FDA 510(k) Decisions During January, 2000  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K992504 01/27/2000 EMS KERMIT (EMS SA) ELECTRO MEDICAL SYSTEMS CYNTHIA J.M. NOLTE
K992489 01/11/2000 3M TR SYSTEM 3M COMPANY LAEL J PICKETT
K001600 11/22/2000 CODA INCUBATOR CELLMATE INTL., INC. MICHAEL D CECCHI
K993526 01/11/2000 SYNEA - LS LOW-SPEED HANDPIECE A-DEC, INC. PATRICK RIDENOUR
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
K992684 01/14/2000 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM ABBOTT DIABETES CARE INC. EVE A CONNER
K001993 11/13/2000 SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS ABBOTT LABORATORIES JOE MAGLIOZZI
K992914 01/27/2000 EXCIMER LASER PHOTOTHERAPY SYSTEM, AL7000 ACCULASE, INC. AL MEMMOLO
K001044 11/03/2000 ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM ACME SPINE, LLC. TIMOTHY WILLIAMS
K993483 01/20/2000 ACON ONE STEP HOME PREGNANCY TEST STRIP ACON LABORATORIES, INC. NORA C.R. YORK
K993657 01/13/2000 ACUMED SUTURE ANCHOR ACUMED, INC. SHARI JEFFERS
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
K991391 01/10/2000 PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF ADVANCED REPRODUCTIVE TECHNOLOGIES GREG HOLLAND
K002573 11/16/2000 ADVANCED UROSCIENCE INNERSHEATH ADVANCED UROSCIENCE, INC. KAREN E PETERSON
K992053 01/13/2000 AESCULAP VASCULAR INSTRUMENTS AESCULAP, INC. MARY ELLEN HOLDEN
K993551 01/13/2000 SOCON SPINAL SYSTEM AESCULAP, INC. LIA S JONES
K002459 11/08/2000 PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH AGILENT TECHNOLOGIES, INC. ROB BUTLER
K992454 01/13/2000 VENAFLOW SYSTEM, MODEL 30A AIRCAST, INC. STEPHEN KENNEY
K993522 01/10/2000 AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT AKTINA MEDICAL PHYSICS CORP. JOAN ZACHAROPOULOS
K992767 01/10/2000 BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR ALBERT BROWNE LTD. CYNTHIA J.M. NOLTE
K993795 01/12/2000 CONVERTORS SURGICAL DRAPES ALLEGIANCE HEALTHCARE CORP. SHARON ROBBINS
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
K993622 01/24/2000 NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY ALPHA OMEGA LTD. SHOSHANA S FRIEDMN
K001520 11/22/2000 ALPHA OMEGA DUAL COOLER-HEATER ALPHA OMEGA, INC. RICHARD MARTIN
K993873 01/03/2000 ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD ALPHATEC MFG., INC. JASON BLAIN
K000065 01/28/2000 CAMLOG CYLINDER IMPLANT SYSTEM ALTATEC BIOTECHNOLOGIES R.J. SLOMOFF
K000100 01/28/2000 CAMLOG ROOTFORM IMPLANT SYSTEM ALTATEC BIOTECHNOLOGIES R.J. SLOMOFF
K000099 01/28/2000 CAMLOG SCREW IMPLANT SYSTEM ALTATEC BIOTECHNOLOGIES R.J. SLOMOFF
K992563 01/18/2000 A-22 HEMODIALYZER ALTHIN MEDICAL AB LARS-OLOF SANDBERB
K992566 01/18/2000 AF-150 HEMODIALYZER ALTHIN MEDICAL AB LARS-OLOF SANDBERG
K992564 01/18/2000 AF-180 HEMODIALYZER ALTHIN MEDICAL AB LARS-OLOF SANDBERG
K992573 01/18/2000 AF-220 HEMODIALYZER ALTHIN MEDICAL AB LARS-OLOF SANDBERB
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
K993151 01/10/2000 RADID DRUG SCREEN 5-PANEL TEST AMERICAN BIO MEDICA CORP. JOHN B DUBECK
K993961 01/24/2000 RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO) AMERICAN BIO MEDICA CORP. HENRY WELLS
K993629 01/21/2000 ABI VEST AIRWAY CLEARANCE SYSTEM AMERICAN BIOSYSTEMS, INC. ERIC J LARSON
K002721 11/29/2000 AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH AMERICAN MEDICAL SYSTEMS, INC. GINGER Z GLASER
