FDA 510(k) Decisions During November, 2000  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K001600 11/22/2000 CODA INCUBATOR CELLMATE INTL., INC. MICHAEL D CECCHI
K000654 11/14/2000 VBMAX A-M SYSTEMS, INC. STEVE GRASSER
K002986 11/29/2000 A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5 A.R.C. LASER AG DANIEL HOEFER
K002139 11/08/2000 ETEST LINEZOLID AB BIODISK ANNE BOLMSTORM
K001993 11/13/2000 SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS ABBOTT LABORATORIES JOE MAGLIOZZI
K001044 11/03/2000 ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM ACME SPINE, LLC. TIMOTHY WILLIAMS
K003434 11/16/2000 ALLEGRO TB, ALLEGRO N ADAC LABORATORIES DAVID KOLESAR
K001510 11/30/2000 OS-2000 OPTICAL SONOGRAPHY SYSTEM ADVANCED DIAGNOSTICS, INC. STEVE HESLER
K002573 11/16/2000 ADVANCED UROSCIENCE INNERSHEATH ADVANCED UROSCIENCE, INC. KAREN E PETERSON
K002459 11/08/2000 PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH AGILENT TECHNOLOGIES, INC. ROB BUTLER
K003370 11/22/2000 JAMSHIDI MARROW ACQUISITION CRADLE ALLEGIANCE HEALTHCARE CORP. LAVENIA FORD
K003109 11/21/2000 COMPLETE BRAND LUBRICATING AND REWETTING DROPS ALLERGAN, INC. PAUL J NOWACKI
K001520 11/22/2000 ALPHA OMEGA DUAL COOLER-HEATER ALPHA OMEGA, INC. RICHARD MARTIN
K002709 11/17/2000 RACE ENDODONTIC FILE AMC GENERAL, INC. RAY T BURKE
K002447 11/16/2000 MODIFICATION TO RAPID DRUG SCREEN 9-PANEL AMERICAN BIO MEDICA CORP. JOHN B DUBECK
K002721 11/29/2000 AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH AMERICAN MEDICAL SYSTEMS, INC. GINGER Z GLASER
K002503 11/09/2000 FETALGARD LITE ANALOGIC CORP. STEVEN A CLARKE
K992493 11/06/2000 VIPON TAMPON ANOTHERWAY PRODUCTS LLC. STEVEN A KILGORE
K002644 11/20/2000 RADIAL HEAD IMPLANT AVANTA ORTHOPAEDICS, INC. LOUISE M FOCHT
K001651 11/22/2000 BIO-RAD %CDT TIA AXIS-SHIELD BIOCHEMICALS, ASA RONALD G LEONARDI
K003193 11/07/2000 DUPLOGRIP BAXTER HEALTHCARE CORP. ARLENE VIDOR
K001685 11/15/2000 PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 BAXTER HEALTHCARE CORP. ROBERT L WILKINSON
K002938 11/29/2000 B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC PETER ZURLO
K003098 11/20/2000 ACCESS ULTRASENSITIVE HGH CALIBRATORS BECKMAN COULTER, INC. MARA CALER
K003488 11/27/2000 SYNCHRON CONTROL BECKMAN COULTER, INC. GAIL LEFEBVRE
K002456 11/02/2000 MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992 BECTON DICKINSON VACUTAINER SYSTEMS James Haynes
K003239 11/30/2000 LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506 BIO-RAD ELIZABETH PLATT
K003242 11/30/2000 LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623 BIO-RAD ELIZABETH PLATT
K003030 11/29/2000 LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET BIO-RAD ELIZABETH PLATT
K003294 11/03/2000 BIOMET LATERAL TROCH PLATE BIOMET, INC. TRACY J BICKEL
K003296 11/06/2000 BIOMET SCK KNEE SYSTEM BIOMET, INC. TRACY J BICKEL
K003428 11/24/2000 ISS OFFSET HEADS BIOMET, INC. DALENE T BINKLEY
K003429 11/30/2000 MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL BIOMET, INC. DALENE T BINKLEY
K003131 11/02/2000 MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT BIOMET, INC. CAROL LAUSTER
K002757 11/24/2000 ONCOLOGY SALVAGE SYSTEM BIOMET, INC. TINA LAKIN
K003475 11/20/2000 TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST BIOSITE INCORPORATED JEFF DAHLEN
