FDA 510(k) Applications Received During April, 2003

FDA 510(k) Number Submission Date Device Name Applicant Contact
K031281 04/22/2003 ERGO SRS 3D LINE USA, INC. NADER SALEHI
K031263 04/21/2003 3M LIQUID BANDAGE, MODEL 120-LB 3M COMPANY ANNA E MCRIGHT
K031287 04/23/2003 STERI-DRAPE SURGICAL DRAPES 3M COMPANY SCOTT S SARDESON
K031350 04/29/2003 3TP SOFTWARE OPTION 3TP LLC VINCENT J MCGILL
K031353 04/29/2003 SOLUTION FACE MASKS A PLUS INTERNATIONAL, INC SOLOMON CHEN
K031260 04/21/2003 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005 ABBOTT DIABETES CARE INC. DONNA K TEMPLEMAN
K031185 04/15/2003 ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE ABBOTT LABORATORIES PATRICIA MELERSKI
K031331 04/28/2003 WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM ABBOTT VASCULAR INC. JOANNA KUSKOWSKI
K031048 04/02/2003 CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST ACCESS BIO INCORPORATE YOUNG HO CHOI
K031052 04/02/2003 CARESTART HCG ONE-STEP PREGNANCY TEST ACCESS BIO INCORPORATE YOUNG HO CHOI
K031226 04/18/2003 STERRAD CYCLESURE BIOLOGICAL INDICATOR ADVANCED STERILIZATION PRODUCTS NATALIE BENNINGTON
K031356 04/11/2003 HEMAPROMPT GASTRIC AERSCHER DIAGNOSTICS ROBERT SCHREIBER
K031216 04/17/2003 MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE AESCULAP GEORG KELLER
K031303 04/24/2003 AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV) AESCULAP, INC. MATTHEW M HULL
K031286 04/23/2003 SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE AESCULAP, INC. GEORG KELLER
K031198 04/16/2003 SCANX 10 AIR TECHNIQUES, INC. JOSEPH CAREY
K031193 04/16/2003 SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION ALCON, INC. KIM B KRACKE
K031271 04/22/2003 ONE-STEP PREGNANCY TEST AMERISOURCE PHARMACAL, INC. FRAN WHITE
K031273 04/22/2003 AMERITEK SURE-POINT HDR NEEDLE TEMPLATE AMERTEK MEDICAL, INC. GREG WIITA
K031233 04/17/2003 ANDIODYNAMICS, INC. ELVS PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K031110 04/08/2003 APEX MODULAR ACETABULAR CUP APEX SURGICAL, LLC. EDWARD J CHEAL
K031153 04/11/2003 MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065 ARROW INTL., INC. WILLIAM G MCLAIN
K031029 04/01/2003 ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM ARTHROCARE CORP. VALERIE DEFIESTA-NG
K031141 04/10/2003 ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE ASAP ENDOSCOPIC PRODUCTS GMBH MARTINA GUNDEROTH
K031319 04/25/2003 OSTEO-G BONE VOID FILLER SYSTEM ASPINE USA, INC. FLOYD G LARSON
K031177 04/14/2003 DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M AXIS-SHIELD DIAGNOSTICS, LTD. EILEEN MCCAFFERTY
K031041 04/01/2003 FLUENCY TRACHEOBRONCHIAL STENT GRAFT BARD PERIPHERAL VASCULAR AYMEE R BERRY
K031038 04/01/2003 ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY BAYER HEALTHCARE, LLC KENNETH T EDDS
K031270 04/21/2003 ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS BECKMAN COULTER, INC. LYNN WEIST
K031297 04/24/2003 ACCESS OV MONITOR ASSAY BECKMAN COULTER, INC. LYNN WEIST
K031269 04/21/2003 ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS BECKMAN COULTER, INC. LYNN WEIST
