FDA 510(k) Decisions During September, 2000  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K002452 09/28/2000 3M RELY X VENEER CEMENT TRY-IN PASTER 3M COMPANY SHANNON PETTIT
K001486 09/15/2000 GENX CODA AIR PURIFICATION SYSTEM INTL., INC. MICHAEL D CECCHI
K002599 09/21/2000 MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045 ACRYMED, INC. BRUCE GIBBONS
K002013 09/29/2000 OMNIPORT ADVANCED SURGICAL CONCEPTS (ASC) MARY MCNAMARA-CULLINANE
K002144 09/28/2000 MEDLINK DIAGNOSTIC OFFLINE WORKSTATION ADVANCED TECHNOLOGY LABORATORIES, INC. TERRENCE J SWEENEY
K001725 09/08/2000 HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A AGILENT TECHNOLOGIES, INC. RICHARD J PETERSEN
K002470 09/08/2000 M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A TRANSDUCER AGILENT TECHNOLOGIES, INC. ANN F MICHAELS
K002508 09/01/2000 EQUIPMENT DRAPES ALLEGIANCE HEALTHCARE CORP. SHARON ROBBINS
K002701 09/13/2000 POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM. (50 MICROGRAMS OR LESS) ALLIANCE RUBBER PRODUCTS SDN. BHD. CHUA HOOI KOON
K002784 09/20/2000 ALOKA UST-5280-5 ALOKA CO., LTD. CHRIS BOHL
K993933 09/14/2000 14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO ARROW INTL., INC. THOMAS D NICKEL
K002032 09/11/2000 C02 LASER MULTIPULSE ASCLEPION-MEDITEC AG WILLIAM KELLEY
K001980 09/27/2000 ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110 ASPECT MEDICAL SYSTEMS, INC. CHRISTINE M VOZELLA
K002734 09/14/2000 ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106 ASPECT MEDICAL SYSTEMS, INC. CHRISTINE M VOZELLA
K002837 09/19/2000 BIS ENGINE ASPECT MEDICAL SYSTEMS, INC. CHRISTINE M VOZELLA
K994137 09/13/2000 ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE ATRIX LABORATORIES, INC. AMY TAYLOR
K001149 09/06/2000 AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK AUGUSTINE MEDICAL, INC. SCOTT D AUGUSTINE
K002679 09/18/2000 6060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351 BAXTER HEALTHCARE CORP. JENNIFER M PAINE
K002739 09/11/2000 INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K BAXTER HEALTHCARE CORP. VICKI DREWS
K002380 09/05/2000 INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM BAXTER HEALTHCARE CORP. VICKI L DREWS
K000664 09/20/2000 VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS BAXTER HEALTHCARE CORP. PAULA A TORRIANNI
K992228 09/29/2000 BAYER IMMUNO 1 HER-2/NEU ASSAY BAYER CORP. GABRIEL J MURACA
K002570 09/14/2000 BIO-LOGIC CEEGRAPH NETLINK BIO-LOGIC SYSTEMS CORP. NORMAN E BRUNNER
K002866 09/25/2000 LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574 BIO-RAD ELIZABETH PLATT
K002865 09/25/2000 LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578 BIO-RAD ELIZABETH PLATT
K001022 09/26/2000 BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 BIOCHECK, INC. ROBIN J HELLEN
K002678 09/19/2000 ASCENT KNEE SYSTEM BIOMET, INC. DALENE T BINKLEY
K002735 09/19/2000 ASCENT XXL OPEN BOX FEMORAL COMPONENT BIOMET, INC. MICHELLE L MCKINLEY
K001461 09/11/2000 TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET BIOMETRIX LTD. MIRIAM ABUTBUL
K002540 09/18/2000 BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS BIONOSTICS, INC. KATHLEEN STORRO
K994008 09/29/2000 BIOSYS FETAL MONITOR, MODEL IFM-500 BIOSYS CO. LTD. GARY J ALLSEBROOK
K000277 09/26/2000 CONSTELLATION CATHETERS BOSTON SCIENTIFIC CORP. ANDREA BOUMIS
