FDA 510(k) Decisions During May, 2003  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K030480 05/14/2003 L600 HAIR REMOVAL A&M TECHNOLOGY PASCAL DANET
K030513 05/12/2003 CELL-DYN 1800 SYSTEM ABBOTT LABORATORIES JOHN DEAN
K030884 05/27/2003 APTUS BLUE ACADENTAL CHRISTOPHER CRAIG
K031001 05/21/2003 ACMI VISTA CTR BIPOLAR LOOP ELECTRODE ACMI CORPORATION GABRIEL J MURACA
K031226 05/02/2003 STERRAD CYCLESURE BIOLOGICAL INDICATOR ADVANCED STERILIZATION PRODUCTS NATALIE BENNINGTON
K031008 05/09/2003 AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE) AESCULAP MATTHEW M HULL
K031286 05/29/2003 SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE AESCULAP, INC. GEORG KELLER
K023673 05/02/2003 AIRLIFE DEMAND NASAL CANNULA ALLEGIANCE HEALTHCARE CORP. SHARON NICHOLS
K023602 05/01/2003 SMALL VOLUME NEBULIZER ALLEGIANCE HEALTHCARE CORPORATION SHARON NICHOLS
K030026 05/02/2003 REPROCESSED ELECTROPHYSIOLOGY CATHETER ALLIANCE MEDICAL CORP. MOIRA BARTON
K030947 05/15/2003 ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM ALVEOLUS, INC. HOWARD L SCHRAYER
K030835 05/22/2003 'RAPID ONE' - PROPOXYPHENE TEST AMERICAN BIO MEDICA CORP. HENRY WELLS
K030518 05/20/2003 AMERITEK SURE-POINT TRACKER SYSTEM AMERTEK MEDICAL, INC. GREG WIITA
K030664 05/23/2003 AMSURE FOLEY INSERTION TRAY AMSINO INTERNATIONAL, INC. CHING CHING SEAH
K030712 05/23/2003 AMSURE URETHRAL CATHETERIZATION TRAY AMSINO INTERNATIONAL, INC. CHING CHING SEAH
K030931 05/09/2003 C3 PATIENT MONITOR ANALOGIC CORP. MARVIN ROSENBAUM
K031110 05/22/2003 APEX MODULAR ACETABULAR CUP APEX SURGICAL, LLC. EDWARD J CHEAL
K030642 05/23/2003 DEFLECTING URETERAL ACCESS SHEATH APPLIED MEDICAL RESOURCES CORP. ANIL BHALANI
K022662 05/09/2003 DIATEK CANNON-CATHETER, MODEL CC5500 ARROW INTL., INC. THOMAS NICKEL
K020738 05/22/2003 AVITA BF1 (VITALIO) BODY FAT ANALYZER AVITA CORPORATION JENNIFER REICH
K030230 05/23/2003 AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR) AVITA CORPORATION JENNIFER REICH
K023253 05/06/2003 PEDIATRIC CENTRAL VENOUS CATHETER KIT B. BRAUN MEDICAL, INC. PATRICIA D WILSON
K024289 05/02/2003 BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION BAUSCH & LOMB INCORPORATED JENNIFER B MURRAY
K030573 05/08/2003 BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341 BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS M. WENDY BALLESTEROS
K031270 05/06/2003 ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS BECKMAN COULTER, INC. LYNN WEIST
K031297 05/02/2003 ACCESS OV MONITOR ASSAY BECKMAN COULTER, INC. LYNN WEIST
K031269 05/02/2003 ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS BECKMAN COULTER, INC. LYNN WEIST
K030828 05/21/2003 TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) BECKMAN COULTER, INC. STAN SUGRUE
K030986 05/16/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TRIMETHOPRIM - GN 0.5-16 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K030907 05/09/2003 STACKED ABR FOR NAVIGATOR PRO BIO-LOGIC SYSTEMS CORP. NORMAN E BRUNNER
K023857 05/16/2003 PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 BIO-RAD CHRISTOPHER BENTSEN
