FDA 510(k) Applications Received During November, 2003

FDA 510(k) Number Submission Date Device Name Applicant Contact
K033576 11/13/2003 LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE ABBOTT LABORATORIES PATRICIA MELERSKI
K033537 11/10/2003 SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005 ABBOTT LABORATORIES JOANNA KUSKOWSKI
K033503 11/05/2003 RFS VACUUM GAUGE SCAVENGING CIRCUIT ACCUTRON, INC. ROBERT N CLARK
K033639 11/24/2003 ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM ACUMED LLC ED BOEHMER
K033735 11/28/2003 VANTAGE PRO ATTENUATION CORRECTION DEVICE ADAC LABORATORIES CHARLENE BRUMBAUGH
K033429 11/04/2003 LAMITRODE SPINAL CORD STIMULATION LEADS ADVANCED NEUROMODULATION SYSTEMS DANIELLE ALARCON
K033597 11/14/2003 ATR 5000, LC 5000, IMPLANT SYSTEM ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.L. DANIELE POLI
K033013 11/10/2003 MDIFICATION TO MEDIPRIME ALGOTEC SYSTEMS, LTD. ELI M ORBACH
K033636 11/19/2003 AMS LARGE PORE POLYPROPYLENE MESH AMERICAN MEDICAL SYSTEMS, INC. ELSA A LINKE
K033722 11/26/2003 APAPORE BONE GRAFT SUBSTITUTE APATECH LTD. BARRY SALL
K033533 11/10/2003 POWDER FREE LATEX EXAMINATION GLOVES APL INTERNATIONAL INCORPORATED LIMITED LEE SON HONG
K033531 11/10/2003 POWDERED LATEX EXAMINATION GLOVES APL INTERNATIONAL INCORPORATED LIMITED LEE SON HONG
K033720 11/26/2003 ARI COLD SPRAY ARI RON ARKIN
K033637 11/19/2003 MEDICAL IMAGE DIGITIZER, MODEL 2908 ARRAY CORP. TAKASHI INAMI
K033584 11/13/2003 ARTHROCARE ARTHROWANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K033718 11/26/2003 MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE ARTHROTEK, INC. PATRICIA SANDBORN BERES
K033532 11/10/2003 ASIA PACIFIC LATEX SDN. BHD. POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES ASIA PACIFIC LATEX SDN BHD LEE SON HONG
K033530 11/10/2003 ASIA PACIFIC LATEX SDN. BHD. POWDER FREE LATEX EXAMINATION GLOVES ASIA PACIFIC LATEX SDN BHD LEE SON HONG
K033397 11/06/2003 AVITA BPM6 SERIES BLOOD PRESSURE METER (OR MONITOR), MODEL BPM6XY AVITA CORPORATION GEO LIN
K033606 11/17/2003 ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST AXIS-SHIELD DIAGNOSTICS, LTD. JUDITH FINLAYSON, PH.D.
K033527 11/07/2003 INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER B. BRAUN MEDICAL, INC. AMY SMITH
K033575 11/12/2003 ONE.CLICK NEEDLE B. BRAUN MEDICAL, INC. JENNIFER A KOSOY
K033723 11/26/2003 DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES BAODING GUANZHONG GLOVE CO., LTD. HUAN-CHUNG LI
K033653 11/21/2003 VENTURI PHACO PACK BAUSCH & LOMB, INC. DENNIS POZZO
K033643 11/20/2003 CO2 CALIBRATOR/DILUENT BAYER HEALTHCARE, DIAGNOSTICS DIVISION KENNETH T EDDS, PH.D.
