FDA 510(k) Applications Received During June, 2004

FDA 510(k) Number Submission Date Device Name Applicant Contact
K041717 06/24/2004 POWERSTICK MALE LATEX CONDOMS A.P.DEAUVILLE, LLC. SCOTT L BAIER
K041687 06/22/2004 ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR ABBOTT LABORATORIES KENT SMITH
K041550 06/09/2004 HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE ABBOTT LABORATORIES PATRICIA MELERSKI
K041759 06/29/2004 ACE CONNECT INTERNAL CONNECTION ACE SURGICAL SUPPLY CO., INC. J. EDWARDS CARCHIDI
K041685 06/22/2004 ACON MULTI-CLIN DRUG SCREEN TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG, PH.D.
K041743 06/28/2004 ACON TRI-FECT DRUG SCREEN TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K041604 06/14/2004 MACRO-MICRO DEPTH ELECTRODE AD-TECH MEDICAL INSTRUMENT CORP. Gary Syring
K041577 06/14/2004 PINNACLE3 RADIATION THERAPY PLANNING SYSTEM ADAC LABORATORIES RANDY VADER
K041614 06/15/2004 MICROLUX DL ADDENT, INC. JOSHUA FRIEDMAN
K041662 06/18/2004 APNEA RISK EVALUATION SYSTEM (ARES) ADVANCED BRAIN MONITORING, INC. DANIEL J LEVENDOWSKI
K041623 06/16/2004 REUSABLE STERILCONTAINER FILTER MODEL #JK090 AESCULAP, INC. MATTHEW M HULL
K041628 06/16/2004 AESKULISA DS DNA G AESKU.DIAGNOSTICS STANLEY AMMONS
K041753 06/29/2004 AESKULISA ENA 6 S AESKU.DIAGNOSTICS STANLEY AMMONS
K041554 06/10/2004 AIP INTENSE PULSED LIGHT SYSTEM AESTHERA CORPORATION C. ROBERT PAYNE
K041701 06/22/2004 AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM AGFA CORP. JEFFERY A JEDLICKA
K041585 06/14/2004 AUTOFUSER AMBULATORY INFUSION PUMP ALGOS, LC ROBERT J BARD
K041734 06/25/2004 AMBU DISPOSABLE ECG ELECTRODE AMBU, INC. SANJAY PARIKH
K041712 06/23/2004 'RAPIDTEC 4' TEST AMERICAN BIO MEDICA CORP. HENRY WELLS
K041696 06/22/2004 RAPID READER AMERICAN BIO MEDICA CORP. FRAN WHITE
K041566 06/10/2004 SONOSURG ULTRASONIC SURGICAL SYSTEM AOMORI OLYMPUS CO., LTD. TINA STEFFANIE-OAK
K041766 06/30/2004 EZY-TRAVEL WRISTBAND APOTHECARY PRODUCTS, INC. DAVID KRAMER
K041711 06/23/2004 ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304 APPLIED MEDICAL RESOURCES CORP. CHERYL BLAKE
K041506 06/07/2004 INTRAVASCULAR ACCESS INTRODUCER SHEATH APPLIED MEDICAL RESOURCES CORP. CHERYL BLAKE
K041745 06/28/2004 VINYL EXAMINATION GLOVES, POWDER FREE, GREEN COLOR ARISTA LATINDO INDUSTRIAL, LTD. P.T. LINGA SUMARTA
K041686 06/22/2004 BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM ARIZANT HEALTHCARE INC. DAVID WESTLIN
K041477 06/03/2004 PATHFINDER ARMSTRONG HEALTHCARE LIMITED PATRICK A FINLAY
K041740 06/28/2004 SILICONE COATED GUIDEWIRE ARROW INTERNATIONAL, INC. SUZANNE SCHORLE
K041589 06/11/2004 ARTHREX FIBERWIRE WITH SILK ARTHREX, INC. ANN WATERHOUSE
K041553 06/09/2004 ARTHREX SUTURE GRAFTING KIT ARTHREX, INC. ANN WATERHOUSE
K041531 06/08/2004 ASAHI PTCA GUIDE WIRE CONFIANZA PRO ASAHI INTECC CO., LTD. YOSHI TERAI