K011399 05/05/2003 BIOMET CRANIOFACIAL ACRYLIC CEMENT BIOMET, INC. MICHELLE L MCKINLEY
K031334 05/22/2003 TEXAS T - PLATE BIOMET, INC. GARY BAKER
K023478 05/13/2003 INBODY AP1 BODY COMPOSITION ANALYZER BIOSPACE CO.,LTD DANIEL KAMM
K022849 05/20/2003 BODY CLOCK TENS N' TONE BODY CLOCK HEALTH CARE LTD JONATHAN BASH
K030349 05/02/2003 HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945 & BFM 960 BONSO ELECTRONICS INTERNATIONAL INC. RUSS PAGANO
K030956 05/23/2003 NAVIGATOR URETERAL ACCESS SHEATH SET BOSTON SCIENTIFIC CORP. JANET A MCGRATH
K030617 05/21/2003 PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE BOSTON SCIENTIFIC SCIMED, INC. ANNE V ROSSI
K031168 05/14/2003 MATRIX STRETCH RESISTANT DETACHABLE COIL BOSTON SCIENTIFIC, TARGET JAMES LEATHLEY
K031202 05/01/2003 MEDIPALM-20 BRAEBON MEDICAL CORP. RICHARD A BONATO
K030489 05/02/2003 BRM2 BRAIN MONITOR BRAINZ INSTRUMENTS LTD. CHRIS MANDER
K023820 05/07/2003 CO2 CLIP BREGAS AB PAUL KRILL
K031295 05/15/2003 BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM C.R. BARD, INC. FRANCES E HARRISON
K031332 05/15/2003 BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH C.R. BARD, INC. TERRINA WILDER
K031186 05/06/2003 LUMINEXX ENDOSCOPIC BILIARY STENT C.R. BARD, INC. THOMAS HIRTE
K031129 05/05/2003 POLY PER-Q-CATH PICC CATHETERS; POLY RADPICC C.R. BARD, INC. PEGGY KEIFFER
K031272 05/20/2003 C.T.M. MOBILITY SCOOTER, MODEL HS-120 C.T.M. HOMECARE PRODUCT, INC. ROBERT S MCQUATE
K031447 05/21/2003 CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G CANON INC. SHEILA DRISCOLL
K030398 05/23/2003 CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221 CARDIAC ASSIST, INC. TIM KRAUSKOPF
K030433 05/01/2003 STRATUSOCT WITH RNFL NORMATIVE DATABASE CARL ZEISS MEDITEC INC R. MICHAEL CROMPTON
K022978 05/09/2003 STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS CASE MEDICAL, INC. MARCIA A FRIEZE
K030748 05/14/2003 AQUASOFT (OCUFILCON D) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER CLEARLAB PTE LTD. MARTIN DALSING
K031123 05/14/2003 CODMAN BACTISEAL BARIUM STRIPED CATHETERS CODMAN & SHURTLEFF, INC. ELIZABETH DOLAN
K023566 05/22/2003 CODMAN ISOCOOL BIPOLAR FORCEPS CODMAN & SHURTLEFF, INC. ELIZABETH DOLAN
K030921 05/15/2003 COLLAGEN TOPICAL WOUND DRESSING COLLAGEN MATRIX, INC. PEGGY HANSEN
K030917 05/14/2003 GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130 COLLINS MEDICAL, INC. DONALD HENTON
K030017 05/01/2003 CHUMP COLOURS 'N MOTION VICTOR R BOX
K030355 05/20/2003 COMFORT POWERED WHEELCHAIR, CONQUEROR LY-EB 202 COMFORT ORTHOPEDIC CO. LTD. KE-MIN JEN
K030356 05/20/2003 COMFORT POWERED WHEELCHAIR, TRAVELLER LY-EB 103 COMFORT ORTHOPEDIC CO. LTD. KE-MIN JEN
K030743 05/09/2003 ETCHANT 40% CONFI-DENTAL PRODUCTS CO. STEPHEN RUDOLPH
K031069 05/15/2003 SURGISIS NERVE CUFF COOK BIOTECH, INC. MARK BLEYER
K023937 05/27/2003 COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM COOK VASCULAR, INC. THOMAS J KARDOS
K021557 05/30/2003 SPECTRUM SILICONE CATHETER COOK, INC. APRIL LAVENDER
K021944 05/14/2003 COZART EIA COTININE URINE KIT COZART BIOSCIENCE LTD. ROBERTO LIDDI
K030786 05/06/2003 MONO-SWIFT CP MEDICAL MARY ANN GREENAWALT