K033603 11/17/2003 INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999 BECKMAN COULTER, INC. VALYNDA MACHEN
K033500 11/05/2003 BD CAREFLOW CENTRAL VENOUS CATHETER BECTON DICKINSON & CO. LESLIE WOOD
K033560 11/12/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS BECTON DICKINSON & CO. KATHRYN BABKA POWERS
K033558 11/12/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS BECTON, DICKINSON & CO. BRADFORD SPRING
K033557 11/12/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN/CLAVULANATE-GRAM NEGATIVE BECTON, DICKINSON & CO. MICHELLE B BANDY
K033455 11/04/2003 ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5 BIOMEDICAL LIFE SYSTEMS, INC. DONNA HERATY
K033627 11/19/2003 Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM BIOMEDIX, INC. JUDY S CHEN
K033489 11/10/2003 AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN BIOMET, INC. PATRICIA SANDBORN BERES
K033611 11/17/2003 CALCIGEN -NAP BONE VOID FILLER BIOMET, INC. MARY L VERSTYNEN
K033519 11/07/2003 CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET BIOMET, INC. GARY BAKER
K033506 11/05/2003 COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE BIOMET, INC. TRACY J BICKEL
K033613 11/17/2003 MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER BIOTRONIK, INC. JON BRUMBAUGH
K033521 11/10/2003 BISBLOCK BISCO, INC. BENJAMIN LICHTENWALNER
K033585 11/13/2003 DIAPEX BISCO, INC. BENJAMIN LICHTENWALNER
K033472 11/03/2003 TESCERA U-BAR AND BARRELS BISCO, INC. BENJAMIN LICHTENWALNER
K033702 11/25/2003 BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM BLACKSTONE MEDICAL, INC. DEAN E CIPORKIN
K033717 11/28/2003 TRANSET FRACTURE FIXATION SYSTEM BONUTTI RESEARCH, INC. PATRICK G BALSMANN
K033742 11/28/2003 BOSTON SCIENTIFIC V-18 CONTROL WIRE BOSTON SCIENTIFIC CORP. DEBORAH THOMAS
K033454 11/13/2003 BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN BRAHMS DIAGNOSTICA, LLC. WILLIAM G FRANK
K033695 11/25/2003 IRRIGATION CHANNEL TUBING, MODEL 100135 BYRNE MEDICAL, INC. J. HARVEY KNAUSS
K033497 11/10/2003 BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM C.R. BARD, INC. AYMEE R BERRY
K033719 11/26/2003 BARD TIGERTAIL URETERAL CATHETER C.R. BARD, INC. FRANCES HARRISON
K033562 11/12/2003 FASTRAC GASTRIC ACCESS PORT KIT C.R. BARD, INC. THOMAS HIRTE, P.E.
K033624 11/18/2003 PACS SOFTWARE SOLUTION 2003 CANON U.S.A., INC. SEAN M CURRY
K033634 11/19/2003 EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED CENTERPULSE ORTHOPEDICS, INC. AUDREY SWEARINGEN
K033664 11/21/2003 MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM CENTERPULSE ORTHOPEDICS, INC. JEAN ASQUITH
K033514 11/06/2003 CODA CX1 MOTION ANALYSIS SYSTEM CHARNWOOD DYNAMICS LTD. DAVID L MITCHELSON
K033608 11/24/2003 AQUIFY MULTI-PURPOSE SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K033701 11/28/2003 FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES CIBA VISION CORPORATION ALICIA M PLESNARSKI
K033579 11/13/2003 REPROCESSED MULTIPLE CLIP APPLIERS CLEAR MEDICAL, INC. MIKE KOVACS
K033578 11/13/2003 REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS CLEAR MEDICAL, INC. MIKE KOVACS
K033593 11/13/2003 REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS CLEAR MEDICAL, INC. MIKE KOVACS
K033592 11/13/2003 REPROCESSED SURGICAL SCISSORS AND GRASPERS CLEAR MEDICAL, INC. MIKE KOVACS
K033591 11/13/2003 REPROCESSED TROCARS CLEAR MEDICAL, INC. MIKE KOVACS