K041726 06/25/2004 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
K041451 06/01/2004 ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50 ASCENSION ORTHOPEDICS, INC. PETER STRZEPA
K041670 06/21/2004 BIS PEDIATRIC SENSOR ASPECT MEDICAL SYSTEMS, INC. RENEE GOULD
K041492 06/04/2004 ASTRA TECH IMPLANTS - DENTAL SYSTEM ASTRA TECH, INC. BRUCE R MANNING
K041681 06/21/2004 ATRICURE DISSECTOR ATRICURE, INC. MARK JOB
K041698 06/22/2004 AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR AXYA MEDICAL, INC. Howard Schrayer
K041748 06/29/2004 AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM) AZOG, INC. AZUBUIKE OGALA
K041683 06/21/2004 B. BRAUN BICARBONATE DIALYSATE B. BRAUN MEDICAL, INC. JENNIFER A PUNG
K041490 06/04/2004 IV ADMINISTRATION SETS WITH ULTRABLOCK UV-RESISTANT TUBING B. BRAUN MEDICAL, INC. JENNIFER A PUNG,
K041508 06/07/2004 BARCOVIEW CORONIS 5MP HD MEDICAL FLAT PANEL DISPLAY SYSTEM BARCO NV BARCOVIEW FRANK FERGUSON
K041738 06/28/2004 BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUME) BAXTER HEALTHCARE CORPORATION KAREN SPRANGER
K041643 06/17/2004 SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT BECKMAN COULTER, INC. MARY BETH TANG
K041478 06/03/2004 BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR BECTON DICKINSON JOHN SCHALAGO
K041572 06/14/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERCILLIN (GN) 0.5-128 UG/ML BECTON, DICKINSON AND CO. MONICA E GIGUERE
K041457 06/01/2004 LIQUICHEK HEMATOLOGY CONTROL (A) BIO-RAD ELIZABETH PLATT
K041561 06/10/2004 LIQUICHEK WHOLE BLOOD VOLATILES CONTROL BIO-RAD MARIA ZEBALLOS
K041444 06/01/2004 BIO-RAD D-10 DUAL PROGRAM BIO-RAD LABORATORIES, INC. JACKIE BUCKLEY
K041658 06/18/2004 BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200 BIO-RAD LABORATORIES, INC. CHRISTOPHER BENSTEN
K041619 06/15/2004 BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 BIOCHECK, INC. ROBIN J HELLEN, M.S.
K041564 06/10/2004 Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01 BIOJECT MEDICAL TECHNOLOGIES INC. LAURENCE A POTTER
K041466 06/02/2004 TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC) BIOMET MANUFACTURING CORP. TRACY J BICKEL, RAC
K041595 06/14/2004 TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870 BIOPRO, INC. DAVID MARK
K041732 06/25/2004 CAVERMAP SURGICAL AID BLUE TORCH MEDICAL TECHNOLOGIES FREDERICK TOBIA
K041606 06/15/2004 EXTRACTOR RX RETRIEVAL BALLOON BOSTON SCIENTIFIC CORP. JAMES D MCMAHON
K041716 06/24/2004 PTFE FELTS AND PLEDGETS BOSTON SCIENTIFIC CORP. MAUREEN MONTBRIAND
K041727 06/25/2004 MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 BOSTON SCIENTIFIC SCIMED, INC. ROBERT Z PHILLIPS
K041703 06/22/2004 IPLAN! BRAINLAB, AG RAINER BIRKENBACH
K041714 06/23/2004 E-PAIN CARE BREG, INC. KATHLEEN BARBER
K041767 06/30/2004 COOLCUBE COOLPEN BRUCE J. SAND M.D. BRUCE J SAND, M.D.