DEN000010 11/20/2000 TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST BIOSITE INCORPORATED JEFF DAHLEN
K003317 11/21/2000 RENEW LS-1 BISCO, INC. CINDY ORIS
K003361 11/28/2000 RENEW LS-2 BISCO, INC. CYNDY ORIS
K002509 11/03/2000 NOVALIS (SHAPED BEAM SURGERY SYSTEM) BRAINLAB AG STEFAN VILSMEIER
K002263 11/27/2000 BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST BRANAN MEDICAL CORP. RAPHAEL WONG
K002272 11/22/2000 BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D BRANAN MEDICAL CORP. RAPHAEL WONG
K002266 11/22/2000 BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST BRANAN MEDICAL CORPORATION RAPHAEL WONG
K002337 11/22/2000 BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST BRANAN MEDICAL CORPORATION RAPHAEL WONG
K002342 11/27/2000 BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST BRANAN MEDICAL CORPORATION RAPHAEL WONG
K002264 11/27/2000 BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST BRANAN MEDICAL CORPORATION RAPHAEL WONG
K002417 11/22/2000 BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C AND 190D BRANAN MEDICAL CORPORATION RAPHAEL WONG
K002587 11/22/2000 BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST BRANAN MEDICAL CORPORATION RAPHAEL WONG
K002265 11/27/2000 BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN TEST BRANAN MEDICAL CORPORATION RAPHAEL WONG
K002268 11/27/2000 BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST BRANAN MEDICAL CORPORATION RAPHAEL WONG
K002418 11/22/2000 BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D BRANAN MEDICAL CORPORATION RAPHAEL WONG
K002499 11/08/2000 BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE BRENTWOOD MEDICAL TECHNOLOGY CORP. GLEN MIZELLE
K002421 11/03/2000 CANDELA MID IR DIODE LASER SYSTEM CANDELA CORP. JOAN CLIFFORD
K003220 11/08/2000 PERSONAL ECG TRANSMITTER, MODEL CG-6550 CARD GUARD SCIENTIFIC SURVIVAL, LTD. LEONID TRACHTENBERG
K991783 11/01/2000 AB-180 XC SYSTEM, MODEL AB-180XC CARDIAC ASSIST, INC. RICHARD G CONFER
K002597 11/17/2000 CN ACQUISITION STATION CARDIONOW, INC. JOHNNY M GARZA
K002792 11/08/2000 CARESIDE CHOLINESTERASE CARESIDE, INC. KENNETH B ASARCH
K002693 11/09/2000 CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS) CBS INTL. B.V. PATRICIA E JANSEN
K002493 11/30/2000 DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K003034 11/30/2000 COLTENE AURA COMPOMER RESTORATIVE SYSTEM COLTENE/WHALEDENT INC. H. J VOGELSTEIN
K003217 11/03/2000 HERMES PORT EXPANDER COMPUTER MOTION, INC. DAVID U THOMAS
K003222 11/03/2000 MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER COMPUTER MOTION, INC. DAVID U THOMAS
K003213 11/29/2000 ALMATEX POWDER-FREE LATEX EXANINATION GLOVES WITH PROTIEN LABELING CLAIM 50 MICROGRAMS OR LESS CONCEPT RUBBER PRODUCTS SDN BHD TEOH HUN LIM
K001249 11/02/2000 QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3 CONSOLIDATED TECHNOLOGIES OF WISCONSIN RUSTY SEWELL
K002288 11/28/2000 ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER COOK, INC. APRIL LAVENDER
K000651 11/24/2000 DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM COOK, INC. LISA WEBB
K003336 11/22/2000 MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM CORDIS CORP. ELENA S JUGO
K003365 11/22/2000 S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS) CORDIS CORP. SAM MIRZA
