FDA 510(k) Decisions During August, 2000  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K001547 08/07/2000 ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP AB BIODISK ANNE BOLMSTROM
K002006 08/10/2000 LIFESHIELD ADDITIVE PIERCING PIN ABBOTT LABORATORIES THOMAS P SAMPOGNA
K002401 08/29/2000 CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION) ADVANCED STERILIZATION PRODUCTS NEELU MEDHEKER
K992831 08/25/2000 AERONEB II, MODEL APN 200 AEROGEN, INC. TRACI V. A EDWARDS
K002009 08/02/2000 HP M2376A DEVICE LINK SYSTEM, MODEL M2376A AGILENT TECHNOLOGIES, INC. MIKE HUDON
K002397 08/17/2000 M2430 DIAGNOSTIC ULTRASOUND SYSTEM WITH THE 21420 TRANSDUCER AGILENT TECHNOLOGIES, INC. PAUL SMOLENSKI
K001467 08/01/2000 DA VINCHI EMG/EP ISA1004EP AIRSEP CORP. PETER WEISENBORN
K001579 08/31/2000 IMPULSE SELECT AIRSEP CORP. JAMES A ALESSI
K993524 08/01/2000 ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS ALARIS MEDICAL SYSTEMS, INC. RENEE L FLUET
K001126 08/07/2000 PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST ALATEX SCIENTIFIC, INC. JANIS FREESTONE
K994395 08/07/2000 INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K994399 08/04/2000 INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K994403 08/14/2000 INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K994400 08/04/2000 INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K994406 08/14/2000 INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K002419 08/15/2000 SURGICAL DRAPES ALLEGIANCE HEALTHCARE COPORATION SHARON ROBBINS
K983299 08/04/2000 ALLEGIANCE GENESIS CONTAINER SYSTEM ALLEGIANCE HEALTHCARE CORP. PATRICIA SHARPE-GREGG
K000788 08/04/2000 APEX MODULAR HIP STEM APEX SURGICAL, LLC. EDWARD J CHEAL
K001420 08/30/2000 SLIDESCAN APPLIED IMAGING CORP. DIANE OATES
K991971 08/04/2000 ARTHREX CHONDRAL DART, MODEL AR-4005B-18 ARTHREX, INC. VERNON C BROWN
K001588 08/17/2000 ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20 ARTHROCARE CORP. BRUCE PROTHRO
K001250 08/16/2000 APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS) ASAHI MEDICAL CO., LTD. DAVID L WEST
K001815 08/10/2000 DC ZIRKON AUSTENAL, INC. RONALD DUDEK
K001799 08/10/2000 DC-TELL AUSTENAL, INC. RONALD DUDEK
K001731 08/29/2000 AVID-NIT LOSS OF RESISTANCE SYRINGE AVID MEDICAL, INC. SEAN F SHEMANSKI
K001981 08/21/2000 DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500 AXIS-SHIELD LTD. EILEEN MCCAFFERTY
K002435 08/24/2000 MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK) AXYA MEDICAL, INC. HOWARD L SCHRAYER
K002085 08/01/2000 ULTRASOUND SCANNER, TYPE 1101 B & K MEDICAL A/S VILLY BRAENDER
K001571 08/04/2000 BAUMER FEMORAL HEAD BAUMER S.A. BRENO C FARAGO, JR.
