FDA 510(k) Applications Received During April, 2002

FDA 510(k) Number Submission Date Device Name Applicant Contact
K021125 04/08/2002 SENSUA! AAC CONSULTING GROUP, INC. EDUARDO MARCH
K021233 04/18/2002 AAP CANNULATED SCREWS AAP IMPLANTATE AG CHRISTIAN ABEL
K021350 04/29/2002 ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348 ABBOTT LABORATORIES FRANK POKROP
K021062 04/02/2002 CHITO-SEAL ABBOTT VASCULAR INC. SEVRINA CIUCCI
K021244 04/19/2002 ACE HA SCREW DENTAL IMPLANT SYSTEM ACE SURGICAL SUPPLY CO., INC. J EDWARD CARCHIDI
K021272 04/22/2002 SIB CATHETER, MODEL 61-7005 ACKRAD LABORATORIES RICHARD HETTENBACH
K021166 04/11/2002 ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR ACMI-CIRCON CORPORATION JOHN A DELUCIA
K021321 04/25/2002 WRIST FUSION PLATE ACUMED, INC. CARRIE MCMICHAEL
K021133 04/05/2002 NIOX ARTICLE NO: 02-1000 AEROCRINE AB SEAN M CURRY
K021175 04/12/2002 AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000 AEROGEN, INC. TRACI V. A EDWARDS
K021327 04/26/2002 ORTHOPILOT HTO MODULE AESCULAP, INC. GEORGE KELLER
K021313 04/25/2002 SEARCH EVOLUTION TOTAL KNEE SYSTEM AESCULAP, INC. JOYCE KILROY
K021337 04/26/2002 AART PECTORALIS IMPLANT AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. CATHERINE RIPLE
K021143 04/09/2002 OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION ALCON UNIVERSAL, LTD. RALPH H LARSEN
K021114 04/05/2002 'RAPIDTEC' 5A MULTIPLE DIP TEST AMERICAN BIO MEDICA CORP. HENRY WELLS
K021072 04/02/2002 FILMSAVER, NT VERSION 5.03 AMERICAN MEDICAL RESOURCES, LTD. (AMR) ELIZABETH N FAULSTICH
K021263 04/22/2002 MODIFICATION TO SPARC SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC. MARK MCINTYRE
K021121 04/08/2002 AROMACRYL AROMACRYL, LLC TANYA L WOODS
K021120 04/08/2002 RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP ARROW INTL., INC. DEBBIE PEACOCK
K021293 04/23/2002 ARTERIA BLOOD FILTER ARTERIA MEDICAL SCIENCE, INC. ALAN HINTON
K021210 04/17/2002 ARTERIA OCCLUSION BALLOON ARTERIA MEDICAL SCIENCE, INC. ALAN HINTON
K021364 04/30/2002 MODIFICATION TO ENTEC PLASMA WANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K021094 04/04/2002 INTROCAN SAFETY IV CATHETER B. BRAUN MEDICAL, INC. PATRICIA D WILSON
K021274 04/22/2002 PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719 BAXTER HEALTHCARE CORP. VIVKI L DREWS
K021151 04/10/2002 AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K021343 04/29/2002 ISOSEEDS I-125 BEBIG ISOTOPEN-UND MEDIZINTECHNIK GMBH SVEN LANGER
K021150 04/10/2002 COULTER CELLPREP BECKMAN COULTER, INC. LOURDES COBA
K021229 04/18/2002 MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244 BECKMAN COULTER, INC. BRUCE BACKLUND
K021304 04/24/2002 PROLITE PULSED LIGHT SYSTEM BIG SKY LASER TECHNOLOGIES, INC. PATRICK MAINE
K021215 04/17/2002 BIO-LOGIC ABAER CUB BIO-LOGIC SYSTEMS CORP. NORMAN E BRUNNER
K021351 04/29/2002 BIOSTEON CROSS PIN BIOCOMPOSITES LTD. J. STEPHEN BRATT
K021270 04/22/2002 ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-2 BIOMEDICAL LIFE SYSTEMS HANS REISS
K021271 04/22/2002 ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-3 BIOMEDICAL LIFE SYSTEMS HANS REISS
K021123 04/08/2002 BACT/ALERT SN CULTURE BOTTLE BIOMERIEUX, INC. RON SANYAL
K021326 04/26/2002 VIDAS TESTOSTERONE (TES), MODEL 30 418 BIOMERIEUX, INC. KELLY ROWLAND