K000743 09/06/2000 BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020 BOSTON SCIENTIFIC SCIMED, INC. DEBORAH A FRANK
K002073 09/19/2000 PAIN CARE 3000 BREG, INC. KATHLEEN BARBER
K001901 09/19/2000 POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135 C.R. BARD, INC. MICHAELA RIVKOWICH
K000830 09/07/2000 CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE CALIFORNIA MEDICAL LABORATORIES, INC. MEHMET BICAKCI
K001093 09/19/2000 CANDELA SPTL-1B PULSED DYE LASER CANDELA CORP. JOAN M CLIFFORD
K000512 09/26/2000 OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010 CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K001244 09/26/2000 BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D CITIZEN WATCH CO., LTD. JOSEPH D EDMONDSON
K002591 09/13/2000 COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K001872 09/07/2000 I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411 CODAN US CORP. RICHARD A BASLER
K002215 09/28/2000 AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA COGENT DIAGNOTICS LTD. DANIELLE M KNIGHT
K002385 09/18/2000 COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM, COOK OB/GYN BRENDA DAVIS
K002383 09/13/2000 COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT COOK OB/GYN BRENDA DAVIS
K002066 09/26/2000 FREEZER TEETHER COOL BABY, INC. DEWAYNE MOORE
K002625 09/13/2000 METHAFILCON A COOPERVISION, INC. BONNIE TSYMBAL
K001784 09/11/2000 VIRIDIS LASER COSMOS MEDICAL TECHNOLOGY JOHN CLARK
K002248 09/21/2000 DINAMAP PRO 1000 MONITOR, MODEL 1000 CRITIKON COMPANY,LLC THOMAS J ENGLISH
K002039 09/27/2000 ECAT PET SCANNER, MODELS ECAT EXACT AND ECAT EXACT HR+ AND ECAT ART CTI PET SYSTEMS, INC. WILLIAM SKREMSKY
K001647 09/26/2000 BN PROSPEC SYSTEM DADE BEHRING, INC. REBECCA S AYASH
K002541 09/26/2000 PROTEIN C REAGENT DADE BEHRING, INC. REBECCA S AYASH
K002878 09/21/2000 DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER DATEX-OHMEDA, INC. DANIEL KOSEDNAR
K002158 09/06/2000 S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE DATEX-OHMEDA, INC. JOEL KENT
K002301 09/08/2000 SUPER 12 DENTAL ALLOY PRODUCTS, INC. RODNEY GUYTON
K002302 09/26/2000 SUPER 14 DENTAL ALLOY PRODUCTS, INC. RODNEY GUYTON
K002299 09/08/2000 SUPER 3 DENTAL ALLOY PRODUCTS, INC. RODNEY GUYTON
K002300 09/26/2000 SUPER 6 DENTAL ALLOY PRODUCTS, INC. RODNEY GUYTON
K002387 09/28/2000 COMFORT CONTROL SYRINGE SYSTEM DENTSPLY INTL. P. JEFFERY LEHN
K002607 09/12/2000 MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL REDUCTION SCREWS AND SACRAL EXTENDERS DEPUY ACROMED LISA GILMAN
K002441 09/01/2000 FENNING HIP STEM DEPUY ORTHOPAEDICS, INC. ARLENE C SAULL
K002329 09/18/2000 PELVX GELLHORN VAGINAL PESSARY 603-608 DESCHUTES MEDICAL PRODUCTS, INC. DENISE BESTWICK
K002354 09/26/2000 CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80 DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K002694 09/15/2000 UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30 DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K002165 09/05/2000 LINEZOLID, 30UG, BBL SENSI-DISC DICKINSON, AND CO. BRADFORD SPRING
K002060 09/07/2000 NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL DONGKUK TECHCO RUBBER INDUSTRIES PETER PARK
K002146 09/27/2000 KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY EASTMAN KODAK COMPANY STEPHEN G SLAVENS