K031200 04/16/2003 MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE BECTON DICKINSON & CO. CYNTHIA LACATENA
K031306 04/24/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN GRAM POSITIVE BECTON, DICKINSON & CO. MICHELLE B BANDY
K031375 04/30/2003 BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580 BESMED HEALTH BUSINESS CORP. DR. JEN KE MIN
K031374 04/30/2003 BESMED VARIOUS MODELS OF TENS, BE-550/BE-660 BESMED HEALTH BUSINESS CORP. DR. JEN KE MIN
K031352 04/29/2003 BIO-LOGIC INSERT EARPHONES BIO-LOGIC SYSTEMS CORP. ERIK C GUNDERSEN
K031231 04/18/2003 LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS BIO-RAD ELIZABETH PLATT
K031043 04/01/2003 D-10 HEMOGLOBIN A1C BIO-RAD LABORATORIES, INC. JACKIE BUCKLEY
K031296 04/23/2003 LIQUI-HEME GLYCO A1C ASSAY BIODIAGNOSTIC INTL PAUL ANAND
K031140 04/10/2003 WATERLASE BIOLASE TECHNOLOGY, INC. IOANA M RIZOIU
K031337 04/28/2003 ACUMEN SURGICAL NAVIGATION SYSTEM BIOMET, INC. KRISTINE C ARNOLD
K031334 04/28/2003 TEXAS T - PLATE BIOMET, INC. GARY BAKER
K031280 04/22/2003 ULTRA-DRIVE 3 BIOMET, INC. PATRICIA SANDBORN BERES
K031028 04/01/2003 THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY BIOPLATE, INC. CAROL E JONES
K031161 04/14/2003 VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER BIOSENSE WEBSTER, INC. WILLIAM WELCH
K031118 04/08/2003 INTRAOS 70 BLUE X IMAGING SRL AL SOSA
K031049 04/02/2003 GUGLIELMI DETACHABLE COIL (GDC) BOSTON SCIENTIFIC, TARGET ROXANE BAXTER
K031168 04/14/2003 MATRIX STRETCH RESISTANT DETACHABLE COIL BOSTON SCIENTIFIC, TARGET JAMES LEATHLEY
K031202 04/16/2003 MEDIPALM-20 BRAEBON MEDICAL CORP. RICHARD A BONATO
K031295 04/23/2003 BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM C.R. BARD, INC. FRANCES E HARRISON
K031332 04/28/2003 BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH C.R. BARD, INC. TERRINA WILDER
K031186 04/15/2003 LUMINEXX ENDOSCOPIC BILIARY STENT C.R. BARD, INC. THOMAS HIRTE
K031129 04/09/2003 POLY PER-Q-CATH PICC CATHETERS; POLY RADPICC C.R. BARD, INC. PEGGY KEIFFER
K031328 04/28/2003 RECOVERY FILTER SYSTEM, MODEL RF-048F C.R. BARD, INC. Mary J Edwards
K031272 04/22/2003 C.T.M. MOBILITY SCOOTER, MODEL HS-120 C.T.M. HOMECARE PRODUCT, INC. ROBERT S MCQUATE
K031301 04/24/2003 ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING Cardinal Health ERICA SETHI
K031207 04/16/2003 SAFETY RELEASE ARCH BAR KIT CASEY SURGICAL, LLC JAMES E STANLEY
K031363 04/30/2003 QCA (VERSION 3.1) CELL ANALYSIS, INC. JOEL HERM
K031183 04/15/2003 TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE CENTERPULSE ORTHOPEDICS, INC. ROBERT M WOLFARTH
K031368 04/30/2003 POWDERED LATEX SURGEON'S GLOVES CEPHAS MEDICAL PRIVATE LTD. THANGIAH IMMANUEL
K031116 04/08/2003 VECTRA (INTELECT) EPR ULTRASOUND CHATTANOOGA GROUP MICK DAVIS
K031077 04/04/2003 VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM CHATTANOOGA GROUP CHERYL L BAGWELL
K031042 04/01/2003 ATAC HEMOGLOBIN A1C REAGENT KIT CLINICAL DATA, INC. WYNN STOCKING
K031044 04/01/2003 ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR CLINICAL DATA, INC. WYNN STOCKING