K002595 11/17/2000 CBS STRAW CRYO BIO SYSTEM GABRIELE LINGENOLELE
K002584 11/16/2000 ECAT ACCEL PET SCANNER CTI PET SYSTEMS, INC. WILLIAM SKREMSKY
K002080 11/16/2000 BEHRING COAGULATION SYSTEM, MODEL BCS DADE BEHRING, INC. RADAMES RIESGO
K002731 11/20/2000 N LATEX B2-MICROGLOBULIN DADE BEHRING, INC. RADAMES RIESGO
K002852 11/27/2000 N/T PROTEIN CONTROL SL DADE BEHRING, INC. REBECCA S AYASH
K000004 11/29/2000 ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509 DAIG CORP. PAUL CORNELISON
K003235 11/06/2000 PE.R.I. II KNEE FRACTURE SYSTEM DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K003146 11/21/2000 CLINIFLO INCENTIVE SPIROMETER DHD HEALTHCARE CORP. LAWRENCE WEINSTEIN
K003093 11/27/2000 ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30 DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K002262 11/28/2000 DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM DIAMEDIX CORP. LYNNE STIRLING
K002047 11/22/2000 DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2 DOCTOR'S RESEARCH GROUP, INC. RICHARD DESLAURIERS
K002608 11/16/2000 INVAC DUNCAN HYND ASSOCIATES, LTD. DIANA UPTON
K003473 11/28/2000 DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM ELSCINTEC SYSTEMS LTD. ELLIOT MARSHALL
K002615 11/13/2000 SURGICAL SYSTEM WITH CRYOGUIDE ENDOCARE, INC. VINCENT CUTARELLI
K003497 11/30/2000 DISPOSABLE PRESSURE MONITOR ENGINEERED MEDICAL SYSTEMS PAUL DRYDEN
K002778 11/22/2000 ENTERIC INJECTION CATHETER WITH IRRIGATION ENTERIC MEDICAL TECHNOLOGIES, INC. JILL M VISOR
K001177 11/13/2000 PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI ENTERIC PRODUCTS, INC. JEFFREY PEACOCK
K001788 11/03/2000 ESTATION ELECTRONIC STETHOSCOPE, MODEL DR200 ERECORDS ENTERPRISES ED GOSS
K002398 11/03/2000 ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING ETHICON ENDO-SURGERY, INC. EDWIN O BILLIPS
K003070 11/07/2000 ETHIBOND EXCEL VALVE LOOP SUTURE ETHICON, INC. GREGORY R JONES
K002672 11/22/2000 VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH ETHICON, INC. KAREN LESSIG
K003133 11/07/2000 MULTIPLE-VINYL EXAM GLOVE, POWDERED EXCELLENCE ENT. CO., LTD. JANNA P TUCKER
K003408 11/17/2000 CT CORD IQ OPTION 1.0 GE MEDICAL SYSTEMS LARRY A KROGER
K002089 11/21/2000 ROSETTA-LT/ROSETTA-RX GENERAL DEVICES MICHAEL SMITH
K001440 11/13/2000 NEXTSTITCH CARDIOVASCULAR VALVE SUTURE GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) MARY E GRAY
K003063 11/22/2000 GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE FINGERTIP PROTECTION GIMBEL GLOVE CO., LLC. GORDON P PARDY
K002662 11/02/2000 HARDYDISK CLINDAMYCIN, 2MCG HARDY DIAGNOSTICS MELISSA M TRAYLOR
K002593 11/29/2000 POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM HARTALEGA SDN BHD NURUL A KONG
K003359 11/27/2000 COLOSCREEN-ES HELENA LABORATORIES PAT FRANKS
K003335 11/17/2000 RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER HILL-ROM AIR-SHIELDS LARRY W KRASLEY
K002692 11/17/2000 DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A HMI INDUSTRIES, INC. JACQUELINE A PURCELL
K003413 11/24/2000 ALUMINA V40 HEAD HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K002552 11/13/2000 HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE HOWMEDICA OSTEONICS CORP. JENNIFER A DAUDELIN