K033488 11/04/2003 CMI MAGNETOCARDIOGRAPH CMI CARDIOMAG IMAGING INC STEVEN KARR
K033524 11/07/2003 COAPT ENDOTINE CHIN 3.5 DEVICE COAPT SYSTEMS, INC. LORI DONDIEGO
K033641 11/20/2003 SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800 COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K033515 11/10/2003 HUBERPRO SAFETY HUBER INFUSION SET COMMAND MEDICAL PRODUCTS JOYCE VYTLACIL
K033736 11/28/2003 MERCI RETRIEVER, MODELS 90065, 90066 CONCENTRIC MEDICAL, INC. KEVIN F MACDONALD
K033594 11/14/2003 OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES CONTAMAC LTD. MARTIN DALSING
K033484 11/07/2003 HUMAN HEART VALVE, CRYOVALVE SG CRYOLIFE, INC. DAVID M FRONK
K033622 11/19/2003 POLARCATH PERIPHERAL DILATATION SYSTEM CRYOVASCULAR SYSTEMS, INC. KIM TOMPKINS
K033431 11/04/2003 LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ CTI PET SYSTEMS, INC. WILLIAM SKREMSKY
K033518 11/07/2003 LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103 CUSTOM PLASTIC PRODUCTS JIM BARLEY
K033525 11/07/2003 DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114 DADE BEHRING, INC. RICHARD M VAUGHT
K033482 11/10/2003 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML) DADE BEHRING, INC. ROBERT EUSEBIO
K033487 11/21/2003 STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI DADE BEHRING, INC. GEORGE M PLUMMER
K033713 11/26/2003 URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A DADE BEHRING, INC. ANDREA M TASKER
K033550 11/12/2003 DXL CALSCAN DEMETECH AB JOAKIM ARWIDSON
K033697 11/25/2003 POWER LED DENTAL PRODUCTS OF USA, INC. GEORGE ECHEVERRI
K033705 11/25/2003 BOBCAT PRO SCALER SYSTEM, MODEL G-130 DENTSPLY INTERNATIONAL P. JEFFERY LEHN
K033667 11/21/2003 CARRARA PRESS SYSTEM DENTSPLY INTL. P. JEFFERY LEHN
K033703 11/25/2003 IDEAL 1 ORTHODONTIC BRACKET ADHESIVE DENTSPLY INTL. P. JEFFERY LEHN
K033553 11/10/2003 PFZ PORCELAIN SYSTEM DENTSPLY INTL. P. JEFFERY LEHN
K033516 11/07/2003 DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS DEPUY ORTHOPAEDICS, INC. TIFFANI D ROGERS
K033563 11/12/2003 SMARTSET GHV GENTAMICIN BONE CEMENT DEPUY ORTHOPAEDICS, INC. TIFFANI D ROGERS
K033714 11/26/2003 MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING DIDECO S.P.A. BARRY SALL
K033600 11/14/2003 INFINITY GAMMAXL DRAEGER MEDICAL SYSTEMS, INC. PENELOPE H GRECO
K033694 11/24/2003 INFINITY MODULAR MONITORS VF4 MODIFICATIONS DRAEGER MEDICAL SYSTEMS, INC. PENELOPE H GRECO
K033498 11/05/2003 NARKOMED 6400, MODEL NM6400 DRAEGER MEDICAL, INC. GALE E WINARSKY
K033635 11/19/2003 MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM EBI, L.P. FREDERIC TESTA
K033464 11/03/2003 EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE EDWARDS LIFESCIENCES LLC. JASON SMITH
K033590 11/10/2003 ERBE HELIX HYDRO-JET ERBE USA, INC. JOHN TARTAL
K033700 11/25/2003 MAMMOTOME EX HAND HELD SYSTEM ETHICON ENDO-SURGERY, INC. CAROL SPRINKLE
K033568 11/13/2003 GYNECARE TVT OBTURATOR SYSTEM ETHICON, INC. SEAN O'BRYAN
K033544 11/10/2003 ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607 EVERYWAY MEDICAL INSTRUMENTS CO., LTD. JAY MANSOUR
K033596 11/14/2003 CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT EXACTECH, INC. GARY MILLER
K033710 11/26/2003 MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU FISHER & PAYKEL HEALTHCARE, LTD. BRETT WHISTON
K033569 11/17/2003 FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH FLOWMEDICA, INC. JEFF ELKINS