K031123 04/09/2003 CODMAN BACTISEAL BARIUM STRIPED CATHETERS Codman & Shurtleff, Inc. ELIZABETH DOLAN
K031323 04/25/2003 DBT, DYNAMIC BUBBLE TRAP CONVERGENZA AG CHRISTIE DEWITT
K031069 04/04/2003 SURGISIS NERVE CUFF COOK BIOTECH, INC. MARK BLEYER
K031304 04/24/2003 SYDNEY IVF PVP COOK UROLOGICAL, INC. BRENDA DAVIS
K031058 04/03/2003 CORD STICK MULTIPLE DRAW SYSTEM CORD STICK CORP. MICHAEL MOEN
K031197 04/16/2003 MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM CORDIS CORP. SAM MIRZA
K031208 04/17/2003 REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 CORGENIX, INC. NANCI DEXTER
K031327 04/25/2003 VERICOR CVP DIAGNOSTICS, INC. T. WHIT ATHEY
K031258 04/21/2003 CYNOSURE PHOTOLIGHT PL CYNOSURE, INC. GEORGE CHO
K031125 04/09/2003 CYNOSURE SMART FILE ND:YAG LASERS CYNOSURE, INC. GEORGE CHO
K031317 04/25/2003 SMART 2940 D ER: YAG LASER CYNOSURE, INC. GEORGE CHO
K031224 04/17/2003 SMARTXIDE CYNOSURE, INC. GEORGE CHO
K031135 04/09/2003 GLUCOSE FLEX REAGENT CARTRIDGE (GLUC) DADE BEHRING, INC. LORRAINE PIESTRAK
K031343 04/29/2003 TPSA FLEX REAGENT CARTRIDGE DADE BEHRING, INC. GEORGE M PLUMMER
K031027 04/01/2003 DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE) DATEX-OHMEDA, INC. WILLIAM E EXNER
K031124 04/08/2003 POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR DATEX-OHMEDA, INC. AL VAN HOUDT
K031074 04/04/2003 DIGITAL AMBULATORY ECG (HOLTER) RECORDER DATRIX LAUREN M LUHMANN
K031213 04/17/2003 AQUASENS FLUID MONITORING SYSTEM DAVOL, INC. BRIAN A KANERVIKO
K031361 04/30/2003 CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP DELTEC, INC. LISA STONE
K031145 04/10/2003 ESTYLUS ELECTRIC MOTOR SYSTEM DENTSPLY INTL. P. JEFFERY LEHN
K031203 04/16/2003 BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST DEPUY ORTHOPAEDICS, INC. DINA L WEISSMAN
K031159 04/14/2003 CALIBRATING MATERIAL, CALIBRATING STANDARDS DIAMOND DIAGNOSTICS, INC. LINDA M STUNDTNER
K031223 04/18/2003 SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR DIDECO S.P.A. BARRY SALL
K031311 04/24/2003 INTEGRADWEB BY DYNAMIC IMAGING, INC. DYNAMIC IMAGING INC. CARL ALLETTO
K031329 04/28/2003 DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY) DYNATRONICS CORP. RON HATCH
K031132 04/09/2003 CONSULTIVA CASE INPUT STATION, MODEL CIS-1 EASTMAN KODAK COMPANY WIDO MENHARDT
K031354 04/29/2003 EBI OMEGA21 SPINAL FIXATION SYSTEM EBI, L.P. FREDERIC TESTA
K031355 04/29/2003 EBI SPINELINK - II SPINAL FIXATION SYSTEM EBI, L.P. FREDERIC TESTA
K031093 04/07/2003 EBI XFIX OPTIROM KNEE FIXATOR EBI, L.P. JON CAPAROTTA
K031045 04/30/2003 AEROLET TOILET LIFT, MODEL AER-01 ECONOMIC HOLLAND B.V. STEPHANIE WOLFKAMP
K031087 04/07/2003 EDWARDS INTRODUCER SHEATH EDWARDS LIFESCIENCES, LLC. Daun Putnam
K031113 04/08/2003 DISPOSABLE POWDER FREE VINYL EXAM GLOVES ELITE INTERNATIONAL, INC. BOBBY LING
K031134 04/09/2003 DISPOSABLE POWDERED VINYL EXAM GLOVES ELITE INTERNATIONAL, INC. BOBBY LING
K031367 04/30/2003 DUOPATH VEROTOXINS GLISA TEST EMD CHEMICALS INC. ANNA G BENTLEY
K031214 04/17/2003 CYCLONE ANTERIOR CERVICAL PLATE SYSTEM ENCORE MEDICAL, L.P. DEBBIE DE LOS SANTOS
