FDA 510(k) Applications Received During August, 2004

FDA 510(k) Number Submission Date Device Name Applicant Contact
K042318 08/26/2004 AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET AALTO SCIENTIFIC LTD. ALAN J VEKICH
K042146 08/09/2004 ROBOCOUCH PATIENT SUPPORT SYSTEM ACCURAY INCORPORATED ANNE SCHLAGENHAFT
K042225 08/17/2004 ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 ACMI CORPORATION TERRENCE E SULLIVAN
K042069 08/02/2004 INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM ACMI CORPORATION TERRENCE E SULLIVAN
K042272 08/23/2004 ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) ACON LABORATORIES, INC. EDWARD TUNG, PH.D.
K042151 08/09/2004 ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST ACON LABORATORIES, INC. EDWARD TUNG
K042297 08/24/2004 ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES ACTA VASCULAR SYSTEMS, INC. RICHARD M RUEDY
K042246 08/19/2004 MULTI-DRIP INFUSION CATHETER ADVANCED INFUSION, INC. JAMES CHRISTENSEN
K042116 08/05/2004 STERRAD NX STERILIZER ADVANCED STERILIZATION PRODUCTS NATALIE BENNINGTON
K042130 08/06/2004 AURA CPAP PATIENT INTERFACE AEIOMED INC. Gary Syring
K042344 08/30/2004 EXCIA TOTAL HIP SYSTEM AESCULAP, INC. JOYCE KILROY
K042279 08/23/2004 AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM AFFYMETRIX, INC. ROBERT LIPSHUTZ
K042266 08/23/2004 ACCLAIM AIR TECHNIQUES, INC. JOSEPH CAREY
K042242 08/19/2004 ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES ALDEN OPTICAL LABS., INC. CHARLES H CREIGHTON
K042227 08/17/2004 INSTANT-VIEW TROPONIN I TEST ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K042252 08/20/2004 NEXFLEX TOTAL HIP SYSTEM ALPHATEC/NEXMED ELLEN A YARNALL
K042201 08/13/2004 NOVEL VBR SPINAL SYSTEM ALPHATEC/NEXMED ELLEN YARNALL
K042250 08/20/2004 SENSATOUCH ALUNA MANAGEMENT CO., LTD. CHARITY MARTIN
K042104 08/04/2004 AMERICAN BANTEX, MODEL MS 3 AMERICAN BANTEX CORP. TRACY S BEST
K042160 08/10/2004 SONOSURG TROCAR AOMORI OLYMPUS CO., LTD. TINA STEFFANIE-OAK
K042300 08/24/2004 AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM APPLIED MEDICAL TECHNOLOGY, INC. CHRIS ZANTOPULOS
K042367 08/31/2004 NYLON THREADED NEEDLE AROS SURGICAL INSTRUMENTS CORP. GRACE HOLLAND
K042126 08/06/2004 PICC ARROW INTL., INC. SUZANNE SCHORLE
K042063 08/02/2004 PRESS TACK NEEDLE ASIA-MED GMBH & CO. KG. - WERK SUHL Kevin Walls
K042221 08/17/2004 CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM BARCO NV BARCOVIEW FRANK FERGUSON
K042105 08/04/2004 CLIPPER DIAGNOSTIC ELECTRODE CATHETER BARD ELECTROPHYSIOLOGY DEBORAH L HERRINGTON
K042062 08/02/2004 PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE BARD PERIPHERAL VASCULAR, INC. SHARI ALLEN
K042251 08/20/2004 BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM BAYER HEALTHCARE, LLC ANDRES HOLLE
K042110 08/05/2004 BEAMCATH BEAMPOINT AB CONSTANCE BUNDY
K042173 08/11/2004 COULTER A T 5DIFF CAP PIERCE (CP) BECKMAN COULTER, INC. LOURDES COBA
K042281 08/24/2004 MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY BECKMAN COULTER, INC. BARBARA STEGMEIER
K042195 08/13/2004 SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747 BECKMAN COULTER, INC. KIM WALKER