K033510 11/13/2003 MODIFICATION TO TELEGRAPH HUMERAL NAIL FOURNITURES HOSPITALIERES INDUSTRIE CHRISTINE QUENDEZ
K033561 11/12/2003 FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER FUJIFILM MEDICAL SYSTEM U.S.A., INC. FRANK GIANELLI
K033711 11/26/2003 FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM FUKUDA DENSHI USA, INC. LARRY D WALKER
K033542 11/10/2003 EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE GALT MEDICAL CORP. DAVID CATLIN
K033469 11/03/2003 GENESIS VERTICAL PLATFORM LIFT GARAVENTA ACCESSIBILITY NORM COOPER
K033492 11/04/2003 MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES LISA LEE MICHELS
K033672 11/24/2003 MODIFICATION TO UNITY NETWORK ID GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES DIANA M THORSON
K033502 11/05/2003 LIGHTSPEED 6.0 CT SCANNER SYSTEM GE MEDICAL SYSTEMS, LLC JOHN W JAECKLE
K033504 11/05/2003 GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM GENERAL ELECTRIC CO. LARRY A KROGER, PH.D.
K033645 11/20/2003 OTOFLEX 100 TYE 1012 GN OTOMETRICS A/S PER PAPE THOMSEN
K033478 11/03/2003 VACUETTE QUICKSHIELD SAFETY TUBE HOLDER GREINER BIO-ONE VACUETTE NORTH AMERICA JUDI SMITH
K033554 11/12/2003 SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS GYRUS ENT L.L.C. GREGORY SREDIN
K033646 11/21/2003 TRIFIT 700 HEALTHFIRST CORP. JAY SKOLNIK
K033628 11/24/2003 ARTIC HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K033665 11/24/2003 VENUS FLOW HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K033629 11/24/2003 VERSYO.BOND HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K033473 11/03/2003 MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT HORIZON MEDICAL PRODUCTS, INC. SCOTT MOELLER
K033716 11/26/2003 TRIDENT ACETABULAR SYSTEM HOWMEDICA OSTEONICS CORP DENISE DUCHENE
K033476 11/03/2003 MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K033619 11/18/2003 NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 IMAGE-GUIDED NEUROLOGICS, INC. DAVID M LEE
K033602 11/18/2003 INSORB ABSORBABLE STAPLE, MODEL SP-B20 INCISIVE SURGICAL, INC. JIM PETERSON
K033559 11/12/2003 12-LEAD GLOVE INEEDMD IRVING WIESEN, ESQ.
K033623 11/18/2003 CELSIUS CONTROL SYSTEM INNERCOOL THERAPIES, INC. STEVE REITZLER
K033631 11/19/2003 MODIFICATION TO COATEST FACTOR VIII INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K033698 11/26/2003 CONTOUR-FLEX VALVE AND SHUNT SYSTEM INTEGRA NEUROSCIENCES IMPLANTS S.A. JUDITH E O'GRADY
K033689 11/25/2003 OSSTELL MENTOR RFA INTEGRATION DIAGNOSTICS LTD TRISH LANDRY
K033708 11/26/2003 MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K033520 11/20/2003 BLUEPHASE IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K033448 11/03/2003 ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER JOHN MFG., LTD. ARTHUR KING MA
K033523 11/07/2003 COLLAGEN-ORC ANTIMICROBIAL MATRIX JOHNSON & JOHNSON MEDICAL, LTD. JOHN D PAULSON
K033564 11/12/2003 POWDER FREE LATEX SURGEONS GLOVES POLYMER COATED STERILE WITH OPTIONAL LABELING CLAIM OF E.P. LESS THAN 50 UG/DM2 KANAM LATEX INDUSTRIES PVT. LTD. RAVI ABRAHAM
K033555 11/12/2003 KENKOWAVE INFRARED PAIN TREATMENT SYSTEM KAYLIGHT CORPORATION DAVID R BALZER
K033676 11/24/2003 PALINDROME 14.5 FR CHRONIC HEMODIALYSIS CATHETER KENDALL JAMES WELSH
K033668 11/24/2003 NAVIPRO KNEE SOFTWARE MODULE KINAMED, INC. VINEET K SARIN