K993550 01/13/2000 AVIVA SYSTEM, MODEL SL1010 AMERICAN TELECARE, INC. CHARLES RICHARD ABRUSCATO
K992719 01/12/2000 AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE AMSINO INTL., INC. RICHARD Y LI
K992016 01/10/2000 AMUKIN D AMUCHINA INTL., INC. LUDOVICO GIAVOTTO
K994107 01/13/2000 AMYSYSTEMS PTS50-50 DEGREE POWER TILT SYSTEM FOR MID-WHEEL OR FRONT-WHEEL DRIVE POWER WHEELCHAIRS. AMYLIOR, INC. SYLVAIN DUGAS
K994072 01/13/2000 AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM AMYLIOR, INC. SYLVAIN DUGAS
K002503 11/09/2000 FETALGARD LITE ANALOGIC CORP. STEVEN A CLARKE
K992493 11/06/2000 VIPON TAMPON ANOTHERWAY PRODUCTS LLC. STEVEN A KILGORE
K993857 01/31/2000 THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (60 MICROGRAMS OR ANSELL PERRY JAMES R CHATTERTON
K990340 01/28/2000 ARTHREX PLA TISSUETAK, MODEL # AR-1940 BU ARTHREX, INC. VERNON C BROWN
K990987 01/13/2000 BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B ARTHREX, INC. VERNON BROWN
K994330 01/18/2000 ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076 ASPECT MEDICAL SYSTEMS, INC. CHRISTINE MORGIDA
K992991 01/27/2000 ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT ATRIUM MEDICAL CORP. KAREN HALL
K992998 01/10/2000 AUTOMATED OPHTHALMICS SOFTIPS AUTOMATED OPHTHALMICS, INC. NORMAN BICKMAN
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
K994313 01/13/2000 MODIFICATION TO BONE ANCHOR AND KIT (BAK) AXYA MEDICAL, INC. HOWARD L SCHRAYER
K994111 01/03/2000 CELSITE, MODELS ST401L, ST405L B. BRAUN/MCGAW VALERIE LEWIS
K993039 01/07/2000 VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700) BAUSCH & LOMB, INC. VANADA JOHNSON
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
K994439 01/14/2000 ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306 BECKMAN COULTER, INC. MICHELE S GUST
K993210 01/05/2000 ACCESS HYBRITECH FREE PSA QC, MODEL 37219 BECKMAN COULTER, INC. MICHEL GUST
K994200 01/18/2000 ACCESS HYBRITECH PSA QC, MODEL 37209 BECKMAN COULTER, INC. MICHELE GUST
K994277 01/14/2000 ACCESS OSTASE QC BECKMAN COULTER, INC. MARA CALER
K003098 11/20/2000 ACCESS ULTRASENSITIVE HGH CALIBRATORS BECKMAN COULTER, INC. MARA CALER
K003488 11/27/2000 SYNCHRON CONTROL BECKMAN COULTER, INC. GAIL LEFEBVRE
K994325 01/12/2000 SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR BECKMAN COULTER, INC. GAIL LEFEBVRE
K993954 01/11/2000 SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS BECKMAN COULTER, INC. LUCINDA STOCKERT
K002456 11/02/2000 MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992 BECTON DICKINSON VACUTAINER SYSTEMS James Haynes
K983866 01/06/2000 BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP BELMONT INSTRUMENT CORP. URAIWAN P LABADINI
K994082 01/28/2000 POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 MICROGRAM OR LESS) BESGLOVE MEDICARE SDN. BHD. LEE AIK LIM
K994037 01/11/2000 THE 4.5MM DIAMETER BICON DENTAL IMPLANT BICON, INC. VINCENT J MORGAN
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
K993238 01/14/2000 FORTOSS-CEMA BIOCOMPOSITES LTD. JS BRATT
K993493 01/07/2000 THE AUTOTAC SYSTEM BIOHORIZONS IMPLANT SYSTEMS, INC. WINSTON D GREER
K993824 01/20/2000 MSAS PROFESSIONAL BIOMERIDIAN, INT. JOE GALLOWAY
K994326 01/07/2000 ASCENT KNEE SYSTEM BIOMET MANUFACTURING, INC. TRACY J BICKEL
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
K994043 01/11/2000 CORRECT TOUCH LATEX POWDERED EXAMINATION GLOVES BIOPRO (M) SDN BHD JAMES H LALE