K031267 04/21/2003 STERICHEK BICARB PH REAGENT STRIPS ENVIRONMENTAL TEST SYSTEMS, INC. DAVID A MORRIS
K031066 04/03/2003 VIEWMATE ULTRASOUND IMAGING SYSTEM EP MEDSYSTEMS JOHN J TALARICO
K031147 04/10/2003 OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR ETHICON ENDO-SURGERY, INC. KIMBERLY SHOEMAKER
K031195 04/16/2003 CUF-COVER (TM) ETHOX CORP. DANIEL KAMM
K031227 04/18/2003 LORDEX POWER TRACTION EQUIPMENT EVER PROSPEROUS INSTRUMENT INC JOHN BOREN
K031307 04/24/2003 FERRIS POLYMEM SILVER WOUND DRESSING FERRIS MFG. CORP. THEODORE THORSEN
K031067 04/04/2003 FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS FIRST QUALITY HYGIENIC, INC. ROBERT J STAAB
K031292 04/23/2003 MODIFICATION TO FOSSA URETERAL STONE SWEEPER FOSSA MEDICAL, INC. PAMELA PAPINEAU
K031117 04/08/2003 SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM GALIL MEDICAL LTD. RONI ZVULONI
K031261 04/21/2003 CARD EP GE MEDICAL SYSTEMS LARRY A KROGER
K031230 04/18/2003 GE PROPELLER IMAGING OPTION FOR MRI GE MEDICAL SYSTEMS LARRY KROGER
K031320 04/25/2003 EK-PRO ARRHYTHMIA DETECTION ALGORITHM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES KAREN M LUNDE
K031209 04/17/2003 GE 1.5T 8 CHANNEL TORSO COIL GE MEDICAL SYSTEMS, INC. LARRY KROGER
K031036 04/01/2003 GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03 GEBAUER CO. AMY J PAUKOVITS
K031259 04/21/2003 MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER GETINGE USA, INC FREDERICK R CATT
K031225 04/17/2003 TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004 GFE MEDIZINTECHNIK GMBH JOHN E SAWYER
K031360 04/30/2003 GI SUPPLY BILIARY STENT GI SUPPLY ROB WHALEN
K031300 04/24/2003 IBC FLOPUMP WITH GBS COATING GISH BIOMEDICAL, INC. J. HARVEY KNAUSS
K031033 04/01/2003 GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD. SHOSHANA FRIEDMAN
K031150 04/10/2003 HEMOBAG, MODEL HBBSD2000 GLOBAL BLOOD RESOURCES, LLC KEITH SAMOLYK
K031151 04/10/2003 TS3 TUBING SET GLOBAL BLOOD RESOURCES, LLC KEITH SAMOLYK
K031302 04/24/2003 SUSTAIN SPACER GLOBUS MEDICAL INC. DANIEL S PAUL
K031104 04/07/2003 POWDERED VINYL EXAM GLOVES, WHITE GLORMED INTL., INC. JANNA P TUCKER
K031082 04/04/2003 EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK GYRUS MEDICAL, INC. MERCEDES P BAYANI
K031080 04/04/2003 EVEREST BIPOLAR LYONS DISSECTING FORCEPS & GYRUS BIPOLAR LYONS DISSECTING FORCEPS GYRUS MEDICAL, INC. MERCEDES BIRYANI
K031078 04/04/2003 EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR MACRO, MICRO & MOLLY FORCEPS GYRUS MEDICAL, INC. MERCEDES P BAYANI
K031079 04/04/2003 EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE GYRUS MEDICAL, INC. MERCEDES BAYANI
K031081 04/04/2003 EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS GYRUS MEDICAL, INC. MERCEDES BAYANI
K031085 04/04/2003 GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES) GYRUS MEDICAL, INC. MERCEDES BAYANI
K031101 04/07/2003 RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 HEMAGEN DIAGNOSTICS, INC. JOSE MONTANEZ
K031217 04/17/2003 GMRS PRESS FIT STEMS WITH PUREFIX HA HOWMEDICA OSTEONICS MARGARET F CROWE