K021254 04/19/2002 LACTOSORB MINI INTERFERENCE SCREW BIOMET ORTHOPEDICS, INC. SARA B SHULTZ
K021071 04/02/2002 PCCS GRAFT DELIVERY SYSTEM BIOMET, INC. LONNIE WITHAM
K021182 04/15/2002 RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR BIOMET, INC. TRACY J BICKEL
K021260 04/19/2002 REDUCED SIZE ONCOLOGY SALVAGE SYSTEM BIOMET, INC. SARA B SHULTZ
K021317 04/25/2002 TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST BIOSITE INCORPORATED JEFFERY R DAHLEN
K021217 04/17/2002 AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP BIOTRONIK, INC. JON BRUMBAUGH
K021046 04/01/2002 COBRA COOLED SURGICAL PROBE, MODEL 1596X BOSTON SCIENTIFIC CORP. SUSAN POOL
K021232 04/18/2002 CONSTELLATION CATHETERS, MODEL 8031M BOSTON SCIENTIFIC CORP. CHRISTINA L ROWE
K021213 04/17/2002 MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS BOSTON SCIENTIFIC CORP. JENNIFER BOLTON
K021057 04/01/2002 BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS BRAHMS DIAGNOSTICA, LLC. WILLIAM G FRANK
K021306 04/24/2002 VECTORVISION CT-FREE KNEE BRAINLAB AG RAINER BIRKENBACH
K021355 04/29/2002 ENDOSSEOUS IMPLANT BRANEMARK INTEGRATION AB RICKARD BRANEMARK
K021165 04/11/2002 NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES BROMAC ASSISTIVE TECHNOLOGY DAVID K BROWN
K021055 04/01/2002 BUSSE UMBILICAL CORD CLAMP CUTTER BUSSE HOSPITAL DISPOSABLES, INC. JOSEPH M AZARY
K021236 04/18/2002 SURGERY AND ACCESSORIES CAMTRONICS, LTD. SCOTT PEASE
K021180 04/15/2002 CANDELA VBEAM PULSED DYE LASER SYSTEM CANDELA CORP. LORRAINE NELSON
K021160 04/11/2002 DERMMATRIX SURGICAL MESH CARBON MEDICAL TECHNOLOGIES, INC. KAREN E PETERSON
K021080 04/03/2002 NONCOR INFUSION SETS; NONCOR PORT INFUSION SETS CARDIOMED SUPPLIES, INC. DONNA MCCOMB
K021131 04/08/2002 CHLORAPREP CENTRIX, INC. JOHN DISCKO
K021146 04/09/2002 D/SENSE 1-STEP CENTRIX, INC. JOHN DISCKO
K021129 04/08/2002 CHARE CARIOVASCULAR PATCH CHASE MEDICAL, INC. DAVE HERNON
K021192 04/15/2002 QACA IGG/IGM ELISA KIT HRP CHESHIRE DIAGNOSTICS LTD. NEIL B STRINGER
K021118 04/08/2002 DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570 CLASS A ENT. SAMANTHA L DRAPER
K021054 04/01/2002 CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER CODONICS, INC. RICK DAYTON
K021176 04/12/2002 COMPUMEDICS SOMTE SYSTEM COMPUMEDICS LIMITED CONSTANCE G BUNDY
K021152 04/10/2002 ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND ACCESSORIES COMPUTER MOTION, INC. DAVID MUNJAL
K021186 04/15/2002 CONDOMI NATURE, CONDOMI STIMULATION, CONDOMI VANILLA GOLD, CONDOMI SUPERSAFE, CONDOMI XXL, CONDOMI STRONG, CONDOMI ERFERT PRODOKTIONSGESELLSCHAFT MBH CAROLANN KOTULA
K021079 04/03/2002 ABCSNARE ELECTROSURGICAL PROBE FOR FLEXIBLE ENDOSCOPES, MODEL 1336XX CONMED CORP. CHARLES M HART
K021299 04/24/2002 CONMED HEATWAVE HAND-CONTROLLED ELETRODE CONMED CORP. IRA D DUESLER
K021237 04/18/2002 COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS COOPERSURGICAL, INC. HAIKO BELL
K021345 04/29/2002 MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018" DELIVERY SYSTEM CORDIS CORP. KAREN WILK
K021191 04/15/2002 AUTOALIGN CORTECHS LABS, INC. JEFFREY M ANDERSON
K021311 04/25/2002 SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL CP MEDICAL MARY ANN GREENAWALT
K021037 04/01/2002 MICROSTREP PLUS PANEL WITH AMPICILLIN DADE BEHRING, INC. CYNTHIA VAN DUKER
