FDA 510(k) Decisions During April, 2003  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K030909 04/10/2003 AAP ACROPLATE AAP IMPLANTATE AG DIPL.-LNG. CHRISTIAN ABEL
K031185 04/30/2003 ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE ABBOTT LABORATORIES PATRICIA MELERSKI
K023256 04/23/2003 PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO ABBOTT LABORATORIES JANET CONNOLLY
K030799 04/08/2003 MICROS 60 ABX DIAGNOSTICS TIM LAWTON
K030261 04/24/2003 BATTERY, RECHARGEABLE ACCESS BATTERY, INC. ALEXANDER B HENDERSON
K024350 04/02/2003 ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K023037 04/09/2003 MID STREAM PREGNANCY TEST ADVANCED DIAGNOSTICS, INC. D.M. CHOUHAN
K030092 04/04/2003 COMPLETE BRAND MULTI-PURPOSE SOLUTION ADVANCED MEDICAL OPTICS, INC. PAUL J NOWACKI
K030461 04/24/2003 A127 LEAD EXTENSION ADVANCED NEUROMODULATION SYSTEMS RASHMI MOZA
K023290 04/03/2003 STERRAD 50 & STERRAD 100S STERILIZERS ADVANCED STERILIZATION PRODUCTS NATALIE BENNINGTON
K021133 04/30/2003 NIOX ARTICLE NO: 02-1000 AEROCRINE AB SEAN M CURRY
DEN030001 04/30/2003 NIOX ARTICLE NO: 02-1000 AEROCRINE AB SEAN M CURRY
K030556 04/22/2003 STEELEX ELECTRODE SET AESCULAP, INC. GEORG KELLER
K024285 04/16/2003 A/T X-RAY 70 AIR TECHNIQUES, INC. JOSEPH CAREY
K030459 04/04/2003 MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS) ALARIS MEDICAL SYSTEMS, INC. RENEE L FLUET
K030430 04/18/2003 POLY STAT SERUM/URINE HCG TEST ALIDEX, INC. HELEN LANDICHO
K030906 04/23/2003 AXCEL SURGICAL LIGHT ALM FREDERICK R CATT
K023869 04/30/2003 'RAPIDTEC'-5M-MULTIPLE DIP TEST AMERICAN BIO MEDICA CORP. HENRY WELLS
K023547 04/15/2003 DIOLASE 980 D LASER SYSTEM AMERICAN DENTAL TECHNOLOGIES, INC. MARCIA VAN VALEN
K030059 04/07/2003 PORTABLE RO+ MODEL MROS09 AMERIWATER BRIAN R BOWMAN
K030594 04/10/2003 I-125 RAPID STRAND, MODEL 7000 AMERSHAM HEALTH SUBHASH PATEL
K030415 04/30/2003 ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K021672 04/16/2003 PANCREATIC DRAINAGE TUBE AOMORI OLYMPUS CO., LTD. LAURA STORMS-TYLER
K030245 04/04/2003 NITRILE EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, PURPLE COLOR ARISTA LATINDO INDUSTRIAL, LTD. P.T. LINGA SUMARTA
K030937 04/23/2003 STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK ARROW INTERNATIONAL, INC. BRANDON EPTING
K030954 04/16/2003 ARTHROCARE PERCD SPINEWAND ARTHROCARE CORP. VALERIE DEFIESTA-NG
K023905 04/30/2003 ATHENA PELVIC MUSCLE TRAINER ATHENA FEMININE TECHNOLOGIES, INC. BARBARA SARKIS
K030881 04/10/2003 AVANTA CARPAL FUSION PLATING SYSTEM AVANTA ORTHOPAEDICS, INC. H. DOUG PLUNKETT
K030062 04/03/2003 ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80, ADL0820-135,ADL0920-80,ADL0920-135,ADL1020-0 AVANTEC VASCULAR CORP. JAMES M SHY
K030974 04/25/2003 EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170 BAXTER HEALTHCARE CORP. DAVID E CURTIN
K030975 04/25/2003 EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210 BAXTER HEALTHCARE CORP. DAVID E CURTIN
K030804 04/10/2003 BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR BAYER HEALTHCARE, LLC ANDRES HOLLE
K030801 04/09/2003 BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL BAYER HEALTHCARE, LLC ANDRES HOLLE
