FDA 510(k) Decisions During July, 2004  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K040465 07/20/2004 LATIT FLOW AB ARDENT CLYDE E INGERSOLL
K040560 07/27/2004 ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING AB BIODISK ANNE BOLMSTROM
K041221 07/13/2004 ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASY ACCU-STAT DIAGNOSTICS, INC. JAMES G BARRONS
K041759 07/22/2004 ACE CONNECT INTERNAL CONNECTION ACE SURGICAL SUPPLY CO., INC. J. EDWARDS CARCHIDI
K041140 07/07/2004 ACELL UBM SURGICAL MESH ML AND MLPLUS ACELL, INC PATSY J TRISLER
K031996 07/23/2004 EXTENTRAC ELITE ADVANCED BACK TECHNOLOGIES DAVID F CUCCIA
K041753 07/14/2004 AESKULISA ENA 6 S AESKU.DIAGNOSTICS STANLEY AMMONS
K033897 07/19/2004 MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM AGA-LINDE HEALTH CARE JAMES JOCHEN ROGERS
K041701 07/22/2004 AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM AGFA CORP. JEFFERY A JEDLICKA
K041241 07/06/2004 MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600 ALARIS MEDICAL SYSTEMS, INC. STACY L LEWIS
K040231 07/13/2004 INTELIPORT OCCLUDING DEVICE ALCON, INC. KIM B KRACKE
K041916 07/30/2004 ALOKA SSD-ALPHA 5 ULTRASOUND SYSTEM ALOKA CO. LTD USA RICHARD J CEHOVSKY
K040991 07/22/2004 AMBU DISPOSABLE PRESSURE MANOMETER AMBU, INC. SANJAY PARIKH
K040754 07/23/2004 AMERICAN BANTEX MS 4 MINI SCOOTER AMERICAN BANTEX CORP. TRACY S BEST
K041376 07/20/2004 C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A ANALOGIC CORP. DONALD J SHERRATT
K041420 07/26/2004 ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K041828 07/30/2004 APEX MEDICAL CPAP MODEL 9S-003 APEX MEDICAL CORP. ALAN CHANG
K041745 07/15/2004 VINYL EXAMINATION GLOVES, POWDER FREE, GREEN COLOR ARISTA LATINDO INDUSTRIAL, LTD. P.T. LINGA SUMARTA
K041153 07/12/2004 SHARPSAWAY II LOCKING DISPOSABLE CUP ARROW INTL., INC. ELIZABETH PRICE
K040907 07/01/2004 ARTHREX SMALL FRAGMENT PLATES AND SCREWS ARTHREX, INC. SALLY FOUST
K041274 07/28/2004 RESORBABLE INTERFERENCE SCREW ARTHROTEK, INC. GARY BAKER
K041726 07/23/2004 HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX ASAHI MEDICAL CO., LTD. DAVID L WEST
K041670 07/06/2004 BIS PEDIATRIC SENSOR ASPECT MEDICAL SYSTEMS, INC. RENEE GOULD
K041681 07/01/2004 ATRICURE DISSECTOR ATRICURE, INC. MARK JOB
K040913 07/23/2004 NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) BAUSCH & LOMB DAVID THOMAS
K031431 07/13/2004 BAWMED RESCUE MASK BAWMED UK BARBARA WOODS
K041738 07/09/2004 BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUME) BAXTER HEALTHCARE CORPORATION KAREN SPRANGER
K041133 07/02/2004 MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER BAYER HEALTHCARE, LLC ANDRES HOLLE
K041561 07/06/2004 LIQUICHEK WHOLE BLOOD VOLATILES CONTROL BIO-RAD MARIA ZEBALLOS
K041938 07/22/2004 MAXIMUS OS (OVERDENTURE SYSTEM) BIOHORIZONS IMPLANT SYSTEMS, INC. WINSTON GREER
K041564 07/16/2004 Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01 BIOJECT MEDICAL TECHNOLOGIES INC. LAURENCE A POTTER
K031140 07/07/2004 WATERLASE BIOLASE TECHNOLOGY, INC. IOANA M RIZOIU