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
K000048 01/31/2000 SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1 BIOSURGICAL CORP. TERRY LAAS
K990856 01/11/2000 HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682 BIRD PRODUCTS CORP. TOM GUTIERREZ
K003317 11/21/2000 RENEW LS-1 BISCO, INC. CINDY ORIS
K003361 11/28/2000 RENEW LS-2 BISCO, INC. CYNDY ORIS
K994252 01/04/2000 INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE BOSTON SCIENTIFIC CORP. ANDREA BOUMIS
K993418 01/21/2000 FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL BOSTON SCIENTIFIC, TARGET ROXANE BAXTER
K993417 01/21/2000 GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC) BOSTON SCIENTIFIC, TARGET ROXANE BAXTER
K993415 01/21/2000 GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2-DIAMETER STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-1 BOSTON SCIENTIFIC, TARGET ROXANE BAXTER
K992916 01/11/2000 BRAINLAB STEREOTACTIC ARC BRAINLAB ERIC LINDQUIST
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
K993900 01/28/2000 COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MODEL 20-115 BRONCUS TECHNOLOGIES, INC. JOHN D'ANGELO
K984083 01/18/2000 MULTIFUNCTION KEITO K5 BUMEDCO INTL., INC. DARROLD GLANVILLE
K993392 01/06/2000 BARD MEMOTHERM FLEXX BILIARY STENT C.R. BARD, INC. CAROL VIERLING
K993840 01/31/2000 BARD UROFORCE BALLOON DILATION CATHETER C.R. BARD, INC. ANGELA L BUNN
K993892 01/06/2000 DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-45 C.R. BARD, INC. MARION GORDON
K002421 11/03/2000 CANDELA MID IR DIODE LASER SYSTEM CANDELA CORP. JOAN CLIFFORD
K993671 01/24/2000 CANDELA SCLERO LONG PULSE DYE LASER CANDELA CORP. JOAN CLIFFORD
K992101 01/06/2000 CRITERION 40 OR PM 40 CARADYNE, LTD. PAUL E DRYDEN
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
K993533 01/24/2000 POWERHEART AECD CARDIAC SCIENCE, INC. STAN E TILLMAN
K002597 11/17/2000 CN ACQUISITION STATION CARDIONOW, INC. JOHNNY M GARZA
K993519 01/14/2000 RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST CARDIOVASCULAR DIAGNOSTICS, INC. PETER SCOTT
K002792 11/08/2000 CARESIDE CHOLINESTERASE CARESIDE, INC. KENNETH B ASARCH
K991023 01/27/2000 STERITITE PERFORATED BOTTOM RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02 - POLYPROPYLENE NON-WOVEN DISPOSABL CASE MEDICAL, INC. LARRY R PILOT
K002693 11/09/2000 CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS) CBS INTL. B.V. PATRICIA E JANSEN
K993949 01/05/2000 SOLO-CARE BRAND HARD SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
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
K993802 01/18/2000 SHARPVIEW IMAGE ENHANCEMENT SYSTEM CONTEXTVISION AB CONSTANCE BUNDY
K993948 01/06/2000 SIS WOUND DRESSING II COOK BIOTECH, INC. NEAL E FEARNOT
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
K993455 01/11/2000 FLIPPER DETACHABLE EMBOLIZATION COIL COOK, INC. KAREN BRADBURN
K994358 01/13/2000 ATW MARKER WIRE STEERABLE GUIDEWIRE CORDIS CORP. DENNIS S GRIFFIN
K993720 01/18/2000 CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER CORDIS CORP. ARIEL MACTAVISH
K994156 01/07/2000 MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY STENT, MODELS PQ294B, PQ394B CORDIS CORP. CHARLES J RYAN
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
K993659 01/18/2000 RENAMEL PACK COSMEDENT, INC. MICHAEL O'MALLEY
K993658 01/18/2000 RENAMEL SCULPT COSMEDENT, INC. MICHAEL O'MALLEY