K031090 04/07/2003 MODIFICATION TO XIA STAINLESS STEEL SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K031127 04/09/2003 ORTHOPEDIC WIRE HOWMEDICA OSTEONICS CORP. DEBRA BING
K031167 04/14/2003 HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX IDT TECHNOLOGY LIMITED STEPHEN LI
K031106 04/08/2003 IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX IMTEC CORP. J. BRAD VANCE
K031122 04/08/2003 HEMOSIL FACTOR X DEFICIENT PLASMA INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K031373 04/30/2003 IXL DIABETES MANAGEMENT SYSTEM INSULET CORP. A. ARTHUR RANKIS
K031086 04/07/2003 CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 INTEGRA NEURO SCIENCES NANCY A MATHEWSON
K031051 04/02/2003 SMARTEP-ASSR, MODEL M811007 INTELLIGENT HEARING SYSTEMS EDWARD MISKIEL
K031096 04/07/2003 MODIFICATION TO TRANSPORT INCUBATOR 185 INTERNATIONAL BIOMEDICS, INC. GERALD MANNING
K031322 04/25/2003 INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS INTRA-LOCK INTERNATIONAL JEFFERY SAKOFF
K031064 04/03/2003 INVACARE POLARIS EX CPAP, MODEL ISP3000 INVACARE CORP. JANICE BROWNLEE
K031176 04/14/2003 INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000 INVACARE CORP. RAE ANN FARROW
K031115 04/08/2003 RH-900 IOMED, INC. CURTIS JENSEN
K031204 04/16/2003 DENTAPORT ZX J. MORITA USA, INC. KEITH A BARRITT
K031342 04/28/2003 JASON MARINE ALL TERRAIN ELECTRIC WHEELCHAIR, MODEL SEEKER II JASON MARINE ENTERPRISES, INC. BRIAN GAGNON
K031148 04/10/2003 IN-VISION IMAGING SYSTEM JOMED, INC. LORRAINE W HUFFMAN
K031346 04/29/2003 JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900 JOMED, INC. LORRY W HUFFMAN
K031277 04/22/2003 JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002 JOMED, INC. TERRY SCHULTZ
K031309 04/24/2003 KUANN DAH, COOL TANK MOTORIZED SCOOTER, KS4L320 KUANN DAH INDUSTRY CO., LTD. Ke-Min Jen
K031282 04/22/2003 OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05 LEMAITRE VASCULAR, INC. BRIAN K KEOGH
K031250 04/19/2003 DBC PRESS ACUPUNCTURE NEEDLES LHASA MEDICAL, INC. KYUNG P RIIHIMAKI
K031060 04/03/2003 NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES LHASA MEDICAL, INC. KYUNG P RIIHIMAKI
K031098 04/07/2003 3-CCD DIGITAL CAMERA SYSTEM LINVATEC CORP. LAURA D SENEFF
K031170 04/14/2003 POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE BROTHERS LONG FIRST (XIAMEN) CO.,LTD. STONE CHEN
K031128 04/09/2003 B-SMART, MODEL B-01 MACOSTA MEDICAL USA, LLC PAMELA PAPINEAU
K031339 04/28/2003 OPTIBOLUS MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS ELLIS ROGERS
K031330 04/28/2003 MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES MASIMO CORP. JAMES J CRONIN
K031372 04/30/2003 PERSONAL DIGITAL WORKSTATION (PDW); FILM DIGITIZING CAMERA AND DIGITAL WORKSTATION MAXXVISION, LLC JAMES K WALKER
K031119 04/08/2003 MAYO CLINIC BC-10 1.5T MAYO MEDICAL VENTURES JADE SADOSTY
K031364 04/30/2003 MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3 MEDICAL ANALYSIS SYSTEMS, INC. PENNY M LAYMAN
K031084 04/04/2003 SOLAR GI SYSTEM MEDICAL MEASUREMENT SYSTEMS,B.V. KARIN OGINK-SOMHORST
K031228 04/18/2003 SYNVITRO HYADASE MEDICULT A/S RONALD G LEONARDI