K033483 11/04/2003 KLS-MARTIN ORTHO ANCHORAGE SYSTEM KLS-MARTIN L.P. JENNIFER DAMATO
K033601 11/14/2003 LABONE MICRO-PLATE COTININE EIA LABONE, INC. LIUMING YU
K033682 11/24/2003 SET GRI-FILL 2.0-1 WAY; 2.0-2 WAYS; LUER CONNECTION TUBE LABORATORIOS GRIFOLS, S.A. SEBASTIAN GASCON
K033573 11/13/2003 LINVATEC 10K IRRIGATION SYSTEM LINVATEC CORP. LAURA D KREJCI
K033657 11/21/2003 MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V LIVING DATA TECHNOLOGIES CORPORATION SUSAN D GOLDSTEIN-FALK
K033565 11/12/2003 LMT NOMAG IC 1,5 LMT LAMMERS MEDICAL TECHNOLOGY GMBH THOMAS M BOHNEN
K033535 11/10/2003 LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES LUMEND, INC. MICHAEL A DANIEL
K033413 11/04/2003 SPINEASSIST DEVICE MAZOR SURGICAL TECHNOLOGIES LTD. AHAVA STEIN
K033666 11/21/2003 HEMADERM MEDAFOR, INC. JENNIFER A MAY
K033685 11/24/2003 NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000 MEDICALCV, INC. DENNY STEGER
K033412 11/05/2003 MEDICLUNG, RELEASE 1 MEDICSIGHT CAROL MACDONALD
K033577 11/26/2003 UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS MEDLINK IMAGING DANIEL KAMM
K033468 11/03/2003 AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE MEDTRONIC PERFUSION SYSTEMS MICHELE PYFFEROEN
K033495 11/05/2003 MODIFICATION TO EQUATION FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K033540 11/10/2003 TRANSXCHANGE SUPPORT CATHETER MEDTRONIC VASCULAR LEISA MARTINEZ
K033688 11/25/2003 MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY MICRO DIRECT, INC. DAVID STASZAK
K033589 11/25/2003 BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR MICROMEDICS, INC. CHARLES K GROTE
K033534 11/10/2003 VITALSENSE MINI-MITTER CO., INC. JACK E MCKENZIE
K033505 11/05/2003 RENACLEAN SH DIALYZER CLEANING SYSTEM MINNTECH CORP. RICHARD M ORMSBEE
K033447 11/10/2003 CLIPLOC SOFT TISSUE MARKER 18G/100MM (4"), /130MM (5 1/8"), /150MM (6"), MODELS 12370, 12372, 12376 MRI DEVICES CORP. THOMAS SCHUBERT
K033567 11/10/2003 MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS MRI DEVICES CORP. THOMAS SCHUBERT
K033543 11/10/2003 NARCOTREND, MODEL COMPACT 4.0 MT MONITORTECHNIK GMBH & CO. KG FRIEDMUND WIELAND
K033512 11/06/2003 PROCYON SPINAL SYSTEM NAS MEDICAL TECHNOLOGIES, INC. MAKOTO NONAKA
K033580 11/18/2003 NEXFLEX TOTAL HIP SYSTEM NEXMED, INC. ELLEN A YARNALL
K033302 11/13/2003 NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040 NICHOLS INSTITUTE DIAGNOSTICS JIMMY WONG
K033475 11/03/2003 WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES NIHON KOHDEN AMERICA, INC. SERRAH NAMINI
K033724 11/26/2003 NOBEL BIOCARE CENTRIC POST, MODELS 31234, 31235 AND 31236 NOBEL BIOCARE UAS INC ELIZABETH J MASON
K033587 11/14/2003 SILVERSEAL NOBLE FIBER TECHNOLOGIES PATRICIA DAVIDSON
K033621 11/18/2003 NDI PASSIVE SPHERES NORTHERN DIGITAL, INC. NANCY RUTH
K033614 11/17/2003 MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215 NORTHGATE TECHNOLOGIES, INC. CASEY KUREK
K033486 11/04/2003 GE PRECISION MPI NRT-NORDISK RONTGEN TEKNIK A/S JAN MALLING
K033470 11/03/2003 SIMULIX EVOLUTION NUCLETRON CORPORATION LISA DIMMICK
K033546 11/12/2003 NUVASIVE SPINAL SYSTEM NUVASIVE, INC. LAETITIA BERNARD
K033651 11/20/2003 OLYMPUS VIDEO URETEROSCOPE, NTSC OLYMPUS WINTER & IBE GMBH TINA STEFFANIE-OAK
K033707 11/26/2003 POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX OSTEOBIOLOGICS, INC. GABRIELE G NIEDERAUER, PH.D.