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
K993463 01/04/2000 INTRAVASCULAR ADMINISTRATION SET CUSTOM ASSEMBLIES, INC. PAUL E DRYDEN
K994427 01/18/2000 CYNOSURE M2 DERMATOLOGY LASER FOR HAIR REMOVAL CYNOSURE, INC. GEORGE CHO
K994437 01/18/2000 CYNOSURE PHOTOGENICA SPIR CYNOSURE, INC. GEORGE CHO
K992957 01/28/2000 ADVANCED D-DIMER DADE BEHRING, INC. REBECCA S AYASH
K992959 01/11/2000 BEHRING COAGULATION SYSTEM (BCS) DADE BEHRING, INC. REBECCA S AYASH
K002080 11/16/2000 BEHRING COAGULATION SYSTEM, MODEL BCS DADE BEHRING, INC. RADAMES RIESGO
K994114 01/20/2000 DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR DADE BEHRING, INC. ROBIN O NORRIS
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
K994115 01/28/2000 TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE DADE BEHRING, INC. ROBIN O NORRIS
K993679 01/14/2000 MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN DADE MICROSCAN, INC. TREVOR WALL
K983953 01/14/2000 MICROSTREP PLUS PANEL, VANCOMYCIN DADE MICROSCAN, INC. SHAROLYN J LENTSCH
K000004 11/29/2000 ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509 DAIG CORP. PAUL CORNELISON
K993531 01/13/2000 PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX DATASCOPE CORP. SUSAN E MANDY
K993897 01/10/2000 CERGOGOLD DEGUSSA - NEY DENTAL, INC. ANDREW J PIETROBONO
K003235 11/06/2000 PE.R.I. II KNEE FRACTURE SYSTEM DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K993465 01/11/2000 DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE DEPUY, INC. ARLENE C SAULL
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
K993920 01/18/2000 ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17 DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K992632 01/27/2000 IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5 DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K992634 01/20/2000 IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5 DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K994085 01/28/2000 IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5 DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K002262 11/28/2000 DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM DIAMEDIX CORP. LYNNE STIRLING
K993738 01/06/2000 DISPOS-A-SCOPE DISPOS-A-SCOPE LAUREL NICHOLAS
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
K993919 01/03/2000 DYNATRON 900 DYNATRONICS CORP. JOHN S RAMSEY
K003473 11/28/2000 DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM ELSCINTEC SYSTEMS LTD. ELLIOT MARSHALL
K994070 01/20/2000 REVELATION POROUS HIP STEM ENCORE ORTHOPEDICS, INC. DEBBIE DE LOS SANTOS
K993376 01/05/2000 ENSTYLET MODELS EC0010, EC0020 ENDOCARDIAL SOLUTIONS, INC. JAMES BULLOCK
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
K993797 01/20/2000 EC-7701 FLUID WARMING CABINET ENTHERMICS MEDICAL SYSTEMS, INC. EMALEE G MURPHY
K992811 01/18/2000 TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING EPIC MEDICAL EQUIPMENT SERVICES, INC. KRISTA OAKES
K001788 11/03/2000 ESTATION ELECTRONIC STETHOSCOPE, MODEL DR200 ERECORDS ENTERPRISES ED GOSS
K991935 01/27/2000 EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEM ESC MEDICAL SYSTEMS LTD. ZVI LADIN
K994190 01/27/2000 IMPREGUM GARANT L DUOSOFT ESPE DENTAL AG ANDRERAS PETERMANN
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K002703 11/21/2000 O-PERM 30 OPTICAL POLYMER RESEARCH, INC. WERNER P SCHUMAN