K042291 08/24/2004 UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS BECKMAN COULTER, INC. MARY BETH TANG
K042061 08/02/2004 0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE BECTON DICKINSON PETER ZURLO
K042301 08/25/2004 PROTENS ELECTRODE BIO PROTECH, INC. E.J. EDWARD
K042324 08/27/2004 LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5 BIO-RAD MARIA ZEBELLOS
K042335 08/30/2004 ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05 BIO-RAD LABORATORIES, INC. MARIA ZEBALLOS
K042336 08/30/2004 METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK BIO-RAD LABORATORIES, INC. MARIA ZEBALLOS
K042231 08/17/2004 GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES BIOCOMPATIBLES U.K. LIMITED JOHN GREENBAUM
K042352 08/30/2004 BIODERM SCIENCES WOUND CREAM BIODERM SCIENCES, INC. EDWARD R GUBISH
K042084 08/03/2004 BIODERM SCIENCES WOUND HEALING SPRAY BIODERM SCIENCES, INC. EDWARD R GUBISH
K042314 08/26/2004 SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE BIOGEN VICTOR J GANGI
K042321 08/26/2004 MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD BIOMET MANUFACTURING CORP. KACY ARNOLD
K042091 08/03/2004 BIOLOX DELTA CERAMIC HEADS BIOMET, INC. PATRICIA SANDBORN BERES
K042093 08/03/2004 VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS BIOMET, INC. TAACY BICKEL JOHNSON
K042083 08/03/2004 MODIFICATION TO VISITOME 20-10 MICROKERATOME BIOVISION AG DALE SADLIK
K042100 08/04/2004 BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR BLACKSTONE MEDICAL, INC. DEAN CIPORKIN
K042134 08/09/2004 VERSATILE 1 WOUND VACUUM SYSTEM BLUE SKY MEDICAL GROUP INCORPORATED RICHARD WESTON
K042065 08/02/2004 WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM BOSTON SCIENTIFIC CORP. KATHLEEN MORAHAN
K042350 08/30/2004 TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR CADWELL LABORATORIES, INC. CHRIS BOLKAN
K042085 08/03/2004 CRONO F CANE S.R.L. DANIEL KAMM
K042296 08/24/2004 BIOMARC PRELOADED TISSUE MARKER DEVICE CARBON MEDICAL TECHNOLOGIES, INC. ROBERT W JOHNSON
K042254 08/20/2004 PMP4 SELFCHECK ECG CARD GUARD SCIENTIFIC SURVIVAL, LTD. NAAMA OREN
K042156 08/10/2004 CARDEON COBRA CATHETER CARDEON CORP. JANE BEGGS
K042139 08/09/2004 VISULAS YAG III CARL ZEISS MEDITEC AG R. MICHAEL CROMPTON
K042129 08/06/2004 F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LUER LOCK CEDIC S.R.L. GIANCARLO GAGLIARDONI
K042142 08/09/2004 CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S CHAD THERAPEUTICS, INC. KEVIN MCCULLOH
K042144 08/09/2004 NICOM CHEETAH MEDICAL INC. BENNY ARAZY
K042176 08/11/2004 AQUIFY LENS COMFORT DROPS CIBA VISION CORPORATION STEVEN DOWDLEY
K042078 08/02/2004 ENDOTINE FOREHEAD TRIPLE DEVICE COAPT SYSTEMS, INC. LORI DONDIEGO
K042232 08/17/2004 NP-2600 SERIES HARDCOPY PRINTERS CODONICS, INC. ALAN DESANTIS
K042354 08/30/2004 MODIFICATION TO: CRESCO TI IMPLANT CONCEPT CRESCO TI SYSTEMS AB J. BENGTSSON
K042230 08/17/2004 POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM CRYOVASCULAR SYSTEMS, INC. KIM TOMPKINS
K042165 08/11/2004 CUTERA TABLETOP AESTHETIC PRODUCT CUTERA, INC. KATHY MAYNOR
K042209 08/16/2004 CONTROL PLASMA N AND CONTROL PLASMA P DADE BEHRING, INC. DONNA A WOLF
K042333 08/30/2004 CONTROL PLASMA N, PROC CONTROL PLASMA DADE BEHRING, INC. RADAMES RIESGO