K021181 04/15/2002 MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K021111 04/05/2002 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K021110 04/05/2002 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K021188 04/15/2002 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K021184 04/15/2002 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K021078 04/03/2002 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K021169 04/11/2002 MICROSTREP PLUS PANEL, AZITHROMYCIN DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K021199 04/16/2002 PRIMECHAIR DALTON MEDICAL CORP. WILL RIDGWAY
K021265 04/22/2002 DATEX-OHMEDA HMEF 500 DATEX-OHMEDA JOEL C KENT
K021279 04/22/2002 DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SOFTWARE DATEX-OHMEDA JOEL C KENT
K021352 04/29/2002 DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSIS DAYTON WATER SYSTEMS DAYNE GILLELAND
K021335 04/26/2002 MONARCH SPINE SYSTEM DEPUY ACROMED LISA GILMAN
K021148 04/10/2002 MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD DEPUY ACROMED LISA GILMAN
K021039 04/01/2002 BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM DEPUYACROMED KAREN F JURCZAK
K021257 04/19/2002 ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K021208 04/16/2002 IMMULITE 2000 MIXED ALLERGEN PANELS DIAGNOSTIC PRODUCTS CORP. ROBERT M DI TULLIO
K021206 04/16/2002 IMMULITE 2000 SPECIFIC ALLERGENS DIAGNOSTIC PRODUCTS CORP. ROBERT M DI TULLIO
K021338 04/26/2002 ACCULEAF DIREX SYSTEMS CORP. LARISA GERSHTEIN
K021324 04/26/2002 FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM) DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. YAEL RUBIN
K021356 04/29/2002 THE DIVACUP MENSTRUAL SOLUTION DIVA INTERNATIONAL INC FRANCINE CHAMBERS
K021312 04/25/2002 EBI DFS OPTIROM ELBOW FIXATOR EBI, L.P. JON CAPAROTTA
K021091 04/04/2002 EBI XFIX DFS SYSTEM EBI, L.P. FREDERIC TESTA
K021240 04/18/2002 EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-200M/HD-200 EIKON HEALTHCARE DEVICE CORP. JEN KE-MIN
K021239 04/18/2002 EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M EIKON HEALTHCARE DEVICE CORP. JEN KE-MIN
K021102 04/04/2002 DM SLEEVE EMILY IKER M.D., A.P.C. JONATHAN S KAHAN
K021100 04/04/2002 300 PV COMPLETE ELECTROTHERAPY SYSTEM EMPI SHEILA HEMEON-HEYER
K021087 04/03/2002 HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300; SOUNDS EASY AUSCULTATION SOFTWARE ERECORDS LIMITED ED GOSS
K021138 04/09/2002 SLEEPSCREEN/APNOESCREEN CARDIO ERICH JAEGER GMBH BRIAN LONG
K021266 04/22/2002 ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018 ETHICON ENDO-SURGERY, INC. KEN CHARAK
K021096 04/04/2002 X-SIZER CATHETER SYSTEM EV3 CORPORATION JILL MUNSINGER
K021112 04/05/2002 INSPIRATION VENTILATOR SYSTEM EVENT MEDICAL LTD MIKE GRIFFITHS
K021340 04/26/2002 AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE EXTERNAL COUNTERPULSATION LAB DAWEI CAI
K021075 04/02/2002 MECHANICAL DAILY USE WHEELCHAIR FIRST WORLD SERVICES, INC. LEONARD FRIER
K021113 04/05/2002 MAMMOPATH FISCHER IMAGING CORP. SAMIR B PALIWAL
K021142 04/09/2002 ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865 FORTUNE MEDICAL INSTRUMENT CORP. TYLER WANG
K021193 04/15/2002 FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 FORTUNE MEDICAL INSTRUMENT CORP. TAIPEI HSIEN