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K002010 11/29/2000 STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 ORASURE TECHNOLOGIES, INC. R. SAM NIEDBALA
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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
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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
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K003414 11/27/2000 VARELISA TG (THYROGLOBULIN) ANTIBODIES, PHARMACIA & UPJOHN CO. KAREN E MATIS
K993585 01/05/2000 VARELISA TPO ANTIBODIES, MODEL 12348/12396 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
K993377 01/13/2000 MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC) POLYMER TECHNOLOGY SYSTEMS, INC. MARGO ENRIGHT
K002586 11/17/2000 MEDPOR PTERIONAL SURGICAL IMPLANT POREX SURGICAL PRODUCTS GROUP HOWARD MERCER
K994263 01/24/2000 SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540 PRECISION DYNAMICS CORP. KALYNA SNYLYK
K002707 11/08/2000 PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING PRECISION VASCULAR SYSTEMS, INC. JOHN R RAGAZZO
K994224 01/31/2000 PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL PRIME DENTAL MANUFACTURING, INC. ROLANDO MARASIGAN
K993870 01/18/2000 UNSCENTED INTERLABIAL MENSTRUAL PAD PROCTER & GAMBLE CO. MARK M ANDERSON
K994272 01/07/2000 AUTOMATED CORE BIOPSY DEVICE PROMEX, INC. JOSEPH L MARK
K002725 11/21/2000 MICROPAQ, MODELS 402 AND 404 PROTOCOL SYSTEMS, INC. DON M ABBEY
K993058 01/24/2000 PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL PURE WATER, INC. RHONDA S MCCOY
K992786 01/24/2000 PURE WATER, INC.'S WATER PURIFICATION SYSTEMS PURE WATER, INC. CYNTHIA P WALTERS
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
K992859 01/10/2000 ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE RADIOMETER AMERICA, INC. VINCENT M SIGMUND
K003236 11/02/2000 RETINADX REGULATORY ASSOCIATES, INC. Kevin Walls
K003142 11/22/2000 MICROMANIPULATOR RESEARCH INSTRUMENTS LTD. BEN MURDOCK
K992286 01/21/2000 DERMAFREEZE RHEALM PHARMACEUTICALS, INC. RICHARD MANN
K994071 01/18/2000 RHIGENE ANA ELISA TEST SYSTEM RHIGENE, INC. DAVE KOLESAR
K003233 11/03/2000 RS NITRILSTST MEDICAL EXAMINATION GLOVES, POWDERED (NON STERILE) BLUE RIVERSTONE RESOURCES SDN. BHD. CHONG CHU MEE
K992851 01/14/2000 ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM ROCHE DIAGNOSTICS CORP. LUANN OCHS
K003261 11/16/2000 CREATININE PLUS ROCHE DIAGNOSTICS CORP. PRISCILLA A HAMILL
K994017 01/27/2000 ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1 ROCHE DIAGNOSTICS CORP. JENNIFER TRIBBETT
K994030 01/27/2000 ONTRAK TESTCUP 5, CAT. 07 6481 7 ROCHE DIAGNOSTICS CORP. JENNIFER TRIBBETT
K994020 01/27/2000 ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2 ROCHE DIAGNOSTICS CORP. JENNIFER TRIBBETT
K993426 01/07/2000 ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z44 ROSSMAX INTERNATIONAL LTD. MICHAEL YEH
K993429 01/07/2000 ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z40 ROSSMAX INTERNATIONAL LTD. MICHAEL YEH
K993460 01/11/2000 ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z43 ROSSMAX INTERNATIONAL LTD. MICHAEL YEH
K992403 01/21/2000 MRP-TITAN ROTEC MEDIZINTECHNIK GMBH ING ULRICH HOLZWARTH
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
K994081 01/18/2000 SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES SAFESKIN CORP. EUGENE V GOORCHENKO