K042347 08/30/2004 MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD DADE BEHRING, INC. GEORGE M PLUMMER
K042315 08/26/2004 CEREBRAL STATE MONITOR - CSM DANMETER A/S HANNE NIELSEN
K042154 08/10/2004 GE DATEX-OHMEDA AISYS CARESTATION DATEX-OHMEDA, INC. DAN KOSEDNAR, RAC
K042196 08/13/2004 SAVEDENT BLUE DENFOTEX LIGHT SYSTEMS LTD JOHN COLLES
K042153 08/09/2004 SOUTH BEACH SMILE LIGHT WHITENING SYSTEM DENTOVATIONS, INC. M. JOYCE HEINRICH
K042178 08/11/2004 ORTHODONTIC CERAMIC BRACKETS DENTSPLY INTL. P. JEFFERY LEHN
K042233 08/18/2004 PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE DEPUY MITEK, A JOHNSON & JOHNSON COMPANY RUTH C FORSTADT
K042325 08/27/2004 TROCHANTERIC NAIL SYSTEM DEPUY ORTHOPAEDICS, INC. STEVE KAHN
K042330 08/27/2004 ACETAMINOPHEN-SL ASSAY DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K042243 08/19/2004 MICROALBUMIN MULTI-CALIBRATOR SET DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K042362 08/31/2004 MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12 DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K042329 08/27/2004 SALICYLATE-SL ASSAY DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K042193 08/12/2004 DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT DIAZYME LABORATORIES CHONG YUAN
K042191 08/12/2004 DIAZYME POTASSIUM ENZYMATIC ASSAY KIT DIAZYME LABORATORIES HUAN TRAN
K042189 08/12/2004 DIAZYME SODIUM ENZYMATIC ASSAY DIAZYME LABORATORIES HUHAN TRAN
DEN040007 08/04/2004 VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER DIGITAL ANGEL CORPORATION KEVIN MCLAUGHLIN
K042276 08/23/2004 D-VAPOR DRAEGER MEDICAL, INC. GALE E WINARSKY
K042086 08/03/2004 FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM DRAEGER MEDICAL, INC. MICHAEL A KELHART
K042313 08/26/2004 INTEGRADWEB MPR/MIP DYNAMIC IMAGING INC. CARL ALLETTO
K042159 08/10/2004 KODAK COLOR MEDICAL IMAGER 1000 EASTMAN KODAK COMPANY STEPHEN SLAVENS
K042158 08/10/2004 KODAK MEDICAL IMAGER 300 EASTMAN KODAK COMPANY STEPHEN SLAVENS
K042268 08/23/2004 EBI CAS SPINE SPACER SYSTEM EBI, L.P. FREDERIC TESTA
K042237 08/18/2004 EBI PERIARTICULAR PLATING SYSTEM EBI, L.P. PETER ALLAN
K042197 08/13/2004 BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE PETER S REICHERTZ
K042269 08/23/2004 LEKSELL GAMMAPLAN 4C WITH MULTIVIEW ELEKTA INSTRUMENT AB ANDERS SKOGLUND
K042349 08/30/2004 EMG MODEL SUA01 SUCTION UNIT EMG TECHNOLOGY CO., LTD. LEONARD FRIER
K042236 08/18/2004 G-SCAN ESAOTE, S.P.A. CARRI GRAHAM
K042204 08/16/2004 MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT EV3 INC GLEN D SMYTHE
K042183 08/11/2004 GLUCOSE TOLERANCE BEVERAGE EVER SCIENTIFIC JAY REINHARDT
K042223 08/17/2004 XLTEK CONNEX IP HEADBOX, MODEL 1054 EXCEL TECH. LTD. NICOLE LANDREVILLE
K042150 08/09/2004 XLTEK TREX MODEL#10309 EXCEL TECH. LTD. NICOLE LANDREVILLE
K042308 08/25/2004 SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018; SHEATH-IN-SHEATH CATHETER, 6 FR., MODEL S00019 FACILE MEDICAL, INC. ALBERT REGO
K042095 08/03/2004 MAMMOTEST FISCHER IMAGING CORP. ROBERT G SCHUEPPERT
K042217 08/16/2004 FLOWMEDIC, MODEL 220 FLOWMEDIC (ISRAEL) LTD JONATHAN KAHAN