K040007 07/07/2004 INTERFERENTIAL STIMULATOR, MODEL BMLS02-6 BIOMEDICAL LIFE SYSTEMS, INC. RICHARD SAXON
K041466 07/01/2004 TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC) BIOMET MANUFACTURING CORP. TRACY J BICKEL, RAC
K031454 07/08/2004 ACUMEN SURGICAL NAVIGATION SYSTEM BIOMET, INC. KRISTINE C ARNOLD
K041352 07/30/2004 COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM BIOMET, INC. GARY BAKER
K040459 07/06/2004 TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS BIOSITE INCORPORATED JEFFREY R DAHLEN
K041293 07/09/2004 BIOPORE BALLOON DILATION CATHETER BIPORE, INC. KEITH PALUCH
K041606 07/07/2004 EXTRACTOR RX RETRIEVAL BALLOON BOSTON SCIENTIFIC CORP. JAMES D MCMAHON
K040155 07/01/2004 PERIPHERAL CUTTING BALLOON BOSTON SCIENTIFIC CORP. RENUKA KRISHNAN
K041716 07/22/2004 PTFE FELTS AND PLEDGETS BOSTON SCIENTIFIC CORP. MAUREEN MONTBRIAND
K041727 07/23/2004 MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 BOSTON SCIENTIFIC SCIMED, INC. ROBERT Z PHILLIPS
K040931 07/22/2004 PATXFER RT BRAINLAB, AG RAINER BIRKENBACH
K041641 07/01/2004 DAVOL DELIVERY SYSTEM C.R. BARD, INC. SUZANNE LASCALZA
K041576 07/02/2004 SOURCELINK C.R. BARD, INC. JOHN C KNORPP
K040986 07/01/2004 CADWELL LIMB MOVEMENT MODULE CADWELL LABORATORIES, INC. CHRIS BOLKAN
K040932 07/01/2004 EASYNET BODY POSITION MODULE CADWELL LABORATORIES, INC. CHRIS BOLKAN
K041414 07/08/2004 CRONO AND CRONO, MODEL 30 CANE S.R.L. DANIEL KAMM
K041700 07/30/2004 CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEAR CANTOR & NISSEL LTD. MARTIN DALSING
K040438 07/01/2004 POWERHEART AED G3A CARDIAC SCIENCE, INC. KENNETH OLSON
K041671 07/22/2004 IMAGENMD CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC MALINIE HASEK
K033679 07/07/2004 COPSIOS BONE VOID FILLER (BVF) CENTERPULSE SPINE-TECH, INC. TIM MILLER
K040031 07/28/2004 CERAGEM-C THERMAL ACUPRESSURE MASSAGER CERAGEM CO., LTD. SUZAN ONEL
K041363 07/27/2004 AOC BONE WAX CEREMED INC. TADEUSZ WEKKUSZ MD
K041645 07/09/2004 DDS-ZR CHARLES SCHARF CHRIS SCHARF
K041773 07/15/2004 OXYGEN MEDICELS, CITICELS CITY TECHNOLOGY LIMITED DEBRA WALLACE
K033592 07/27/2004 REPROCESSED SURGICAL SCISSORS AND GRASPERS CLEAR MEDICAL, INC. MIKE KOVACS
K033488 07/07/2004 CMI MAGNETOCARDIOGRAPH CMI CARDIOMAG IMAGING INC STEVEN KARR
K041020 07/07/2004 CADSTREAM VERSION 3.1 CONFIRMA, INC. PATRICIA A MILBANK
K041044 07/29/2004 CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET COOK, INC. JENNIFER BOSLEY
K041138 07/23/2004 LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS COOPERVISION, INC. BONNIE J TSYMBAL
K041417 07/20/2004 DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR, MODELS RF423, RC423 DADE BEHRING, INC. RICHARD M VAUGHT
K041150 07/22/2004 MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS DADE BEHRING, INC. ROBERT EUSEBIO
K041870 07/27/2004 N APOLIPOPROTEIN STANDARD SERUM DADE BEHRING, INC. DONNA A WOLF
K041907 07/23/2004 TRIO MONITOR DATASCOPE CORP. SUSAN E MANDY
K041772 07/28/2004 DATEX-OHMEDA PRESTN.01 MODULE (MODEL FAMILY M-PRESTN.01) AND ACCESSORIES DATEX-OHMEDA JOEL C KENT
K041790 07/23/2004 DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWARE DATEX-OHMEDA JOEL C KENT