K030291 04/17/2003 COULTER ACT 5DIFF AUTOLOADER (AL) BECKMAN COULTER, INC. LOURDES COBA
K030606 04/21/2003 COULTER LH 750 BODY FLUIDS APPLICATION BECKMAN COULTER, INC. STAN SUGRUE
K031002 04/29/2003 SYNCHRON SYSTEMS OPIATE REAGENT BECKMAN COULTER, INC. KIM WALKER
K030677 04/01/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-VANCOMYCIN GRAM POSITIVE BECTON, DICKINSON & CO. MICHELLE B BANDY
K031009 04/28/2003 MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM BIO-LOGIC SYSTEMS CORP. NORMAN E BRUNNER
K030555 04/11/2003 GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A BIOMET, INC. LONNIE WITHAM
K030051 04/04/2003 VERSABOARD, MODEL 7040 BIONIX DEVELOPMENT CORP. JAMES HUTTNER
K030388 04/24/2003 IMPACT SUTURE ANCHOR. MODEL 433510 BIONX IMPLANTS, LTD. TUIJA ANNALA
K030806 04/08/2003 BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY BIOPLATE, INC. CAROL E JONES
K031028 04/28/2003 THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY BIOPLATE, INC. CAROL E JONES
K023205 04/24/2003 ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP BIOTRONIK, INC. Jon Brumbaugh
K030585 04/28/2003 SCULPTING RESIN BISCO, INC. STEPHEN SMITH
K030595 04/24/2003 BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM BLACKSTONE MEDICAL, INC. DEAN E CIPORKIN
K030862 04/17/2003 BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR BLACKSTONE MEDICAL, INC. DEAN E CIPORKIN
K030855 04/17/2003 MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT BOSTON SCIENTIFIC CORP. PAIGE SWEENEY
K023288 04/02/2003 COBRA BIPOLAR CLAMP, MODEL 15902 BOSTON SCIENTIFIC EP TECHNOLOGIES APRIL MALMBORG
K030172 04/03/2003 SMALL HIGH SPEED MOTOR DRILL SYSTEM BRASSELER USA I, L.P. ANTHONY V ROSE
K030175 04/17/2003 2 BASIC CAPINTEC, INC. MARY ANNE DELL
K030451 04/30/2003 CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE CARBON MEDICAL TECHNOLOGIES, INC. ROBERT W JOHNSON
K030216 04/02/2003 COLONCARE CARE PRODUCTS, INC. HUBERT POTOTSCHNIG
K022417 04/10/2003 CARE STIM CARE REHAB AND ORTHOPAEDIC CHRISTIAN E HUNT
K023614 04/07/2003 STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM CASE MEDICAL, INC. MARCIA A FRIEZE
K030533 04/17/2003 ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST CENOGENICS CORP. NITZ KATZ
K030259 04/24/2003 AMATOMICAL SHOULDER WITH REMOVABLE HEAD CENTERPLUS ORTHOPEDICS, INC AUDREY SWEARINGEN
K030167 04/02/2003 MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER CLEARLAB PTE LTD. MARTIN DALSING
K030690 04/30/2003 CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS CODONICS, INC. RICK DAYTON
K030850 04/08/2003 ENHANCE HUMAN SERUM ALBUMIN CONCEPTION TECHNOLOGIES GRACE HOLLAND
K021237 04/10/2003 COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS COOPERSURGICAL, INC. HAIKO BELL
K030927 04/17/2003 POWDERED VINYL EXAM GLOVES, WHITE COPIOUMED INTL., INC. JANNA P TUCKER
K030056 04/22/2003 WORRY-REMOVER IRRIGATOR CORISEN GROUP, LTD. WEI N ZUO
K030234 04/28/2003 COZART EIA COCAINE ORAL FLIUD KIT COZART BIOSCIENCE LTD. ROBERTO LIDDI
K024339 04/07/2003 COZART EIA OPIATES ORAL FLUID KIT COZART BIOSCIENCE LTD. ROBERTO LIDDI