K042332 08/30/2004 TITANIUM TELEGRAPH HUMERAL NAIL FOURNITURES HOSPITALIERES INDUSTRIE CHRISTINE QUENDEZ
K042076 08/02/2004 FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5 FUJINON, INC. JOSEPH M AZARY
K042348 08/30/2004 GRADIA DIRECT LOFLO GC AMERICA, INC. TERRY JORITZ
K042200 08/13/2004 MI PASTE GC AMERICA, INC. TERRY L JORITZ
K042148 08/09/2004 HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES GE MEDICAL SYST. INFORMATION TECHNOLOGIES LISA M BAUMHARDT
K042177 08/11/2004 MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES LISA M BAUMHARDT
K042257 08/20/2004 DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION GENERAL ELECTRIC CO. DAVID DUERSTELER
K042168 08/09/2004 CONCORD Radiopaque Bone Cement Globus Medical, Inc Kelly J Baker
K042077 08/02/2004 BITECH BIPOLAR SCISSORS GUENTER BISSINGER MEDIZINTECHNIK GMBH FRANZ MENEAN
K042218 08/05/2004 ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM GUIDANT CORP. LARAINE PANGELINA
K042322 08/26/2004 STERICHEK BLOOD LEAK REAGENT STRIPS HACH COMPANY DAVID A MORRIS, PH.D.
DEN040009 08/25/2004 HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK) HAMILTON THORNE BIOSCIENCES DIARMAID DOUGLAS-HAMILTON
K042265 08/23/2004 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR MODEL# HL888 HEALTH & LIFE CO., LTD. PAUL HUNG
K042273 08/23/2004 MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY HEALTH HERO NETWORK, INC. GEOFFREY J CLAPP
K042088 08/03/2004 SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301 HEARTSINE TECHNOLOGIES, INC. WILLIAM J SMIRLES
K042199 08/13/2004 TRANSLUX POWER BLUE HERAEUS KULZER GMBH CHERYL V ZIMMERMAN
K042080 08/03/2004 TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM HOME DIAGNOSTICS, INC. KAREN DEVINCENT
K042081 08/03/2004 PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE HOSPIRA, INC. TOM KOZMA
K042343 08/30/2004 SCORPIO NRG KNEE SYSTEM HOWMEDICA OSTEONICS CORP DENISE DUCHENE
K042212 08/16/2004 IMPLANTMASTER I-DENT DAN LAOR
K042182 08/11/2004 Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432 ICU MEDICAL, INC. DALE FAIRCHILD
K042289 08/24/2004 MDI ORTHO IMTEC CORP. J. BRAD VANCE
K042357 08/31/2004 IDI-MRSA ASSAY INFECTIO DIAGNOSTIC (I.D.I.) INC. JUDITH SMITH
K042143 08/09/2004 EXCELLA-M SPINAL SYSTEM INNOVASIS, INC. BRENT A FELIX
K042208 08/16/2004 ISIS MER SYSTEM/ELEKTA MER SYSTEM INOMED MEDIZINTECHNIK GMBH ANDERS SKOGLUND
K042267 08/23/2004 INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP INOVEL LLC WILLIAM WAWRZYNIAK
K042341 08/30/2004 ULTRACLIP II US INRAD MELISSA LALOMIA
K042192 08/12/2004 LOW FLOW OSV II HYDROCEPHALUS VALVE INTEGRA NEUROSCIENCES IMPLANTS S.A. JUDITH E O'GRADY
K042277 08/23/2004 SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM INTEGRA NEUROSCIENCES, LTD. NIKKI HINTON
K042102 08/04/2004 YIXIN SAFETY SYRINGE JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP LIU KUN SHENG
K042241 08/19/2004 K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C KAMIYA BIOMEDICAL CO. BRIAN SCHLIESMAN
K042340 08/30/2004 KASIOS TCP KASIOS BIOMATERIALS LAETITA BERNARD
K042066 08/02/2004 KLSA MARTIN HAND DISTRACTOR KLS-MARTIN L.P. JENNIFER DAMATO
K042133 08/09/2004 DRY LASER IMAGER, MODEL DRYPRO MODEL 793 KONICA MINOLTA MEDICAL & GRAPHIC, INC. SHINICHI YAMANAKA