K041464 06/02/2004 BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER BUSSE HOSPITAL DISPOSABLES MUHAMAD ANSARI
K041659 06/18/2004 C-BOOT C-BOOT LTD. AVI ABRAHAM
K041652 06/17/2004 ACUPUNCTURE NEEDLES C.A.I. INDUSTRIES CORP. LU RAO
K041641 06/17/2004 DAVOL DELIVERY SYSTEM C.R. BARD, INC. SUZANNE LASCALZA
K041576 06/11/2004 SOURCELINK C.R. BARD, INC. JOHN C KNORPP
K041546 06/09/2004 DIGITAL FUNDUS CAMERA, MODEL CF-60DSI CANON INC. SHEILA DRISCOLL
K041700 06/22/2004 CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEAR CANTOR & NISSEL LTD. MARTIN DALSING
K041671 06/21/2004 IMAGENMD CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC MALINIE HASEK
K041630 06/16/2004 ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS CARDIOVASCULAR SYSTEMS INCORPORATED Gary Syring
K041486 06/04/2004 VASOSTASIS VASCULAR CLOSURE SYSTEM CARDIVA MEDICAL, INC. AUGUSTINE LIEN
K041645 06/17/2004 DDS-ZR CHARLES SCHARF CHRIS SCHARF
K041518 06/07/2004 CODMAN DURAFORM DURAL GRAFT IMPLANT Codman & Shurtleff, Inc. ELIZABETH DOLAN
K041655 06/18/2004 BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS) COWELL MEDI CO LTD. DAE KYU CHANG
K041569 06/10/2004 CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002 CURELIGHT LTD JONATHAN S KAHN
K041689 06/22/2004 POLYURETHANE BLOOD PRESSURE CUFFS D. E. HOKANSON, INC. D. EUGENE HOKANSON
K041503 06/07/2004 HOVERJACK AIR PATIENT LIFT DEVICE D.T. DAVIS ENTERPRISES LTD. DAVID T DAVIS
K041438 06/01/2004 ADVANCED D-DIMER ASSAY DADE BEHRING, INC. KATHLEEN DRAYLYONS
K041627 06/16/2004 CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR DAKO A/S DANA OLSEN
K041524 06/08/2004 GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM DATEX-OHMEDA, INC. DAN KOSEDNAR
K041680 06/21/2004 ORAJEL ADVANCED TOOTH DESENSITIZER DEL PHARMACEUTICALS, INC. MARLENE TIETJEN
K041458 06/01/2004 MARE DENTAL OPERATIVE UNIT DENIMED ELECTRONICA S.H. GEORGE ECHEVERRI
K041707 06/23/2004 CERCON CERAM EXPRESS CERAMIC SYSTEM DENTSPLY INTL. P. JEFFERY LEHN
K041656 06/18/2004 MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT DEPUY ORTHOPAEDICS, INC. TIFFANI ROGERS
K041722 06/24/2004 MODIFICATION TO VBR SPINAL SYSTEM DEPUY SPINE, INC. LISA GILMAN
K041666 06/18/2004 DC-ACETA/SAL CONTROLS DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K041582 06/14/2004 MODIFICATION TO TRIPTER X-1 COMPACT DUET DIREX SYSTEMS CORP. LARISA GERSHTEIN
K041622 06/16/2004 MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM DRAEGER MEDICAL, INC. MICHAEL A KELHART
K041739 06/28/2004 EDWARDS E360 SURGICAL ABLATION DEVICE EDWARDS LIFESCIENCES, LLC. ELIZABETH MORAN
K041629 06/16/2004 LYSUS INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K041522 06/07/2004 FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS ELEKON INDUSTRIES U.S.A., INC. KRISTA OAKES
K041644 06/17/2004 FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE) ELEKON INDUSTRIES U.S.A., INC. KRISTA OAKES
K041647 06/17/2004 FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE) ELEKON INDUSTRIES U.S.A., INC. KRISTA OAKES
K041598 06/14/2004 LASEREX, MODEL LP4532 Ellex Medical Pty. Ltd. KEVIN HOWARD
K041708 06/23/2004 ENPATH SAFETY INTRODUCER ENPATH MEDICAL INCORPORATED KARYL HASKELL
K041638 06/17/2004 TARGETSCAN BIOPSY KIT ENVISIONEERING, LLC. TOM KAPPEL
K041637 06/17/2004 TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM ENVISIONEERING, LLC. TOM KAPPEL
K041639 06/17/2004 TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM ENVISIONEERING, LLC. TOM KAPPEL
K041442 06/01/2004 EP-4 CLINICAL STIMUTATOR EP MEDSYSTEMS JAMES E KUHN JR.
K041599 06/14/2004 COBRA ADHERE SURGICAL SYSTEM ESTECH, INC. CRAIG COOMBS
K041575 06/14/2004 FENZIAN TREATMENT SYSTEM EUMEDIC LIMITED LEWIS W WARD
K041757 06/29/2004 FEMSPEC DISPOSABLE VAGINAL SPECULUM FEMSPEC L.L.C. GERALD JAY SANDERS
K041470 06/02/2004 MORTON IUI CATHETERS FERTILITY TECHNOLOGY RESOURCES, INC. CONSTANCE W STURGEON
K041596 06/14/2004 ARCHITECT STAT CK-MB IMMUNOASSAY FISHER DIAGNOSTICS JOSEFINA INFANTAS
K041456 06/01/2004 SNAP-OFF SCREWS FOURNITURES HOSPITALIERES INDUSTRIE CHRISTINE QUENDEZ
K041509 06/07/2004 ANKYLOS DENTAL IMPLANT SYSTEM FRIADENT GMBH CAROL PATTERSON
K041471 06/02/2004 G-BOND GC AMERICA INC. TERRY L JORITZ
K041543 06/08/2004 GE DISCOVERY ST GE HEALTHCARE LARRY A KROGER
K041476 06/03/2004 GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM GE MEDICAL SYSTEMS, LLC LARRY A KROGER PH.D.