K033249 11/10/2003 PAJUNK MODULAR HANDLE INSTRUMENTS PAJUNK GMBH LYNETTE L HOWARD
K033549 11/26/2003 STARLUX PULSED LIGHT SYSTEM PALOMAR MEDICAL PRODUCTS, INC. MARCY MOORE
K033507 11/18/2003 MRJ PARAMED SRL DIANA UPTON
K033648 11/20/2003 PERFORMANCE WATER TREATMENT SYSTEM PERFORMANCE WATER SYSTEMS, LLC ROBERT DOWNEY
K033513 11/06/2003 EASI ECG ALGORITHM PHILIPS MEDICAL SYSTEMS DAVID OSBORN
K033680 11/24/2003 M2376A PHILIPS DEVICE LINK SYSTEM PHILIPS MEDICAL SYSTEMS HERBERT VAN DYK
K033737 11/28/2003 ALLURA XPER FD20 PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. LYNN HARMER
K033677 11/24/2003 BRAIN PERFUSION OPTION PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. ROBERT L TUROCY
K033715 11/26/2003 PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER PHILIPS MEDICAL SYSTEMS, INC. DAVID OSBORN
K033662 11/21/2003 SYNERGY SPINE ARRAY COIL PHILIPS MEDICAL SYSTEMS, INC. DUANE C PRASCHAN
K033604 11/17/2003 TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L PIE MEDICAL COLLEEN DENSMORE
K033730 11/28/2003 PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES PMT CORP. ERIC CAILLE
K033706 11/26/2003 POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS POLYMEDCO, INC. HELEN LANDICHO
K033726 11/28/2003 PVS "PIVOT" STEERABLE DELIVERY SYSTEM MICROCATHETER PRECISION VASCULAR RICK GAYKOWSKI
K033309 11/12/2003 PREMIER IMPLANT CEMENT, MODEL 3001450 PREMIER DENTAL PRODUCTS CO. BARRY HALE
K033471 11/04/2003 PHOSPHOLIN ES AND CALCIUM CHLORIDE R2 DIAGNOSTICS, INC. PEGGY S CARTER
K033460 11/25/2003 CHEETAH WHEELCHAIR R82 A/S KIRK MACKENZIE
K033566 11/26/2003 MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062 RAPID DIAGNOSTICS, INC. ROBIN J HELLEN
K033551 11/10/2003 EVOLVE RELIANCE ORTHODONTIC PRODUCTS, INC. BENJAMIN LICHTENWALNER
K033479 11/03/2003 PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY REMEL INC DAVID TEICHER
K033630 11/17/2003 MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK RHEIN 83 SRL JOSEPH E GRASSO
K033528 11/07/2003 MESACUP-2 TEST JO-1, MODEL 10756 RHIGENE, INC. NANCI DEXTER
K033163 11/07/2003 CAUTION CONDOMS RICHARD VAN HAUSSEN AMERICA, INC. RICHARD QUAISON
K033485 11/04/2003 ENDOSCOUT ROBIN MEDICAL, INC. BENNY ARAZY
K033612 11/17/2003 FACTOR II (PROTHROMBIN) G20210A KIT ROCHE DIAGNOSTICS CORP. ROBERT A GREGG
K033607 11/17/2003 FACTOR V LEIDEN KIT ROCHE DIAGNOSTICS CORP. ROBERT A GREGG
K033610 11/17/2003 HDL-CHOLESTEROL PLUS 2ND GENERATION ROCHE DIAGNOSTICS CORP. SHERRI L COENEN
K033734 11/28/2003 LIGHTCYCLER INSTRUMENT VERSION 1.2 ROCHE DIAGNOSTICS CORP. ROBERT A GREGG
K033501 11/05/2003 MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS) ROCHE DIAGNOSTICS CORP. SHERRI L COENEN
