FDA 510(k) Applications Received During September, 2004

FDA 510(k) Number Submission Date Device Name Applicant Contact
K042458 09/13/2004 A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM A.M. SURGICAL, INC. CAROLANN KOTULA
K042392 09/02/2004 DAPTOMYCIN AB BIODISK ANNE BOLMSTROM
K042390 09/02/2004 ETEST FOR GEMIFLOXACIN AB BIODISK ANNE BOLMSTROM
K042423 09/07/2004 VERIFYNOW-ASPIRIN ASSAY ACCUMETRICS, INC. BARBARA STEVENS
K042376 09/01/2004 ACUMEN SHEATH, MODEL TTW7807 ACUMEN MEDICAL, INC. MARYBETH GAMBER
K042381 09/01/2004 CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508 ACUMEN MEDICAL, INC. MARYBETH GAMBER
K042496 09/17/2004 ADEPT ULTRALITE 532 LASER ADEPT MEDICAL CONCEPTS JERRY MCFARLAND
K042562 09/21/2004 LENS PLUS REWETTING DROPS ADVANCED MEDICAL OPTICS, INC. PETER XU
K042450 09/09/2004 STERRAD NX CHALLENGE PACK ADVANCED STERILIZATION PRODUCTS JOSEPH M ASCENZI
K042644 09/27/2004 AESKULISA TTG A AND AESKULISA TTG G AESKU, INC STANLEY AMMONS
K042397 09/07/2004 SCANX 14 AIR TECHNIQUES, INC. JOSEPH CAREY
K042440 09/09/2004 ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM ALPHATEC/NEXMED ELLEN YARNALL
K042673 09/29/2004 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC/NEXMED ELLEN A YARNALL
K042682 09/29/2004 AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR AMBU, INC. SANJAY PARIKH
K042462 09/10/2004 AMERICAN DENTAL IMPLANT AMERICAN DENTAL IMPLANT CORPORATION STEVEN B LOMBARDI
K042592 09/23/2004 INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304 AMERICAN MEDICAL SYSTEMS, INC. KRISTYN BENSON
K042401 09/03/2004 VARI-ABLE APB (ADAPTABLE POSITIONING BASE) AMERICAN TRACK ROADSTERS, INC. GREG PEEK
K042575 09/22/2004 AMPLIFE DIGITAL CLINICAL THERMOMETER AMPLIFE CORPORATION SUSAN D GOLDSTEIN-FALK
K042685 09/29/2004 METRICATH SYSTEM ANGIOMETRX INC. TIM VERSPAGEN
K042413 09/07/2004 ACS MODEL NCP-2 APPLIED CARDIAC SYSTEMS R. BEN GHADIMI
K042542 09/27/2004 CYTOVISION FOR CEP XY APPLIED IMAGING CORP. DIANE C DAY
K042443 09/09/2004 SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL ARKRAY, INC. HELEN LANDICHO
K042460 09/10/2004 TI - SCREW ANCHOR SP ARTHROTEK, INC. GARY BAKER
K042690 09/29/2004 ASCENSION PYROSPHERE (PCS) ASCENSION ORTHOPEDICS, INC. PETER STRZEPA
K042638 09/27/2004 RADIANCE PORCELAIN AURIDENT, INC. BRUCE D SPIVACK
K042486 09/13/2004 PROCEDUR 10 SYRINGE DEVICE AVANCA MEDICAL DEVICES, INC. FRANK FERGUSON
K042487 09/13/2004 PROCEDUR SF SAFETY SYRINGE DEVICE AVANCA MEDICAL DEVICES, INC. FRANK FERGUSON
K042411 09/07/2004 ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY AXIS-SHIELD LTD. SUSAN LEONARD
K042488 09/13/2004 PERIFIX CATHETER AND CONTIPLEX CATHETER B. BRAUN MEDICAL, INC. AMY SMITH
K042580 09/22/2004 TIDI BRAND STERILIZATION WRAP BANTA HEALTHCARE GROUP, LTD. INA GORDON
K042445 09/09/2004 SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT BARD ACCESS SYSTEMS, INC. CHARLES MORREALE
K042410 09/09/2004 BAXJECT II BAXTER HEALTHCARE CORP. RON LAGERQUIST
K042651 09/28/2004 FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS BECKMAN COULTER, INC. VALYNDA MACHEN
K042459 09/10/2004 SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT BECKMAN COULTER, INC. KIM WALKER
K042491 09/14/2004 BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER BECTON DICKINSON & CO. LESLIE WOOD