K001935 08/22/2000 ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565 BECKMAN COULTER, INC. ANGELA M BYLAND
K002453 08/31/2000 ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479 BECKMAN COULTER, INC. JAN OLSEN
K002109 08/31/2000 OLEEVA FOAM BIO MED SCIENCES, INC. MARK E DILLON
K002535 08/30/2000 LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513 BIO-RAD ELIZABETH PLATT
K002120 08/21/2000 LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573 BIO-RAD ELIZABETH PLATT
K002536 08/30/2000 LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER) BIO-RAD ELIZABETH PLATT
K002460 08/31/2000 LIQUICHEK LIPIDS CONTROL, MODEL 641, 642 BIO-RAD ELIZABETH PLATT
K002196 08/07/2000 LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483 BIO-RAD ELIZABETH PLATT
K002070 08/25/2000 BIOLOK SCREW BIOCOMPOSITES LTD. J.STEPHEN BRATT
K001724 08/04/2000 STIMULAN -CALCIUM SULFATE BONE VOID FILTER BIOCOMPOSITES LTD. STEPHEN BRATT
K002020 08/25/2000 LACTOSORB MENISCAL SCREW BIOMET MANUFACTURING, INC. MARY VERSTYNEN
K001580 08/17/2000 GROSS FEMORAL COMPONENT BIOMET, INC. TINA LAKIN
K984390 08/07/2000 LACTOSORB PANELS AND FASTENERS BIOMET, INC. TRACY J BICKEL
K002379 08/31/2000 M2A 28MM RINGLOC LINER BIOMET, INC. MICHELLE L MCKINLEY
K001760 08/31/2000 RADIOLUCENT COLLES FRACTURE KIT BIOMET, INC. TRACY J BICKEL
K002333 08/31/2000 BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220 BIOSENSE WEBSTER, INC. MARIA D OCHOA
K001736 08/02/2000 GALEO HYDRO AND GALEO HYDRO J-TIP BIOTRONIK, INC. Jon Brumbaugh
K001727 08/09/2000 MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES BLEASE MEDICAL EQUIPMENT LTD. ART WARD
K993875 08/11/2000 BMT ANSCORE HEALTH MANAGEMENT SYSTEM BOSTON MEDICAL TECHNOLOGIES, INC. CESIDIO TEMPESTA
K001134 08/31/2000 GAZELLE BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. JENNIFER BOLTON
K001338 08/30/2000 MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. ABBY LIPMAN
K994155 08/03/2000 EXCELSIOR 1018 MICROCATHETER BOSTON SCIENTIFIC, TARGET ROXANNE K BAXTER
K002181 08/11/2000 GDC ULTRASOFT COIL BOSTON SCIENTIFIC, TARGET JAMES LEATHLEY
K001743 08/25/2000 ULTIMA SMARTBELT, MODEL 0560 BRAEBON MEDICAL CORP. RICHARD A BONATO
K002321 08/14/2000 PAIN CARE 2000L BREG, INC. KATHLEEN BARBER
K002351 08/26/2000 FLUOROTEX II SURGICAL MESH BRIDGER BIOMED, INC. BRUCE G RUEFER
K002205 08/10/2000 CARONY BRUNO INDEPENDENT LIVING AIDS, INC. RICHARD KELLER
K002063 08/10/2000 BIOTRACE, MODEL 1730 BRYAN CORP. ROSE S LOGSDON
K001803 08/04/2000 ACCELERATOR RECIPROCATING CANNULA BYRON MEDICAL REGINA S HARRIS
K000983 08/26/2000 CERAMIX PORCELAIN SYSTEM C-MIX ART WARD
K002230 08/18/2000 CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002 CAMBRIDGE HEART, INC. JOHN GREENBAUM
K001589 08/18/2000 CANDELA DYNAMIC COOLING DEVICE CANDELA CORP. JOAN M CLIFFORD
K001462 08/21/2000 CARESIDE HEMOGLOBIN CARESIDE, INC. KENNETH B ASARCH
K002174 08/22/2000 DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3 CASCO-NERL DIAGNOSTICS CORPORATION (MAINE) KAREN HICKEY
K001975 08/04/2000 CERALAS D10 810NM LASER, MODEL CERALAS D10-60 CERAMOPTEC, INC. CAROL J MORELLO
K000859 08/23/2000 OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1 CHARLES A. SMITH CHARLES A SMITH
K000685 08/15/2000 CHARTER MEDICAL NEONATAL SYRINGE SET CHARTER MEDICAL, LTD. K. ALICE PREVILLE
K001662 08/02/2000 CHASE CARDIOVASCULAR PATCH CHASE MEDICAL, INC. DAVE HERNON
K001858 08/17/2000 OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITE CHINA NANTONG GUANGDA TEXTILE CO., LTD. YONG ZHANG
K993806 08/14/2000 DIALGUARD ENDOTOXIN REMOVAL DEVICE CLARIGEN, INC. EDIT HEGYI
K000388 08/08/2000 CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL) CLEARWATER COLON HYDROTHERAPY, INC. STUART K BAKER
K992905 08/01/2000 CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM Codman & Shurtleff, Inc. JAMES M FLAHERTY
K001598 08/22/2000 BIOBAR, IMPLANTABLE BIODEGRADABLE COLLAGEN MEMBRANE FOR GUIDED BONE REGENERATION COL-BAR LTD. JOHNATHAN S KAHAN
K002065 08/22/2000 PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR COMFORT RUBBER GLOVES INDUSTRIES SDN BHD CHEE Y FOO
K993140 08/02/2000 WATER FOR TISSUE CULTURE, MODELS 1500 CONCEPTION TECHNOLOGIES GREG HOLLAND
K001300 08/30/2000 D. R. MEDICAL CONTROLLED PRESSURE GARMENTS CONFECTION MEDICALE D.R., INC. GUY HOUDE
K002002 08/17/2000 SUREFIT DISPERSIVE ELECTRODE CONMED CORP. IRA D DUESLER, JR.