K991390 01/18/2000 1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI SAGE BIOPHARMA GREG HOLLAND
K992285 01/07/2000 SALTER AIRE COMPRESSOR SALTER LABS DUANE KAZAL
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
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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
K993880 01/12/2000 SHANGHAI GLOVMAX ENTERPRISE CO, LTD., POWDER-FREE VINYL PATIENT EXAMINATION GLOVES SHANGHAI GLOVMAX ENTERPRISE CO.,LTD MAO-SHENG LEE
K993859 01/12/2000 SHANGHAI GLOVMAX ENTERPRISE CO., LTD. PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES SHANGHAI GLOVMAX ENTERPRISE CO.,LTD MAO-SHENG LEE
K994258 01/20/2000 SENSI-PRO DISPOSABLE POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES SHINEMOUND ENTERPRISE, INC. HUAN-CHUNG LI
K994248 01/28/2000 SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES SHINEMOUND ENTERPRISE, INC. HUAN-CHUNG LI
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
K994316 01/14/2000 MAGNETOM OPEN VIVA WITH PERMANENT MAGNET SIEMENS MEDICAL CORP. JAMIE YIEH
K992116 01/12/2000 SIEMEMNS INFINITY ETC02 POD SIEMENS MEDICAL SOLUTIONS USA, INC. PENELOPE H GRECCO
K003179 11/09/2000 SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. PENELOPE H GRECO
K993963 01/13/2000 SIGMA MANUAL WHEELCHAIR SIGMA DISTRIBUTION & SUPPLY, INC. ARTHUR KESHISHYAN
K994216 01/27/2000 PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM SIMS DELTEC, INC. LISA STONE
K991861 01/18/2000 1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE SIMS PORTEX, INC. TIMOTHY J TALCOTT
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
K992396 01/12/2000 BIORCI SCREW SMITH & NEPHEW ENDOSCOPY, INC. DEMETRIOS TSAKONAS
K991162 01/28/2000 BIOLOX ALUMINA CERAMIC FEMORAL HEAD SMITH & NEPHEW, INC. DAVID HENLEY
K994084 01/20/2000 SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES SMITH & NEPHEW, INC. JANICE HASELTON
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
K992749 01/14/2000 ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841 SPACELABS MEDICAL, INC. NANCY GERTLAR
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
K994019 01/20/2000 CAUTERY GRASPER/DISSECTOR STARION INSTRUMENTS BRIAN GRIGSBY
K994173 01/20/2000 STELLARTECH RADIOFREQUENCY GENERATOR,MODEL 1025A-115, STELLARTECH RADIOFREQUENCY GENERATOR, MODEL 1025A-230 STELLARTECH RESEARCH CORP. JAMES R SANTOS
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
K994388 01/14/2000 XE CHECK STRECK LABORATORIES, INC. PAUL KITTELSON
K993239 01/18/2000 STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX STRYKER CORP. NICOLE PETTY
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
K993667 01/28/2000 SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS SULZER MEDICA EDWARD E NEWTON
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
K993864 01/20/2000 COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES SUPERMAX SDN BHD STANLEY THAI
K993865 01/20/2000 GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES SUPERMAX SDN BHD STANLEY THAI
K002916 11/28/2000 SURGI-VISION PROSTATE COIL SURGI-VISION, INC. NANCY E TAYLOR
K993713 01/28/2000 RIM-FIX, ACETABULAR CUP SURGICAL IMPLANTS INC. DOUGLAS W STUART
K992007 01/14/2000 PHARMASEED, MODEL BT-103-1 SYNCOR PHARMACEUTICALS, INC. GARY GILMORE
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
K993026 01/27/2000 ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS SYVA CO. PAUL L ROGERS JR.