K031317 05/22/2003 SMART 2940 D ER: YAG LASER CYNOSURE, INC. GEORGE CHO
K031224 05/09/2003 SMARTXIDE CYNOSURE, INC. GEORGE CHO
K031343 05/15/2003 TPSA FLEX REAGENT CARTRIDGE DADE BEHRING, INC. GEORGE M PLUMMER
K030812 05/21/2003 DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE DATEX-OHMEDA JOEL KENT
K031361 05/23/2003 CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP DELTEC, INC. LISA STONE
K023424 05/09/2003 IGI-SYSTEM DENX ADVANCED DENTAL SYSTEMS KOBY BEN-BARAK
K030508 05/20/2003 DEPILASE TRIO LASE LASER SYSTEM DEPILASE GROUP LTD. MARIO LUCA RUSSO
K030510 05/14/2003 DEPILASE TWIN YAG LASER SYSTEM DEPILASE GROUP LTD. MARIO LUCA RUSSO
K030506 05/09/2003 DEPILASE YAG LASE PLUS LASER SYSTEM DEPILASE GROUP LTD. MARIO LUCA RUSSO
K031223 05/02/2003 SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR DIDECO S.P.A. BARRY SALL
K030972 05/30/2003 FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH) DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. HILA WACHSLER-AVRAHAMI
K030776 05/09/2003 MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL DISCUS DENTAL, INC. YOGI SHAH
K030952 05/19/2003 DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421 DOLPHIN MEDICAL INC. BILL CURNAN
K030781 05/29/2003 KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW MANAGER,KODAK DIRECTVIEW CX/DX, KODAK DIRECTVIB EASTMAN KODAK COMPANY LINDA J MOORE
K030347 05/02/2003 20.1" MONOCHROME LCD MONITOR, RADIFORCE G20 EIZO NANAO CORPORATION AKIRA WAKAYAMA
K031134 05/20/2003 DISPOSABLE POWDERED VINYL EXAM GLOVES ELITE INTERNATIONAL, INC. BOBBY LING
K030667 05/28/2003 ENCORE ANTERIOR SPINAL STAPLE SYSTEM ENCORE MEDICAL, L.P. DEBBIE DE LOS SANTOS
K030925 05/15/2003 PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01 ETHICON ENDO-SURGERY, INC. CAROL SPRINKLE
K031430 05/22/2003 CEMEX SYSTEM FAST EXACTECH, INC. GARY J MILLER
K023740 05/13/2003 SYREX PRE-FILLED SYRINGE EXCELSIOR MEDICAL CORP. DAVID LUMIA
K030346 05/02/2003 TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER FMD, LLC STEVEN CHERNOFF
K023338 05/09/2003 PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2 FMS, FINAPRES MEDICAL SYSTEMS BV CHRISTINE EMANUEL
K031292 05/22/2003 MODIFICATION TO FOSSA URETERAL STONE SWEEPER FOSSA MEDICAL, INC. PAMELA PAPINEAU
K030497 05/20/2003 FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES FRESENIUS MEDICAL CARE ART EILINSFELD
K031378 05/30/2003 FRESENIUS ULTRAFLUX HEMODIALYZER FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR EILINSFELD
K023963 05/05/2003 ADHOC CLAW FUTURE MEDICAL SYSTEMS, INC. STEVE JANIN
K031117 05/23/2003 SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM GALIL MEDICAL LTD. RONI ZVULONI
K030592 05/23/2003 GAMBRO POLYFLUX, MODEL 140H, 170H, 210H GAMBRO RENAL CARE PRODUCTS JEFFREY R SCHIDMAN
K023615 05/06/2003 GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR GAMBRO RENAL PRODUCTS JEFFREY R SHIDEMAN
K031396 05/13/2003 ADVANTAGE WORKSTATION PASTING 1.1 GE MEDICAL SYSTEMS LARRY A KROGER
K031261 05/06/2003 CARD EP GE MEDICAL SYSTEMS LARRY A KROGER
K031230 05/02/2003 GE PROPELLER IMAGING OPTION FOR MRI GE MEDICAL SYSTEMS LARRY KROGER