K033491 11/04/2003 ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS ROCHE DIAGNOSTICS CORP. JENNIFER TRIBBETT
K033548 11/12/2003 ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER ROCHE DIAGNOSTICS CORP. JENNIFER TRIBBETT
K033477 11/03/2003 HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT ROCHESTER MEDICAL CORP. ROB ANGLIN
K033660 11/24/2003 STORZ RANEY SCALP CLIP, MODEL 1-20-004-05 RUDOLF STORZ GMBH ANGELIKA SCHERP
K033656 11/21/2003 SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE SAUFLON PHARMACEUTICALS, LTD. LIGIA DELACRUZ
K033538 11/10/2003 BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8 SAUTER AG HANS STADLER
K033674 11/24/2003 MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS SERADYN INC. LES PADILLA
K033539 11/10/2003 DISPOSAL POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, GREEN COLOR SHEN WEI (USA), INC. CYNTHIA LIU
K033693 11/24/2003 POWDER-FREE VINYL EXAMINATION GLOVES SHEN WEI (USA), INC. CYNTHIA LIU
K033692 11/24/2003 POWDERED VINYL EXAMINATION GLOVES SHEN WEI (USA), INC. CYNTHIA LIU
K033650 11/26/2003 ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER SIEMENS MEDICAL SOLUTIONS USA, INC. ISKRA MRAKOVIC
K033675 11/24/2003 PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER SIRONA DENTAL SYSTEMS GMBH MARY MCNAMARA-CULLINANE
K033640 11/20/2003 SIROSON L AND SIROSONIC L ULTRASONIC SCALERS SIRONA DENTAL SYSTEMS GMBH MARY MCNAMARA-CULLINANE
K033683 11/24/2003 SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR SMART GLOVE CORP. SDN BHD FOO KHON PU
K033552 11/12/2003 JAX-TCP SMITH & NEPHEW, INC. KIM P KELLY
K033509 11/06/2003 MODIFICATION TO VERSABOND BONE CEMENT SMITH & NEPHEW, INC. DAVID HENLEY
K033669 11/21/2003 SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS) SMITH & NEPHEW, INC. DAVID HENLEY
K033686 11/24/2003 PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM SMITHS MEDICAL MD, INC. PATRICIA A LAFORTE
K033655 11/26/2003 SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR SOFLEX CONTACT LENS INDUSTRIES LTD. KEVIN WALLS
K033191 11/28/2003 SOHNIKS SOHNIKS ENDOSCOPY, INC. MARC HOSKINS
K033678 11/25/2003 SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038 SPECTRANETICS CORP. MICHAEL J RYAN
K033517 11/13/2003 SPINAL CONCEPTS INC. CADENCE AND TRAXIS SPINAL CONCEPTS, INC. LISA PETERSON
K033663 11/28/2003 SPINAL CONCEPTS INC. CODA SPINAL CONCEPTS, INC. LISA PETERSON
K033508 11/06/2003 PLUS PIVOT LINK UNIVERSAL SYSTEM SPINEVISION, INC. LYNNETTE WHITAKER
K033586 11/14/2003 MODIFICATION TO AURORA DS SYNERON MEDICAL LTD. AMIR WALDMAN
K033556 11/12/2003 SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM SYNTHES (USA) BONNIE SMITH