K003391 11/28/2000 OSTEONICS ALUMINA C-TAPER HEAD HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K003379 11/30/2000 V-40/C-TAPER ADAPTER SLEEVE HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K001213 11/03/2000 CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60 HUDSON RESPIRATORY CARE, INC. DANA HOUGHTON
K003471 11/20/2000 MAGNA TEK ESU-400 HUTTINGER MEDIZINTECHNIK GMBH & CO KG BERNHARD HUG
K002764 11/24/2000 HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR HYDROCISION, INC. DEBBIE IAMPIETRO
K001948 11/01/2000 CVPROFILOR D0-2020 CARDIOVASCULAR PROFILING SYSTEM HYPERTENSION DIAGNOSTICS, INC. CHARLES F CHESNEY
K002886 11/24/2000 IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) IMPLANTECH ASSOCIATES, INC. EDWARD LEICHT
K003181 11/07/2000 IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX-YYY-ZZZZ IMPLEX CORP. JOHN SCHALAGO
K000023 11/06/2000 FRIENDLY LIGHT ER:YAG PULSED LASER INNOTECH USA, INC. THOMAS BECZE
K002600 11/15/2000 LITWIN CRUICATE ANCHOR INSTRUMENT MAKAR, INC. LANNY L JOHNSON
K002472 11/29/2000 DELTA 32 AND DELTA 32 TACT INSTRUMENTARIUM IMAGING, INC. TOMMI JOKINIEMI
K002392 11/02/2000 VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V INTEGRA NEUROCARE LLC. NANCY MATHEWSON
K002765 11/24/2000 LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE INTEGRA NEUROSCIENCES NANCY MATHEWSON
K001521 11/27/2000 SOFTSENS INTEGRATED BIOSENSING TECHNOLOGIES RONALD LUICH
K003204 11/07/2000 BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT INTRACEL CORP. SHANE WARD
K003373 11/28/2000 PROCAD ADD-ON IVOCLAR NORTH AMERICA, INC. ANDY GULATI
K002872 11/02/2000 R&D PROJECT DW271#11A IVOCLAR NORTH AMERICA, INC. ANDY GULATI
K002598 11/22/2000 EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING J. H. EMERSON CO. GEORGE EMERSON
K002640 11/08/2000 FREEDOM AUTOMATIC FILM PROCESSOR J. MORITA USA, INC. VICTOR MAZZANTI
K002993 11/16/2000 HERACERAM J.F. JELENKO & CO., INC. RAPHAEL JUDKINS
K003011 11/28/2000 SELF ETCH BONDING PRIMER JENERIC/PENTRON, INC. ANUMARIE TENERO
K002904 11/06/2000 WILLI GELLER CREATION AND LF PORCELAIN JENSEN INDUSTRIES, INC. JOHN SLANSKI
K003197 11/22/2000 VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES, YELLOW KAOHSIUNG BROTHERS PRODUCTS CORP. STONE CHEN
K002924 11/03/2000 3D ENDOSCOPE KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN KENNEN
K000806 11/30/2000 KARL STORZ HYSTEROMAT II KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN KENNAN
K002704 11/03/2000 KSEA MINIATURE NEUROENDOSCOPE KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN KENNAN
K002806 11/21/2000 K-DEFIB/PACE, MODEL KDP-60A KATECHO, INC. WARREN R WALTERS
K000870 11/07/2000 KM-10 TENS ELECTRODE KATECHO, INC. WARREN R WALTERS
K002708 11/28/2000 KAVO CORUND HANDPIECE 2013 KAVO AMERICA JOHN WESTERMEIER
K002805 11/09/2000 KENDRO HERACELL CO2 INCUBATOR KENDRO LABORATORY PRODUCTS, L.P. SUSAN D GOLDSTEIN-FALK
K002859 11/16/2000 SSW-STERILE SOLUTION WARMER KMI KOLSTER METHODS, INC. ALWIN H KOLSTER
K002390 11/02/2000 QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H LSI INTL., INC. JAMES C LANES
K003315 11/08/2000 SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA MALLINCKRODT, INC. JAMES C KEEVEN
K003167 11/08/2000 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES MASIMO CORP. JAMES J CRONIN