K042472 09/10/2004 BD DIRECTIGEN EZ FLU A + B BECTON, DICKINSON & CO. GREG PAYNE
K042400 09/03/2004 MUCOTROL CONCENTRATED ORAL GEL WAFER BELCHER PHARMACEUTICALS, INC. KOTHA SEKHARAM
K042636 09/30/2004 BIOPLUS BERKELEY ADVANCED BIOMATERIALS, INC. FRANCOIS GENIN
K042586 09/22/2004 BEST BREAST BRACHYTHERAPY APPLICATOR BEST MEDICAL INTERNATIONAL, INC. JOSEPH C WANG
K042637 09/27/2004 THE 5.0 X 6.0MM DENTAL IMPLANT BICON, INC. VINCENT J MORGAN
K042446 09/09/2004 QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS BIO-RAD LABORATORIES, INC. MARIA ZEBALLOS
K042553 09/20/2004 BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER BIOCARDIA, INC. DANIEL C ROSENMAN
K042532 09/17/2004 BIOCARE SYSTEMS PREMIR 818 BIOCARE SYSTEMS, INC. CLAY ANSELMO
K042429 09/08/2004 THE PRODIGY SYSTEM DENTAL IMPLANTS BIOHORIZONS IMPLANT SYSTEMS, INC. WINSTON GREER
K042711 09/30/2004 MODEL BMLS03-7 BIOMEDICAL LIFE SYSTEMS, INC. GARY BUSSETT
K042616 09/23/2004 BIOMEDIX PADNET LAB BIOMEDIX, INC. WILLIAM ROGERS
K042552 09/21/2004 BIO-CORE INTERFERENCE SCREW BIOMET, INC. SUSAN ALEXANDER
K042409 09/03/2004 MODULAR ARTHRODESIS NAIL BIOMET, INC. GARY BAKER
K042678 09/29/2004 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM BIONIME CORPORATION SUSAN D GOLDSTEIN-FALK
K042379 09/03/2004 ANEMIAPRO SELF-SCREENER BIOSAFE LABORATORIES, INC. JACK A MAGGIORE
K042681 09/29/2004 CARTO RMT EP NAVIGATION SYSTEM BIOSENSE WEBSTER, INC. DIANA THORSON
K042528 09/20/2004 INBODY, MODEL 3.0 BIOSPACE CORPORATION LIMITED DANIEL KAMM
K042708 09/30/2004 ERA 3000 PACING SYSTEM ANALYZER BIOTRONIK, INC. JON BRUMBAUGH
K042373 09/01/2004 GALEO FOCUS GUIDE WIRE BIOTRONIK, INC. JON BRUMBAUGH
K042514 09/16/2004 MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM BLACKSTONE MEDICAL, INC. DEAN E CIPORKIN
K042568 09/21/2004 EXCELSIOR 1018 AND SL-10 MICROCATHETERS BOSTON SCIENTIFIC CORP. VICTOR HAM
K042539 09/20/2004 GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL BOSTON SCIENTIFIC CORP. JAMES LEATHLEY
K042469 09/13/2004 BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER BRAEMAR, INC. DARREN DERSHEM
K042543 09/20/2004 IPLAN! DIGITAL TEMPLATING BRAINLAB AG RAINER BIRKENBACH
K042391 09/02/2004 KOLIBRI IMAGE GUIDED SURGERY SYSTEM BRAINLAB AG JENS WITTE
K042512 09/15/2004 VECTORVISION ACL BRAINLAB AG RAINER BIRKENBACH
K042513 09/15/2004 VECTORVISION OSTEOTOMY BRAINLAB AG RAINER BIRKENBACH
K042395 09/02/2004 OUTPATIENT III MINOR SURGERY LIGHT BURTON MEDICAL PRODUCTS CORP. ASLE ASMUL
K042696 09/30/2004 BODYGUARD INFUSION PUMP SYSTEM CAESAREA MEDICAL ELECTRONICS LTD. GALI TZURY
K042615 09/24/2004 CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE CARBON MEDICAL TECHNOLOGIES, INC. ROBERT W JOHNSON
K042574 09/22/2004 ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL) CARDINAL HEALTH ERICA SETHI
K042672 09/29/2004 14F DUAL FLOATING DIALYSIS CATHETER/TRAY CARDIOMED SUPPLIES, INC. CHRISTIAN G DUBE
K042641 09/30/2004 CHEMVIEW-10 CENOGENICS CORP. NITZA KATZ
K042548 09/20/2004 CERASYS - ZR CERASYS, INC. JIN KIM
K042647 09/28/2004 EXAM-PACS COACTIV, LLC CARL ALLETTO
K042473 09/13/2004 COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM COBE CARDIOVASCULAR, INC. JACK ELLISON