K031351 04/29/2003 FLEX-NECK PD CATHETER, INFANT MEDIGROUP, INC. JOHN A NAVIS
K031321 04/25/2003 LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001 MEDLOGIC GLOBAL LIMITED MEL LONGHURST
K031032 04/01/2003 VERDICT II, PROFILE II MEDTOX DIAGNOSTICS, INC. ALAN MORRIS
K031037 04/01/2003 EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE MEDTRONIC PERFUSION SYSTEMS RONALD W BENNETT
K031211 04/17/2003 ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH MEDTRONIC VASCULAR LYNN JENSEN
K031247 04/18/2003 CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM MEDTRONIC VASCULAR SCOTT CUNDY
K031274 04/22/2003 MODEL 5071 MYOCARDIAL PACING LEAD MEDTRONIC VASCULAR TINA BENOIT
K031285 04/23/2003 MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD MEGADYNE MEDICAL PRODUCTS, INC. RONDA K MAGNESON
K031369 04/30/2003 MERCATOR HEALTHCARE MALE LATEX CONDOM MERCATOR HEALTHCARE LTD. ELI J CARTER
K031210 04/17/2003 MODEL 4951M MYOCARDIAL UNIPOLAR LEAD METRONIC, INC. TINA BENOIT
K031102 04/07/2003 MICROLAB SPIROMETER MICRO DIRECT, INC. DAVID R STASZAK
K031050 04/02/2003 PCW PERCUTANEOUS COMPRESSION WIRE MILLENNIUM MEDICAL TECHNOLOGIES, INC. DAVID W SCHLERF
K031248 04/18/2003 CONSULTIVA REPORT STATION, MODEL RS-1 MIRAMEDICA, INC WIDO MENHARDT
K031131 04/09/2003 KLINIDRAPE SURGICAL DRAPES MOLNLYCKE HEALTH CARE LINDA A HENDRICKS
K031182 04/15/2003 ELI 200+ AUDICOR MORTARA INSTRUMENT, INC. HARLAN L VAN MATRE
K031262 04/21/2003 ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760 NDO SURGICAL, INC. ERIC BANNON
K031173 04/14/2003 NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013 NEEDLETECH PRODUCTS, INC. RICK TRIPP
K031184 04/15/2003 COOL TOUCH 3 NEW STAR LASERS, INC. DONALD V JOHNSON
K031070 04/04/2003 CARBON FIBER BRIDGE, MODEL 28757 NOBEL BIOCARE AB ELIZABETH J MASON
K031345 04/29/2003 NOBEL DIRECT, MODELS 30937, 30938 NOBEL BIOCARE UAS INC ELIZABETH J MASON
K031073 04/04/2003 PERIOGLAS PLUS - SETTABLE BONE GRAFT SUBSTITUTE NovaBone Products, LLC DAVID M GAISSER
K031349 04/29/2003 OTP 1.2 NUCLETRON CORP. LISA DIMMICK
K031158 04/11/2003 SWIFT 2.0, MODEL 132.001 NUCLETRON CORP. LISA DIMMICK
K031149 04/10/2003 OLYMPIC CFM 6000 OLYMPIC MEDICAL CORP. EDWARD B. (TED) WEILER
K031305 04/24/2003 OLYMPUS ULTRASONIC SURGICAL SYSTEM OLYMPUS OPTICAL CO., LTD. TINA STEFFANIE-OAK
K031347 04/29/2003 ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8 OLYMPUS OPTICAL CO., LTD. LAURA STORMS-TYLER
K031256 04/21/2003 XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE OLYMPUS OPTO-ELECTRONICS CO., LTD. TINA STEFFANIE-OAK
K031083 04/04/2003 OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500 OPUS MEDICAL, INC. JAMES W HART
K031201 04/16/2003 ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEM ORTHO DEVELOPMENT CORP. NADEEM AHMED
K031031 04/01/2003 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS Ortho-Clinical Diagnostics, Inc. ANN M QUINN
K031219 04/17/2003 MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR) ORTHOFIX, INC. MARY BIGGERS
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K031212 04/17/2003 TEMPORARY RESIN CEMENT PARKELL, INC. NELSON J GENDUSA