K021140 04/09/2002 FOSSA EXPANDING DOUBLE PIGTAIL URETERAL STENT FOSSA INDUSTRIES, INC. GLORIA KOLB
K021109 04/05/2002 ESOP CO-CR FEMORAL HEADS FOURNITURES HOSPITALIERES ANDRE WEITH
K021108 04/05/2002 ESOP HA FEMORAL STEM FOURNITURES HOSPITALIERES ANDRE WEITH
K021060 04/02/2002 FRESENIUS ICARE MONITORING SYSTEM FRESENIUS MEDICAL CARE NORTH AMERICA NICHOLE RIEK
K021318 04/25/2002 XIVE DENTAL IMPLANT SYSTEM FRIADENT GMBH CAROL PATTERSON
K021238 04/18/2002 FRYE ADJUSTING INSTRUMENT FRYE HEALTH SYSTEMS DEBORAH F KONENMAN
K021261 04/19/2002 SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 GALIL MEDICAL LTD. JONATHAN S KAHAN
K021038 04/01/2002 GC ELITE CEMENT 100 GC AMERICA, INC. TERRY L JORITZ
K021135 04/09/2002 MODEL 2120IS SERIES MATERNAL/FETAL MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES JOELLE NEIDER
K021049 04/01/2002 OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM GE OEC MEDICAL SYSTEMS BILL GISLASON
K021366 04/30/2002 MAC-LAB/CARDIOLAB EP/COMBOLAB GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN LISA LEE MICHELS
K021325 04/26/2002 MODIFICATION OF APEXPRO TELEMETRY SYSTEM GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN JOELLE NEIDER
K021316 04/25/2002 ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR GENZYME CORP. BARABRA PIZZA
K021258 04/19/2002 GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER GERM TERMINATOR CORPORATION DAVID LINK
K021052 04/01/2002 MODEL GT010706 ELECTRONIC THERMOMETER GLOBAL TREASURE INDUSTRIES LTD.
K021353 04/26/2002 POWDER-FREE-VINYL EXAMINATION GLOVES, COLOR: WHITE GLORMED INTL., INC. JANNA P TUCKER
K021308 04/25/2002 GLOVCO POWDER-FREE NITRILE EXAMINATION GLOVES GLOVCO (M) SDN. BHD. TAN PENG HOCK
K021153 04/10/2002 GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000 GOLDWAY US, INC. Y. JUSTIN CHEN
K021154 04/10/2002 GOLDWAY PATIENT MONITOR, MODEL # UT4000F GOLDWAY US, INC. Y. JUSTIN CHEN
K021043 04/01/2002 GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC GRAMSMED LLC ANTHONY J DIMERCURIO
K021284 04/18/2002 EASYTRAK GUIDING CATHETER GUIDANT CORP. KAREN S ALSOP
K021283 04/18/2002 GUIDANT BALLOON CATHETER, SEVERAL MODELS GUIDANT CORP. KAREN S ALSOP
K021228 04/18/2002 HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE GUIDANT CORP. JENNIFER PAE RIGGS
K021285 04/18/2002 HI-TORQUE EXTRA S'PORT GUIDEWIRE GUIDANT CORP. KAREN S ALSOP
K021282 04/18/2002 LV-1 HEMOSTASIS VALVE, MODEL #6789 GUIDANT CORP. KAREN S ALSOP
K021250 04/19/2002 MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD) HANDPIECE UNLIMITED MARTINA GUNDEROTH
K021194 04/15/2002 RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM HEMAGEN DIAGNOSTICS, INC. JOSE A MONTANEZ
K021314 04/25/2002 SCEPTRE-VS HITACHI MEDICAL SYSTEMS AMERICA, INC. ROBERT H MCCARTHY
K021197 04/16/2002 SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16" HOSUK CO., LTD. CAROLE STAMP
K021136 04/09/2002 TEKNIQUE-HOVEROUND POWER WHEEL CHAIR HOVEROUND CORP. TONY DIGIOVANNI
K021310 04/25/2002 36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) HOWMEDICA OSTEONICS CORP. JENNIFER A DAUDELIN
K021252 04/19/2002 BLOOD-PRESSURE METER IDT TECHNOLOGY LIMITED LILY LI
K021248 04/19/2002 ICASE IKEEPS, INC. E. J. SMITH
K021174 04/12/2002 ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR IMAGYN SURGICAL JULIE POWELL
K021163 04/11/2002 OCTEIA 25-HYDROXY VITAMIN D IMMUNODIAGNOSTIC SYSTEMS LTD. PAUL PUNTIN
K021280 04/22/2002 INION HEXALON BIODEGRADABLE ACL/PCL SCREW INION LTD. HANNA MARTTILA
K021322 04/25/2002 ENDOSSOUS IMPLANTS INTRA-LOCK INTERNATIONAL JEFFERY SAKOFF
K021243 04/19/2002 ILT TORQUER, MODEL 114TR1 INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K021323 04/26/2002 MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K021036 04/01/2002 INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000 INTUITIVE SURGICAL, INC. DAVID CASAL
K021358 04/29/2002 EMBRYO BIOPSY MEDIUM IRVINE SCIENTIFIC SALES CO., INC. WENDELL LEE
K021372 04/30/2002 VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY J. MORITA USA, INC. KEITH A BARRITT
K021088 04/04/2002 JOGUIDE CARDIOVASCULAR GUIDING C ATHETER JOMED CATHETER, INC. NORMAN L HALL
K021219 04/17/2002 SMARTWIRE/SMARTMAP PRESSURE SYSTEM JOMED, INC. TERRY SCHULTZ
K021050 04/01/2002 KSEA NEUROENDOSCOPES AND ACCESSORIES KARL STORZ ENDOSCOPY-AMERICA, INC. JAMES A LEE
K021083 04/03/2002 VERACAM LUMALITE, INC. W. EDWARD JOHANSEN
K021164 04/11/2002 MACROPORE OS TRAUMA MACROPORE BIOSURGERY, INC. KENNETH K KLEINHENZ
K021145 04/09/2002 ACCOMMODATOR WHEELCHAIR, MODEL #2000X MARKEN INTERNATIONAL, INC. STEVE RIFFEL
K021231 04/18/2002 NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT MATRITECH, INC. MELODIE R DOMURAD
K021247 04/19/2002 PNEUMOPERITONEUM INSUFFLATION NEEDLE MECTRA LABS, INC. CHARLES E ALLGOOD
K021360 04/30/2002 SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000 MED-TEC,INC. DONALD F RIIBE
K021368 04/30/2002 MEDELA "BASIC 30" AND "DOMINANT 50" SUCTION PUMPS, MODELS 037, 057 MEDELA AG RERNER FREI
K021155 04/10/2002 MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL MEDICAL ANALYSIS SYSTEMS, INC. PENNY M LAYMAN
K021230 04/18/2002 HERO MEDICAL DECISION NETWORKS WILLIAM E KING
K021171 04/12/2002 Q-STRESS ECHO BED MEDICAL POSITIONING, INC. CAROL PATTERSON
K021168 04/11/2002 JUMP START, MODEL 970300 MEDICAL RESEARCH LABORATORIES, INC. JOEL ORLINSKY
K021287 04/23/2002 TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT MEDTRONIC PERFUSION SYSTEMS PREETI JAIN
K021061 04/02/2002 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K021226 04/18/2002 MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K021170 04/12/2002 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. RICHARD W TREHARNE
K021106 04/05/2002 MODIFICATION TO TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K021256 04/19/2002 Z3 GUIDE CATHETER MEDTRONIC VASCULAR FRED L BOUCHER
K021077 04/03/2002 MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD MEGADYNE MEDICAL PRODUCTS, INC. RONDA K MAGNESON
K021275 04/22/2002 MICOMED POSTERIOR DOUBLEROD SYSTEM MICOMED ORTHO GMBH CORRINE M TAFLINGER
K021066 04/02/2002 MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM MICRO THERAPEUTICS, INC. TOM DAUGHTERS
K021139 04/09/2002 TRULINE REINFORCED VALVED INFUSION CATHETER MICRO THERAPEUTICS, INC. TOM DAUGHTERS
K021305 04/24/2002 MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH OPTIONAL THERMAL PRINTER MICROLIFE CORP. SUSAN D GOLDSTEIN-FALK
K021084 04/04/2002 LIGHT SABER SPINAL NEEDLE MINRAD, INC. KIM S DEVITO
K021200 04/16/2002 COMPAS MORGAN SCIENTIFIC, INC. PATRICK F MORGAN
K021264 04/22/2002 TRZ-CG POWER POSITIONING SYSTEM WITH CENTER-OF-GRAVITY SHIFTING POWER TILT, RECLINE, AND POWER ELEVATING SEAT MOTION CONCEPTS DAVID CIOLFE
K021255 04/19/2002 Y.E.S 10 WHEELCHAIR MOVINGPEOPLE.NET PEGGY SPILIADIS
K021098 04/04/2002 DAUM-LECTRIC MRI DRILLING MACHINE MRI DEVICES DAUM GMBH E. J SMITH
K021115 04/08/2002 GYNEFLEX NAISSANCE HOLDINGS, LC NANCY E TAYLOR
K021089 04/04/2002 OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR NELLCOR PURITAN BENNETT, INC. GINA TO
K021090 04/04/2002 OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER NELLCOR PURITAN BENNETT, INC. GINA TO
K021196 04/16/2002 NEURON THERAPEUTICS, INC., 14-GAUGE LUMBAR PUNCTURE SET, MODEL PN1000735 NEURON THERAPEUTICS, INC. JUDY P WAYS
K021144 04/09/2002 SUBDURAL STRIP ELECTRODE NICOLET BIOMEDICAL, INC. GARY SYRING
K021222 04/17/2002 LAD, MODEL LAD-01 NORWOOD ABBEY , LTD. ROBERT HANDREN
K021336 04/26/2002 NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE NOVABONE PRODUCTS, LLC DAVID M GAISSER
K021286 04/23/2002 MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES NUCLETRON CORP. LISA DIMMICK
K021328 04/26/2002 SMART BAG MO O-TWO SYSTEMS INTERNATIONAL INC. KEVIN BOWDEN
K021288 04/23/2002 ORS-1000LD O.R. SOLUTIONS, INC. STEVE HANNES
K021289 04/23/2002 WARMER 2000LD O.R. SOLUTIONS, INC. STEVE HANNES
K021074 04/02/2002 VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA OLYMPUS AMERICA, INC. LAURA STORMS-TYLER
K021073 04/02/2002 VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V OLYMPUS AMERICA, INC. LAURA STORMS-TYLER
K021179 04/15/2002 DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A OLYMPUS OPTICAL CO., LTD. LAURA STORMS-TYLER
K021204 04/16/2002 OLYMPUS BF TYPE UM40 OLYMPUS OPTICAL CO., LTD. LAURA STORMS-TYLER
K021082 04/03/2002 ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0 ON SITE GAS SYSTEMS, INC. C. BARTON GULLONG
K021362 04/30/2002 LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) ORGAN RECOVERY SYSTEMS, INC. STANLEY J HARRIS
K021105 04/05/2002 FORTAFLEX SURGICAL MESH ORGANOGENESIS, INC. MICHAEL L SABOLINSKI
K021107 04/05/2002 FORTAFLEX SURGICAL SLING ORGANOGENESIS, INC. MICHAEL L SABOLINSKI
K021207 04/16/2002 STARLIGHT ORTHOMERICA PRODUCTS, INC. DEANNA FISH
K021221 04/17/2002 O&P CRANICAL MOLDING HELMET ORTHOTIC & PROSTHETIC LAB, INC. THOMAS MALONE
K021342 04/29/2002 NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR OSTEOMEDICS, INC. ALBERT ENAYATI
K021341 04/29/2002 NORMED BONE TRANSPORT DISTRACTION DEVICE OSTEOMEDICS, INC. ALBERT ENAYATI
K021331 04/26/2002 DEXACARE G4 OSTEOMETER MEDITECH, INC. RAJA KRISHNAMURTI
K021278 04/22/2002 EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE PENTAX PRECISION INSTRUMENT CORP. PAUL SILVA
K021276 04/22/2002 FG-36UX FIBER ULTRASOUND GASTROSCOPE PENTAX PRECISION INSTRUMENT CORP. PAUL SILVA
K021092 04/04/2002 PHILIPS TL 20W/01RS UV-B, PHILIPS PL-S 9W/01/2P UV, AND PHILIPS PL-L 36W/01/4P UV-B PHILIPS LIGHTING CO. TONI J HOFFMANN
K021300 04/24/2002 MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B PHILIPS MEDICAL SYSTEMS DAVE OSBORN
K021347 04/29/2002 MODIFICATION TO M2376A DEVICELINK SYSTEM PHILIPS MEDICAL SYSTEMS DENISE HALEY
K021251 04/19/2002 ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I. PHILIPS MEDICAL SYSTEMS DAVE OSBORN
K021178 04/15/2002 SL-PLUS LATERALIZED STEM PLUS ORTHOPEDICS HARTMUT LOCH
K021099 04/04/2002 REX, VERSION 1.0 POINTDX, INC ROBERT ANDERSON
K021357 04/29/2002 MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT POREX SURGICAL, INC. HOWARD MERCER
K021249 04/19/2002 SURGASSIST FLEXSHAFT 2, MODEL FS2 14 POWER MEDICAL INTERVENTIONS, INC. BARBARA J WHITMAN
K021076 04/03/2002 PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM PRIMELINE MEDICAL PRODUCTS, INC. BRENDA LEE
K021065 04/02/2002 PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM PRIMUS GLOVES PRIVATE LTD. JOSEPH J E PEREIRA
K021329 04/26/2002 RITA SYSTEM RITA MEDICAL SYSTEMS ERIN MAZZONE
K021218 04/17/2002 ELECSYS CORTISOL TEST SYSTEM ROCHE DIAGNOSTICS CORP. SHERRI L COENEN
K021190 04/15/2002 PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422 ROCHE DIAGNOSTICS CORP. JENNIFER TRIBBETT
K021225 04/18/2002 ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I ROSSMAX INTERNATIONAL LTD. MICHAEL YEH
K021211 04/17/2002 MODIFICATION TO SANARUS VISICA TREATMENT SYSTEM SANARUS MEDICAL, INC. VINCENT CUTARELLI
K021137 04/09/2002 SANARUS CENTRICA CORE TISSUE BIOPSY SYSTEM SANARUS MEDICAL, INC. VICENT CUTARELLI
K021223 04/18/2002 BELIMED STEAM STERILIZER, MODEL TOP 5000 SAUTER AG HANS STADLER
K021064 04/02/2002 QUANTIM 16 AUTOCLAVE SCICAN BRENDA MURPHY
K021246 04/19/2002 SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3 SENSIDYNE, INC. GEORGE MASON
K021162 04/11/2002 AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT II
K021063 04/02/2002 GREAT TOE IMPLANT SIGNAL MEDICAL CORP. LOUIS A SERAFIN
K021202 04/16/2002 ULTRAQUIET SOUND TECHNIQUE SYSTEM, LLC HOWARD M HOLSTEIN
K021097 04/04/2002 QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52 SPACELABS MEDICAL, INC. EDWARD M BASILE
K021130 04/09/2002 SPECATH CENTRAL VENOUS CATHETER KITS SPECIAL MEDICAL CO. LTD. SUSAN D GOLDSTEIN-FALK
K021212 04/17/2002 24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS SPIRE BIOMEDICAL INC DONALD FICKETT
K021295 04/24/2002 SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR ST. SHINE OPTICAL CO., LTD. KEVIN WALLS
K021363 04/30/2002 ENDOVASCULAR GUIDE WIRE STEREOTAXIS, INC. GARY RAUVOLA
K021296 04/24/2002 SIMPLICITY QD EASY P INFUSION SET STERLING MEDIVATIONS, INC. JOEL S DOUGLAS
K021216 04/17/2002 SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION PUMPS STERLING MEDIVATIONS, INC. JOEL DOUGLAS
K021045 04/01/2002 ERA IMPLANT STERNGOLD MARIA RAO
K021367 04/30/2002 STERNGOLD 66, MODEL #1180230 STERNGOLD MARIA RAO
K021126 04/08/2002 EVERSTICK ORTHO STICK TECH LTD. WILLIAM TROETEL
K021051 04/01/2002 ANNULOFLO SYSTEM, MITRAL MODEL AR700 SULZER CARBOMEDICS, INC. TEFFANY HANKINSON
K021371 04/30/2002 SUNSPEX TECHNOLOGIES MODEL SE 02 SUNPEX TECHNOLOGY CO., LTD. JUDY HSU
K021298 04/24/2002 ELEMENTS DIAGNOSTIC UNIT SYBRON ENDO/ANALYTIC COLLEEN BOSWELL
K021253 04/19/2002 ULTRASONIC TIPS WITH DIAMOND COATING SYBRON ENDO/ANALYTIC COLLEEN BOSWELL
K021149 04/10/2002 AURORA DS SYNERON MEDICAL LTD. AMIR WALDMANN
K021059 04/02/2002 SYNTEX POWDER-FREE LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM SYNTEX HEALTHCARE PRODUCTS CO. LTD. TAN SWU CHOON
K021058 04/02/2002 SYNTEX POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM SYNTEX HEALTHCARE PRODUCTS CO. LTD. TAN SWU CHOON
K021241 04/19/2002 SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I SYSMEX CORPORATION OF AMERICA NINA M GAMPERLING'
K021185 04/15/2002 NERVUS MONITOR TAUGAGREINING HF E.J. SMITH
K021161 04/11/2002 TSO3 OZONE CHEMICAL INDICATOR TECHNOLOGIES OF STERILIZATION WITH OXONE, TSO3 INC CHARLES O HANCOCK
K021081 04/03/2002 HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER THE BINDING SITE, LTD. JAY H GELLER
K021245 04/19/2002 DEGOTZEN SYNCHRO THE GOTZEN GROUP, INC. DONALD R HILL
K021132 04/09/2002 UNI-PATCH ULTRASOUND COUPLING GEL THE LUDLOW COMPANY LP M. BETH RICE
K021172 04/12/2002 RSV OIA THERMO BIOSTAR, INC. KOHN G ADAMS
K021042 04/01/2002 THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS; MODELS # 7456, 7457, 7458,7459,7475,7476 THERMO FORMA, INC. RICHARD L MILLER
K021117 04/08/2002 TTI THERMOMED MODEL 1.8 INSTRUMENT THERMOSURGERY TECHNOLOGIES, INC. GENE R HEDIN
K021056 04/01/2002 PERMACOL TISSUE SCIENCE LABORATORIES, PLC HOWARD M HOLSTEIN
K021333 04/26/2002 ARTEMIS ULTRALINK, LLC. GEORGE D WISEMAN
K021262 04/22/2002 MAGNETOM SYMPHONY QUADRATURE TX/RX HEAD COIL USA INSTRUMENTS, INC. CHRISTIE SHUMAKER
K021330 04/26/2002 MAGNETOM TRIO QUADRATURE TX/RX HEAD COIL USA INSTRUMENTS, INC. CHRISTIE SHUMAKER
K021141 04/09/2002 MILLENNIUM 5000 MEUROVASCULAR COIL USA INSTRUMENTS, INC. CHRISTIE SHUMAKER
K021268 04/22/2002 ECLIPSE, HELIOS OPTION VARIAN MEDICAL SYSTEMS, INC. LINDA S NASH
K021344 04/29/2002 B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM VISION-SCIENCES, INC. PAMELA PAPINEAU
K021290 04/23/2002 VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE ACTIVATION AND PIP, MODEL 9100 VISTA MEDICAL TECHNOLOGIES, INC. GRAHAM BAILLIE
K021315 04/25/2002 SURE-LOK VITAL SIGNS, INC. THOMAS W DIELMANN
K021041 04/01/2002 WA RUBBERMATE LATEX POWDER-FREE EXAM GLOVES W.A. RUBBERMATE CO., LTD. LARA N SIMMONS
K021224 04/17/2002 ENDOCERVICAL BLOCK NEEDLE WALLACH SURGICAL DEVICES, INC. MICHAEL MALIS
K021124 04/08/2002 ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER WFR/AQUAPLAST CORP. J DAMON KIRK
K021242 04/19/2002 PORTALLOY 54 WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
K021334 04/26/2002 WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5 WIENER LABORATORIES S.A.I.C. VIVIANA CETOLA
K021332 04/26/2002 WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA WIENER LABORATORIES S.A.I.C. VIVIANA CETOLA
K021044 04/01/2002 MADETT WOLFE TORY MEDICAL, INC. TIM WOLFE
K021349 04/29/2002 METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES) WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K021346 04/29/2002 STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX WRIGHT MEDICAL TECHNOLOGY, INC. ROGER D BROWN
K021119 04/08/2002 POWDERED BROWN LATEX SURGICAL GLOVES, STERILE WITH EXPIRATION DATE LABELING CLAIM & PROTEIN CONTENT LABELING CLAIM WRP ASIA PACIFIC SDN. BHD. KK LEONG
K021159 04/11/2002 POWDERED LATEX SURGIACAL GLOVES, STEERILE WITH EXPIRATION DATE LABELING CLAIM WRP ASIA PACIFIC SDN. BHD. K. K LEONG
K021095 04/04/2002 HOLY DRAGON BRAND ACUPUNCTURE NEEDLES WUJIANG CITY HUA XIN MEDICAL APPLIANCE CO., LTD. LAURA J THORNE
K021048 04/01/2002 THERMOMETER MODELS ST8631 Z7 INTERNATIONAL PHIL ZULUETA
K021227 04/18/2002 SOFTLASE G2-SURGICAL DIODE LASER SYSTEM ZAP LASERS, LLC JAY GOBLE
K021103 04/05/2002 MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY


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