K000251 08/30/2000 SPECTRUM SILICONE FOLEY CATHETER COOK UROLOGICAL, INC. BRENDA DAVIS
K001704 08/31/2000 ATHOS COSMOS MEDICAL TECHNOLOGY JOHN CLARK
K002190 08/10/2000 POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP) CP MEDICAL PATRICK FERGUSON
K001106 08/16/2000 MASTERSITE NEEDLELESS LUER ACTIVATED IV CONNECTOR, MODEL MS 1000 CREATIVE PLASTIC TECHNOLOGY ROBERT J BARD
K002388 08/25/2000 EHC500 DESKTOP PATIENT STATION, MODEL EHC500 CYBERCARE, INC. J. TERRY DRURY
K001645 08/04/2000 SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 DADE BEHRING, INC. RADAMES RIESGO
K002365 08/25/2000 DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET DATASCOPE CORP. JOANN WOLF
K001814 08/23/2000 DATEX-OHMEDA COMPACT AIRWAY MODULE M-CAIOVX AND M-COVX (VERSION 01) AND ACCESSORIES DATEX-OHMEDA JOEL KENT
K002298 08/24/2000 SUPER 1 DENTAL ALLOY PRODUCTS, INC. RODNEY GUYTON
K001470 08/04/2000 E-Z LINK CROSS CONNECTOR DEPUY ACROMED KAREN F JURCZAK
K001991 08/25/2000 TITAN POROCOAT HIP PROSTHESIS DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K001523 08/10/2000 ULTIMA METAL-ON-METAL ACETABULAR CUP DEPUY ORTHOPAEDICS, INC. CHERYL HASTINGS
K001922 08/29/2000 DEPUY NEUFLEX PIP FINGER DEPUY, INC. JANET G JOHNSON
K990517 08/01/2000 EXPLORER CVS TRANSCRANIAL DOPPLER DIAGNOSTIC MEDICAL SYSTEMS FRANK FERGUSON
K001767 08/07/2000 DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM DIAMEDIX CORP. LYNNE STIRLING
K001875 08/21/2000 DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM DIAMEDIX CORP. LYNNE STIRLING
K002086 08/17/2000 PRIMAFLOW DMG USA, INC. PAMELA PAPINEAU
K000475 08/22/2000 BRACHYSEED DRAXIMAGE, INC. R.J. FLANAGAN
K000204 08/01/2000 WIN-1 TANGO DURACARE MEDICAL EQUIPMENT, L.C. ROBERT S MCQUATE
K001994 08/04/2000 EEI SLUSH PAN DRAPE EAGLE ENDOSCOPIC, INC. JOHN MAYALL
K001565 08/10/2000 STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB EDWARDS LIFESCIENCES, LLC. JOHN W SMITH
K001847 08/24/2000 ANTERIOR CERVICAL PLATE SYSTEM ENCORE ORTHOPEDICS, INC. JOANNA MONAHON
K002223 08/22/2000 EPIC SPO2 FINGER SENSOR, MODEL E412-20 EPIC MEDICAL EQUIPMENT SERVICES, INC. KRISTA OAKES
K002364 08/10/2000 PROTEMP H ESPE DENTAL AG ANDREAS PETERMANN
K002141 08/16/2000 ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT EXACTECH, INC. Lisa Simpson
K000919 08/31/2000 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128 EXCEL TECH. LTD. DEBBIE DAVY
K001496 08/01/2000 A.V. FISTULA NEEDLE EXELINT INTERNATIONAL CO. ARMAND HAMID
K002129 08/25/2000 FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN FERRIS MFG. CORP. THEODORE THORSEN
K991522 08/04/2000 MICROTARGETING ELECTRODE FHC, INC. FREDERICK HAER
K000158 08/24/2000 VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9 FISMA, INC. DOUGLAS A KANE
K001810 08/14/2000 URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING FLEXSITE DIAGNOSTICS, INC. DONALD R STONE
K991495 08/28/2000 FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS FLUID PROCESS SYSTEMS, INC. STEPHEN C HAMBRIC
K002277 08/25/2000 FRESENIUS OPTIFLUX 200NR FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR EILINSFELD