K002285 09/26/2000 ATAC PAK ALP REAGENT KIT ELAN DIAGNOSTICS WYNN STOCKING
K001986 09/27/2000 SURGITRON IEC II ELLMAN INTL., INC. FRANK LIN
K002028 09/29/2000 BRAVO PH MONITORING SYSTEM ENDONETICS, INC. WILLIAM A KNAPE
K002793 09/26/2000 KETAC CEM U ESPE DENTAL AG ANDREAS PETERMANN
K002414 09/25/2000 PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE FISHER & PAYKEL HEALTHCARE, LTD. BRETT WHISTON
K002040 09/11/2000 FMS SOLO FUTURE MEDICAL SYSTEMS, INC. PATRICK JANIN
K002177 09/14/2000 THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES HAEMOSCOPE CORP. ELI COHEN
K994340 09/20/2000 CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ HAI LABORATORIES, INC. RICHARD C LANZILLOTTO
K002770 09/26/2000 IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10 HDC CORP. EARL SMART
K002750 09/18/2000 HL168T HEALTH & LIFE CO., LTD. PAUL YANG
K001900 09/11/2000 ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST HELIX DIAGNOSTICS, INC. VIRGINIA CAPPEL
K002711 09/28/2000 HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER HOLOGIC, INC. DENISE DUCHENE
K002320 09/14/2000 ACCOLADE C FEMORAL COMPONENT HOWMEDICA OSTEONICS CORP. NANCY J RIEDER
K002654 09/22/2000 HOWMEDICA OSTEONICS SHOULDER SCREW HOWMEDICA OSTEONICS CORP. JENNIFER A DAUDELIN
K993773 09/13/2000 HUMID-HEAT HUDSON RCJ AB CONSTANCE G BUNDY
K001882 09/19/2000 BABY DOPPLEX 4002-TWINS, MODEL BD4002 HUNTLEIGH HEALTHCARE, INC. AUDREY A WITKO
K993282 09/18/2000 IPI HUMIDIFIER CHAMBER I.P.I. MEDICAL PRODUCTS MAZH SAID, PH.D
K000145 09/13/2000 MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDER FREE INDUSTRIAL CLOTHINGS, LTD. SYED UMAIR AHMED
K000139 09/13/2000 MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDERED INDUSTRIAL CLOTHINGS, LTD. SYED UMAIR AHMED
K000142 09/13/2000 MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDER FREE INDUSTRIAL CLOTHINGS, LTD. SYED UMAIR AHMED
K000141 09/13/2000 MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDERED INDUSTRIAL CLOTHINGS, LTD. SYED UMAIR AHMED
K000143 09/13/2000 MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERED INDUSTRIAL CLOTHINGS, LTD. SYED UMAIR AHMED
K000138 09/13/2000 MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERFREE INDUSTRIAL CLOTHINGS, LTD. SYED UMAIR AHMED
K000515 09/15/2000 PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150, INTERPORE CROSS INTL. PROSIE REY-FESSLER
K001992 09/25/2000 ILT 0.014 CATHETER, MODEL C114NL2 INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K002030 09/26/2000 OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES INVIVO RESEARCH, INC. FRANCIS CASEY
K002722 09/11/2000 DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505 JAWON MEDICAL CO., LTD. WON-HEE PARK
K001023 09/22/2000 FREEDOM, MODEL 4660 JOHNSON & JOHNSON CONSUMER COMPANIES, INC. JOSEPH KICEINA
K001918 09/19/2000 KSEA PERCUTANEOUS FORAMINOSCOPY SET KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN KENNAN
K001958 09/25/2000 KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYSTONE MEDICAL 12 F DUO-FLOW AND 14F DUO-FLOW 400 XL CATH KEYSTONE MEDICAL ALAN P SCHWARTZ
K002322 09/18/2000 MODIFICATION TO PANAVIA F KURARAY AMERICA, INC. KOICHI KIKUCHI
K002413 09/19/2000 ULTRASORB SUTURE ANCHOR LI MEDICAL TECHNOLOGIES, INC. RHODEMANN LI
K000997 09/07/2000 ZORTRAN DETECTOR LUCENT MEDICAL SYSTEMS CINDY PESTKA