K022834 05/13/2003 DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MELISSA ROBINSON
K031320 05/06/2003 EK-PRO ARRHYTHMIA DETECTION ALGORITHM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES KAREN M LUNDE
K023943 05/06/2003 CT COLONOGRAPHY GE MEDICAL SYSTEMS, INC. LARRY A KROGER
K031209 05/23/2003 GE 1.5T 8 CHANNEL TORSO COIL GE MEDICAL SYSTEMS, INC. LARRY KROGER
K031259 05/12/2003 MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER GETINGE USA, INC FREDERICK R CATT
K030726 05/30/2003 GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING GISH BIOMEDICAL, INC. J. HARVEY KNAUSS
K031300 05/14/2003 IBC FLOPUMP WITH GBS COATING GISH BIOMEDICAL, INC. J. HARVEY KNAUSS
K030512 05/14/2003 GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM GUIDANT CORP. NANCY LINCE
K031398 05/20/2003 IS-1 HEMOSTASIS VALVE, MODEL 6799 GUIDANT CORP. COLLEEN MCCARTER BLOOM
K030549 05/14/2003 HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE PILOT 150 GUIDE WIRE WITH HYDROCOAT HYDROPHG GUIDCORP STACEY BROWN
K030343 05/02/2003 DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE GYRUS ENT L.L.C. GREGORY SREDIN
K031082 05/21/2003 EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK GYRUS MEDICAL, INC. MERCEDES P BAYANI
K031080 05/16/2003 EVEREST BIPOLAR LYONS DISSECTING FORCEPS & GYRUS BIPOLAR LYONS DISSECTING FORCEPS GYRUS MEDICAL, INC. MERCEDES BIRYANI
K031078 05/16/2003 EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR MACRO, MICRO & MOLLY FORCEPS GYRUS MEDICAL, INC. MERCEDES P BAYANI
K031079 05/21/2003 EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE GYRUS MEDICAL, INC. MERCEDES BAYANI
K031081 05/21/2003 EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS GYRUS MEDICAL, INC. MERCEDES BAYANI
K030515 05/02/2003 HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS HANS RUDOLPH, INC. KEVIN RUDOLPH
K030997 05/02/2003 POWDERED VINYL EXAM GLOVES, WHITE HEYUAN HONGLI INDUSTRIES, INC. JANNA P TUCKER
K021952 05/02/2003 HIVOX DREAMATE DM-800 HIVOX BIOTEK, INC. KE-MIN JEN
K022998 05/20/2003 HOME CARE VAREIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-311, HT-311N, HT-312 HOME CARE TECHNOLOGY CO., LTD. SHU-CHEN CHENG
K031217 05/23/2003 GMRS PRESS FIT STEMS WITH PUREFIX HA HOWMEDICA OSTEONICS MARGARET F CROWE
K014199 05/06/2003 SURGICAL SIMPLEX P WITH TOBRAMYCIN HOWMEDICA OSTEONICS CORP. WILLIAM J CYMBALUK
K023662 05/28/2003 PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER HWADONG INTERNATIONAL COMPANY LTD. MARIAN COCHRAN
K030741 05/01/2003 AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA HYCOR BIOMEDICAL LTD. DANIELLE M KNIGHT
K021813 05/09/2003 HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM HYDROCISION, INC. DEBBIE IAMPIETRO
K031388 05/22/2003 MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM HYPOGUARD USA, INC. BRUCE A MACFARLANE
K030432 05/01/2003 IMC-HEARTWAY MODEL HPS ELECTRIC POWERED WHEELCHAIR IMC-HEARTWAY, LLC JUAN CARLOS RIVERA
K030775 05/12/2003 AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM IMMUNO CONCEPTS, N.A., LTD ERIC S HOY