K001823 08/16/2000 LINKMAX GC AMERICA, INC. TERRY L JORITZ
K001946 08/30/2000 NEUROVASCULAR ARRAY COIL GE MEDICAL SYSTEMS, INC. LARRY A KROGER
K970569 08/14/2000 BIO-BLOCKS GEISTLICH-PHARMA PETER S REICHERTZ
K001923 08/25/2000 REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 7800 GENDRON, INC. FREDERIC W STROBEL
K002209 08/18/2000 GE MARQUETTE ECG ANALYSIS PROGRAM GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN KRISTIN PABST
K002340 08/22/2000 VINYL EXAMINATION GLOVE, POWDER-FREE, YELLOW GLORMED INTL., INC. JANNA P TUCKER
K000736 08/08/2000 LA JOIE GOOMI EHWA, INC. MANOH PARK
K002206 08/24/2000 HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRO GUIDANT CORP. MARGARET ANDERSON
K994118 08/14/2000 OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS GUILIN LATEX FACTORY PETER WEI
K002021 08/24/2000 HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE GYRUS ENT L.L.C. ALICIA FARAGE
K002378 08/29/2000 MODULAR PORP AND TORP MODEL TBD GYRUS ENT L.L.C. ALICIA FARAGE
K002464 08/29/2000 SMITH & NEPHEW OFF-CENTERED PORP GYRUS ENT L.L.C. ALICIA FARAGE
K000913 08/10/2000 POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) HANDSAFE PRODUCTS SDN. BHD. NG KOK HWA
K001456 08/07/2000 CONSENSUS KNEE SYSTEM HAYES MEDICAL, INC. WILLIAM J GRIFFIN
K002221 08/09/2000 KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170 HEINZ KURZ GMBH MEDIZINTECHNIK DAGMAR S MASER
K000084 08/04/2000 ENRAF-NONIUS SONOPULS 190 SYSTEM HENLEY HEALTHCARE, INC. REBECCA STOUT
K001860 08/10/2000 PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA HOMEDICS, INC. MICHEAL NELSON
K001614 08/04/2000 STRYKER TRAUMA PELVIC SET HOWMEDICA OSTEONICS CORP. MARY-CATHERINE DILLON
K001449 08/04/2000 TRIDENT ACETABULAR SHELLS: PS HOWMEDICA OSTEONICS CORP. TERRY S POWELL
K001448 08/04/2000 TRIDENT ACETABULAR SHELLS: PS-HA HOWMEDICA OSTEONICS CORP. TERRY S POWELL
K001653 08/18/2000 XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY HOWMEDICA OSTEONICS CORP. MARY-CATHERINE DILLON
K001615 08/18/2000 HUNTER SCIENTIFIC INJECTION PIPETTES HUNTER SCIENTIFIC LIMITED MARK RAWE
K001677 08/14/2000 BABY DOPPLEX 4000 (BD4000) HUNTLEIGH DIAGNOSTICS LTD. B. J COLLEYPRIEST
K001409 08/02/2000 GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER HYPERBARIC TECHNOLOGIES, INC. PAUL E DRYDEN
K001759 08/24/2000 HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ IMPLEX CORP. JOHN SCHALAGO
K001471 08/07/2000 THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ IMPLEX CORP. JOHN A SCHALAGO
K984570 08/30/2000 MINOLTA PULSOX-3/MINOLTA PULSOX-3I IN-X CORP. CHARLIE HENRY
K993913 08/09/2000 TRUE INFINITY EXTRUSION & ENGINEERING, INC. DOUGLAS WILKINS
K994109 08/03/2000 DETRUSAN 500 INNOVAMED USA, INC. E.H. CZADILEK
K000732 08/16/2000 QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
DEN000007 08/16/2000 QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K001928 08/02/2000 SIGMA INSTRUMENTARIUM IMAGING, INC. DOUG WOODS
K002400 08/30/2000 MODIFICATION OF ACL ADVANCE INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K001648 08/28/2000 INTRASTENT DOUBLESTRUT PARAMOUNT INTRATHERAPEUTICS, INC. CATHY YOHNK