K041552 06/09/2004 GE VIVID 7 BT04 GENERAL ELECTRIC CO. ALLEN SCHUH
K041688 06/22/2004 GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04 GENERAL ELECTRIC CO. ALLEN SCHUH
K041521 06/08/2004 VOLUME VIEWER PLUS GENERAL ELECTRIC MEDICAL SYSTEMS LARRY KRUEGER
K041605 06/15/2004 PRECISION RXI ANALOG X-RAY SYSTEM GENERAL MEDICAL MERATE S.P.A. Kevin Walls
K041563 06/10/2004 OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS GLAXOSMITHKLINE CONSUMER HEALTHCARE, L.P. ANTHONY G AMITRANO
K041718 06/24/2004 KELES FACEMASK GREAT LAKES ORTHODONTICS, LTD. DAVE GRAVER
K041501 06/07/2004 GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS GUANGZHOU FORTUNIQUE LTD. JANE B CAMPBELL
K041574 06/14/2004 CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 GUIDANT CORPORATION AMITA SHENAI
K041762 06/30/2004 FINISHING WIRE SUPPORTRAK GUIDANT CORPORATION JENNIFER TANG
K041633 06/16/2004 GYRUS PLASMACISION LAPAROSCOPIC SPATULA GYRUS MEDICAL, INC. DAVID E CHADWICK
K041636 06/17/2004 H&S-CONDUCTIVITY STANDARD SOLUTION H & S TECHNICAL SERVICES JOHN HYTE
K041504 06/07/2004 HEMAMYST SURGICAL APPLICATOR SYSTEM, MODEL H-AS01 HAEMACURE CORP. ELAINE WHITMORE
K041502 06/07/2004 THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY HAEMOSCOPE CORP. ELI COHEN
K041694 06/22/2004 DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETER HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., JI BO
K041692 06/22/2004 INFRARED EAR THERMOMETER, ET-100 SERIES HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., JI BO
K041693 06/22/2004 WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., JI BO
K041690 06/22/2004 MONARCH NASAL IMPLANT HANSON MEDICAL, INC. GERALD HANSON
K041580 06/14/2004 IMAGERAYI HENRY SCHEIN, INC. W. EDWARD JOHANSEN
K041555 06/10/2004 SECURVIEW DX SOFTCOPY WORKSTATION HOLOGIC, INC. RICHARD FOLLETT
K041591 06/14/2004 SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS HOWMEDICA OSTEONICS CORP KAREN ARIEMMA
K041706 06/23/2004 HOFFMANN II FOOT RING HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K041709 06/23/2004 NUMELOCK II SYSTEM HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K041710 06/23/2004 VERSAWAVE DENTAL ER:YAG LASER SYSTEM HOYA CONBIO JIM GREEN
K041721 06/24/2004 LVI AESTHETIC LASER HOYA PHOTONICS, INC. JIM GREEN
K041702 06/22/2004 EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.) IBT SA RUTH FEICHT
K041517 06/07/2004 INFUSIONCATH, MODELS VI0020, VI20024, VI0028, VI0032, VI0036, VI0040, VI0044 ID LLC MARIO ARBESU
K041728 06/25/2004 HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE IMMUNOSTICS, INC. JEFFREY FLEISHMAN
K041590 06/14/2004 AUTODETECT SYRINGE INDIGO ORB, INC. ROBERT CHIN
K041761 06/30/2004 RAPIDIACOLON INFINITT CO., LTD. CARL ALLETTO
K041500 06/07/2004 STARPACS ORTHOPEDICS SYSTEM INFINITT CO., LTD. CARL ALLETTO
K041583 06/11/2004 PEEK CEMENT RESTRICTOR X-BOX INNOVASIS, INC. BRENT A FELIX
K041650 06/17/2004 MICRO PRIME INNOVX MEDICAL, INC. ELAINE DUNCAN
K041620 06/16/2004 NEURA WRAP NERVE PROTECTOR INTEGRA LIFESCIENCES CORP. DIANA M BORDON
K041581 06/14/2004 COMPACS, VERSION 1.0 INTELLIGENT IMAGES SRL MAURIZIO PAIGGIO
K041449 06/01/2004 SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT INTERPORE CROSS INTL. WENDY SPIELBERGER