K031205 04/16/2003 PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. LINDA K DILLON
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K031187 04/15/2003 HEARTSTART MRX, MODEL M3535A PHILIPS MEDICAL SYSTEMS PETER OHANIAN
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K031095 04/07/2003 SENSE BODY COIL PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. DUANE C PRASCHAN
K031165 04/14/2003 PLUS ORTHOPEDICS CEMENTED HIP STEM PLUS ORTHOPEDICS J.D. WEBB
K031057 04/03/2003 PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT PORTEX, INC. TIMOTHY J TALCOTT
K031357 04/30/2003 GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION SYSTEM OCCLUSION GUIDEWIRE, 200 CM POSSIS MEDICAL, INC. MARK STENOIEN
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K031114 04/08/2003 PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA RAVEN BIOLOGICAL LABORATORIES, INC. WENDY ROYALTY-HANN
K031099 04/07/2003 SORB+HISORB+CARTRIDGE RENAL SOLUTIONS, INC. RICHARD G CONFER
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K031094 04/07/2003 FLUID FILLED TEETHERS ROYAL KING INFANT PRODUCTS CO. LTD. DALBIR SINGH KHURANA
K031348 04/11/2003 HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY SALIMETRICS LLC. EVE SCHWARTZ
K031359 04/30/2003 S-MONOVETTE EDTA K2-GEL SARSTEDT, INC. PETER RUMSWINKEL
K031236 04/18/2003 AUTO-BAND LIGATOR SCANDIMED. A.S. KRISTIAN K JENSEN
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K031293 04/23/2003 SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD. JAMES CHU
K031108 04/08/2003 SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT JAMES CHU
K031370 04/30/2003 SHINMED MODE SW-988 UNTRASONIC NEBULIZER SHINING WORLD HEALTH CARE CO., LTD. JEN KE-MIN
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K031169 04/14/2003 MOTILITY VISUALIZATION SYSTEM SIERRA SCIENTIFIC INSTRUMENTS, INC. SEAN M CURRY
K031154 04/11/2003 SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X SINTEA BIOTECH, INC. MARIANNE GRUNWALDT
K031181 04/15/2003 EXTERNAL FIXATION SYSTEMS SMITH & NEPHEW, INC. DAVID HENLEY
K031371 04/30/2003 SAPHYRE BIPOLAR ABLATION PROBES SMITH & NEPHEW, INC. LINDA GUTHRIE
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K031222 04/17/2003 SCANLUBE SONOTECH, INC. MARGARET J LARSON
K031097 04/07/2003 POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB SOPHYSA SA JACQUELINE E MASSE
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K031318 04/25/2003 TRAXIS CEMENT RESTRICTOR SPINAL CONCEPTS, INC. LISA PETERSON
K031265 04/21/2003 SHIRAZ-JAVA SPINAL FIXATION SYSTEM SPINE NEXT SA DIANE JOHNSON
K031341 04/28/2003 STICK FLOW STICK TECH LTD. WILLIAM TROETEL
K031055 04/03/2003 ITI DENTAL IMPLANT SYSTEM STRAUMANN USA LINDA JALBERT
K031278 04/22/2003 STRYKER FLEXIBLE URETEROSCOPE Stryker Endoscopy CHRISTOPHER L COOK
K031068 04/04/2003 STRYKER VISUM SURGICAL LIGHTING SYSTEM Stryker Endoscopy MELISSA MURPHY
K031249 04/18/2003 MODIFICATION TO STRYKER PAINPUMP STRYKER INSTRUMENTS NICOLE PETTY
K031289 04/23/2003 QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424 SUNRISE MEDICAL, INC. MICHAEL CHELLSON