K042693 09/30/2004 IV ADMINISTRATION SET B400 SP CODAN US CORP. ROHIT PATEL
K042588 09/22/2004 CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005093 CONFLUENT SURGICAL,INC ERIC ANKERUD
K042611 09/24/2004 LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE COOK, INC. EARL KNIGHT
K042691 09/29/2004 VERTEFIX VERTEBROPLASTY PROCEDURE SET COOK, INC. JENNIFER J BOSLEY
K042518 09/16/2004 ZILVER 518 BILIARY STENT COOK, INC. LELAND KEYT
K042435 09/08/2004 COOPER PROSTHETIC COOPERVISION, INC. BONNIE J TSMBAL
K042680 09/29/2004 RHIGENE HEP-ANA TEST SYSTEM CORGENIX, INC. YUSUKE KOBE
K042385 09/08/2004 DOC BAND-POSTOP CRANIAL TECHNOLOGIES, INC. TIMOTHY R LITTLEFIELD
K042569 09/21/2004 8600 VITAL SIGNS MONITOR CRITICARE SYSTEMS, INC. ALEX KAPLAN
K042541 09/20/2004 MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM CRYOVASCULAR SYSTEMS, INC. KIM TOMPKINS
K042467 09/15/2004 LSO PET/CT HIREZ 64 CTI PET SYSTEMS, INC. M. ALAINE MEDIO
K042650 09/28/2004 BIOMOVE 3000 CURATRONIC, LTD. ARAVA HACOHEN
K042626 09/27/2004 NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM CYBERKINETICS, INC. BURKE T BARRETT
K042384 09/01/2004 NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM CYBERKINETICS, INC. (CKI) BURKE T BARRETT
K042502 09/23/2004 3 SERIES PHOTOTHERAPY CABINET DAAVLIN DISTRIBUTING CO. DAVID W SWANSON
K042407 09/03/2004 EMIT CAFFEINE ASSAY DADE BEHRING, INC. YUK-TING LEWIS
K042687 09/29/2004 ENZYGNOST F+2 (MONOCLONAL) TEST KIT DADE BEHRING, INC. DONNA WOLF
K042437 09/08/2004 DORSAL INTRAMEDULLARY PLATE DEO VOLENTE ORTHOPAEDICS, LLC DINA L WEISSMAN, J.D.
K042591 09/23/2004 SMARTMIX PRE-FILLED MIXING SYSTEM DEPUY ORTHOPAEDICS, INC. TIFFANI ROGERS
K042508 09/15/2004 SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM DEPUY SPINE, INC. SHARON STAROWICZ
K042544 09/20/2004 UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM DEPUY SPINE, INC. SHARON STAROWICZ
K042664 09/28/2004 LPS UPPER EXTREMITY DEPUY, INC. TIFFANI D ROGERS
K042439 09/09/2004 AZURYT MODEL CLT 1401, CO2 SURGICAL LASER SYSTEM DIAMOND AGE SYSTEMS, INC. GEOFFREY D SWANK
K042522 09/16/2004 JAUNDICE METER, MODEL JM 103 DRAEGER MEDICAL INFANT CARE, INC. THOMAS M MCINTOSH
K042656 09/28/2004 INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5 DRAEGER MEDICAL SYSTEMS, INC. PENELOPE H GRECO
K042419 09/07/2004 FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM DRAEGER MEDICAL, INC. MICHAEL A KELHART
K042607 09/24/2004 PRIMUS US DRAEGER MEDICAL, INC. JAMES J BRENNAN
K042547 09/20/2004 DRAGON HEART PISTON SYRINGE DRAGON HEART MEDICAL DEVICES CO., LTD. JINA YU
K042478 09/15/2004 CAPSULE TENSION RING INSERTER, MODEL 7-810 DUCKWORTH & KENT, LTD. MARTIN LOCK
K042500 09/14/2004 DUOPROSS SYRINGES DUOPROSS MEDITECH CORPORATION FRANK FREGUSON
K042703 09/30/2004 CYBIRD LED CURING LIGHT DXM CO., LTD. CAROLANN KOTULA
K042408 09/03/2004 IQQA-CHEST SOFTWARE PACKAGE EDDA TECHNOLOGY, INC. DANIEL KAMM
K042456 09/10/2004 MODIFICATION TO LYSUS INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K042710 09/30/2004 SURGITRON RADIOLASE II ELLMAN INT'L INC. FRANK LIN
K042493 09/14/2004 ENSITE SYSTEM, MODEL EE3000 ENDOCARDIAL SOLUTIONS, INC. KAREN J MCKELVEY
K042686 09/29/2004 ENERGEX ENERGEX SYSTEMS, INC. TRISH LANDRY