K042248 08/19/2004 KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. HEATHER VIELE
K042338 08/30/2004 CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE LAKE REGION MFG., INC. KAREN MORTENSEN
K042364 08/31/2004 PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES LAMONT MEDICAL INC Gary Syring
K042295 08/24/2004 SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020 LINVATEC BIOMATERIALS, LTD. TUIJA ANNALA
K042261 08/23/2004 MACROPORE PURICEL LIPOPLASTY SYSTEM MACROPORE BIOSURGERY, INC. KENNETH K KLEINHENZ
K042184 08/12/2004 GOODKNIGHT H20, MODEL M-114600-00 MALLINCKRODT DEVELOPPEMENT FRANCE MOUSTAFA ANKI
K042112 08/05/2004 INFANT FEEDING TUBE MARIAN MEDICAL, INC. SANDY WINKLER
K042346 08/30/2004 LNCS OXIMETRY SENSORS MASIMO CORPORATION JAMES J CRONIN
K042228 08/17/2004 BEELINE MOTIV, PROPOLIS, PCA MCKINLEY, INC. MICHELLE PRATTE
K042359 08/31/2004 SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL MEDICAL DESIGNS, LLC PAUL JOHN AXT
K042311 08/26/2004 PACSPARTNER MEDICAL STANDARD CO., LTD. CARL ALLETTO
K042164 08/11/2004 SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE) MEDLINE INDUSTRIES, INC. BRUCE GIBBINS
K042198 08/13/2004 PS MEDICAL NEUROSURGICAL IMPLANTS MEDTRONIC NEUROSURGERY JEFFREY HENDERSON
K042167 08/11/2004 MODIFICATION TO: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K042210 08/16/2004 MSD SILO SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K042235 08/18/2004 ORION ANTERIOR CERVICAL PLATING SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K042194 08/12/2004 ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY MEDTRONIC VASCULAR LYNN JENSEN
K042070 08/02/2004 HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20 MEDTRONIC VASCULAR DAWN STENSTROM
K042175 08/11/2004 HEPARINASE HR ACT CONTROL, MODEL 550-12 MEDTRONIC VASCULAR DAWN STENSTROM
K042190 08/12/2004 MODEL 6416 TEMPORARY PACING LEAD SYSTEM MEDTRONIC VASCULAR PAULA CORDERO
K042206 08/16/2004 PURPLE/BLACK HEPARIN ASSAY CONTROL MEDTRONIC VASCULAR DAWN STENSTROM
K042187 08/12/2004 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
K042171 08/11/2004 AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232 MICRO-MEGA SOCIETE ANONYME PHILIPPE GARCIA
K042096 08/04/2004 MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM MISONIX, INC. RONALD R MANNA
K042345 08/30/2004 LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) MONDEAL MEDICAL SYSTEMS GMBH ANGELIKA SCHERP
K042082 08/03/2004 AIRSTRIP OB MP4 SOLUTIONS, LP WILLIAM CAMERON POWELL
K042103 08/04/2004 NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL MRI DEVICES CORPORATION TOM SCHUBERT
K042125 08/06/2004 AFT MUSCULOSKELETAL TRANSPLANT FOUNDATION KAREN HARDWICK
K042353 08/30/2004 AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS NATIONAL DISPLAY SYSTEMS RON HANSEN
K042339 08/30/2004 NEOPLANT IMPLANT SYSTEM NEOBIOTECH CO., LTD. DAE KYU CHANG
K042170 08/11/2004 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
K042113 08/05/2004 ZOE FLUID STATUS MONITOR NONINVASIVE MEDICAL TECHNOLOGIES, LLC. ALDEN KAY
K042108 08/04/2004 VISTA PLUS NOVACOR DOMINIQUE GRENIER
K042109 08/05/2004 DIASYS INTEGRA II NOVACOR FRANCE DOMINIQUE GRENIER
