORP KAREN ARIEMMA
K041001 04/19/2004 OMEGA 2 SYSTEM HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K040926 04/26/2004 ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000 HUDSON DIAGNOSTIC IMAGING LLC MARTIN E WENDELKEN
K041007 04/19/2004 MILLENIUM, MODELS 2000, 2001 AND 2002 HYPERBARIC FOR LIFE LLC RICK RYDER
K040923 04/08/2004 LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA IBL GMBH GARY LEHNUS
K040834 04/02/2004 NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000 IMAGE-GUIDED NEUROLOGICS, INC. DAVID M LEE
K041077 04/26/2004 IMALUX OCT PROBE GUIDE IMALUX CORPORATION STEPHANIE A.S. HARRINGTON
K040885 04/12/2004 QUANTA LITE GP210 ELISA INOVA DIAGNOSTICS, INC. GARY L NORMAN
K040855 04/02/2004 INSTRUMED LAPAROSCOPE AND ACCESSORIES INSTRUMED INTERNATIONAL, INC. HAIKO BELL
K040843 04/01/2004 HEMOSIL VON WILLEBRAND ACTIVITY INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K040879 04/05/2004 QUANTEX FERRITIN INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K040860 04/02/2004 INTEGRA BONE FIXATION SYSTEM INTEGRA LIFESCIENCES CORPORATION DONNA R WALLACE
K041048 04/22/2004 POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE INTERNACIONAL FARMACEUTICA, S.A. DE C.V. CAROLANN KOTULA
K040766 04/01/2004 OPTISOURCE, MODEL 1032P INTERNATIONAL BRACHYTHERAPY S.A. RUTH FEICHT
K040853 04/12/2004 PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101 INTERNATIONAL HOSPITAL SUPPLY CO. ANGELIKA SCHERP
K040928 04/09/2004 EXPANDABLE PEEK VBR IMPLANT INTERPORE CROSS INTL. WENDY SPIELBERGER
K040948 04/12/2004 INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC DELIVERY INSTRUMENT, MODEL P/N 400170 INTUITIVE SURGICAL, INC. MICHAEL H YRAMATEGUI
K041072 04/26/2004 KUSCHALL CHAMPION, KUSCHALL COMPACT, KUSCHALL ULTRA-LIGHT INVACARE CORPORATION CARROLL L MARTIN
K040915 04/20/2004 MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M INVIVO RESEARCH, INC. NEIL BATTISTE
K041108 04/30/2004 ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA ISCIENCE SURGICAL CORPORATION JUDY F GORDON
K040951 04/12/2004 SR ADORO IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K041006 04/19/2004 TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR KENDALL JAMES WELSH
K041123 04/30/2004 RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG01477/FG01703 KERBEROS PROXIMAL SOLUTIONS, INC. TOM MASON
K040677 04/12/2004 COMBI SELF PROPELLED SHOWER COMMODE KJAERULFF REHABILITATION A/S PHILIP L HARRIS
K040891 04/05/2004 KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES) KLS-MARTIN L.P. JENNIFER DAMATO
K040936 04/09/2004 PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE LEDA CO., LTD. DAVID J BLOCH
K040844 04/02/2004 LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM LIFE SPINE, LLC. MICHAEL S BUTLER
K041128 04/30/2004 SUTURE ARROW LINVATEC CORP. ELIZABETH M PAUL
K041105 04/30/2004 MACROPORE HYDROSORB SPINE SYSTEM MACROPORE BIOSURGERY, INC. KENNETH KLEINHENZ
K041125 04/30/2004 MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM) MASEP MED SCIENCE & TECH. DEVELOPMENT (SHENZHEN) C SUSAN D GOLDSTEIN-FALK
K040992 04/26/2004 15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706 MEDCOMP JEAN CALLOW
K040899 04/06/2004 MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP MEDEX, INC. BARBARA LAW
K040880 04/05/2004 MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 MEDICAL ANALYSIS SYSTEMS, INC. PENNY M LAYMAN
K040852 04/01/2004 PREVIEW TREATMENT PLANNING SOFTWARE MEDICAL MEDIA SYSTEMS, INC. PATSY J TRISLER
K041054 04/23/2004 MEDLINE STRIDER MAXI 3 MEDLINE INDUSTRIES, INC. ANDREA HAFERKAMP
K041055 04/23/2004 MEDLINE STRIDER MAXI 4 MEDLINE INDUSTRIES, INC. MARGARET STEPHENS
K041053 04/23/2004 MEDLINE STRIDER MICRO 3 MEDLINE INDUSTRIES, INC. MARGARET STEPHENS
K040841 04/01/2004 POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) MEDLINE INDUSTRIES, INC. JENNIFER MASON
K041047 04/22/2004 ULTRADENT CARBON MASK - UPI #342 MEDSPRING GROUP, INCORPORATED BRUCE DAVIS
K041000 04/21/2004 DUREPAIR DURA REGENERATION MATRIX MEDTRONIC NEUROSURGERY JEFFREY HENDERSON