K030613 04/17/2003 VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100 CRITICARE SYSTEMS, INC. ALEX KAPLAN
K030303 04/29/2003 FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE CRYOCATH TECHNOLOGIES, INC. JEAN-PIERRE DESMARAIS
K030340 04/11/2003 AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) CYTOMEDIX CARELYN P FYLLING
K024342 04/23/2003 RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000 DAITO CO., LTD. EDWARD EPSTEIN
K023454 04/23/2003 DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE M-MINIC AND ACCESSORIES DATEX-OHMEDA JOEL C KENT
K031213 04/30/2003 AQUASENS FLUID MONITORING SYSTEM DAVOL, INC. BRIAN A KANERVIKO
K030983 04/25/2003 TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY DELTEC, INC. LISA STONE
K030133 04/29/2003 SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE DENTALEZ GROUP WILLIAM GUSCOTT
K030833 04/10/2003 DEPUY ACROMED VBR SYSTEM DEPUY ACROMED KAREN F JURCZAK
K030979 04/24/2003 MODIFICATION TO DEPUY SOLUTION SYSTEM HIP PROSTHESIS DEPUY ORTHOPAEDICS, INC. KARLA A HAM
K030365 04/29/2003 DEROYAL DRAPES, STERILE, NON-STERILE DEROYAL INDUSTRIES, INC. AUDREY DANIELS
K030364 04/28/2003 DEROYAL GOWNS, STERILE, NON-STERILE DEROYAL INDUSTRIES, INC. AUDREY DANIELS
K030136 04/07/2003 DRIP ALERT DRIP ALERT, INC. POLLY D HESEMAN
K030854 04/16/2003 PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400 E-Z-EM, INC. JUDY HAUSER
K030353 04/25/2003 MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS EAGLE VISION, INC. BILLY HANNAFORD
K031087 04/24/2003 EDWARDS INTRODUCER SHEATH EDWARDS LIFESCIENCES, LLC. Daun Putnam
K030395 04/08/2003 EMPI ACTION PATCH IONTOPHORESIS SYSTEM EMPI SUSAN ONEL
K023794 04/01/2003 CONSTRAINED LINER ENCORE MEDICAL, L.P. DEBBIE DE LOS SANTOS
K020925 04/29/2003 CARBODISSECTING ENDOSCOPE ENDO SURGICAL DEVICES, INC. DEBBIE IAMPIETRO
K030129 04/22/2003 MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 ENDOCARDIAL SOLUTIONS, INC. KAREN J MCKELVEY
K030297 04/28/2003 FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130 ENRAF-NONIUS B.V. RICK COELET
K030656 04/08/2003 ENVAN HEART RATE MONITOR ENVAN, LLC MARIE MARLOW
K030562 04/03/2003 TUOHY EPIDURAL NEEDLE EPIMED INTERNATIONAL, INC. CHRISTOPHER B LAKE
K030686 04/02/2003 OPTETRAK TOTAL KNEE SYSTEM - MOLDED METAL-BACK TIBIAL COMPONENT EXACTECH, INC. GARY MILLER
K022112 04/03/2003 FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020 FORTUNE MEDICAL INSTRUMENT CORP. JESSICA CHAN
K022124 04/03/2003 GALEMED PEAK FLOW METER, MODELS 3751/3752 GALEMED CORP. BRUCE KUO
K030953 04/10/2003 GE 3.0T GENERAL PURPOSE FLEX COIL GE MEDICAL SYSTEMS, INC. LARRY KROGER
K030934 04/17/2003 GE LOGIQ 9 MODEL 2375600 GE MEDICAL SYSTEMS, INC. ALLEN SCHUH
K030027 04/01/2003 GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49% GELFLEX LABORATORIES PETER G BRYANT
K030673 04/04/2003 FLEXIBLE TIP THERMOMETER, MODEL 011206 GLOBAL TREASURE INDUSTRIES LTD. FRAN WHITE
K021154 04/11/2003 GOLDWAY PATIENT MONITOR, MODEL # UT4000F GOLDWAY US, INC. Y. JUSTIN CHEN
K030292 04/15/2003 GROMAN PREPMASTER GROMAN INC. BARRY B GROMAN
K030198 04/01/2003 HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM HAND INNOVATIONS, INC. RICHARD D BLISS, JR.