K002044 09/12/2000 MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT MAGNA FORTIS CORPORATION MARK WERBLUD
K002005 09/22/2000 BOLUSPRO ULTRA MARCONI MEDICAL SYSTEMS, INC. ROBERT L TUROCY
K002647 09/13/2000 MARIETTA CONTACT LENS SERVICE, COLOR ENHANCED TINTED SOFT CONTACT LENS MARIETTA CONTACT LENS SERVICE MARTIN DALSING
K002477 09/08/2000 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES MASIMO CORP. JAMES J CRONIN
K002574 09/06/2000 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, MODEL RADICAL, LNOP-ADT, LNOP-PDT MASIMO CORP. JAMES J CRONIN
K002682 09/13/2000 MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES MASIMO CORP. JAMES J CRONIN
K000825 09/21/2000 4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER MEDI-DYNE, INC. NORMAN HALL
K002072 09/11/2000 PROLITE VL PULSED LIGHT SYSTEM MEDICAL BIO CARE SWEDEN AB CONNIE WHITE HOY
K002416 09/11/2000 GOLDEN-RULE SCALING CATHETER MEDICAL DEVICE TECHNOLOGIES, INC. KARL SWARTZ
K002451 09/29/2000 MODIFICATION TO: PRONTO DRY MEDICAL INSTRUMENTS CORPORATION, AG JOHN C MATHERLY
K001869 09/18/2000 DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE MEDICOTEST A/S EMALEE G MURPHY
K002685 09/15/2000 CORDLESS COMPACT MOBILE X-RAY SYSTEM MEDISON RADIOLOGY SYSTEMS, INC. JOHN W LEE
K002655 09/06/2000 DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-550 MEDITEC CO., LTD. D H CHANG
K001937 09/22/2000 MEDLINE ELECTRONIC POSITIONING CHAIR MEDLINE INDUSTRIES, INC. LARA SIMMONS
K002776 09/28/2000 MODIFICATION TO PROFILE -II MEDTOX DIAGNOSTICS, INC. MICHAEL TURANCHIK
K002346 09/27/2000 WIRE, GUIDE, CATHETER, MODEL QSW1000 MEDTRONIC AVE, INC. LINDA (LINN) LAAK
K991502 09/12/2000 MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022 MEDTRONIC PS MEDICAL JEFFREY HENDERSON
K002399 09/27/2000 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
K000885 09/26/2000 DRX HBA1C - FOR PRESCRIPTION HOME USE METRIKA, INC. JOEL M BLATT
K001717 09/20/2000 MICOR CONDUCTION CATHETER MICOR, INC. JEREMIAH COSTELLO
K002723 09/28/2000 REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS; REBAR MICRO CATHETER: REBAR-10 (1.7F), 170 CM, DUAL MA MICRO THERAPEUTICS, INC. MARIBELLE AGUINALDO
K001806 09/12/2000 REFRACTIVE SURGERY BLADES MILLENNIUM BIOMEDICAL, INC. JERRY KAENI
K002602 09/05/2000 OBC-63 MEBREAST ARRAY COIL MRI DEVICES CORP. THOMAS SCHUBERT
K002293 09/13/2000 3D MOTOR-DRIVEN COARSE MANIPULATOR MM-188NE NARISHIGE CO., LTD. MITSUKO YONEYAMA
K002653 09/22/2000 MMN-1 COARSE MANIPULATOR NARISHIGE CO., LTD. MITSUKO YONEYAMA
K002658 09/22/2000 MMO-202N THREE-AXIS JOYSTICK OIL HYDRAULIC MICROMANIPULATOR NARISHIGE CO., LTD. MITSUKO YONEYAMA
K002659 09/22/2000 MMO-202ND THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANPULATOR NARISHIGE CO., LTD. MITSUKO YONEYAMA
K002291 09/13/2000 MOTOR-DRIVE MANIPULATOR MM-89 NARISHIGE CO., LTD. MITSUKO YONEYAMA
K980937 09/15/2000 NICORE MODEL ESP -1 NICORE EQUIPMENT & LEASING, INC. MICHAEL G FARROW
K000643 09/07/2000 INPLANT ORTHODONTIC ANCHOR SYSTEM NOBEL BIOCARE UAS INC JEFF HAUSHEER
K000975 09/25/2000 LIPIDURE REWETTING DROPS NOF CORP. ANN KUROWSKI
K993675 09/05/2000 PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM NOMOS CORP. FRANCIS X DOBSCHA
K001833 09/28/2000 PREFERENCE TREATMENT SYSTEM NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC. LEE MYERS