K001666 08/24/2000 MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM INTUITIVE SURGICAL, INC. DAVID CASAL
K002171 08/10/2000 INVACARE LIFT CHAIR INVACARE CORP. EDWARD A KROLL
K002317 08/25/2000 MODEL 9000 BARIATRIC WHEELCHAIR INVACARE CORP. EDWARD A KROLL
K002170 08/04/2000 MODEL 9000 PEDIATRIC WHEELCHAIR INVACARE CORP. EDWARD A KROLL
K002157 08/25/2000 RANGER II M6, MODEL IN-888WNL INVACARE CORP. HOWARD M HOLSTEIN
K001967 08/14/2000 PVP-POLYVINYLPYRROLIDONE REAGENT, MODEL CAT#2210 INVITROCARE, INC. ROBERT E LOVINS
K001410 08/01/2000 PHORESOR MODEL PM2000 IOMED, INC. W. TIM MILLER
K002048 08/30/2000 JBC OPAQUE AND GLITTER J.B.C AND CO. PRISCILLA L MIER
K002222 08/31/2000 RD-2104 J.F. JELENKO & CO., INC. RAPHAEL JUDKINS
K002041 08/16/2000 WILLI GELLER CREATION & AV PORCELAIN JENSEN INDUSTRIES, INC. JOHN SLANSKI
K991864 08/31/2000 ROTAFLOW CENTRIFUGAL PUMP SYSTEM JOSTRA MEDIZINTECHNIK AG KATHY JOHNSON
K001740 08/22/2000 KSEA MONOPOLAR VAPORIZATION ELECTRODES KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN KENNAN
K002167 08/25/2000 KARMAN WHEELCHAIR KARMAN HEALTHCARE, INC. ALEX C HORNG
K002202 08/25/2000 KARMAN WHEELCHAIR KARMAN HEALTHCARE, INC. ALEX C HORNG
K001655 08/10/2000 PERMLASTIC 2 KERR CORP. COLLEEN BOSWELL
K002239 08/08/2000 SIGMA 110/330 DIAGNOSTIC ULTRASOUND SYSTEM KONTRON MEDICAL SYSTEMS SAS GEORGE MYERS
K001908 08/18/2000 KONTUR 55 SOFT LENS KONTUR KONTACT LENS CO., INC. KEVIN M RANDALL
K001914 08/10/2000 CLEARFIL REPAIR KURARAY COMPANY, LTD. KOICHI KIKUCHI
K001913 08/04/2000 CLEARFIL ST OPAQUER KURARAY COMPANY, LTD. KOICHI K IKUCHI
K002200 08/25/2000 CAPELLA MADSEN ELECTRONICS, INC. JIM BERGERSON
K002138 08/29/2000 PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380 MAERSK MEDICAL A/S JENNIFER LYONS
K001162 08/09/2000 GOLDFINGER DEVICE MALI-TECH LTD. AHAVA STEIN
K001609 08/10/2000 MALLARD AIR OXYGEN ACCUBLENDER MALLARD MEDICAL, INC. ROBERT PEARSON
K994124 08/11/2000 NIPROTECT POWDER-FREE NITRILE EXAMINATION GLOVES MAPA PROFESSIONAL ALEJANDRO SANCHEZ
K002279 08/18/2000 ML EYE SPEAR, MODEL ML 27 ES MED-LOGICS, INC. GARY MOCNIK
K001052 08/30/2000 MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX MED-TEC,INC. DONALD F RIIBE
K002287 08/25/2000 WIZAIR COMPRESSION SYSTEM MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD. SHOSHANA FRIEDMAN
K002116 08/09/2000 S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0 MEDICAL DEVICE CONSULTANTS, INC. CYNTHIA J NOLTE
K002100 08/25/2000 XIMX SYSTEM MEDICAL MANAGER RESEARCH DEVELOPMENT JEFFREY K SHAPIRO
K994283 08/30/2000 MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM MEDIS MEDICAL IMAGING SYSTEMS, B.V. J.I. HOLLANDER
K002185 08/01/2000 SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON AMERICA, INC. GARY J ALLSEBROOK
K002491 08/25/2000 COMBISON 301 PW ULTRASOUND SYSTEM AND TRANSDUCERS MEDISON CO., LTD. GARY J ALLSEBROOK
K001498 08/10/2000 THE FUGO BLADE MEDISURG LTD. RICHARD J FUGO
K993042 08/17/2000 MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT MEDIVATORS, INC. NORMAN MINER
K001404 08/08/2000 GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON MEDNET LOCATOR, INC. JUDY CHANDLER