K041562 06/10/2004 CRYOTIP IRVINE SCIENTIFIC SALES CO., INC. WENDELL LEE
K041755 06/29/2004 CROMAX HIGH SPEED TURBINE HANDPIECE J.R. MEDICAL TECHNOLOGIES, INC. J. HARVEY KNAUSS
K041678 06/21/2004 KARMA POWER WHEELCHAIR, MODEL KP-25 KARMA MEDICAL PRODUCTS CO., LTD. JEN KE-MIN
K041677 06/21/2004 KARMA SCOOTER, MODEL KS-747.2 KARMA MEDICAL PRODUCTS CO., LTD. JEN KE-MIN
K041642 06/17/2004 V.A.C. GRANUFOAM SILVER DRESSING KINETIC CONCEPTS, INC. JUDITH HARBOUR
K041461 06/02/2004 KMI DISTAL VOLAR RADIUS PLATE SYSTEM KINETIKOS MEDICAL, INC. JOHN G SPAMPINATO
K041584 06/14/2004 KYPHX HV-R BONE CEMENT, MODEL C01A KYPHON, INC. CINDY DOMECUS
K041454 06/01/2004 KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A KYPHON, INC. CINDY DOMESCUS
K041624 06/16/2004 PTCA STEERABLE HYDROPHILIC GUIDEWIRE LAKE REGION MFG., INC. KAREN MORTENSEN
K041565 06/10/2004 LAZRPULSR 4X LED HEALING LIGHT LLC MICHAEL B KINDER
K041446 06/01/2004 NASALCEASE LES LABORATORIRES BROTHIER, S.A. RICHARD J FREER, PH.D.
K041747 06/29/2004 IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE) LIFEPOINT,INC DAVID B GOLDBERG
K041746 06/29/2004 IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE) LIFEPOINT,INC DAVID B GOLDBERG, PH.D.
K041535 06/08/2004 LSC LIFESTAND COMPACT LIFESTAND CAROLANN KOTULA
K041713 06/23/2004 SUPER REVO HERCULINE SUTURE ANCHOR LINVATEC CORP. ELIZABETH M PAUL
K041520 06/07/2004 MANTRA TENS MODEL NT3 MANTRA INTL. (HK) LTD. ROBERT B SPERTELL
K041485 06/04/2004 MARPAC MESSENGER MODEL #501 MARPAC, INC. EVELYN TRUJILLO
K041724 06/24/2004 COMPASS M10 SYSTEM MEDCARE FLAGA BERGLIND HALLGRIMSDOTTIR
K041579 06/14/2004 MEDELA SINGLE USE SILC CUP, MODEL 077.0791 MEDELA AG WERNER FREI
K041600 06/14/2004 QWIKCHECK-BEADS MEDICAL ELECTRONICS SYSTEMS LTD. Erika B Ammirati
K041448 06/01/2004 HEXAPOD RT COUCHTOP MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH SANDOR CSABA ATS
K041621 06/16/2004 LITEPORT LP100 SURGICAL ILLUMINATOR MEDICAL VISION INDUSTRIES, INC. DAVID SCHLERF
K041527 06/08/2004 AARHUS ANCHORAGE SYSTEM MEDICON, E.G. COLLEEN BOSWELL
K041459 06/02/2004 LIFEPAK 12 DEFIBRILLATOR/MONITOR MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. MICHELLE ACKERMANN
K041452 06/01/2004 MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K041556 06/10/2004 MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K041460 06/02/2004 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. RICHARD TREHARNE
K041523 06/08/2004 XPS 3000 SYSTEM MEDTRONIC XOMED, INC. MARTIN D SARGENT
K041626 06/16/2004 IMMUNOCARD STAT! FLU A & B MERIDIAN BIOSCIENCE, INC. SUSAN ROLIH
K041445 06/01/2004 IMMUNOCARD STAT! RSV MODEL #750630 MERIDIAN BIOSCIENCE, INC. SUSAN ROLIH
K041649 06/17/2004 SAPPHIRE NXT DETACHABLE COIL SYSTEM MICRO THERAPEUTICS, INC. FLORIN TRUUVERT
DEN040008 06/17/2004 CEDIA SIROLIMUS ASSAY MICROGENICS CORP. DAVID CASAL
K041551 06/09/2004 MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES) MICROVENTION, INC. VINCENT CUTARELLI
K041632 06/16/2004 MINIMESH POLYPROPYLENE MESH MPATHY MEDICAL DEVICES, LTD. LOUIS J MAZZARESE
K041481 06/03/2004 MODEL BBC-127 BIOPSY BREAST COIL MRI DEVICES CORP. THOMAS E TYNES
K041573 06/14/2004 NANMA VACUUM PUMP PROXZEK MODEL 2M9498S NANMA MFG CO., LTD. YOLANDA SMITH