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K031120 04/08/2003 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES SYNMERTEX CO, LTD ALBERT LING
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K031175 04/14/2003 CLICK'X MONOAXIAL SCREWS AND HOOKS SYNTHES (USA) JOHN WALSH
K031178 04/14/2003 SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATES SYNTHES (USA) LISA M BOYLE
K031276 04/22/2003 SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM SYNTHES (USA) JON GILBERT
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K031065 04/03/2003 SYRINGEX SAFETY SYRINGE, MODEL 0322G1.5 SYRINGEX MEDICAL, INC. JOHN JONES
K031179 04/15/2003 TAGA VELOCITY HUMIDIFIER TAGA MEDICAL TECHNOLOGIES, INC. GARY AUSTIN
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K031062 04/03/2003 TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN) TAIJECT MEDICAL DEVICE CO., LTD. JIM-SON CHOU
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K031335 04/28/2003 POWDER FREE LATEX EXAM GLOVES TAN SIN LIAN INDUSTRIES SDN. BHD. LEE TAN
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K031040 04/01/2003 THERIFIL BONE FILLER THERICS, INC. UMBERTO V PARROTTA, JR
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K031315 04/24/2003 TMC ELECTRICAL SCOOTER, EASY 321 TMC TECHNOLOGY CORP. JEN KE-MIN
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K031218 04/17/2003 MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS TORNIER Mireille Lemery
K031088 04/04/2003 TRIMED PLAN, VERSION 2.2 TRIMED SYSTEMS, INC SHERRY ZHANG
K031189 04/15/2003 UUHC REPROCESSED COMPRESSION SLEEVE DEVICES UNIVERSITY OF UTAH HOSPITALS AND CLINICS JACK SPEER
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K031056 04/03/2003 MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL USA INSTRUMENTS, INC. CHRISTIE SHUMAKER
K031366 04/30/2003 PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL USA INSTRUMENTS, INC. CHRISTIE SHUMAKER
K031139 04/10/2003 PREMIER III PHASED ARRAY CTL SPINE COIL USA INSTRUMENTS, INC. CHRISTIE SHUMAKER
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K031172 04/14/2003 SPIRIT III TOTALSENSE CARDIAC COIL USA INSTRUMENTS, INC. CHRISTIE SHUMAKER
K031358 04/30/2003 TRANSVAGINAL DOPPLER PROBE VASCULAR CONTROL SYSTEMS, INC KATHLEEN ROBERTS
K031091 04/07/2003 VTI 20 MHZ GATED DOPPLER VASCULAR TECHNOLOGY INCORPORATED DAVID L REGAN
K031194 04/16/2003 SPIROSOFT VIASYS HEALTHCARE GMBH EARL DRAPER
K031089 04/07/2003 GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY W.L. GORE & ASSOCIATES,INC TRACY DE VAN WOLF
K031034 04/01/2003 SPIN DOWN RAPIDFLAP WALTER LORENZ SURGICAL, INC. KIM REED
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K031326 04/25/2003 IMAGINE REFLEX WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
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K031130 04/09/2003 YA MEI FIRST AID KIT YA MEI TECHNOLOGY CO., LTD. Kevin Walls
K031199 04/14/2003 ENTERALITE INFINITY ENTERAL FEEDING PUMP ZEVEX INTL., INC. SEAN M CURRY
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