K991977 09/27/2000 TYSHAK, MODEL 102 AND Z-MED, MODEL 302 NUMED, INC. NICHELLE LAFLESH
K001176 09/21/2000 DISPOSABLE MICROKERATOME BLADES-PE OASIS MEDICAL, INC. YVONNE FERNANDEZ
K002242 09/20/2000 POLESTAR N-10 ODIN TECHNOLOGIES LTD. ADI ICKOWICZ
K001056 09/29/2000 OLYMPIC WARM-UP OLYMPIC MEDICAL CORP. JOSEPH P STEFANILE
K994103 09/05/2000 OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR GASTROINTESTINAL TRACT OLYMPUS AMERICA, INC. LAURA STORMS-TYLER
K001766 09/08/2000 OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE OLYMPUS OPTICAL CO., LTD. LAURA STORMS-TAYLOR
K994112 09/29/2000 MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA) ONCOGENE SCIENCE, INC. WALTER P CARNEY
K002448 09/11/2000 LATEX EXAMINATION GLOVES, POWDERED, (CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM). OON CORP. RESOURCES CLEMENT K K OON
K000847 09/27/2000 ORALUBE ORASYSTEMS BERNARD SESSMAN
K000678 09/18/2000 RAEBBITT/EVOLUTION POWERED WHEELCHAIR OTTO BOCK ORTHOPEDIC INDUSTRY, INC. WILLIAM JACKSON
K002544 09/13/2000 MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM OXFORD INSTRUMENTS BARRY BRIGHT
K002360 09/26/2000 CLOUD CUFF PARTS PORT, LTD. CATHY SEBASTIAN
K002111 09/08/2000 RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/GUARDIAN POLYMER-COATED POWDERED EXAMINATION GLOVES. CONTAI PERUSAHAAN PELINDUNG GETAH (M) SDN BHD PETER YEW NIENG CHOON
K001987 09/06/2000 EXPLORER GRADIENT PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. PETER ALTMAN
K001796 09/06/2000 GYROSCAN INTERA (R7.5) PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. PETER ALTMAN
K002016 09/06/2000 PHILIPS INTEGRIS ALLURA PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. PETER ALTMAN
K992476 09/13/2000 PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS PILLING WECK SURGICAL RICHARD G JONES
K001175 09/18/2000 SERAGARD VASCULAR ACCESS PATCH PLATINUM SERVICES, INC. NANCY Y STREET
K001342 09/07/2000 P.O.P. PAIN KIT POST OPERATIVE PAIN MANAGEMENT CHARLES ROWLAND II
K001970 09/26/2000 JET 1 POWERED WHEELCHAIR PRIDE MOBILITY PRODUCTS CORP. GENE KULON
K001951 09/08/2000 PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306 PRIMELINE MEDICAL PRODUCTS, INC. KATHERINE CO
K002096 09/08/2000 TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR; TAMPAX TAMPONS, OPEN END FLUSHABLE APPLICATOR PROCTER & GAMBLE CO. MARK M ANDERSON
K001366 09/19/2000 PROSTEC 125I BRANCHYTHERAPY SNAPSEED PROSTEC LLC. AL WEISENBORN
K002001 09/06/2000 BREEZE SLEEPGEAR WITH DREAMSEAL PURITAN BENNETT CORP. DARIN BUSCH
K994420 09/18/2000 POWDER FREE LATEX EXAMINATION PATIENT GLOVES PURNABINA SDN BHD LIEW YOON FONG
K002087 09/13/2000 BESTEX POWDER-FREE LATEX EXAM GLOVES WITH LABELING CLAIM. (50 MICROGRAMS OR LESS) QINGDAO BESTEX RUBBER & PLASTIC PRODUCTS CO., LTD ZECHUAN SHAO
K001995 09/08/2000 SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER QRS DIAGNOSTIC, LLC. JILL R KRALL
K002366 09/18/2000 QUEST MPS BACK-UP SYSYEM QUEST MEDICAL, INC. DOUG BRYAN
K001599 09/18/2000 ACTI-FLEX IV ADMINISTRATION SET R-GROUP INTL. KERRY ANNE KAHN
K002290 09/13/2000 ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS) RADIOMETER MEDICAL A/S KIRSTEN RONO
K000705 09/08/2000 RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223 RESPIRONICS, INC. DAVID J VANELLA