K041542 06/08/2004 CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS NEUSOFT DIGITAL MEDICAL SYSTEMS CO., LTD. WANG ZHIQIANG
K041704 06/23/2004 NEWGEL AND NEWGEL PLUS E NEWMEDICAL TECHNOLOGY, INC. HAITHAM MATLOUB
K041751 06/29/2004 COMPRESSION ANASTOMOSIS CLIP (CAC) NITI MEDICAL TECHNOLOGIES LTD. ORLY MAOR
K041661 06/18/2004 NOBEL BIOCARE ENDOSSEOUS IMPLANTS NOBEL BIOCARE UAS INC ELIZABETH J MASON
K041560 06/10/2004 FLO-ASSISTANT NORTHGATE TECHNOLOGIES, INC. CASEY KUREK
K041613 06/15/2004 NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE NovaBone Products, LLC DAVID M GAISSER
K041715 06/23/2004 INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001 NUCLETRON CORP. LISA DIMMICK
K041719 06/24/2004 ONCENTRA-VISIR NUCLETRON CORP. LISA DIMMICK
K041447 06/01/2004 NUVASIVE ANTERIOR CERVICAL PLATE SYSTEM NUVASIVE, INC. LAETITIA BERNARD
K041668 06/18/2004 OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT OLYMPUS AMERICA INC. BEV HARDING
K041494 06/04/2004 OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2 OLYMPUS CORPORATION TINA STEFFANIE-OAK
K041705 06/23/2004 RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2 OMNISONICS MEDICAL TECHNOLOGIES ANNE M KULIS
K041664 06/18/2004 PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C ON SITE GAS SYSTEMS, INC. C. BART GULLONG
K041679 06/21/2004 COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT ONYX MEDICAL INC. ROGER MACHSON
K041440 06/01/2004 OPUS MAGNUM ANCHOR WITH INSERTER OPUS MEDICAL, INC. LAURA N KASPEROWICZ
K041764 06/30/2004 THE VITROS 5,1 FS CHEMISTRY SYSTEM ORTHO-CLINICAL DIAGNOSTICS CAREY A MAYO
K041720 06/24/2004 VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II Ortho-Clinical Diagnostics, Inc. MARLENE A HANNA
K041616 06/15/2004 BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID ORTHOS (UK) LIMITED ALAN RORKE
K041443 06/01/2004 OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM OSTEOIMPLANT TECHNOLOGY, INC. SAM SON
K041665 06/18/2004 L1-PRO SYSTEM PELIKAN TECHNOLOGIES, INC JACK S GREEN
K041495 06/04/2004 PENTADEFLUE IV SOLUTION ADMINISTRATION SETS PENTAFERTE S.P.A VITTORIO SERVIDORI
K041496 06/04/2004 PENTATRASFU BLOOD TRANSFUSION SETS PENTAFERTE S.P.A VICTOR PEREIRA
K041736 06/28/2004 PFA PATCH PERITEC BIOSCIENCES, LLC. ROBERT M DICKSON
K041578 06/14/2004 QUICKSCREEN, MODELS 9177X AND 9178X PHAMATECH CARL MONGIOVI
K041674 06/21/2004 THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT PHILIPS MEDICAL SYSTEMS J.P. OUELLETTE
K041602 06/14/2004 PANORAMA 1.0T PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. JOSEPH S ARNAUDO
K041741 06/28/2004 M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN PHILIPS MEDICAL SYSTEMS, INC. BARRY WYSHOGROD
K041675 06/21/2004 PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS PIE MEDICAL CARRI GRAHAM
K041682 06/21/2004 CAAS MRV PIE MEDICAL IMAGING B.V. CARLA DE VRIES
K041750 06/29/2004 PTS PANELS CHOL+GLU TEST PANEL POLYMER TECHNOLOGY SYSTEMS, INC. MARGO ENRIGHT
K041635 06/16/2004 G5 I HBA1C TEST, G5 II HBA1C TEST PROVALIS DIAGNOSTICS LTD. THOMAS M TSAKERIS
K041607 06/15/2004 QUINTON Q-TE; RMS QUINTON CARDIOLOGY, INC. KAREN BROWNE
K041450 06/01/2004 MODIFICATION TO NICO WITH MARS, MODEL 7300 RESPIRONICS NOVAMETRIX, INC. KEVIN MADER
K041568 06/10/2004 EOCD RESPIRONICS, INC. LOU ANNE KINNEY