K041368 07/29/2004 DENTIUM CO., LTD. IMPLANTIUM DENTIUM CO., LTD. CATHRYN N CAMBRIA
K041707 07/30/2004 CERCON CERAM EXPRESS CERAMIC SYSTEM DENTSPLY INTL. P. JEFFERY LEHN
K040281 07/09/2004 LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM) DEPUY ORTHOPAEDICS, INC. DINA L WEISSMAN
K041656 07/01/2004 MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT DEPUY ORTHOPAEDICS, INC. TIFFANI ROGERS
K041119 07/19/2004 EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. SHARON STAROWICZ
K033959 07/01/2004 LPS DEPUY, INC. DINA L WEISSMAN
K041085 07/22/2004 LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY DEPUY, INC. TIFFANI ROGERS
K041416 07/02/2004 EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER DEROYAL SHARON COOK
K040362 07/12/2004 DIAPHARMA FACTOR X KIT DIAPHARMA GROUP, INC. JENNIFER J KIBLINGER
K041014 07/14/2004 TSH-CTK-3 IRMA DIASORIN, INC. DAVID M IKEDA
K041213 07/22/2004 3DSCOPE DIREX SYSTEMS CORP. LARISA GERSHTEIN
K041582 07/07/2004 MODIFICATION TO TRIPTER X-1 COMPACT DUET DIREX SYSTEMS CORP. LARISA GERSHTEIN
K041622 07/08/2004 MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM DRAEGER MEDICAL, INC. MICHAEL A KELHART
K041178 07/16/2004 EMPOWER TRANSFER SET, (CAT. NO. 7725) E-Z-EM, INC. JUDY HAUSER
K040935 07/06/2004 EBI XFIX DFS SYSTEM EBI, L.P. FREDERIC TESTA
K033463 07/28/2004 EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE EDWARDS LIFESCIENCES LLC. JASON SMITH
K041644 07/29/2004 FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE) ELEKON INDUSTRIES U.S.A., INC. KRISTA OAKES
K040979 07/23/2004 ELEKTA MICRODRIVE, MODEL 916716 ELEKTA INSTRUMENT AB ANDERS SKOGLUND
K032905 07/06/2004 3DKNEE POROUS COATED FEMORAL COMPONENT ENCORE ORTHOPEDICS, INC. KIMBERLY L PRUITT
K033949 07/02/2004 VARILUX VISIONPRINT SYSTEM (VPS) ESSILOR INTL. MARC J SCHEINESON
K041325 07/02/2004 DISPOSABLE COLORED VINYL SYNTHETIC EXAM GLOVE, POWDER FREE EST INTERNATIONAL CORPORATION ELIZABETH DENG
K041599 07/27/2004 COBRA ADHERE SURGICAL SYSTEM ESTECH, INC. CRAIG COOMBS
K040678 07/14/2004 EUSURE BLOOD GLUCOSE MONITORING SYSTEM EUMED BIOTECHNOLOGY CO., LTD. KE-MIN JEN
K041575 07/16/2004 FENZIAN TREATMENT SYSTEM EUMEDIC LIMITED LEWIS W WARD
K033858 07/12/2004 TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE EUROPEAN CUSTOM MANUFACTURING BV MAARTEN KANTERS
K041596 07/21/2004 ARCHITECT STAT CK-MB IMMUNOASSAY FISHER DIAGNOSTICS JOSEFINA INFANTAS
K041814 07/20/2004 FS SERIES WHEELCHAIR FOSHAN DONGFANG MEDICAL EQUIPMENT MANUFACTORY(LTD) PANG JIANXUN
K041042 07/16/2004 SPLIT SEPTUM INJECTION SITES FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR EILINSFELD
K040946 07/01/2004 ANKYLOS DENTAL IMPLANT SYSTEM FRIADENT GMBH CAROL PATTERSON
K041813 07/23/2004 GE LOGIQ 7 ULTRASOUND BT04 GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA ALLEN SCHUH
K041921 07/26/2004 GE SIGNA PROFILE 6 INCH GP COIL GE MEDICAL SYSTEMS, LLC LARRY A KROGER
K022823 07/01/2004 VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 GEISTER MEDIZINTECHNIK GMBH DAGMAR MASER