K003244 11/08/2000 MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES MASIMO CORP. JAMES J CRONIN
K002781 11/29/2000 MEDICAL CABLES PATIENT MONITORING CABLES FOR ECG, EEG, SPO2, AND BLOOD PRESSURE MONITORS MEDICAL CABLES, INC. CHRISTOPHER FONTANA
K003525 11/22/2000 VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON AMERICA, INC. GARY ALLSEBROOK
K003353 11/22/2000 MEDLINE ALOE TOUCH STERILE NITRILE EXAMINATION GLOVES WITH ALOE VERA MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K002023 11/13/2000 MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714 MEDMIRA LABORATORIES, INC. TODD BISHOP
K002363 11/01/2000 MEDOVATIONS ESOPHAGEAL DILATOR MEDOVATIONS, INC. MICHAEL J BROWN
K001663 11/16/2000 FRONT-LOAD POLYPROPYLENE SYRINGE MEDRAD, INC. FRANK W PELC III
K002572 11/16/2000 MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005 MEDTRONIC PS MEDICAL JANET MCAULEY
K002103 11/02/2000 SIMPLICITY SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. RICHARD TREHARNE
K002931 11/24/2000 METRX SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
K001714 11/03/2000 MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149 MERCURY MEDICAL RON RUPENSKI
K001347 11/03/2000 MERIDIAN-II AND MERDIAN-PLUS MERIDIAN CO., LTD. SOO-RANG LEE
K002812 11/08/2000 IRIS RETRACTING PHACOEMULSIFICATION SLEEVE MICHAEL REYNARD, M.D. MICHAEL REYNARD
K001544 11/17/2000 VAGINAL APPLICATOR SHIELDED MICK RADIO-NUCLEAR INSTRUMENTS, INC. FELIX MICK
K003308 11/14/2000 MICROLIFE DIGITAL INFRARED EAR THERMOMETER, IR1DAI, IR1DB1, IR1DD1 MICROLIFE CORP. SUSAN D GOLDSTEIN-FALK
K002059 11/13/2000 AMT SPINAL SYSTEM MICRON PRECISION ENGINEERING, INC. FRANK E BAILY
K002864 11/21/2000 MODEL 6600GE-64: TRAMA NECK ARRAY MIDWEST R.F. LLC. RALPH S HASHOIAN
K002860 11/22/2000 MODEL 6900GE-64: C-SPINE ARRAY MIDWEST R.F. LLC. RALPH S HASHOIAN
K002774 11/16/2000 HRH-63 HEAD ARRAY COIL MRI DEVICES CORP. THOMAS SCHUBERT
K003340 11/08/2000 OBC-149 BREAST ARRAY COIL MRI DEVICES CORP. THOMAS SCHUBERT
K003331 11/08/2000 QWH-149 WRIST ARRAY COIL MRI DEVICES CORP. THOMAS SCHUBERT
K003349 11/13/2000 ALLON 2001 MODIFIED MTRE ADVANCED TECHNOLOGY LTD. PAUL DRYDEN
K003287 11/06/2000 MODEL K7 EVALUATION DEVICE MYOTRONICS-NOROMED, INC. FRAY ADIB
K003302 11/22/2000 IM-5A INJECTOR NARISHIGE CO., LTD. MITSUKO YONEYAMA
K003303 11/22/2000 IM-5B MICROINJECTOR NARISHIGE CO., LTD. MITSUKO YONEYAMA
K003304 11/22/2000 IM-6 MICROINJECTOR NARISHIGE CO., LTD. MITSUKO YONEYAMA
K003300 11/22/2000 MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR NARISHIGE CO., LTD. MITSUKO YONEYAMA
K003298 11/21/2000 MO-202U THREE-AXIS JOYSTICK HYDRAULIC MICROMANIPULATOR NARISHIGE CO., LTD. MITSUKO YONEYAMA
K001455 11/02/2000 ACCUWELL TSH, MODEL KAW-TSH-960 NEOMETRICS, INC. DAVID SCHWARTZ
K001564 11/24/2000 SCAN LT40 (40 CHANNELS) NEURO SCAN LABS DAVID B JONES
K001692 11/24/2000 NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8 NEUROSOFT, INC. DAVID B JONES
K002766 11/30/2000 NICOLET VASOGUARD NICOLET BIOMEDICAL DAVID W WAGNER
K002623 11/20/2000 PURESPERM 40 AND PURESPERM 80 NIDACON INTERNATIONAL AB DANIEL KAMM
K002630 11/21/2000 PURESPERM WASH NIDACON INTERNATIONAL AB DANIEL KAMM
K001433 11/07/2000 CNS-9300 SERIES CENTRAL STATION NIHON KOHDEN AMERICA, INC. BONNIE BISHOP