K001406 08/08/2000 HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES MEDNET LOCATOR, INC. JUDY CHANDLER
K001969 08/16/2000 GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300 MEDTRONIC VASCULAR FRED L BOUCHER
K001898 08/31/2000 VASOTRAX MEDWAVE, INC. DONNA R LUNAK
K000593 08/04/2000 SONIC, MODEL SO-100 METRON MEDICAL AUSTRALIA PTY LTD ROB HOPKINS
K001940 08/11/2000 MICOR ANESTHESIA CONDUCTION KIT MICOR, INC. JEREMIAH COSTELLO
K002212 08/03/2000 MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608 MICRO THERAPEUTICS, INC. MARIBELLE AGUINALDO
K000969 08/22/2000 MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1 MICROLIFE CORP. SUSAN D GOLDSTEIN-FALK
K001182 08/01/2000 MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1 MICROLIFE CORP. SUSAN D GOLDSTEIN-FALK
K001829 08/18/2000 MINIMED PARADIGM INSULIN PUMP, MODEL 511 MINIMED, INC. JENNIFER LYONS
K001828 08/18/2000 PARADIGM 1.5ML RESERVOIR, MODEL 326 MINIMED, INC. JENNIFER LYONS
K001827 08/18/2000 PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325 MINIMED, INC. JENNIFER LYONS
K001832 08/18/2000 PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318 MINIMED, INC. JENNIFER LYONS
K000355 08/23/2000 3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR MINNESOTA MINING AND MFG. CO. GRETCHEN KEENAN
K002402 08/31/2000 VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM MITEK PRODUCTS MARY P LEGAW
K002422 08/31/2000 VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM MITEK PRODUCTS MARY P LEGRAW
K993698 08/16/2000 SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX MOGUL ENTERPRISES JAMIL MOGUL
K001944 08/14/2000 HAC-300 HEAD ARRAY COIL MRI DEVICES CORP. TOM SCHUBERT
K002539 08/30/2000 OBC-096 BREAST ARRAY COIL MRI DEVICES CORP. THOMAS SCHUBERT
K001903 08/29/2000 NEOCONTROL PELVIC FLOOR THERAPY SYSTEM NEOTONUS, INC. SHEILA HEMEON-HEYER
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K992133 08/04/2000 NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL NEWPORT MEDICAL INSTRUMENTS, INC. ROBERT W DICK
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K000517 08/31/2000 LIFE SCOPE EC, MODEL BSM-1102 NIHON KOHDEN AMERICA, INC. BONNIE BISHOP
K002260 08/25/2000 SPINA SYSTEM NORTH AMERICAN MEDICAL CORPORATION (NAM) CARLOS BECERRA
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K993788 08/04/2000 R.TEST EVOLUTION NOVACOR DIV. LYNETTE L HOWARD
K000718 08/24/2000 CHROMOSTREAK NOVAMED LTD. GERALD M SLUTZKY
K001560 08/24/2000 ODONTOSURGE 3 ODONTO-WAVE JAMES DIEROFF
K002313 08/30/2000 COMPLEXED PSA MICROTITER ELISA ONCOGENE SCIENCE, INC. SHERYL BROWN-SHIMER
K002121 08/30/2000 TOTAL PSA MICROTITER ELISA ONCOGENE SCIENCE, INC. SHERYL BROWN-SHIMER
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K002114 08/11/2000 RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES: CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER PERUSAHAAN PELINDUNG GETAH (M) SDN BHD PETER YEW NIENG CHOON
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K001909 08/25/2000 PLAINSENSE WHEELCHAIR PLAINSENSE WHEELCHAIRS, INC.