K002465 09/08/2000 SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876 RESPIRONICS, INC. DAVID J VANELLA
K001800 09/12/2000 ACCUWARM EMG HEAT LAMP RJL ASSOCIATES, LLC. RONALD LUICH
K001907 09/05/2000 CAMIT DIABETES MANAGEMENT SOFTWARE ROCHE DIAGNOSTICS CORP. MIKE FLIS
K994349 09/06/2000 COAGUCHEK S SYSTEM, MODEL 2138280 ROCHE DIAGNOSTICS CORP. JENNIFER TRIBBETT
K002609 09/05/2000 TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K002051 09/05/2000 INVIDOS SCANDITRONIX MEDICAL AB EVA LARSTEN
K002767 09/27/2000 COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICE SEMLER TECHNOLOGIES, INC. HERBERT J SEMLER
K002461 09/26/2000 HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT SHOFU DENTAL CORP. CINDY RHOADES
K002553 09/15/2000 DS DS I-SERIES SMV AMERICA LONNIE MIXON
K001842 09/15/2000 ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100 SOMANETICS CORP. RONALD A WIDMAN
K992465 09/21/2000 SOPHY SU8 PRESSURE ADJUSTABLE VALVE SOPHYSA SA JACQUELINE MASSE
K002371 09/15/2000 K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM SPINEOLOGY, INC. PAMELA SNYDER
K002833 09/28/2000 MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER STANDARD IMAGING, INC. RAYMOND RIDDLE
K002796 09/28/2000 MODIFICATION TO PROVIDENT HIP SYSTEM STELKAST COMPANY DONALD A STEVENS
K001984 09/27/2000 PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT STELKAST COMPANY DONALD A STEVENS
K001642 09/12/2000 INSIGHT IMAGE GUIDED SURGICAL SYSTEM SURGICAL INSIGHTS, INC. JON T LEA
K001765 09/07/2000 LOOK COLLAGEN SPACERS, MODEL 1514B SURGICAL SPECIALTIES CORP. LINDA F TEXTER
K002710 09/29/2000 MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS (LINE EXTENSION) SYNTHES (USA) BONNIE J SMITH
K001945 09/22/2000 SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES SYNTHES (USA) ANGELA J SILVESTRI
K001941 09/22/2000 SYNTHES MODULAR FOOT SYSTEM SYNTHES (USA) ANGELA J SILVESTRI
K002517 09/12/2000 USS VAS SYNTHES (USA) JONATHAN GILBERT
K002026 09/06/2000 CAPIOX ARTERIAL FILTER TERUMO MEDICAL CORP. GARRY A COURTNEY
K000095 09/26/2000 OLYMPUS SONOSURG TROCAR XT3900 SYSTEM THE OLYMPUS OPTICAL CO. LAURA STORMS-TYLER
K002559 09/12/2000 EL-ANA PROFILES-2K1 THERATEST LABORATORIES, INC. MARIUS TEODORESCU
K001926 09/22/2000 VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES THORATEC LABORATORIES CORP. DONALD A MIDDLEBROOK
K002511 09/11/2000 FETALTROL TRILLIUM DIAGNOSTICS, LLC. BRUCE H DAVIS
K001768 09/19/2000 OCCU-FLO PUNCTUM PLUGS U.S. IOL, INC. TERESA BURTON
K001874 09/25/2000 PERIPHERALLY INSERTED CENTRAL CATHETER UTAH MEDICAL PRODUCTS, INC. KEVIN L CORNWELL
K002432 09/01/2000 STRATO X VILLA SISTEMI MEDICALI S.P.A. JEFF MOELLER
K000599 09/08/2000 VITALOGRAPH BASE STATION VITALOGRAPH, INC. PHIL HEMES
K002255 09/18/2000 LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC) WOLFE TORY MEDICAL, INC. TIM WOLFE
K002579 09/08/2000 DERMAGRIP POWDERFREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS) WRP SPECIALTY PRODUCTS SDN. BHD. MOHD HAIZAN HUSSEIN
K000727 09/19/2000 BUFFLIGHT CLT SURGICAL LASER SYSTEM Y-BEAM TECHNOLOGIES, INC. JUDY F GORDON
K002029 09/21/2000 ZOLL M SERIES NIBP OPTION, MODEL MSERIES NIBP OPTION ZOLL MEDICAL CORP. PAUL DIAS
K002004 09/21/2000 ZYBIT ZYMED MEDICAL INSTRUMENTATION GRETEL LUMLEY


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