K002473 11/08/2000 WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES NIHON KOHDEN AMERICA, INC. BONNIE BISHOP
K003444 11/21/2000 MODEL WS-500 DIGITAL WRIST BLOOD PRESSURE MONITOR NIHON SEIMITSU SOKKI CO., LTD. ROBERT D WAXHAM
K002813 11/21/2000 NIPRO SAFETOUCH SAFETY FISTULA NEEDLE NIPRO MEDICAL CORP. RICHARD D BLISS
K002475 11/09/2000 REPLACE TPS COATED IMPLANTS NOBEL BIOCARE UAS INC DON KENNARD
K000404 11/22/2000 PC ECG 1200 NORAV MEDICAL LTD. STEVE SPRINGROSE
K002724 11/17/2000 NUMALINK NUMA, INC. LARRY SMITH
K003114 11/01/2000 NUMED TYSHAK AND Z-MED PTV CATHETERS NUMED, INC. NICHELLE R LAFLESH
K003052 11/01/2000 NUMED TYSHAK II AND Z-MED II PTV CATHETERS NUMED, INC. NICHELLE R LAFLESH
K002677 11/13/2000 NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM NUVASIVE, INC. R. STEPHEN REITZLER
K002966 11/08/2000 OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR OCU-EASE OPTICAL PRODUCTS, INC. CHARLES R VERNETTE
K002703 11/21/2000 O-PERM 30 OPTICAL POLYMER RESEARCH, INC. WERNER P SCHUMAN
K002620 11/16/2000 SURESMILE SYSTEM ORA METRIX, INC. NANCY BUTCHER
K002010 11/29/2000 STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 ORASURE TECHNOLOGIES, INC. R. SAM NIEDBALA
K003256 11/08/2000 PCCR DIGITAL IMAGING DEVICE OREX COMPUTED RADIOGRAPHY LTD ROSINA ROBINSON
K003112 11/02/2000 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS Ortho-Clinical Diagnostics, Inc. SUSAN WERNER
K003028 11/24/2000 CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC OSTEOGENICS BIOMEDICAL, INC. CHAD BARTEE
K003384 11/24/2000 VERSALINK TITANIUM ROD-TO-ROD COUPLERS OSTEOTECH, INC. KIM THURMAN
K002787 11/29/2000 MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120 PALCO LABS, INC. RICHELLA GOO
K002649 11/21/2000 ARAMIS DERMATOLOGICAL LASER PALOMAR MEDICAL TECHNOLOGIES, INC. Marcy Moore
K002024 11/22/2000 PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA PANBIO, INC. DAVID C BISHOP
K002486 11/09/2000 PRECIMED TRAUMA SYSTEM PATRICK BERDOZ PATRICK BERDOZ
K003414 11/27/2000 VARELISA TG (THYROGLOBULIN) ANTIBODIES, PHARMACIA & UPJOHN CO. KAREN E MATIS
K002476 11/09/2000 LUMBOPERITONEAL SHUNT SYSTEM PHOENIX BIOMEDICAL CORP. COURTNEY SMITH
K002357 11/09/2000 100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS PIE MEDICAL COLLEEN J HITTLE
K002629 11/20/2000 SILMAX CONTOUR CARVING BLOCK IMPLANT PILLAR SURGICAL, INC. ROB FRITZENKOTTER
K002633 11/21/2000 SILMAX PECTORAL IMPLANT PILLAR SURGICAL, INC. ROB FRITZENKOTTER
K002582 11/03/2000 PILLING E-FRAZIER BIPOLAR SUCTION TUBE PILLING ELIZABETH LAZARO
K002571 11/16/2000 MULITPLE MALE LATX CONDOM PLEASURE LATEX PRODUCTS SDN. BHD. KOI-YONG LIM
K002199 11/20/2000 MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET POINTE SCIENTIFIC, INC. RON JAMISON
K002214 11/21/2000 SINUSCOPE AND BACCESSORIES POLLUX ENDOSCOPY, INC. PRECIOUS J RESCH
K002586 11/17/2000 MEDPOR PTERIONAL SURGICAL IMPLANT POREX SURGICAL PRODUCTS GROUP HOWARD MERCER
K002707 11/08/2000 PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING PRECISION VASCULAR SYSTEMS, INC. JOHN R RAGAZZO
K002725 11/21/2000 MICROPAQ, MODELS 402 AND 404 PROTOCOL SYSTEMS, INC. DON M ABBEY
K002752 11/20/2000 BAYONET FORCEPS BIPOLAR IRRIGATING Q2 MEDICAL ERIC MILLS
K001278 11/29/2000 SENSAIRE DIAGNOSTIC SPIROMETER QRS DIAGNOSTIC, LLC. JILL R KRALL