K041610 06/15/2004 MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207 RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K041441 06/01/2004 SAS INFLUENZA A TEST SA SCIENTIFIC, INC. RICARDO R MARTINEZ
K041439 06/01/2004 SAS INFLUENZA B TEST SA SCIENTIFIC, INC. RICARDO R MARTINEZ
K041646 06/17/2004 THERMOTEK Q5 SAAT LTD. E.J. Smith
K041667 06/18/2004 SAN-MAR LABS LUBRICATING JELLY SAN-MAR LABORATORIES, INC. SIMON SANDERS
K041749 06/29/2004 SCANDIUS ACL RECONSTRUCTION SYSTEM SCANDIUS BIOMEDICAL, INC. ERIC BANNON
K041548 06/09/2004 SENTEC DIGITAL MONITOR MODEL #SDM SENTEC INC. STEPHEN GORSKI
K041763 06/30/2004 SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES SHIMADZU CORP. TAKESHI OZAKI
K041484 06/04/2004 UNDECIDED SIEMENS MEDICAL SOLUTIONS USA, INC. RICHARD K ANDERSEN
K041482 06/11/2004 DECAPINOL ORAL RINSE SINCLAIR PHARMACEUTICALS LIMITED MICHAEL KILLEEN
K041465 06/02/2004 SINON SN-L402 LIGHTWEIGHT WHEELCHAIR SINON CORPORATION JEN KE-MIN
K041453 06/01/2004 SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023 SMITH & NEPHEW, INC. KAREN PROVENCHER
K041455 06/01/2004 SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM SONOSCAPE COMPANY LIMITED BOB LEIKER
K041559 06/10/2004 55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH55 SPIRE BIOMEDICAL INC DONALD FICKETT
K041540 06/08/2004 COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS STANDARD TEXTILE CO., INC. BRADLEY J BUSHMAN
K041653 06/17/2004 COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS STANDARD TEXTILE CO., INC. BRADLEY J BUSHMAN
K041541 06/08/2004 COMPEL MLR SURGICAL GOWNS STANDARD TEXTILE CO., INC. BRADLEY J BUSHMAN
K041539 06/08/2004 COMPEL SURGICAL GOWNS STANDARD TEXTILE CO., INC. BRADLEY J BUSHMAN
K041530 06/08/2004 EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001 STARGATE INTERNATIONAL, INC. ROBERT H WALKER
K041558 06/10/2004 STOCKERTIR PURGE CONTROL (APC) SYSTEM STOCKERT INSTRUMENTE GMBH ROSINA ROBINSON
K041754 06/29/2004 STRYKER MAESTRO SYSTEM STRYKER CORP. NICOLE PETTY
K041651 06/17/2004 STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM STRYKER LEIBINGER WADE T RUTKOSKIE
K041601 06/14/2004 SURFIX KNEE OSTEOTOMY SYSTEM SURFIX TECHNOLOGIES NORMAN F ESTRIN
K041593 06/14/2004 FEATHERLIFT EXTENDED LENGTH APTOS THREAD SURGICAL SPECIALTIES CORP. RICHARD JONES
K041617 06/15/2004 STALIF TT SURGICRAFT LTD. JANET M WEBB
K041512 06/07/2004 NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE SUTURES INDIA PRIVATE LIMITED L.G. CHANDRASEKHAR
K041514 06/07/2004 TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE SUTURES INDIA PRIVATE LIMITED L.G. CHANDRASEKHAR
K041515 06/07/2004 TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE SUTURES INDIA PRIVATE LIMITED L.G. CHANDRASEKHAR
K041511 06/07/2004 TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE SUTURES INDIA PRIVATE LIMITED L.G. CHANDRASEKHAR
K041510 06/07/2004 TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE SUTURES INDIA PRIVATE LIMITED L.G. CHANDRASEKHAR
K041474 06/02/2004 MAXCEM SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K041669 06/21/2004 VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD SYNOVIS SURGICAL INNOVATIONS JAMES JENKINS