K030808 04/21/2003 HANSON MEDICAL CALF IMPLANT HANSON MEDICAL, INC. JOHN HARRISON
K030809 04/21/2003 HANSON MEDICAL GLUTEAL IMPLANT HANSON MEDICAL, INC. JOHN HARRISON
K030151 04/10/2003 CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM HAYES MEDICAL, INC. WILLIAM J GRIFFIN
K030205 04/01/2003 CONSENSUS UNIPOLAR HEAD, COCR HAYES MEDICAL, INC. WILLIAM J GRIFFIN
K030498 04/11/2003 HL888HA HEALTH & LIFE CO., LTD. SUSAN CHEN
K030499 04/17/2003 HL888HM HEALTH & LIFE CO., LTD. SUSAN CHEN
K030541 04/24/2003 HL888JF HEALTH & LIFE CO., LTD. SUSAN CHEN
K024207 04/14/2003 VINCO BRAND ACUPUNCTURE NEEDLE HELIO MEDICAL SUPPLIES, INC. ERIC CHENG
K030572 04/01/2003 HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE HENKE SASS WOLF OF AMERICA, INC. LYNETTE HOWARD
K020421 04/29/2003 GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES HENNIG ENTERPRISES EUROPE S.R.L. GEORGE O'NEIL
K030318 04/03/2003 P2 POLYETHER HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K021622 04/01/2003 HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 HILL-ROM AIR-SHIELDS MONICA FERRANTE
K023001 04/08/2003 HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-326L HOME CARE TECHNOLOGY CO., LTD. SHU-CHEN CHENG
K031090 04/24/2003 MODIFICATION TO XIA STAINLESS STEEL SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K031127 04/28/2003 ORTHOPEDIC WIRE HOWMEDICA OSTEONICS CORP. DEBRA BING
K023412 04/09/2003 THERMO BUDDY, MODELS TB-100, TB-110, TB-120 HUBDIC CO., LTD GUENTER GINSBERG
K022294 04/25/2003 APNEACHECK IM SYSTEMS DAVID T KRAUSMAN
K021174 04/29/2003 ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR IMAGYN SURGICAL JULIE POWELL
K030427 04/18/2003 HP-3 HD ELECTRIC WHEELCHAIR IMC-HEARTWAY, LLC JUAN CARLOS RIVERA
K023073 04/07/2003 SEED LINK IMPLANT SCIENCES CORP. JOHN J MUNRO
K030243 04/23/2003 ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314 IMTEC CORP. J.BRAD VANCE
K024117 04/22/2003 INSORB ABSORBABLE STAPLES, MODEL SP-B20 INCISIVE SURGICAL, INC. JIM PETERSON
K022614 04/08/2003 INVIGRA INDUS MEDICARE LTD. P. JANARDHAN REDDY
K031013 04/17/2003 INFINTT CO., LTD. STARPACS SYSTEM INFINITT COMPANY CARL ALLETTO
K030681 04/24/2003 QUANTA PLEX ENA PROFILE 5 INOVA DIAGNOSTICS, INC. BRYS C MYERS
K030723 04/03/2003 IVS INTRODUCER SET, MODEL 1003 INTEGRATED VASCULAR SYSTEMS, INC. SUSAN TURNER
K030181 04/17/2003 INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM INTERNATIONAL BIOPHYSICS CORP. LEN HICKEY
K030818 04/02/2003 HEMOCHRON RESPONSE/SYSTEM INTERNATIONAL TECHNIDYNE CORP. JOHN CLAY
K030984 04/24/2003 SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14, SAFE CROSS ANGLED SUPPORT CATHETER, SAFE CROT INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K030436 04/15/2003 BIO UNIVERSAL IVOCLAR VIVADENT, INC. ANDERJEET GULATI
K030435 04/15/2003 BIOUNIVERSAL PKF IVOCLAR VIVADENT, INC. ANDERJEET GULATI
K023365 04/18/2003 LEFORTE SYSTEM BONE SCREW JEIL MEDICAL CORPORATION DANIEL KAMM