K042556 09/20/2004 SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022, ENTER MEDICAL CORPORATION TZONG-FUH KUO
K042700 09/30/2004 IMAGE MEDICAL ACQUISITION STATION (IMAS) ERAD IMAGEMEDICAL CORP. GARY J ALLSEBROOK
K042603 09/24/2004 GYNECARE PROLENE FASTENER SYSTEM ETHICON, INC. SEAN O'BRYAN
K042529 09/17/2004 BALANCEBACK VNG SYSTEM FALL PREVENTION TECHNOLOGIES, LLC KEITH KRAVITZ
K042564 09/21/2004 HEMOR-RITE CRYOTHERAPHY FAMA HOLDINGS INTERNATIONAL CORP FRANK MELENDEZ
K042561 09/24/2004 TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER FMD, LLC YOUSRY FARAGALLA
K042667 09/29/2004 SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT), FPRCH 2024 (SEEDNETGOLD) GALIL MEDICAL LTD. JONATHAN S KAHN
K042348 09/07/2004 GRADIA DIRECT LOFLO GC AMERICA, INC. TERRY JORITZ
K042694 09/30/2004 ADVANCED LUNG ANALYSIS II GE MEDICAL SYSTEMS LARRY A KROGER
K042642 09/27/2004 AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR) GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES ANDREW KLUESSENDORF
K042525 09/17/2004 CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES CAROL ALLOIAN
K042602 09/24/2004 REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING GE MEDICAL SYSTEMS, LLC MARK M STAUFFER
K042559 09/21/2004 GEM-TWIN TENS/ MODELS GM3XY/Z GEMORE TECHNOLOGY CO., LTD. BODEN S.P. LAI
K042427 09/09/2004 GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER GENEMED, INC. DAVID BALZER
K042448 09/09/2004 DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT GENERAL ATOMICS HUAN TRAN
K042322 09/07/2004 STERICHEK BLOOD LEAK REAGENT STRIPS HACH COMPANY DAVID A MORRIS, PH.D.
K042495 09/14/2004 CUMULASE HALOZYME THERAPEUTICS INC. DON KENNARD
K042503 09/15/2004 KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM HEINZ KURZ GMBH MEDIZINTECHNIK DAGMAR MASER
K042501 09/14/2004 ETG-4000 OPTICAL TOPOGRAPHY SYSTEM HITACHI MEDICAL CORP. DOUG THISTLEWAITE
K042428 09/08/2004 SCEPTREP3 PET/CT HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUGLASS THISTLETHWAITE
K042480 09/13/2004 INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS HOLOGIC, INC. DANIEL F PHELAN
K042719 09/30/2004 HOME HEALTH POWER WHEELCHAIR, MODEL HC-200 HOME HEALTH TECHNOLOGY CO., LTD. KE-MIN JEN
K042609 09/24/2004 HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE HOSPIRA, INC. RAY SILKAITIS
K042545 09/20/2004 HOVEROUND MPV-5 POWERCHAIR HOVEROUND CORP. TONY DIGIOVANNI
K042396 09/02/2004 T2 PROXIMAL HUMERAL NAIL HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K042578 09/22/2004 I-PROMOTIONS CONTACT LENS CASE I-PROMOTIONS, INC. CHARLOTTE SLANKARD
K042697 09/30/2004 SECOND LOOK VIEWER ICAD INC. JOHN ROSENSTENGEL
K042507 09/15/2004 UBIPACS ICM CO., LTD. CARL ALLETTO
K042519 09/16/2004 GAMMA-B 1,25-DIHYDROXY VITAMIN D IMMUNODIAGNOSTIC SYSTEMS LTD. PAUL PUNTIN
K042431 09/08/2004 PROCON2 INCONTINENT CONTROL DEVICES, INC. NYLE ELLIOTT
K042546 09/20/2004 FUNHALER, MODEL FH 101 INFAMED LTD. JOHN D GREENBAUM
K042679 09/29/2004 IR VIEWER INFRARED IMAGING SYSTEMS, INC. DALE SIEGEL
K042557 09/20/2004 INNOJECT AUTO-INJECTOR INNOJECT, INC JONATHAN S KAHAN
K042631 09/27/2004 EAR THERMOMETER, MODEL WL-320X INNOVATECH, INC TONY C CHANG
K042576 09/22/2004 COATEST SP FVIII INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K042558 09/21/2004 EQUI-FLOW VALVE AND SHUNT SYSTEM INTEGRA NEUROSCIENCES IMPLANTS S.A. JUDITH O'GRADY
K042483 09/13/2004 INVACARE PRO, COMPACT AND PORTABLE DESKTOP INVACARE CORPORATION CARROLL MARTIN
K042538 09/20/2004 SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SAEXXXXXXXXX INVATEC INNOVATIVE TECHNOLOGIES MIKE WINEGAR
K042537 09/20/2004 SUBMARINE PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SUVXXXXXXXXX INVATEC INNOVATIVE TECHNOLOGIES MIKE WINEGAR
K042624 09/27/2004 AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. MIKE WINEGAR
K042706 09/30/2004 OSSATURA DENTAL ISOTIS ORTHOBIOLOGICS, INC PAUL DONER
K042635 09/28/2004 DENALI SPINE SYSTEM K2M, LLC RICHARD W WOODS
K042241 09/07/2004 K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C KAMIYA BIOMEDICAL CO. BRIAN SCHLIESMAN
K042394 09/07/2004 DIAGNODENT PERIO TIP (ACCESSORY) KAVO AMERICA CORPORATION DANIEL KAMM
K042461 09/15/2004 KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304 KENDALL PAUL W EVANS
K042572 09/21/2004 KENDALL CO2NFIRM NOW CO2 DETECTOR KENDALL BRIDGET GARDNER
K042573 09/21/2004 KLS MARTIN DRILL-FREE MMF SCREW KLS-MARTIN L.P. JENNIFER DAMATO
K042418 09/03/2004 KD-575 MEMORY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., LIU YI
K042386 09/07/2004 DIRECT DIGITIZER, REGIUS MODEL 190 KONICA MINOLTA MEDICAL & GRAPHIC, INC. SHINICHI YAMANAKA
K042618 09/27/2004 LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR) LAGLOVE (M) SDN. BHD. G. BASKARAN
K042560 09/21/2004 STELLAR 404 MONITORING SYSTEM LARSEN & TOUBRO LIMITED HARRY GUGNANI
K042596 09/23/2004 LSA HELIUM LIFESTAND STEFANIE D BANKSTON
K042517 09/15/2004 BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS LINVATEC BIOMATERIALS, LTD. TUIJA ANNALA
K042666 09/29/2004 LUTH-ALL SUB-Q NEEDLE SET LUTH-ALL MEDICAL PRODUCTS, LLC SHEPARD G BENTLEY
K042534 09/17/2004 MARINA MEDICAL FINGER PROTECTORS MARINA MEDICAL INSTRUMENTS, INC. JAY MANSOUR
K042536 09/20/2004 MASIMO SET RAD 57 PULSE CO-OXIMETER MASIMO CORPORATION JAMES J CRONIN
K042590 09/23/2004 TRANSDERM IONTO SYSTEM, MK 2 MATTIOLI ENGINEERING CORP. MELISSA MAHALL
K042382 09/01/2004 DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD MED-GENERAL TECHNOLOGIES LLC PAUL MCCREIGHT
K042432 09/08/2004 PHARMGUARD TOOLBOX, MODEL G6000782 MEDEX, INC. BARBARA LAW
K042526 09/17/2004 DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX MEDICAL ACTION INDUSTRIES, INC. ROBIN BLANKENBAKER
K042527 09/17/2004 SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 MEDICAL ACTION INDUSTRIES, INC. ROBIN BLANKENBAKER
K042464 09/13/2004 V-CORE FULL CORE BREAST BIOPSY INSTRUMENT MEDICAL DEVICE TECHNOLOGIES, INC. NICOHL WILDING
K042674 09/29/2004 COLON CAR 1.2 MEDICSIGHT CAROL MACDONALD
K042383 09/01/2004 RSA-CMS MEDIS MEDICAL IMAGING SYSTEMS, B.V. J.I. HOLLANDER
K042659 09/28/2004 MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS MEDISISS BRANDI JAMES
K042404 09/03/2004 LIFEPAK, MODEL 1000 MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. SHERRI POCOCK
K042465 09/23/2004 PS MEDICAL STRATA II VALVE MEDTRONIC NEUROSURGERY JEFFREY HENDERSON