K040943 04/20/2004 MEDTRONIC PS MEDICAL STRATA VALVE MEDTRONIC NEUROSURGERY JEFF HENDERSON
K040962 04/14/2004 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K041030 04/21/2004 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K041118 04/29/2004 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K040812 04/06/2004 DETECT SURGICAL PACING AND MAPPING TOOL MEDTRONIC VASCULAR EDWARD VALDEZ
K040869 04/02/2004 EXPORT CATHETER MEDTRONIC VASCULAR FRED L BOUCHER
K040959 04/19/2004 MENTOR GENESIS PENILE PROSTHESIS MENTOR CORP. DONNA A CRAWFORD
K041003 04/28/2004 IMMUNOCARD TOXINS A & B, MODEL 712050 MERIDIAN BIOSCIENCE, INC. SUSAN ROLIH
K041056 04/23/2004 10-SECOND DIGITAL THERMOMETER, MODELS ST87, ST89, ST80, ST88 MESURE TECHNOLOGY CO.,LTD. ROGER LU
K040758 04/12/2004 MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT MICROGENICS CORP. DAVID CASAL
K041058 04/23/2004 MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS MISONIX, INC. RONALD R MANNA
K032836 04/28/2004 M3 MICROKERATOME MORIA S.A. MELANIE RENAUD-SAMIRI
K040937 04/12/2004 TEM 3000 HEAD COIL MR INSTRUMENTS, INC. GENE BERGHOFF
K041082 04/26/2004 NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER NEWPORT MEDICAL INSTRUMENTS, INC. RICHARD WATERS
K040892 04/06/2004 MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905 NIDEK MEDICAL PRODUCTS, INC. JENNIFER MCWILLIAMS
K040875 04/02/2004 CAP-ONE, MODEL TG-920P NIHON KOHDEN AMERICA, INC. SERRAH NAMINI
K041016 04/20/2004 NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS NOVA BIOMEDICAL CORP. PAUL W MACDONALD
K040858 04/05/2004 ORALIEF THERAPY FOR SENSITIVE TEETH NOVAMIN TECHNOLOGY, INC. DAVID C GREENSPAN
K041093 04/27/2004 NUMED MULLINS X PTA CATHETER NUMED, INC. NICHELLE LAFLESH
K040830 04/02/2004 PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS NUMED, INC. NICHELLE R LAFLESH
K040940 04/12/2004 BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM OLYMPUS CORPORATION TINA STEFFANIE-OAK
K040900 04/06/2004 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
K041008 04/19/2004 EYE-CEPT REWETTING DROPS OPTICS LABORATORY, INC. J.R. CHEN
K041032 04/21/2004 MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS ORBUS MEDICAL TECHNOLOGIES DAVID L CAMP
K040965 04/20/2004 PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES PAJUNK GMBH LYNETTE HOWARD
K041086 04/27/2004 PALOMAR STARLUX PULSED LIGHT SYSTEM PALOMAR MEDICAL PRODUCTS, INC. MARCY MOORE
K041068 04/26/2004 WEST NILE VIRUS IGG INDIRECT ELISA PANBIO LIMITED CRAIG BREADMORE
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K041111 04/28/2004 MAGNETOM C! MR SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. NEALIE HARTMAN
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K040840 04/01/2004 TERATECH MODEL 10V5 SMART PROBE TERATECH CORP. CHARLES F HOTTINGER
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K040848 04/02/2004 EZ SMART VIP INTERNATIONAL WHOLESALERS, CORP. DAVID L ROSEN
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K040984 04/15/2004 VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE VISION-SCIENCES, INC. PAMELA PAPINEAU
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K040916 04/15/2004 VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE VITALCARE GROUP, INC. MICHAEL MCAVENIA
K041124 04/29/2004 IRRIGATION TUBING SET 2.2M AND 3.8M W&H DENTALWERK BURMOOS RALF BENDA
K041096 04/28/2004 WAGNER STERISET STERILIZATION CONTAINER WAGNER GMBH LARA N SIMMONS
K040918 04/09/2004 WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2 WAKO CHEMICALS, USA, INC. LORI CREASY
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K040930 04/09/2004 ZILVER BILIARY STENT SYSTEM USW WILSON-COOK MEDICAL, INC. MARGE WALLS-WALKER
K040980 04/15/2004 ALLOMATRIX C PUTTY, ALLOMATRIX CUSTOM PUTTY, ALLOMATRIX DR PUTTY, IGNITE SCAFFOLD, MODELS 860C, 86XC, 86DR, 860D, 860T WRIGHT MEDICAL TECHNOLOGY, INC. ROGER D BROWN
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K040967 04/21/2004 DISPOSABLE POWDER FREE VINYL EXAMINATION GLOVES ZI BO HONG WANG PLASTIC & RUBBER PRODUCTS CO. LTD. HUAN-CHUNG LI
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