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K001808 08/04/2000 DORO HEADREST SYSTEM PRO-MED INSTRUMENTS GMBH ANITA THIBEAULT
K001392 08/21/2000 GLYCOSAL HBA1C TEST PROVALIS DIAGNOSTICS LTD. TOM TSAKERIS
K000888 08/15/2000 SANSIBAR CPAP SYSTEM PRYM MEDICAL LTD. SHOSHANA FRIEDMAN
K000653 08/04/2000 AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002 PULMONOX MEDICAL CORP. PAULA TOMAT
K002319 08/30/2000 PURILENS SALINE SOLUTION PURILENS, INC. ART WARD
K001492 08/09/2000 QUINTON Q-STRESS, MODEL 000483 QUINTON, INC. DAVID HIMES
K001414 08/09/2000 KWIKKMODEL R-DENTAL DENTALERZEUGNISSE GMBH ANDREAS SPRAFKE
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K993409 08/18/2000 REMED MALE TUTTI FRUTTI CONDOM (COCONUT) PREVENTOR, LUCKY BOY, SUMMIT REMED PHARMA E.J. Smith
K993403 08/18/2000 REMED MALE TUTTI FRUTTI CONDOM (STRAWBERRY) PREVENTOR, LUCKY BOY, SUMMIT REMED PHARMA E.J. Smith
K000808 08/25/2000 RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE RICH-MAR CORP. DAVID RICHARDS
K002353 08/10/2000 ELECSYS CA 15-3 CALCHECK ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K002148 08/22/2000 ELECSYS HCG TEST SYSTEM ROCHE DIAGNOSTICS CORP. PRISCILLA A HAMILL
K000568 08/04/2000 HDL CHOLESTEROL PLUS ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K001641 08/03/2000 TAMPONS ROSTAM LTD. ROBERT J STAAB
K000114 08/10/2000 RS-4M+MUSCLE STIMULATOR RS MEDICAL JOEL S FADEN
K001943 08/23/2000 CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY SANGUI BIOTECH, INC. JOHN J KIANG
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K002107 08/04/2000 IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA. SCIMEDX CORP. GARY LEHNUS,PH.D
K002134 08/07/2000 ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM SELFCARE, INC. CAROL A ADILETTO, M.S.
K000700 08/31/2000 SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR SENSIDYNE, INC. HOWARD MILLS
K002218 08/15/2000 NITRILE EXAM GLOVE, POWDER-FREE, COLOR BLUE SHANGHAI CHAMPION PLASTIC PRODUCTS CO., LTD. JANNA P TUCKER
K002217 08/11/2000 NITRILE EXAM GLOVE, POWDER-FREE, COLOR WHITE SHANGHAI CHAMPION PLASTIC PRODUCTS CO., LTD. JANNA P TUCKER
K002220 08/15/2000 NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE SHANGHAI CHAMPION PLASTIC PRODUCTS CO., LTD. JANNA P TUCKER
K002216 08/11/2000 NITRILE EXAMINATION GLOVE, PRE-POWDERED, COLOR WHITE SHANGHAI CHAMPION PLASTIC PRODUCTS CO., LTD. JANNA T TUCKER
K001077 08/02/2000 LUBRIGEL PERSONAL LUBRICANT SHEFFIELD LABORATORIES, DIV. OF FARIA LIMITED, LLC KATHLEEN HACKU
K002015 08/09/2000 SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT JAMES CHU
K002012 08/09/2000 SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT JAMES CHU
K994231 08/10/2000 SIEMENS INTEGRATED OPERATING SYSTEM (SIOS) SIEMENS MEDICAL CORP. MALGORZATA STANEK
K001400 08/01/2000 ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. JUDI HOFFMAN
K002225 08/08/2000 OR TABLE/MAGNETOM OPEN VIVA SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. JAMIE YIEH
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K001764 08/09/2000 HOTLINE 2 FLUID WARMER SIMS LEVEL 1, INC. GABRIEL J MURACA JR.