K022062 05/06/2003 IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 IMPACT INSTRUMENTATION, INC. LESLIE H SHERMAN
K023483 05/06/2003 KALAZAR DETECT INBIOS INTL., INC. ESTELA I RAYCHAUDHURI
K023733 05/14/2003 COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR INGENJORSFIRMAN BJORN BERGDAHL AB BJORN BERGDAHL
K023887 05/30/2003 INION OTPS BIODEGRADABLE MINI PLATING SYSTEM INION LTD. HANNA MARTTILA
K030889 05/23/2003 ULTRAEKOGEL MODELS EK 2000 & EK 2001 INMED LTDA. JAY MANSOUR
K031122 05/19/2003 HEMOSIL FACTOR X DEFICIENT PLASMA INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K031086 05/14/2003 CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 INTEGRA NEURO SCIENCES NANCY A MATHEWSON
K023908 05/16/2003 INTERPORE CROSS CEMENT RESTRICTOR INTERPORE CROSS INTL. PROSIE REY-FESSLER
K030131 05/20/2003 OSSATURA BCP BONE VOID FILLER ISOTIS NV MARY MCNAMARA-CULLINANE
K030699 05/29/2003 VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC J. MORITA MFG. CORP. KEITH A BARRITT
K030450 05/06/2003 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH J. MORITA USA, INC. KEITH A BARRITT
K031148 05/28/2003 IN-VISION IMAGING SYSTEM JOMED, INC. LORRAINE W HUFFMAN
K031277 05/14/2003 JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002 JOMED, INC. TERRY SCHULTZ
K030607 05/02/2003 KAVO EVEREST G-BLANK, KAVO EVEREST G-CERAM, COATING CERAMIC LF-3-PFM, GLAZE AND COLORINGS/STAINING/SHADES KAVO AMERICA JENNIFER POTTALA
K030646 05/06/2003 BELLEGLASS POINT 4 KERR DENTAL MATERIALS CENTER COLLEEN BOSWELL
K030536 05/06/2003 LAC-MAC LIMITED INNERBLOC O.R. GOWN LAC MAC, LTD. JEFFREY O STULL
K031362 05/30/2003 LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALS LAC MAC, LTD. JEFFREY O STULL
K030300 05/09/2003 OPAQUE HERRICK LACRIMAL PLUG LACRIMEDICS, INC. JERRY HENDERSON
K030976 05/30/2003 CAREO RETRACTABLE SAFETY SYRINGE LIFE-SHIELD PRODUCTS, INC ROSINA ROBINSON
K030527 05/20/2003 LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS LUMENIS ANDREA L RUTH
K023068 05/28/2003 PAPILLON MASK SET MAP MEDIZINTECHNIK FUR ARZT UND PATIENT GMBH ROGER KOTTER
K031330 05/12/2003 MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES MASIMO CORP. JAMES J CRONIN
K030502 05/20/2003 14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55 MEDCOMP MEGHAN J TINTLE
K031364 05/30/2003 MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3 MEDICAL ANALYSIS SYSTEMS, INC. PENNY M LAYMAN
K021230 05/09/2003 HERO MEDICAL DECISION NETWORKS WILLIAM E KING
K030439 05/08/2003 HEADFIX MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH CORNELIA DAMSKY
K031552 05/30/2003 MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS MEDISON AMERICA, INC. BOB DEPALMA
K030996 05/30/2003 MSI SA ELECTRODES MEDSPHERE INTERNATIONAL, INC ERIC KAO
K030839 05/30/2003 MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM ("AURORA") MEDTRONIC AVE, INC. MARLENE COBB-CARLSON
K031037 05/13/2003 EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE MEDTRONIC PERFUSION SYSTEMS RONALD W BENNETT