K993028 01/27/2000 ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90 SYVA CO. PAUL L ROGERS
K993031 01/27/2000 ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 SYVA CO. PAUL L ROGERS
K993029 01/27/2000 ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 SYVA CO. PAUL L ROGERS
K993982 01/27/2000 SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL SYVA CO. PAUL L ROGERS
K993987 01/27/2000 SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL SYVA CO. PAUL L ROGERS
K993985 01/27/2000 SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL SYVA CO. PAUL L ROGERS
K993984 01/18/2000 SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL SYVA CO. PAUL L ROGERS
K993988 01/27/2000 SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL SYVA CO. PAUL L ROGERS
K994005 01/20/2000 SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL SYVA CO. PAUL L ROGERS
K993986 01/27/2000 SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL SYVA CO. PAUL L ROGERS
K993983 01/27/2000 SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL SYVA CO. PAUL L ROGERS
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
K992436 01/20/2000 GOWN BACK, MODEL 13-403N; 13-404N; 13-405N TECHSTYLES STEPHANIE T HOWARD
K000067 01/20/2000 ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H TECO DIAGNOSTICS DINDO CARRILLO
K003424 11/21/2000 PINNACLE R/O II OR RADIFOCUS INTRODUCER II TERUMO MEDICAL CORP. YUK-TING LEWIS
K991647 01/04/2000 TFX MEDICAL INTRODUCER KIT TFX MEDICAL GROUP JULIE A BEAUMONT
K994095 01/18/2000 LATEX CONDOM THAI NIPPON RUBBER INDUSTRY CO., LTD. ELI J CARTER
K990530 01/31/2000 KERLIX MD ANTIMICROBIAL GAUZE DRESSING THE KENDALL COMPANY, L.P. DAVID A OLSON
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
K993664 01/11/2000 SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES TOP GLOVE SDN. BHD. WEE-CHAI LIM
K993574 01/18/2000 OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON TOSHIBA AMERICA MRI, INC. KEN NEHMER
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
K993839 01/12/2000 ENA PROFILE ELISA TEST SYSTEM TRINITY BIOTECH USA WAYNE KVETKOSKY
K001525 11/29/2000 CAPTIA SYPHILIS-G ELISA TEST SYSTEM TRINITY BIOTECH, PLC WAYNE KVETKOSKY
K993784 01/27/2000 UNIGRAFT UNICARE BIOMEDICAL STAN YANG
K994040 01/18/2000 PHASED ARRAY KNEE AND FOOT COIL USA INSTRUMENTS, INC. RONY THOMAS
K994042 01/31/2000 SHARP 9000 PHASED ARRAY BRAIN COIL USA INSTRUMENTS, INC. RONY THOMAS
K991959 01/06/2000 PSI TITANIUM ANEURYSM CLIP V. MUELLER NEURO/SPINE TERRY JOHNSTON
K002990 11/06/2000 VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001 VASCULAR TECHNOLOGY INCORPORATED DAVID L REGAN
K992941 01/12/2000 LEMAITRE BILIARY CATHETER VASCUTECH, INC. TRENT G KAMKE
K002780 11/17/2000 VIATRONIX VISUALIZATION SYSTEM (VVS) VIATRONIX, INC. SUSAN D GOLDSTEIN-FALK
K993599 01/18/2000 DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019 VIDAR SYSTEMS CORP. MARY "PENNIE" DRINKARD
K993598 01/20/2000 MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205 VIDAR SYSTEMS CORP. MARY "PENNIE" DRINKARD
K991916 01/14/2000 VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS VIRGINIA WATER SYSTEMS, INC. WILLIAM G GARRAHAN
K992529 11/17/2000 TISSUE SPECTROSCOPE VITAL MEDICAL LTD. BRUCE F MACKLER
K994056 01/12/2000 ADMIRA VOCO GMBH EVAN DICK
K003153 11/15/2000 SOLOBOND PLUS VOCO GMBH EVAN DICK
K993827 01/20/2000 UFI GEL HARD VOCO GMBH SHUOJIA DONG
K993927 01/14/2000 WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD WAKO CHEMICALS, USA, INC. TONYA MALLORY
K993924 01/14/2000 WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD WAKO CHEMICALS, USA, INC. TONYA MALLORY
K993928 01/18/2000 WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD WAKO CHEMICALS, USA, INC. TANYA MALLORY
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
K992675 01/20/2000 PATIENT NITRILE EXAMINATION GLOVES (POWDERED) WEAR SAFE MALAYSIA SDN. BHD. CLAUDE COTTET
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
K992658 01/18/2000 OSOM ULTRA STREP A TEST, MODEL 147 WYNTEK DIAGNOSTICS, INC. SHU-CHING CHENG
K993582 01/20/2000 MODIFICATION TO LASER-SHIELD II XOMED, INC. ROY BERENS
K992855 01/21/2000 XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT XOMED, INC. DAVID TIMLIN
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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