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K000811 08/25/2000 NLITE SYSTEM, SLS MODEL NUMBER A00-1025 SLS BIOPHILE LTD. MICHAEL KIERNAN
K001681 08/25/2000 POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM SMV AMERICA FRANCOIS ROCHE
K001604 08/14/2000 DANA DIABECARE SOOIL DEVELOPMENT CO., LTD. CYNTHIA J NOLTE
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K001476 08/04/2000 TORQUE INSTRUMENT, MODEL 8500 SPINALIGHT, INC. T. A COX
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K002118 08/09/2000 STOCKERT COMPACT SYSTEM VERSION 2.0 STOECKERT INSTRUMENTE CYNTHIA J. M. NOLTE
K993166 08/04/2000 STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM Stryker Endoscopy TODD MILLER
K002324 08/24/2000 MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA SULZER MEDICA FRANCES E HARRISON
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K001793 08/17/2000 SYNTHES SCALLOPED DISTAL TIBIA PLATE SYNTHES (USA) ANGELA J SILVESTRI
K001683 08/21/2000 SYSMEX R-500 SYSMEX CORPORATION OF AMERICA NINA GAMPERLING
K990100 08/02/2000 POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE TE ME NA S.A.R.L. JOE HARMS
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K002238 08/22/2000 CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING TERUMO CARDIOVASCULAR SYSTEMS CORP. GARRY A COURTNEY
K001572 08/14/2000 NEOLUS NEEDLE TERUMO EUROPE N.V. M J AERTS
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K001636 08/24/2000 C-REACTIVE PROTEIN ANTISERUM KIT THE BINDING SITE, LTD. JAY H GELLER
K001556 08/21/2000 HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY THE BINDING SITE, LTD. JAY H GELLER
K001712 08/31/2000 3D ACTIVETRAC THE SAUNDERS GROUP DOUGLAS G TOMASKO
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K001818 08/30/2000 UTERINE TENACLUM HOOK TOWNE BROTHERS (PVT.), LTD. ABDUL GHAFOOR
K002258 08/08/2000 ULTRAGUIDE CT-GUIDE 1010 ULTRAGUIDE LTD. GEORGE MYERS
K002008 08/16/2000 SURGICAL DYNAMICS SPINAL RETRACTOR UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC JENNIFER E SCHUCK
K001590 08/02/2000 DND 101 UROGYN LTD. KENNETH T BURCK
K001870 08/14/2000 MILLENNIUM 9000 PHASED ARRAY NEUROVASCULAR COIL USA INSTRUMENTS, INC. TORI BRUNS
K002276 08/29/2000 PSI SKULL CLAMP V. MUELLER NEURO/SPINE GARY COOPER
K000401 08/24/2000 VAPOTHERM, MODEL 2000I VAPOTHERM, INC. WILLIAM NILAND
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K002194 08/18/2000 TREATVISION VARIAN MEDICAL SYSTEMS, INC. LINDA S NASH
K001633 08/24/2000 LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 & LHCEK0000 VASCA, INC. DOUGLAS E FERGUSON
K001938 08/29/2000 VECTOR TARGETING SYSTEM VECTOR MEDICAL, INC. ERIN MCGURK
K000796 08/11/2000 MAGIC MOBILITY 4 X 4 WHEELCHAIR VESTIL MANUFACTURING CORP. RICK MICHAEL
K001553 08/03/2000 BREAS PV 100 CPAP SYSTEM VITAL SIGNS, INC. ANTHONY P MARTINO
K993934 08/15/2000 V QUICK PATCH VQ CORP. MICHAEL A PRICE
K993052 08/03/2000 VYGON 2 FR EPICUTANEO PUR-CATHETER VYGON CORP. ROBERT SCHIFF
K993442 08/03/2000 VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR) VYGON CORP. ROBERT SCHIFF
K000356 08/25/2000 C.T.M. MOBILITY SCOOTER, MODEL H2-686, HS-740, HS-580 WAREPALMY ENTERPRISE LLC (USA) ROBERT S MCQUATE
K000354 08/25/2000 C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570 WAREPALMY ENTERPRISE LLC (USA) ROBERT S MCQUATE
K001878 08/03/2000 WATER PURIFIER WATERCLAVE, L.L.C. M. JOSEPH OLK
K000574 08/09/2000 IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE) WR MEDICAL ELECTRONICS CO. PATRICK J ANDERSON
K002149 08/31/2000 LINEAGE ACETABULAR SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K001706 08/16/2000 WMT MODULAR SHOULDER SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. LYNNE WITKOWSKI
K000737 08/01/2000 COAXIAL DILATOR SET XENTEK MEDICAL, INC. JIM EDDINGS


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