K030932 05/16/2003 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K030840 05/15/2003 MODIFICATION TO HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K031518 05/22/2003 EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODELS 774XX, 775XX, 776XX, 777XX, 788XX, MEDTRONIC VASCULAR DAWN STENSTROM
K031274 05/22/2003 MODEL 5071 MYOCARDIAL PACING LEAD MEDTRONIC VASCULAR TINA BENOIT
K024278 05/29/2003 PACEART SYSTEM MEDTRONIC VASCULAR KAREN RUTH-JARMON
K031285 05/19/2003 MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD MEGADYNE MEDICAL PRODUCTS, INC. RONDA K MAGNESON
K030588 05/07/2003 ARTEGRAL AND POLYSTAR SELECTION MERZ DENTAL GMBH JAMES DELANEY
K031210 05/16/2003 MODEL 4951M MYOCARDIAL UNIPOLAR LEAD METRONIC, INC. TINA BENOIT
K031017 05/30/2003 SYS*STIM 208 AND 208A METTLER ELECTRONICS CORP. ROBERT E FLEMING
K030649 05/22/2003 DRI COTININE EIA ASSAY MICROGENICS CORP. LAKSHMI ANNE
K031406 05/30/2003 EXOJET TISSUE MANAGEMENT SYSTEM MITEK WORLDWIDE SERGIO J GADALETA
K031514 05/23/2003 MODIFICATION TO TRUPEAK PEAK FLOW METER MONAGHAN MEDICAL CORP. JAMES A COCHIE
K030632 05/07/2003 PD CASTA-H MOUNTAIN MEDICO, INC. RUTH C JOLINE
K030728 05/23/2003 FYRELINK VL MPACS, LLC. GREG SOPOTNICK
K030805 05/21/2003 MYTHOS 500 MSQ (M2) LTD. ARAVA HACOHEN
K030561 05/09/2003 MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODELS HPL-100 AND HPL-100A MYTECH TECHNOLOGY CO., LTD. SHU CHEN CHENG
K030443 05/09/2003 MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST NASTECH PHARMACEUTICAL COMPANY, INC. PETER C APRILE
K031262 05/23/2003 ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760 NDO SURGICAL, INC. ERIC BANNON
K030930 05/23/2003 OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N NELLCOR PURITAN BENNETT, INC. GINA TO
K022274 05/29/2003 CARECOMPANION PATIENT STATION & NURSE STATION NEPTEC DESIGN GROUP, LTD. JOHN SCHNEIDER
K023286 05/02/2003 CARECOMPANION PATIENT STATION/CARECOMPANION PATIENT STATION NEPTEC DESIGN GROUP, LTD. JOHN SCHNEIDER
K031184 05/21/2003 COOL TOUCH 3 NEW STAR LASERS, INC. DONALD V JOHNSON
K030453 05/12/2003 COOLTOUCH ND: YAG LASER SYSTEM NEW STAR LASERS, INC. DAVID R HENNINGS
K030589 05/21/2003 MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS NUMED, INC. NICHELLE R LAFLESH
K031149 05/14/2003 OLYMPIC CFM 6000 OLYMPIC MEDICAL CORP. EDWARD B. (TED) WEILER
K031347 05/09/2003 ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8 OLYMPUS OPTICAL CO., LTD. LAURA STORMS-TYLER
K030929 05/02/2003 ANA DETECT ORGENTEC DIAGNOSTIKA GMBH MICHAEL H FOLEY
K023594 05/15/2003 TENO FIX ORTHEON MEDICAL, LLC. JONATHAN S KAHAN
K031219 05/28/2003 MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR) ORTHOFIX, INC. MARY BIGGERS
K031156 05/09/2003 NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005 ORTHOSOFT, INC. CHRISTOPHER MCLEAN
K030827 05/23/2003 NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204 ORTHOSOFT, INC. CHRISTOPHER MCLEAN
K030448 05/09/2003 OSTEOMED 2.0 LOCKING PLATES AND SCREWS OSTEOMED L.P. DAWN T HOLDEMAN
K030375 05/05/2003 SOFT-TOUCH TENS ELECTRODE PAIN MANAGEMENT TECHNOLOGIES JOSHUA LEFKOVITZ
K030469 05/09/2003 LAPAROSHIELD CONDITIONED INSUFFLATION SET PALL MEDICAL JONATHAN S KAHAN
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