K041611 06/15/2004 SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP SYNTHES (USA) LISA M BOYLE
K041533 06/08/2004 SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS SYNTHES (USA) Lisa Boyle
K041648 06/17/2004 NITI-S STENT & INTRODUCER, MODEL EOXXXX TAEWOONG MEDICAL CO., LTD JAMES HARVY KNAUSS
K041752 06/29/2004 TEH LIN POWERED WHEELCHAIR, MDG-601 TEH LIN PROSTHETIC & ORTHOPAEDIC, INC. JEN KE-MIN
K041493 06/04/2004 CEMENTEK TEKNIMED SA J.D. WEBB
K041697 06/22/2004 TERUMO CIRCUIT CONNECTORS Terumo Cardiovascular Systems Corporation GARRY A COURTNEY
K041592 06/14/2004 CORAL SPINAL SYSTEM THEKEN SURGICAL RANDY THEKEN
K041657 06/18/2004 THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT THERMO ELECTRON CORPORATION BOLA NICHOLSON
K041557 06/10/2004 MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W THOMSON & NIELSEN ELECTRONICS, LTD. MARY HERBERT
K041499 06/07/2004 SSA-770A, APLIO VERSION 5.5 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K041737 06/28/2004 5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A) TOTOKU ELECTRIC CO., LTD MIKIO HASEGAWA
K041534 06/08/2004 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL TREK DIAGNOSTIC SYSTEMS, LTD. CYNTHIA C KNAPP
K041660 06/18/2004 TRIMEDYNE HOLMIUM LASER SYSTEMS TRIMEDYNE, INC. GLENN YEIK
K041771 06/30/2004 TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEM TWIN STAR MEDICAL, INC. JONATHAN KAHAN
K041625 06/15/2004 LTD POLYAXIAL FIXATION SYSTEM U.S. SPINAL TECHNOLOGIES, LLC. ELAINE DUNCAN
K041608 06/15/2004 C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS UNILENS CORP., USA JOSEPHA BRUNO
K041545 06/09/2004 CONTACT DETACH UNOMEDICAL A/S JOHN M LINDSKOG
K041544 06/09/2004 COOK SIDEARM CORE TISSUE BIOPSY DEVICE UROLOGICAL INC. CINDY RUMPLE
K041695 06/22/2004 LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE USA INSTRUMENTS, INC. JAMES WRENN
K041487 06/04/2004 QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT USA INSTRUMENTS, INC. JAMES WRENN
K041587 06/14/2004 LIGASURE PRECISE MODEL #LS1200/LIGASURE 5MM LAPAROSCOPIC SEALER DIVIDER MODEL # LS1500 VALLEYLAB CHARLES COPPERBERG
K041519 06/07/2004 MODIFICATION TO: ON-BOARD IMAGER DEVICE VARIAN MEDICAL SYSTEMS, INC. VY TRAN
K041528 06/08/2004 MODIFICATION TO EPTFE GRAFT VASCUTEK LTD. STEVEN ARICK
K041516 06/04/2004 DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9 VEGA TECHNOLOGIES, INC. JOSEPH LU
K041473 06/02/2004 VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM VORTRAN MEDICAL TECHNOLOGY 1, INC. JAMES LEE
K041468 06/02/2004 PREMICATH, 1261.205 VYGON CORP. COURTNEY SMITH
K041691 06/22/2004 CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT WEST PHARMACEUTICAL SERVICES, INC. DAVID WEISER
K041663 06/18/2004 ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM WRIGHT MEDICAL TECHNOLOGY, INC. BRIAN J YOUNG
K041586 06/14/2004 PROFEMUR S HIP STEM WRIGHT MEDICAL TECHNOLOGY, INC. JEANINE H REDDEN
K041469 06/02/2004 ANTERIOR COMPACT SYSTEM X-SPINE SYSTEMS JANET M WEBB
K041491 06/04/2004 ZEWA MFM-007 BLOOD PRESSURE MONITOR ZEWA, INC. THOMAS ZEINDLER
K041525 06/08/2004 HEMOVAC BLOOD REINFUSION SYSTEM ZIMMER, INC. CINDY J DICKEY
K041549 06/09/2004 ZIMMER TRABECULAR METAL HUMERAL STEM ZIMMER, INC. DALENE BINKLEY


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