K042524 09/17/2004 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K042499 09/14/2004 ORION ANTERIOR CERVICAL PLATING SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K042498 09/14/2004 VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K042453 09/10/2004 MODIFICATION TO EQUATION FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K042402 09/03/2004 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K042489 09/14/2004 6F Z4 GUIDE CATHETER MEDTRONIC VASCULAR FRED L BOUCHER
K042627 09/27/2004 EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65 MESURE TECHNOLOGY CO.,LTD. JOHN CHEN
K042554 09/21/2004 AUTO THERM 390, MODEL ME 390 METTLER ELECTRONICS CORP. ROBERT E FLEMING
K042171 09/02/2004 AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232 MICRO-MEGA SOCIETE ANONYME PHILIPPE GARCIA
K042595 09/23/2004 SPIRO'AIR MORGAN SCIENTIFIC, INC. PATRICK MORGAN
K042504 09/17/2004 "CATHY" STERILE DISPOSABLE I.V. CANNULA WITH CATHETER MYCO MEDICAL SUPPLIES, INC. SANJIV KUMAR
K042484 09/13/2004 NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER NAI TECHNOLOGY PRODUCTS ROBERT E JOHNSON
K042380 09/02/2004 SILICONE BLOCK NATIONAL MEDICAL DEVICES, INC. JAMES ELIST
K042339 09/07/2004 NEOPLANT IMPLANT SYSTEM NEOBIOTECH CO., LTD. DAE KYU CHANG
K042689 09/29/2004 NICHOLS ADVANTAGE CORTISOL NICHOLS INSTITUTE DIAGNOSTICS JIMMY WONG
K042676 09/29/2004 NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY NICHOLS INSTITUTE DIAGNOSTICS XIE QIYL
K042492 09/17/2004 HAND STC, MODEL 60MM NITI MEDICAL TECHNOLOGIES LTD. ORLY MAOR
K042434 09/08/2004 MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55 NOUVAG AG ERICH FORSTER
K042406 09/03/2004 OLYMPUS LACTATE, OSR6193 OLYMPUS AMERICA, INC. BEV HARDING
K042506 09/15/2004 OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M OMRON HEALTHCARE, INC. IWAO KOJIMA
K042505 09/15/2004 OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N OMRON HEALTHCARE, INC. IWAO KOJIMA
K042584 09/22/2004 OPUS MINIMAGNUM ANCHOR WITH INSERTER OPUS MEDICAL, INC. LAURA N KASPEROWICZ
K042665 09/29/2004 SMART BITEBLOC ORIDION MEDICAL 1987 LTD. SANDY BROWN
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K042565 09/21/2004 ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER ORTHO DEVELOPMENT CORP. WILLIAM J GRIFFIN
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K042566 09/21/2004 VASC-ALERT VASC-ALERT, INC. JOHN B KENNEDY
K042372 09/13/2004 HDS INTRA-ORAL IMAGING SYSTEM VATECH VALUE ADDED TECHNOLOGY CO., LTD DANIEL KAMM
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K042670 09/29/2004 FUTURABOND NR VOCO GMBH GERALD W SHIPPS
K042669 09/29/2004 IONOFIL PLUS AC VOCO GMBH GERALD W SHIPPS
K042457 09/10/2004 URO PRO W.O.M. WORLD OF MEDICINE AG SUSANNE RAAB
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K042550 09/21/2004 MULTI-LIPID CALIBRATOR WAKO CHEMICALS, USA, INC. LORI CREASY
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K042516 09/16/2004 OTOMIMIX WALTER LORENZ SURGICAL, INC. KIM REED
K042474 09/13/2004 ARION WAVELIGHT LASER TECHNOLOGIE AG THORSTEN CRETER
K042634 09/27/2004 WIDE 1MP LCD MONITOR SYSTEM WIDE CORPORATION CARL ALLETTO
K042530 09/17/2004 CONSERVE PLUS HA ACETABULAR SHELLS WRIGHT MEDICAL TECHNOLOGY, INC. JEANINE H REDDEN
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K042695 09/30/2004 NCB PLATING SYSTEM ZIMMER GMBH STEPHEN H MCKELVEY
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