K042132 08/09/2004 NOVASYS TRANSURETHRAL RF SYSTEM NOVASYS MEDICAL, INC. DEBRA REISENTHEL
K042089 08/03/2004 NX STAGE WATER PURIFICATION SYSTEM NX STAGE MEDICAL INC NORMA LEMAY
K042079 08/02/2004 OSS/(SCARF)- AND OSW-SCREW O.M.T. OBERFLACHEN-UND MATERIALTECHNOLOGIE GMBH H. DARREL DARBY II
K042073 08/02/2004 OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM OLSEN MEDICAL TERRY JOHNSON
K042140 08/09/2004 OLYMPUS BF TYPE UC160-OL8 OLYMPUS CORPORATION TINA STEFFANIE-OAK
K042274 08/23/2004 PSD-60/ENDOPLASMA OLYMPUS SHIRAKAWA CO., LTD. TINA STEFFANIE-OAK
K042278 08/23/2004 ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5) ORAL OSTEODISTRACTION, L.P. ARTHUR WARD
K042202 08/13/2004 TEMPTELLER - HIGH SPEED DIGITAL THERMOMETERS, MODELS DT-302, DT-312, DT-412, DT-502 ORIENTAL SYSTEM TECHNOLOGY, INC. SUSAN D GOLDSTEIN-FALK
K042303 08/25/2004 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS ORTHO-CLINICAL DIAGNOSTICS SARAH GLOVER
K042310 08/25/2004 ORTHO-PRO CANNULATED BONE SCREWS ORTHO-PRO LLC J.D. WEBB
K042305 08/25/2004 OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221 901, OSSAPLAST ORTHO, 3.0ML, MODEL# 221 903 OSSACUR AG KRISTI KISTNER
K042309 08/25/2004 BIOSOMNIA-V3 OXFORD BIOSIGNALS LIMITED SIMON J GRIFFIN
K042157 08/10/2004 DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD. ANDY HOLLINGSWORTH
K042331 08/30/2004 PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. LINDA K DILLON
K042334 08/30/2004 ALLURA 3D-CA, RELEASE 1 PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. LYNN HARMER
K042368 08/31/2004 PRACTIX CONVENIO PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. LYNN HARMER
K042293 08/24/2004 BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. ROBERT L TUROCY
K042306 08/25/2004 PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH EGON PFEIL
K042122 08/06/2004 SMARTINFUSER PAINPUMP PRECISE MEDICAL PRODUCTS OFER SHAI
K042215 08/16/2004 RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT PREMIER DENTAL PRODUCTS CO. VINCE D'ALESSANDRO
K042131 08/09/2004 PROMEDICAL SURGICAL DRAPES PROMEDICAL PRODUCTS CO., LTD. BOYD HARRIS
K042111 08/05/2004 PROMEDICAL SURGICAL GOWNS PROMEDICAL PRODUCTS CO., LTD. BOYD HARRIS
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K042074 08/02/2004 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS VANGUARD MEDICAL CONCEPTS, INC. HEATHER CRAWFORD
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K042114 08/05/2004 MDL SERIES DIODE LASERS, MODEL MDL-10/15 VISION LASERTECHNIK, GMBH ROBERT S HEAD
K042275 08/23/2004 VISTAKON (SENOFILCON A) SOFT CONTACT LENS VISTAKON ANNETTE M HILLRING
K042188 08/12/2004 VOLCANO THERAPEUTICS, INC. VOLCANO IVUS SYSTEM VOLCANO THERAPEUTICS, INC. JAMES FARNWORTH
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K042118 08/06/2004 ATHENA MULTI-LYTE EBV IGG TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K042092 08/03/2004 ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
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K042271 08/23/2004 NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACES ZIMMER, INC. BRANDON HIPSHER
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