K033618 11/18/2003 SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM SYNTHES (USA) BONNIE SMITH
K033654 11/21/2003 FORCE FIBER TELEFLEX MEDICAL LYNN MATOS
K033681 11/24/2003 GLIDESHEATH TERUMO CORP. MARK UNTERREINER
K033583 11/13/2003 PROGREAT TERUMO MEDICAL CORP. MARK UNTERREINER
K033599 11/14/2003 ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS THE LAGADO CORP. JOHN M SZABOCSIK
K033424 11/12/2003 ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002 TRANSONIC SYSTEMS, INC. MARK S ALSBERGE
K033522 11/07/2003 SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC. CINDY KNAPP
K033690 11/24/2003 TROPHYPAN AND TROPHYPAN C TROPHY RADIOLOGIE MARIE-PIERRE LABAT-CAMY
K033240 11/10/2003 BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S200 TUNG KENG ENTERPRISE CO., LTD. KE-MIN JEN
K033220 11/10/2003 BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S280 TUNG KENG ENTERPRISE CO., LTD. JEN KE-MIN
K033541 11/10/2003 "LONG LOVE" CONDOM UNIDUS CORP. ELI J CARTER
K033658 11/21/2003 E.P.T. PREGNANCY TEST UNIPATH LTD. LOUISE ROBERTS
K033490 11/04/2003 SPIRIT 5000 CARDIAC COIL USA INSTRUMENTS, INC. CHRISTIE SHUMAKER
K033499 11/06/2003 MALIS IRRIGATION MODULE 1000 VALLEY FORGE SCIENTIFIC CORP. JERRY L MALIS
K033659 11/21/2003 VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK VARIAN INC LORNA GAMBOA
K033633 11/19/2003 VASCON POLARIS GUIDING CATHETER VASCON LLC STEPHEN F VADAS
K033721 11/26/2003 VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT VASCULAR SOLUTIONS, INC. SARA L COON
K033709 11/28/2003 VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE VASCULAR SOLUTIONS, INC. GREGORY W SACHS
K033547 11/12/2003 VNUS VESSEL AND TISSUE COAGULATION SYSTEM VNUS MEDICAL TECHNOLOGIES, INC. SAM NANAVATI
K033704 11/25/2003 MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS VYGON US LLC COURTNEY SMITH
K033671 11/24/2003 GORE BIOABSORBABLE MESH W. L. GORE & ASSOCIATES, INC. BRANDON HANSEN
K033670 11/24/2003 GORE TRI-LOBE BALLOON CATHETER W. L. GORE & ASSOCIATES, INC. BRANDON HANSEN
K033740 11/28/2003 LORENZ STERNAL CLOSURE SYSTEM WALTER LORENZ SURGICAL, INC. KIM REED
K033615 11/18/2003 WFSI'S REPROCESSED COMPRESSION SLEEVE DEVICES WHEATON FRANCISCAN SERVICES INC., SUPPLY CHAIN JACK SPEER
K033529 11/10/2003 TIE-IN TRAPEZIUM WRIGHT MEDICAL TECHNOLOGY, INC. KATIE LOGEROT
K033699 11/26/2003 LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 08586 ZEST ANCHORS, INC. FLOYD G LARSON
K033405 11/13/2003 LONGFEI LFY-I-5 OXYGEN CONCENTRATOR ZHEJIANG LONGFEI INDUSTRIAL CO., LTD. COCO WANG
K033652 11/20/2003 MINIMALLY INVASIVE SOLUTIONS OSTEOTOMY GUIDE INSTRUMENT ZIMMER, INC. STEPHEN MCKELVEY


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact