FDA 510(k) Decisions During May, 2002  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K021460 05/22/2002 OCO DENTAL IMPLANT "O" CO., INC. DAVID D DALISE
K020365 05/03/2002 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE 3T MEDICAL SYSTEMS, LLC. ROBERT P EATON
K020618 05/14/2002 AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL AALTO SCIENTIFIC LTD. KENNETH GAUTHIER
K020579 05/13/2002 AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03 AARON MEDICAL INDUSTRIES RICHARD A KOZLOFF
K020452 05/07/2002 HIGH SILVER CONVENTIONAL AB ARDENT CLYDE E INGERSOLL
K021350 05/14/2002 ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348 ABBOTT LABORATORIES FRANK POKROP
K011461 05/28/2002 ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR ACCESS CARDIOSYSTEMS, INC. DAVID BARASH
K013596 05/16/2002 MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP) ACCUMETRICS, INC. RHONDA MOE
K021244 05/03/2002 ACE HA SCREW DENTAL IMPLANT SYSTEM ACE SURGICAL SUPPLY CO., INC. J EDWARD CARCHIDI
K021272 05/21/2002 SIB CATHETER, MODEL 61-7005 ACKRAD LABORATORIES RICHARD HETTENBACH
K021166 05/09/2002 ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR ACMI-CIRCON CORPORATION JOHN A DELUCIA
K020313 05/08/2002 ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE ACON LABORATORIES CO. EDWARD TUNG
K020771 05/15/2002 ACON ONE STEP DRUG SCREEN TEST CARD ACON LABORATORIES, INC. EDWARD TUNG
K021614 05/30/2002 DIGITAL CLINICAL THERMOMETER, MODEL ACT 3020 ACTHERM, INC. RICHARD HSIEH
K021612 05/30/2002 DIGITAL CLINICAL THERMOMETER, MODELS ACT 2030, 2038 ACTHERM, INC. RICHARD HSIEH
K013886 05/10/2002 AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) ADVANCED DIAGNOSTICS, INC. STEVE HESSLER
K021175 05/15/2002 AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000 AEROGEN, INC. TRACI V. A EDWARDS
K021447 05/22/2002 TELE-CLINIQ DATA TRANSMISSION SYSTEM BLOOD PRESSURE MEASUREMENT SYSTEM AEROTEL MEDICAL SYSTEMS (1998) LTD. GEORGE MYERS
K020648 05/01/2002 GRIDLOCK 195 ADHESIVE ALLODEX SYSTEMS MELVYN A STEINBERG
K021263 05/15/2002 MODIFICATION TO SPARC SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC. MARK MCINTYRE
K021439 05/29/2002 MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO ANIMAS CORP. MICHAEL J ANDREWS
K020865 05/08/2002 ONLINE POWDER FREE, LATEX EXAMINATION GLOVES APL PRODUCTS SDN. BHD. LEE SON HONG
K020577 05/22/2002 APPLIED URETERAL CATHETER APPLIED MEDICAL RESOURCES CORP. ANIL BHALANI
K021121 05/28/2002 AROMACRYL AROMACRYL, LLC TANYA L WOODS
K021120 05/02/2002 RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP ARROW INTL., INC. DEBBIE PEACOCK
K021364 05/30/2002 MODIFICATION TO ENTEC PLASMA WANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K020408 05/02/2002 SYSTEM 2000 CONTROLLER, SYSTEM 5000 CONTROLLER, FOOTSWITCH, POWER CORD, AND VISAGE WANDSFF ARTHROCARE CORP. BRUCE PROTHRO
K020634 05/08/2002 MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER ATRIUM MEDICAL CORP. JOSEPH P DE PAOLA
K020349 05/02/2002 ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS AXIS-SHIELD DIAGNOSTICS, LTD. EILEEN A MCCAFFERTY
K020348 05/02/2002 ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS AXIS-SHIELD DIAGNOSTICS, LTD. EILEEN A MCCAFFERTY
K020687 05/02/2002 DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300 AXIS-SHIELD DIAGNOSTICS, LTD. EILEEN MCCAFFERTY
K013587 05/14/2002 BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS BABIES BEST, INC. JAY SALKIN
K020375 05/03/2002 THE NURTURE III BREAST PUMP BAILEY MEDICAL ENGINEERING BARRY BAILEY
K020927 05/16/2002 BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS BAUSCH & LOMB DEBRA L. B KETCHUM
K020802 05/31/2002 RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION BAUSCH & LOMB INCORPORATED PAUL G STAPLETON
K021274 05/17/2002 PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719 BAXTER HEALTHCARE CORP. VIVKI L DREWS
K020354 05/03/2002 BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL) BAYLIS MEDICAL CO., INC. KRIS SHAH
K021343 05/20/2002 ISOSEEDS I-125 BEBIG ISOTOPEN-UND MEDIZINTECHNIK GMBH SVEN LANGER
K020842 05/15/2002 ERTAPENEM 10UG BBL SENSI-DISC BECTON DICKINSON & CO. MICHELLE BANDY
K020321 05/23/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON, DICKINSON & CO. BRADFORD M SPRING
K021215 05/15/2002 BIO-LOGIC ABAER CUB BIO-LOGIC SYSTEMS CORP. NORMAN E BRUNNER
K021498 05/24/2002 LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL BIO-RAD MARIA ZEBALLOS
K021415 05/29/2002 LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469 BIO-RAD ELIZABETH PLATE
K021414 05/29/2002 LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467 BIO-RAD ELIZABETH PLATE
K021411 05/29/2002 LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463 BIO-RAD ELIZABETH PLATE
K021384 05/29/2002 LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444 BIO-RAD ELIZABETH PLATT
K013897 05/21/2002 SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW BIO-SCAN S.A RICHARD M SANO
K020962 05/24/2002 G4 SLEEVED NAIL BIOMET MANUFACTURING, INC. TRACY J BICKEL
K020381 05/06/2002 EXPANDABLE KNEE BIOMET ORTHOPEDICS, INC. PATRICIA SANDBORN BERES
K021403 05/31/2002 HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM BIOMET ORTHOPEDICS, INC. DALENE T BINKLEY
K021380 05/28/2002 OSS LES PROXIMAL FEMORAL COMPONENT BIOMET, INC. PATRICIA SANDBORN BERES
K021182 05/13/2002 RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR BIOMET, INC. TRACY J BICKEL
K020628 05/24/2002 CURELLE, PREFERRED CURELLE, CUTEQ 2.5 BIOTEQUE AMERICA, INC. DENIS DORSEY
K021217 05/01/2002 AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP BIOTRONIK, INC. JON BRUMBAUGH
K013642 05/22/2002 AVEA BIRD PRODUCTS CORP. TOM GUTIERREZ
K020730 05/22/2002 ORION NASAL CPAP SYSTEM BIRD PRODUCTS CORP. TOM GUITERREZ
K020600 05/22/2002 BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER) BLACKSTONE MEDICAL, INC. ALAN LOMBARDO
K020620 05/23/2002 BLACKSTONE III DEGREE ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER) BLACKSTONE MEDICAL, INC. ALAN LOMBARDO
K020538 05/15/2002 BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES BOEHRINGER LABORATORIES CHRISTOPHER RADL
K021232 05/16/2002 CONSTELLATION CATHETERS, MODEL 8031M BOSTON SCIENTIFIC CORP. CHRISTINA L ROWE
K012113 05/03/2002 INDWELLING FECAL MANAGEMENT SYSTEM BOWEL MANAGEMENT SYSTEMS, LLC COLLEEN J HITTLE
K014283 05/22/2002 LATEX SURGEONS GLOVE (POWDER FREE) BRIGHTWAY GLOVES PVT. LTD. N. PARAMASIVAN
K014278 05/14/2002 LATEX SURGEONS GLOVE (POWDERED) BRIGHTWAY GLOVES PVT. LTD. N. PARAMASIVAN
K020614 05/24/2002 IRRIGATING CANNULA CA GUARD, LTD. AL WEISENBORN
K013855 05/09/2002 MICROJET CRONO H CANE S.R.I. DANIEL KAMM
K013840 05/14/2002 MICROJET CRONO PAR AND CRONO APO-GO CANE SRL DANIEL KAMM
K013822 05/08/2002 MICROJET CRONO PCA CANE SRL DANIEL KAMM, PE
K012132 05/09/2002 CHROMAGEN V3.0 READING AID SOFT CONTACT LENS CANTOR & NISSEL LTD. MARTIN DALSING
K020449 05/10/2002 CARDIONOW CARDIOLOGY WIDE AREA ARCHIVE AND RETRIEVAL SYSTEM CARDIONOW, INC. JOHNNY M GARZA
K020637 05/28/2002 SELECT STIM CARE REHAB AND ORTHOPAEDIC CHRISTIAN HUNT
K020516 05/16/2002 CARE IFC PLUS CARE REHAB, INC. CHRISTIAN E HUNT
K013960 05/23/2002 APATIGHT HA-BONE GRAFT SUBSTITUTE CERABIO, LLC JAMES J CASSIDY
K013966 05/16/2002 APATIGHT-TCP BONE GRAFT SUBSTITUTE CERABIO, LLC JAMES J CASSIDY
K021192 05/16/2002 QACA IGG/IGM ELISA KIT HRP CHESHIRE DIAGNOSTICS LTD. NEIL B STRINGER
K021395 05/13/2002 MODIFICATION TO 30" EXTENSION SET CHURCHILL MEDICAL SYSTEMS, INC. KEVIN PALUCH
K021118 05/28/2002 DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570 CLASS A ENT. SAMANTHA L DRAPER
K021054 05/09/2002 CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER CODONICS, INC. RICK DAYTON
K011344 05/17/2002 INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400 COLLINS MEDICAL, INC. JONATHAN S KAHAN
K020732 05/30/2002 SS MATRIX COOK BIOTECH, INC. MARK BLEYER
K021591 05/22/2002 PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS CORDIS NEUROVASCULAR, INC. MARITZA CELAYA
K020723 05/08/2002 DIMENSION ALDL CALIBRATOR, MODEL DC131 DADE BEHRING, INC. RICHARD M VAUGHT
K020724 05/09/2002 DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131 DADE BEHRING, INC. RICHARD M VAUGHT
K020692 05/10/2002 EMIT 2000 VANCOMYCIN ASSAY DADE BEHRING, INC. DONNA A WOLF
K020845 05/08/2002 EMIT 2000 VANCOMYCIN CALIBRATORS DADE BEHRING, INC. DONNA A WOLF
K020820 05/09/2002 MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME DADE BEHRING, INC. CYNTHIA VAN DUKER
K020822 05/08/2002 MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - VANCOMYCIN DADE BEHRING, INC. CYNTHIA VAN DUKER
K020398 05/16/2002 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML) DADE BEHRING, INC. MAUREEN MENDE
K021037 05/06/2002 MICROSTREP PLUS PANEL WITH AMPICILLIN DADE BEHRING, INC. CYNTHIA VAN DUKER
K020627 05/06/2002 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXACIN DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K020937 05/06/2002 MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K020939 05/17/2002 MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K012195 05/07/2002 STEAM STERILIZATION INTERGRATOR DANA PRODUCTS, INC. HARRY BALA
K020760 05/03/2002 STARFLOW HV DANVILLE MATERIALS, INC. CRAIG R BRUNS
K020513 05/16/2002 EPY-50 DDC TECHNOLOGIES, INC. DMITRY DONSKOY
K020893 05/28/2002 NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE DENNIS R. BAILEY, DDS DENNIS R BAILEY
K021416 05/13/2002 AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL DENTSPLY INTL. P. JEFFERY LEHN
K021413 05/10/2002 AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL DENTSPLY INTL. P. JEFFERY LEHN
K021410 05/08/2002 AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL DENTSPLY INTL. P. JEFFERY LEHN
K021148 05/08/2002 MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD DEPUY ACROMED LISA GILMAN
K020541 05/20/2002 AGILITY ANKLE REVISION PROSTHESIS DEPUY, INC. JANET G JOHNSON
K020816 05/14/2002 IRON-PC-SL ASSAY MODEL # 151-10, 151-26 DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K021208 05/30/2002 IMMULITE 2000 MIXED ALLERGEN PANELS DIAGNOSTIC PRODUCTS CORP. ROBERT M DI TULLIO
K021206 05/30/2002 IMMULITE 2000 SPECIFIC ALLERGENS DIAGNOSTIC PRODUCTS CORP. ROBERT M DI TULLIO
K020945 05/31/2002 AXSYM INTACT PTH, MODEL 2G06 DIAGNOSTIC SYSTEMS LABORATORIES, INC. CARROLL POTTS
K020430 05/09/2002 DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) DIATEK, INC. JON WILSON
K021324 05/23/2002 FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM) DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. YAEL RUBIN
K020510 05/03/2002 SMOKE EVACUATION HOSES/TUBING DM MEDICAL INC. ROBERT W MAYS
K020726 05/15/2002 DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE DUKAL CORP. PATRICK J LAMB
K020887 05/16/2002 EBI AIS SPINE SYSTEM EBI, L.P. FREDERIC TESTA
K021312 05/23/2002 EBI DFS OPTIROM ELBOW FIXATOR EBI, L.P. JON CAPAROTTA
K021091 05/03/2002 EBI XFIX DFS SYSTEM EBI, L.P. FREDERIC TESTA
K021031 05/16/2002 EBI XFIX RAIL SYSTEM EBI, L.P. MICHAEL T TAGGART
K021102 05/08/2002 DM SLEEVE EMILY IKER M.D., A.P.C. JONATHAN S KAHAN
K013712 05/31/2002 ENTERYX INJECTOR ENTERIC MEDICAL TECHNOLOGIES JILL M VISOR
K020684 05/23/2002 FINESUN EMS STIMULATOR FINESUN WORLDWIDE INTL. CO., LTD. CHI-CHU WU CHEN
K021108 05/03/2002 ESOP HA FEMORAL STEM FOURNITURES HOSPITALIERES ANDRE WEITH
K020566 05/09/2002 FUJIREBIO DIAGNOSTICS CA 19-9 RIA FUJIREBIO DIAGNOSTICS, INC. DANIEL J O'SHANNESSY
K021038 05/03/2002 GC ELITE CEMENT 100 GC AMERICA, INC. TERRY L JORITZ
K021435 05/22/2002 DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MELISSA ROBINSON
K021135 05/09/2002 MODEL 2120IS SERIES MATERNAL/FETAL MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES JOELLE NEIDER
K021491 05/22/2002 HISPEED DUAL GE MEDICAL SYSTEMS, INC. LARRY A KROGER
K021325 05/07/2002 MODIFICATION OF APEXPRO TELEMETRY SYSTEM GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN JOELLE NEIDER
K020661 05/24/2002 UNITY IS PATIENT VIEWER GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN KAREN WEBB
K021258 05/10/2002 GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER GERM TERMINATOR CORPORATION DAVID LINK
K020341 05/02/2002 GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD. SHOSHANA FRIEDMAN
K021308 05/14/2002 GLOVCO POWDER-FREE NITRILE EXAMINATION GLOVES GLOVCO (M) SDN. BHD. TAN PENG HOCK
K021284 05/02/2002 EASYTRAK GUIDING CATHETER GUIDANT CORP. KAREN S ALSOP
K021283 05/02/2002 GUIDANT BALLOON CATHETER, SEVERAL MODELS GUIDANT CORP. KAREN S ALSOP
K021228 05/15/2002 HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE GUIDANT CORP. JENNIFER PAE RIGGS
K021285 05/02/2002 HI-TORQUE EXTRA S'PORT GUIDEWIRE GUIDANT CORP. KAREN S ALSOP
K021282 05/02/2002 LV-1 HEMOSTASIS VALVE, MODEL #6789 GUIDANT CORP. KAREN S ALSOP
K020701 05/24/2002 SYNCRUS INTERNAL CARDIOVERSION SYSTEM GUIDANT CORPORATION, CARDIAC SURGERY DEBBIE COGAN
K020778 05/28/2002 GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420 GYRUS ENT L.L.C. JEFFERY W COBB
K013615 05/29/2002 MICRO-INDUCTION 1000 SYSTEM HARBINGER MEDICAL, INC. HAROLD HOIUM
K020643 05/28/2002 EZ-SCOPE AN & EZ-SCOPE AN LITE HEALTH POLICY RESORTERS GROUP, LLC T. WHIT ATHEY
K021479 05/21/2002 CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 HEINZ KURZ GMBH MEDIZINTECHNIK DAGMAR MASER
K020914 05/23/2002 ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 HELENA LABORATORIES PATRICIA FRANKS
K020625 05/06/2002 SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 HELENA LABORATORIES PATRICIA FRANKS
K013376 05/08/2002 QFLOW 500 PERFUSION MONITORING SYSTEM HEMEDEX INCORPORATED DEBBIE IAMPIETRO
K020679 05/06/2002 INRATIO HEMOSENSE, INC. JUDITH BLUNT
K020652 05/15/2002 HERNIAMESH T-SLING HERNIAMESH LORENA TRABUCCO
K020471 05/02/2002 HIVOX EAR THERMOMETER, TS SERIES HIVOX BIOTEK, INC. KE-MIN JEN
K021310 05/21/2002 36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) HOWMEDICA OSTEONICS CORP. JENNIFER A DAUDELIN
K020615 05/13/2002 SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS HOWMEDICA OSTEONICS CORP. WILLIAM J CYMBALUK
K020384 05/06/2002 T2 ARTHRODESIS NAIL SYSTEM HOWMEDICA OSTEONICS CORP. WILLIAM J CYMBALUK
K020355 05/14/2002 I-STAT PROTHROMBIN TIME TEST I-STAT CORPORATION PAUL VANDERERF
K020908 05/22/2002 HDM97 IBP INSTRUMENTS GMBH WERNER PFINGSTMANN
K020909 05/22/2002 HDM99 IBP INSTRUMENTS GMBH WERNER PFINGSTMANN
K020576 05/01/2002 VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE ID BIOMEDICAL CORP. DAVID CLARY
K021163 05/10/2002 OCTEIA 25-HYDROXY VITAMIN D IMMUNODIAGNOSTIC SYSTEMS LTD. PAUL PUNTIN
K014235 05/16/2002 OSSEOTITE NT DENTAL IMPLANTS & ACCESSORIES IMPLANT INNOVATIONS, INC. JEANNETTE G DAILEY
K021025 05/20/2002 MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ IMPLEX CORP. ROBERT POGGIE
K021465 05/22/2002 MIDAS TOUCH LATEX EXAMINATION GLOVES-POLYMER COATED, POWDER FREE INDUSTRIAL CLOTHINGS, LTD. UMAIR AHMED
K013021 05/30/2002 LIGHTLANCE LASER SKIN PERFORATOR INNOTECH USA, INC. HOWARD HOLSTEIN
K021024 05/16/2002 HEMOSIL HIGH ABNORMAL CONTROL ASSAYED INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K021022 05/14/2002 HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED) INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K021023 05/14/2002 HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED) INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K021323 05/22/2002 MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K020849 05/20/2002 APEX 800 LASER SYSTEM, MODEL APEX 800 IRIDEX CORP. JOHN D'ANGELO
K020374 05/03/2002 OCULIGHT SL/SLX IRIDEX CORP. JOHN D'ANGELO
K013802 05/01/2002 FRC POSTEC IVOCLAR VIVADENT, INC. DONNA M HARTNETT
K012496 05/17/2002 CARBON POST J. MORITA USA, INC. KEITH A BARRITT
K021088 05/02/2002 JOGUIDE CARDIOVASCULAR GUIDING C ATHETER JOMED CATHETER, INC. NORMAN L HALL
K021219 05/17/2002 SMARTWIRE/SMARTMAP PRESSURE SYSTEM JOMED, INC. TERRY SCHULTZ
K020640 05/28/2002 KSEA SCB MEDIA CONTROL KARL STORZ ENDOSCOPY-AMERICA, INC. JAMES A LEE
K013982 05/21/2002 KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT KINAMED, INC. VINEET SARIN
K020781 05/06/2002 WET CHAMBER KINETIC CONCEPTS, INC. JUITH A HARBOUR
K020554 05/03/2002 MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM KINETIKOS MEDICAL, INC. FLOYD G LARSON
K011859 05/01/2002 KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS KLIMAMED TECHNOLOGIE MEDIZINGERATE GMBH
K020763 05/10/2002 COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT) LIN-ZHI INTERNATIONAL, INC. CHIU CHIN CHANG
K020254 05/10/2002 PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011 LIN-ZHI INTERNATIONAL, INC. CHIU CHIN CHANG
K020377 05/06/2002 PRE-LOADED BIOSTINGER HORNET LINVATEC CORP. LAURA D SENEFF
K020633 05/15/2002 NATURAL AND COLORED LATEX CONDOM WITH FLAVORS LS RUBBER SDN BHD RAJILA VOHRA
K020591 05/16/2002 BCLEAR LUMENIS C. ROBERT PAYNE JR.
K020623 05/02/2002 DUOPRO SAFETY SYRINGE (DUOPROSS) M.K. MEDITECH CO. LTD. ROSINA ROBINSON
K020562 05/16/2002 APEX INTRAMEDULLARY NAIL SYSTEM MAGLY ORTHOPEDICS, LLC DAVE STINSON
K020993 05/21/2002 ILLUMINATOR AUTOMATIC TUNE VOX AND INTERFACE CABLE (ATIB) MAGNA-LAB, INC. JOHN GEISEL
K021145 05/16/2002 ACCOMMODATOR WHEELCHAIR, MODEL #2000X MARKEN INTERNATIONAL, INC. STEVE RIFFEL
K020393 05/03/2002 MASTER & FRANK SURGICAL DRAPES (STERILE) MASTER & FRANK ENTERPRSES CO.LTD. FRANK WU
K020563 05/21/2002 MEDAMICUS AXIA RSN MEDAMICUS, INC. KARYL D HASKELL
K020315 05/24/2002 14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL MEDCOMP FLORENCE A CAIKOSKI
K020465 05/22/2002 MEDCOMP ASH SPLIT-CATH II MEDCOMP FLORENCE A CAIKOSKI
K021368 05/15/2002 MEDELA "BASIC 30" AND "DOMINANT 50" SUCTION PUMPS, MODELS 037, 057 MEDELA AG RERNER FREI
K020780 05/20/2002 TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP MEDEX, INC. BARBARA LAW
K012979 05/08/2002 COMPRESSIBLE LIMB SLEEVE MEDICAL DEVICE SERVICES, INC. RON EAMES
K021606 05/31/2002 EN-SNARE ENDOVASCULAR SNARE AND CATHETER MEDICAL DEVICE TECHNOLOGIES, INC. KARL SWARTZ
K012614 05/01/2002 KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN MEDICAL INSTRUMENTS TECHNOLOGY, INC. JACK SPEER
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