K024325 04/04/2003 JI-EE ELECTRIC SCOOTER, ESTHETE ES 1 JI-EE INDUSTRY CO., LTD. Ke-Min Jen
K030540 04/16/2003 HTS ARRAY COIL JOCKEY CLUB MRI ENGINEERING CENTER FRANCIS LEE
K030009 04/02/2003 KSEA POWERSHAVER SYSTEM S2 KARL STORZ ENDOSCOPY RENATE A MACLAREN
K030385 04/15/2003 IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR KAWASUMI LABORATORIES AMERICA, INC. JACK PAVLO
K030959 04/25/2003 BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100 LASER PERIPHERALS LLC. JEFFREY M STEIN
K030362 04/14/2003 SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATES LEONHARD LANG GMBH ELAINE DUNCAN
K030893 04/02/2003 LEVO COMBI LEVO AG THOMAS RAEBER
K030422 04/14/2003 LINA-BAG, MODELS LB-60, LB-100 LINA MEDICAL CML APS NIELS KORNERUP
K030203 04/21/2003 LONG WELL LW-6DXX SERIES BODY FAT ANALYZER LONG WELL ELECTRONICS CORP. JENNIFER REICH
K030147 04/15/2003 LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS LUMENIS, LTD. ANNA WORDEN
K030323 04/02/2003 MRI-CADDY MAMMENDORFER INSTITUTE FOR PHYSICS & MEDICINE GMBH ROBERT N CLARK
K021876 04/08/2003 MAS WITH OR WITHOUT SYRINGE MARINA MEDICAL INSTRUMENTS, INC. JAY MANSOUR
K030905 04/09/2003 MEDAMICUS FLOWGUARD PEELABLE INTRODUCER MEDAMICUS, INC. KARYL HASKELL
K030270 04/11/2003 3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE VASCU-PICC, 5F X 60 CM SINGLE LUMEN SILICON MEDCOMP MEGHAN J TINTLE
K030942 04/28/2003 MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL MEDICAL ANALYSIS SYSTEMS, INC. PENNY M LAYMAN
K023231 04/04/2003 ELFCARE DEVICE, MODELS 314A THROUGH 314G MEDISEB LTD. AHAVA STEIN
K023621 04/10/2003 BIOFLEX PROFESSIONAL THERAPY SYSTEM MEDITECH INTERNATIONAL, INC. RICHARD KEEN
K030696 04/11/2003 RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE) MEDTRONIC PERFUSION SYSTEMS PREETI JAIN
K030735 04/18/2003 MODIFIED VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K030736 04/02/2003 VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K023553 04/22/2003 MASTERGRAFT MATRIX MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
K030779 04/24/2003 5F MEDTRONIC LAUNCHER GUIDE CATHETER MEDTRONIC VASCULAR FRED L BOUCHER
K031003 04/11/2003 STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES MEDTRONIC XOMED, INC. MARTIN D SARGENT
K030888 04/02/2003 EVA EMPTY SOLUTION CONTAINER METRIX CO. JAMES J OLDHAM
K030880 04/18/2003 VECTORSONIC, MODEL VU-270 METRON MEDICAL AUSTRALIA PTY LTD DAVE TOMAN
K030110 04/03/2003 CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MICK RADIO-NUCLEAR INSTRUMENTS, INC. FELIX MICK
K030940 04/09/2003 NOMAD ND1000M AUGMENTED VISION SYSTEM MICROVISION INCORPORATED KARL BYLUND
K030416 04/14/2003 CERACAST-V MOUNTAIN MEDICO, INC. PAUL C CHANG
K030823 04/09/2003 ALGO 3I NEWBORN HEARING SCREENER NATUS MEDICAL, INC. RON KOHLHARDT
K023234 04/17/2003 ENDOSCOPIC PLICATION SYSTEM NDO SURGICAL, INC. ERIC BANNON
K030715 04/24/2003 SAFFRON NM GUIDING CATHETER NEICH MEDICAL (SHENZHEN) COMPANY LIMITED RAYMOND LIN