K041922 07/28/2004 GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR GENERAL ELECTRIC CO. DAVID DUERSTELER
K041552 07/02/2004 GE VIVID 7 BT04 GENERAL ELECTRIC CO. ALLEN SCHUH
K041688 07/08/2004 GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04 GENERAL ELECTRIC CO. ALLEN SCHUH
K040010 07/19/2004 GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS GENESIS MEDICAL INTERVENTIONAL, INC. ANNE WORDEN
K041039 07/20/2004 FERTELL MALE FERTILITY TEST GENOSIS LTD. SHARON A SEGAL
K041232 07/22/2004 GETTIG UNIVERSAL VIAL ACCESS PIN GETTIG PHARMACEUTICAL INSTRUMENT CO. JAMES A BENZ
K041225 07/15/2004 SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES-POWERED GRAND WORK PLASTIC PRODUCTS CO., LTD. JAMES CHU
K040682 07/28/2004 SYNTHETIC VINYL PATIENT EXAMINATION GLOVES-POWDER FREE GRAND WORK PLASTIC PRODUCTS CO., LTD. JAMES CHU
K041574 07/12/2004 CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 GUIDANT CORPORATION AMITA SHENAI
K041340 07/28/2004 GUIDANT MICROWAVE ABLATION SYSTEM GUIDANT CORPORATION, CARDIAC SURGERY NANCY GALLO
K041636 07/02/2004 H&S-CONDUCTIVITY STANDARD SOLUTION H & S TECHNICAL SERVICES JOHN HYTE
K041081 07/01/2004 FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES HAND INNOVATIONS, INC. AL WEISENBORN
K041157 07/30/2004 MODIFICATION TO SMALL BONE FIXATION SYSTEM HAND INNOVATIONS, INC. AL WEISENBORN
K041391 07/09/2004 FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES HARTALEGA SDN BHD TITO ALDAPE
K040896 07/16/2004 MODIFICATION TO ENCOMPASS HEARTLAB, INC. RICHARD PETROCELLI
K041013 07/07/2004 SUILE OINTMENT WOUND DRESSING HEDONIST BIOCHEMICAL TECHNOLOGIES CO., LTD. ERIC LUO, PH.D.
K041001 07/01/2004 OMEGA 2 SYSTEM HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K041233 07/28/2004 ARTHROJET XT HYDROCISION, INC. DEBBIE IMAMPIETRO
K040923 07/22/2004 LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA IBL GMBH GARY LEHNUS
K041702 07/16/2004 EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.) IBT SA RUTH FEICHT
K041410 07/28/2004 PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118 ICU MEDICAL INC DALE FAIRCHILD
K040782 07/13/2004 N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX IMAGE ANALYSIS, INC. BEN ARNOLD
K040756 07/14/2004 THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX IMPLEX CORP. MARCI HALEVI
K041761 07/13/2004 RAPIDIACOLON INFINITT CO., LTD. CARL ALLETTO
K041103 07/27/2004 ACNELIFT INNER ACT, LLC RONNIE LAMBERTON
K041583 07/22/2004 PEEK CEMENT RESTRICTOR "X-BOX" INNOVASIS, INC. BRENT A FELIX
K041620 07/16/2004 NEURA WRAP NERVE PROTECTOR INTEGRA LIFESCIENCES CORP. DIANA M BORDON
K040686 07/30/2004 M'ATH STD INTELLIGENCE IN MEDICAL TECHNOLOGIES SCOTT PEASE
K040766 07/22/2004 OPTISOURCE, MODEL 1032P INTERNATIONAL BRACHYTHERAPY S.A. RUTH FEICHT
K041794 07/19/2004 C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM INTERPORE CROSS INTL. WENDY SPIELBERGER
K041449 07/01/2004 SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT INTERPORE CROSS INTL. WENDY SPIELBERGER
K040237 07/07/2004 INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENT CONTROL SYSTEM AND ENDOSCOPIC INSTRUMENTS INTUITIVE SURGICAL, INC. USHA KREADEN