K003096 11/30/2000 FASTPACK CALIBRATORS Qualigen, Inc. DOROTHY DEINZER
K003095 11/29/2000 FASTPACK CONTROL Qualigen, Inc. DOROTHY DEINZER
K003069 11/27/2000 ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM QUEST INTL., INC. ROBERT A CORT
K003208 11/07/2000 R & D 3K RETIC R & D SYSTEMS, INC. KENNETH T EDDS
K003236 11/02/2000 RETINADX REGULATORY ASSOCIATES, INC. Kevin Walls
K003142 11/22/2000 MICROMANIPULATOR RESEARCH INSTRUMENTS LTD. BEN MURDOCK
K003233 11/03/2000 RS NITRILSTST MEDICAL EXAMINATION GLOVES, POWDERED (NON STERILE) BLUE RIVERSTONE RESOURCES SDN. BHD. CHONG CHU MEE
K003261 11/16/2000 CREATININE PLUS ROCHE DIAGNOSTICS CORP. PRISCILLA A HAMILL
K002520 11/13/2000 ROVERS SPATULA ROVERS MEDICAL DEVICES B.V. TODD M GATES
K002502 11/08/2000 CERAM-PRIME S & C POLYMER GMBH JURGEN ENGELBRECHT
K002098 11/24/2000 SALUMEDICA NERVE CUFF SALUMEDICA, L.L.C. DAVID N KU
K002062 11/09/2000 SAMSUNG 10DR IMPLANT SYSTEM SAMSUNG SDS CO., LTD CARL ALLETTO
K001563 11/22/2000 SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET SCION CARDIOVASCULAR, INC. DAVID B JONES
K003046 11/24/2000 IMAGE VASCULAR LASER SCITON, INC. PETER ALLEN
K003282 11/01/2000 FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H SEIN ELECTRONICS CO., LTD. WON KY KIM
K003321 11/22/2000 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR SHANGHAI ANTARES INDUSTRIES, INC. JOHN LAI
K002818 11/29/2000 NIRTRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDERED, NON STERILE SIAM SEMPERMED CORP. LTD. WILLIAM HARRIS
K002819 11/29/2000 NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR) POWDERED, NON STERILE SIAM SEMPERMED CORP. LTD. WILLIAM HARRIS
K003179 11/09/2000 SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. PENELOPE H GRECO
K002463 11/08/2000 STELLAR SKYTRON, DIV. THE KMW GROUP, INC. KARI OGREEN
K000253 11/16/2000 SILENT NIGHT V SLEEP SOLUTIONS, INC. CAROLE M SYKES
K002740 11/30/2000 TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS SMITH & NEPHEW, INC. KIM P KELLY
K002991 11/28/2000 ZAP DUAL CURING LIGHT SOFT-CORE TEXAS, INC. ROY MARTIN
K003399 11/16/2000 SONOSITE HAND-CARRIED ULTRASOUND SYSTEM SONOSITE,INC. MICHAEL A HOFFMAN
K002521 11/13/2000 SPARTAN MTS SPARTAN MARKETING GROUP ALDO E EAGLE
K003079 11/21/2000 SPECIALTY TINT SOFT CONTACT LENS SPECIALTY TINT ROBERT BREECE
K003087 11/07/2000 MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION SPORICIDIN INTL. HAROLD E PLANK
K002834 11/29/2000 SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR SRS MEDICAL SYSTEMS, INC. LEE BRODY
K002861 11/29/2000 EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124 STERITEC PRODUCTS, INC. LINDA NELSON
K003007 11/17/2000 GALAXY STERNGOLD SUSAN L SPEAR
K002374 11/01/2000 ITI DENTAL IMPLANT SYSTEM MONOTYPE IMPLANT STRAUMANN USA LINDA JALBERT
K002619 11/16/2000 NEWGEN SYSTEM STRYKER INSTRUMENTS ROBIN L ROWE
K002843 11/15/2000 SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010 SULTAN CHEMISTS, INC. CLARK SMITH
K002575 11/15/2000 INTER-OP DURASUL ACETABULAR INSERTS (4MM) SULZER ORTHOPEDICS, INC. MITCHELL A DHORITY
K002786 11/17/2000 BIOSENSORS CENTRAL VENOUS CATHETER KITS SUNSCOPE INTL., INC. JORGE HAIDER
K002916 11/28/2000 SURGI-VISION PROSTATE COIL SURGI-VISION, INC. NANCY E TAYLOR
K002605 11/20/2000 4.0/2.5 MM SELF-DRILLING SCHANZ SCREW SYNTHES (USA) BONNIE J SMITH