K030918 04/01/2003 SUPEROPEN 0.35T, MODEL NSM-P035 NEUSOFT DIGITAL MEDICAL SYSTEMS CO., LTD. WANG ZHIQIANG
K020754 04/21/2003 NICOLET PIONEER TC8080 NICOLET BIOMEDICAL Gary Syring
K021978 04/08/2003 PETIT SOPHIA NISHITOMO CO., INC. LLOYD DUPLANTIS
K023623 04/22/2003 NOVAVISION, MODEL 2.0 NOVAVISION, INC. SANDRA J.P. DENNIS
K030471 04/17/2003 OPHTEC ENCLAVATION NEEDLE OPHTEC USA RICK MCCARLEY
K023676 04/24/2003 APPLANATION TONOMETER OPTILASA S.L. JOSE M BOBES
K030235 04/23/2003 F1 DIODE LASER SYSTEM OPUS MEDICAL, INC. RENE VAN DE ZANDE
K023308 04/14/2003 LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS ORBUS MEDICAL TECHNOLOGIES JIM CLOSSICK
K024300 04/03/2003 MICROCAP PLUS/NPB-75 ORIDION MEDICAL 1987 LTD. SANDY BROWN
K030619 04/01/2003 ODI 7.0MM CANNULATED SCREW SYSTEM ORTHOPEDIC DESIGNS, INC. PATRICK J COSGROVE
K030208 04/16/2003 IMBIBE II SYRINGE ORTHOVITA, INC. ANDREINA IDE
K022277 04/01/2003 OSTEOMED CRANIAL FLAP FIXATION SYSTEM OSTEOMED CORP. DAWN T HOLDEMAN
K020418 04/29/2003 GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES P.T. GREENLEAF GEORGE O'NEIL
K030603 04/14/2003 PROANGLE DISPOSABLE PROPHY ANGLE PAC-DENT INTERNATIONAL (SUZHOU), LTD. XU WANG
K030620 04/14/2003 PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. LINDA K DILLON
K024170 04/14/2003 L1 SYSTEM PELIKAN TECHNOLOGIES, INC JACK GREEN
K023818 04/03/2003 FIBERFILL AGP PENTRON CLINICAL TECHNOLOGIES ANNMARIE TENERO
K030447 04/14/2003 AT HOME DRUG CUP, MODEL 9150X PHAMATECH CARL MONGIOVI
K022950 04/18/2003 MINIPHYSIONIZER 2.0 AND ELECTRODES PHYSION, INC. ERIC J NEMETH
K030971 04/24/2003 MODIFICATION TO MODULAR PLUS REVISION STEM PLUS ORTHOPEDICS J.D. WEBB
K030457 04/08/2003 REX, VERSION 3.0 POINTDX, INC FRANCIS BONK
K023860 04/28/2003 MICROALBUMIN REAGENT SET AND CALIBRATORS POINTE SCIENTIFIC, INC. RON JAMISON
K030061 04/07/2003 PS 3000 DIGATAL PHOTOSPOT SYSTEM PRECISE OPTICS RICHARD KEEN
K023991 04/28/2003 CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 PRECISION BIOLOGIC STEPHEN L DUFF
K030283 04/22/2003 BABY POD PRISM ENTERPRISES, INC. ELAINE DUNCAN
K030826 04/03/2003 PRECISET DAT AMPHETAMINE QUANTIMETRIX CORP. GEBHARD NEYER
K030882 04/04/2003 RABBIT MOBILE STANDING FRAME R82 A/S KIRK L MACKENZIE
K030697 04/04/2003 RADIONICS SINGLE USE GROUND PAD (DGP-HP) RADIONICS, INC. KEVIN J O'CONNELL
K030772 04/11/2003 RDI EXTENDED RANGE CRP CALIBRATOR SET REFERENCE DIAGNOSTICS, INC. JOSEPH LAWLOR
K030798 04/09/2003 MIRAGE ACTIVA MASK RESMED LTD. DAVID D'CRUZ
K023847 04/30/2003 HEMO-STREAM HEMODIALYSIS CATHETER SET REX MEDICAL SUSAN D GOLDSTEIN-FALK
K030967 04/21/2003 RITA STARBURST SDE ELECTROSURGICAL DEVICE RITA MEDICAL SYSTEMS ERIN MAZZONE
K030936 04/01/2003 RITA CLIPS FOR INFUSION PUMPS RITA MEDICAL SYSTEMS INC VICKI HACKER
K030740 04/01/2003 MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM ROCHE DIAGNOSTICS CORP. SHERRI L COENEN
K030213 04/11/2003 ONLINE DAT II CANNABINOIDS II ROCHE DIAGNOSTICS CORP. KERWIN KAUFMAN
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