K041344 07/16/2004 OPEN BORE SYRINGE ISOTIS NV ELIANE SCHUTTE
K041159 07/27/2004 JMS ABSORBABLE ANCHOR AND APPLICATOR JMS, INC. JOHN I SHIPP
K033448 07/12/2004 ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER JOHN MFG., LTD. ARTHUR KING MA
K033930 07/28/2004 KAPP CUSTOM ULNAR HEAD WRIST IMPLANT KAPP SURGICAL INSTRUMENT, INC. ALBERT SANTILLI
K041678 07/23/2004 KARMA POWER WHEELCHAIR, MODEL KP-25 KARMA MEDICAL PRODUCTS CO., LTD. JEN KE-MIN
K041151 07/22/2004 KERBEROS OCCLUDING GUIDE CATHETER AND ACCESSORIES KERBEROS PROXIMAL SOLUTIONS, INC. MICHAEL A DANIEL
K041584 07/07/2004 KYPHX HV-R BONE CEMENT, MODEL C01A KYPHON, INC. CINDY DOMECUS
K041454 07/09/2004 KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A KYPHON, INC. CINDY DOMESCUS
K041624 07/16/2004 PTCA STEERABLE HYDROPHILIC GUIDEWIRE LAKE REGION MFG., INC. KAREN MORTENSEN
K041446 07/01/2004 NASALCEASE LES LABORATORIRES BROTHIER, S.A. RICHARD J FREER, PH.D.
K040844 07/23/2004 LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM LIFE SPINE, LLC. MICHAEL S BUTLER
K041324 07/19/2004 CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER LIFECORE BIOMEDICAL, INC. KIM E AVES
K041713 07/22/2004 SUPER REVO HERCULINE SUTURE ANCHOR LINVATEC CORP. ELIZABETH M PAUL
K041128 07/29/2004 SUTURE ARROW LINVATEC CORP. ELIZABETH M PAUL
K041105 07/28/2004 MACROPORE HYDROSORB SPINE SYSTEM MACROPORE BIOSURGERY, INC. KENNETH KLEINHENZ
K041819 07/22/2004 GOODKNIGHT 425, MODELM-114500-00 MALLINCKRODT DEVELOPPEMENT FRANCE JAMES BONDS
K040554 07/16/2004 ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256 MANUFACTURING TECHNOLOGY, INC. JOHN G SCHNEIDER
K040576 07/01/2004 MICROMESAM BASIC-SET MAP MEDIZINTECHNIK FUR ARZT UND PATIENT GMBH DAVID D'CRUZ
K041223 07/29/2004 MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E MAQUET CRITICAL CARE AB JAMIE YIEH
K041815 07/29/2004 LNCS OXIMETRY SENSORS MASIMO CORP. JAMES J CRONIN
K041327 07/20/2004 MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES MED2000 S.R.L. SUSAN D GOLDSTEIN-FALK
K041326 07/27/2004 MEDCOMMONS OPEN RADIOLOGY GATEWAY MEDCOMMONS, INC. CHAS BURR
K040992 07/29/2004 15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706 MEDCOMP JEAN CALLOW
K041101 07/07/2004 MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 23001, 23002, 23003, 23004, AND 24001 MEDICAL ADHESIVEONLINE, LLC. ADAM SHAW
K041600 07/27/2004 QWIKCHECK-BEADS MEDICAL ELECTRONICS SYSTEMS LTD. ERIKA B AMMIRATI
K041807 07/22/2004 LUNG CAR 1.1 MEDICSIGHT CAROL MACDONALD
K041162 07/27/2004 ORTHO-CMS MEDIS MEDICAL IMAGING SYSTEMS, B.V. J.I. HOLLANDER
K041789 07/15/2004 NONINVASIVE BLOOD PRESSURE MONITOR, MODELS MD-880B AND MD-900T MEDITEC CO., LTD. RONALD D ARKIN
K041345 07/22/2004 PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES MEDIX, INC. BARBARA LAW
K040841 07/08/2004 POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) MEDLINE INDUSTRIES, INC. JENNIFER MASON
K041459 07/01/2004 LIFEPAK 12 DEFIBRILLATOR/MONITOR MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. MICHELLE ACKERMANN
K041318 07/19/2004 MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP MEDTRONIC MINIMED MARK J FAILLACE
K041317 07/19/2004 MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP MEDTRONIC MINIMED MARK J FAILLACE
K041000 07/27/2004 DUREPAIR DURA REGENERATION MATRIX MEDTRONIC NEUROSURGERY JEFFREY HENDERSON
K033926 07/07/2004 HOURGLASS VERTEBRAL BODY SPACER MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K041556 07/01/2004 MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K041460 07/01/2004 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. RICHARD TREHARNE
K040483 07/23/2004 EQUESTRA FLUID DELIVERY SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K041338 07/19/2004 MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES MEDTRONIC VASCULAR SCOTT CUNDY
K041413 07/12/2004 XPS 3000 SYSTEM MEDTRONIC XOMED, INC. MARTIN D SARGENT
K041523 07/23/2004 XPS 3000 SYSTEM MEDTRONIC XOMED, INC. MARTIN D SARGENT
K031397 07/29/2004 MERLIN E-MASK MERLIN MEDICAL LIMITED ROBERT STEELE
K031395 07/16/2004 MERLIN RESUSCITATOR MERLIN MEDICAL LIMITED ROGERT STEELE
K041649 07/16/2004 SAPPHIRE NXT DETACHABLE COIL SYSTEM MICRO THERAPEUTICS, INC. FLORIN TRUUVERT
K041302 07/01/2004 REFUGE SOUND GENERATOR MICRO-EAR TECHNOLOGY, INC. DEBORAH SHAFFER
DEN040008 07/28/2004 CEDIA SIROLIMUS ASSAY MICROGENICS CORP. DAVID CASAL
K034069 07/28/2004 CEDIA SIROLIMUS ASSAY MICROGENICS CORP. DAVID CASAL
K041411 07/21/2004 MICROLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL BP-3BTO-AP MICROLIFE CORP. SUSAN D GOLDSTEIN
K041551 07/07/2004 MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES) MICROVENTION, INC. VINCENT CUTARELLI
K030290 07/26/2004 PERIOLASE ND:YAG DENTAL LASER SYSTEM MILLENNIUM DENTAL TECHNOLOGIES, INC. DAVID M HARRIS
K041286 07/21/2004 DYNACAD V1.0 MRI DEVICES CORP. TOM TYNES
K041481 07/19/2004 MODEL BBC-127 BIOPSY BREAST COIL MRI DEVICES CORP. THOMAS E TYNES
K040400 07/20/2004 MYO-TRODE SG DISPOSABLE ELECTRODE MYOTRONICS-NOROMED, INC. FRAY ADIB
K041312 07/23/2004 NOBELRONDO DENTAL CERAMIC-ALUMINA NOBEL BIOCARE UAS INC ELIZABETH J MASON
K040019 07/23/2004 SILVERSEAL NOBLE FIBER TECHNOLOGIES PATRICIA DAVIDSON
K040439 07/08/2004 MDI TRIGGER GUARD NORTH AMERICAN TECHNICAL SERVICES (NATS) CORP. RICHARD LANZILLOTTO
K033614 07/29/2004 MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215 NORTHGATE TECHNOLOGIES, INC. CASEY KUREK
K041719 07/22/2004 ONCENTRA-VISIR NUCLETRON CORP. LISA DIMMICK
K041424 07/02/2004 NXSTAGE SYSTEM ONE NXSTAGE MEDICAL, INC. NORMA LEMAY
K041793 07/16/2004 OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 OLYMPUS AMERICA, INC. BEV HARDING
K041494 07/01/2004 OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2 OLYMPUS CORPORATION TINA STEFFANIE-OAK
K041664 07/29/2004 PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C ON SITE GAS SYSTEMS, INC. C. BART GULLONG
K033826 07/01/2004 ORTHOPEDIC ALLIANCE SPINE SYSTEM ORTHOPEDIC ALLIANCE LLC ROGER WILLIAMS
K031701 07/08/2004 OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM OSTEOMED L.P. DAWN T HOLDEMAN
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