K002935 11/16/2000 SYNTHES 1.5MM TI BROW LIFT SCREW SYNTHES (USA) THOMAS M MAGUIRE
K002362 11/01/2000 SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS) SYNTHES (USA) BONNIE J SMITH
K001841 11/15/2000 35/CD CINECONVERTER TAGARNO A/S MAX JENS JENSEN
K003306 11/22/2000 C. DIFFICILE TOX A/B II TECHLAB, INC. DAVID M LYERLY
K003424 11/21/2000 PINNACLE R/O II OR RADIFOCUS INTRODUCER II TERUMO MEDICAL CORP. YUK-TING LEWIS
K002840 11/17/2000 MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM THE PHANTOM LABORATORY, INC. JOSHUA R LEVY
K002720 11/09/2000 FORMULA ONE STERILE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) MADE FROM ALLO TILLOTSON HEALTHCARE CORP. F.W. PERRELLA
K002680 11/13/2000 TISSUELINK MONOPOLAR FLOATING BALL' TISSUELINK MEDICAL, INC. ROBERTA THOMPSON
K001947 11/22/2000 T.I.M.S., VERSION 2.00 TOTAL MEDICAL INFORMATION MANAGEMENT SYSTEMS, INC. DON BEAVERS
K002816 11/22/2000 TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV TRANSONIC SYSTEMS, INC. MARK S ALSBERGE
K001676 11/02/2000 OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A TRIMEDYNE, INC. SUSAN H GAMBLE
K001525 11/29/2000 CAPTIA SYPHILIS-G ELISA TEST SYSTEM TRINITY BIOTECH, PLC WAYNE KVETKOSKY
K002990 11/06/2000 VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001 VASCULAR TECHNOLOGY INCORPORATED DAVID L REGAN
K002780 11/17/2000 VIATRONIX VISUALIZATION SYSTEM (VVS) VIATRONIX, INC. SUSAN D GOLDSTEIN-FALK
K992529 11/17/2000 TISSUE SPECTROSCOPE VITAL MEDICAL LTD. BRUCE F MACKLER
K003153 11/15/2000 SOLOBOND PLUS VOCO GMBH EVAN DICK
K002184 11/24/2000 COD COMPRESSION OSTEOTOMY DEVICE WALTER ABENDSCHEIN, M.D. WALTER ABENDSCHEIN
K002714 11/28/2000 WARTNER WART REMOVAL SYSTEM WARTNER MEDICAL PRODUCTS JUDY MAGNER
K002530 11/14/2000 WELCH ALLYN SPOT CHECK DEVICE WELCH ALLYN, INC. JOSEPH D BUCHANAN
K993852 11/29/2000 FIRST CHECK HOME DRUG TEST PANEL 4 WORLDWIDE MEDICAL CORP. LARRY R PILOT
K002683 11/22/2000 WMT ULTRA-FIT MODULAR SHOULDER SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K001613 11/22/2000 COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) WRP ASIA PACIFIC SDN. BHD. YUE WHA CHOW
K002064 11/28/2000 COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL WRP ASIA PACIFIC SDN. BHD. YUE WAH CHOW
K003019 11/03/2000 PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILE WRP ASIA PACIFIC SDN. BHD. YUE WAH CHOW
K003132 11/17/2000 DERMAGRIP POWDER FREE BLUE POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAM OR LESS OF TOTAL WA WRP SPECIALTY PRODUCTS SDN. BHD. MOHD HAIZAN HUSSEIN
K003309 11/22/2000 DERMAGRIP POWDER FREE GREEN POLYMER COATED EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE WRP SPECIALTY PRODUCTS SDN. BHD. MOHD HAIZAN HUSSEIN
K003307 11/22/2000 DERMAGRIP POWDER FREE PINK POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL W WRP SPECIALTY PRODUCTS SDN. BHD. MOHD HAIZAN HUSSEIN
K002961 11/21/2000 MINITUB MULTI-PURPOSE CASSETTES ZANDER MEDICAL SUPPLIES, INC. FRIEDEL MW ZANDER
K003184 11/20/2000 RS BIOTECH GALAXY 'R' CO2 INCUBATOR ZANDER MEDICAL SUPPLIES, INC. FRIEDEL MW ZANDER
K002687 11/09/2000 ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3 ZYNERGY CARDIOVASCULAR, INC. JING ZHANG


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