FDA 510(k) Applications Received During February, 2000

FDA 510(k) Number Submission Date Device Name Applicant Contact
K004009 12/26/2000 3M ATTEST 290 AUTO-READER 3M COMPANY STEPHAN NORSTED
K003723 12/04/2000 3M LITTMANN 3M COMPANY LINDA JOHNSEN
K003949 12/21/2000 TACKER, MODEL R65-933 A & A MEDICAL, INC. JIHAD MANSOUR
K000654 02/28/2000 VBMAX A-M SYSTEMS, INC. STEVE GRASSER
K003762 12/06/2000 ALI 3D TOOL MODULE FOR MEDICAL IMAGES A.L.I. TECHNOLOGIES, INC. ROBERT MACNEIL
K000596 02/22/2000 ETEST GATIFLOXACIN AB BIODISK ANNE BOLMSTROM
K000582 02/22/2000 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001 ABBOTT DIABETES CARE INC. EVE CONNER
K003746 12/04/2000 3D-DOCTOR ABLE SOFTWARE CORP. YECHENG WU
K000366 02/04/2000 FIXATION STYLETS, MODELS 335-287 AND 335-288 ACCUFIX RESEARCH INSTITUTE MICHAEL J ANDREWS
K000478 02/14/2000 THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1 ACCURAY, INC. LUANNE NG
K000550 02/18/2000 OTW MEGALINK SDS BILIARY STENT SYSTEM ADVANCED CARDIOVASCULAR SYSTEMS, INC. SANDRA SUNDELL
K000547 02/18/2000 ATR TECNIKA ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.P. DANIELE POLI
K003708 12/01/2000 ADVANTAGE THC/COCAINE TEST ADVANTAGE DIAGNOSTICS CORP. JANIS FREESTONE
K000486 02/14/2000 ABC CERVICAL PLATING SYSTEM AESCULAP, INC. LIA S JONES
K003759 12/06/2000 AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR AESCULAP, INC. DAVID W SCHLERF
K003740 12/04/2000 MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION AESCULAP, INC. DAVID W SCHLERF
K003965 12/22/2000 MRI SAFE INSTRUMENTS AESCULAP, INC. LISA M MILLINGTON
K003978 12/22/2000 AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N 102006, P/N 102007 AFX, INC. NANCY NORRIS
K003763 12/06/2000 2010 PLUS HOLTER FOR WINDOWS AGILENT TECHNOLOGIES GRETEL LUMLEY
K003940 12/21/2000 2010 PLUS HOLTER FOR WINDOWS AGILENT TECHNOLOGIES GRETEL LUMLEY
K003819 12/11/2000 HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A AGILENT TECHNOLOGIES, INC. TERESA SKARR
K000635 02/25/2000 MODIFICATION TO HP M2376A DEVICE LINK SYSTEM AGILENT TECHNOLOGIES, INC. MIKE HUDON
K000655 02/28/2000 PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE AHAVA STEIN AHAVA STEIN
K000637 02/25/2000 CUSTOMCORNEA MEASUREMENT DEVICE (CCMD) ALCON LABORATORIES, INC. S.K. MCGARVEY
K003768 12/06/2000 MONARCH II IOL DELIVERY SYSTEM ALCON RESEARCH, LTD. SHERRI J LAKOTA
K000385 02/07/2000 OPTI-FREE EXPRESS LENS DROPS ALCON UNIVERSAL, LTD. RALPH H LARSEN
K003881 12/15/2000 INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K003879 12/15/2000 INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP) ALFA SCIENTIFIC DESIGNS, INC. NAIISHU WANG
K003845 12/12/2000 MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP) ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K003847 12/12/2000 MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE) ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K000417 02/08/2000 CONVERTORS EQUIPMENT DRAPES ALLEGIANCE HEALTHCARE CORP. SHARON ROBBINS
K003739 12/04/2000 ALOKA SSD-4000 ALOKA CO., LTD. CHRISTOPER BOHL
K003999 12/26/2000 AVIVA SYSTEM, MODEL SL 2020; AVIVA SLX SYSTEM SYSTEM, MODEL SLX 1010 AMERICAN TELECARE, INC. CHARLES RICHARD ABBRUSCATO
K003901 12/18/2000 ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER ANGIODYNAMICS, INC. TERI JUCKETT
K003769 12/06/2000 ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES, MODEL 87 ANSELL HEALTHCARE PRODUCTS, INC. JAMES R CHATTERTON
K003771 12/06/2000 ENCORE POWDER-FREE LATEX SURGICAL GLOVES, ORTHOPAEDIC WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) ANSELL HEALTHCARE PRODUCTS, INC. JAMES R CHATTERTON
K003895 12/18/2000 X-TENDA CUFF POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MICROGRAMS OR LESS, MODEL STYLE 21 ANSELL PERRY JAMES R CHATTERTON
K003787 12/08/2000 NEWTOM QR-DVT 9000 APERIO SERVICES, LLC GREGORY W BOWMAN
K003923 12/20/2000 APEX MODULAR ZIRCONIA FEMORAL HEAD APEX SURGICAL, LLC. EDWARD J CHEAL
K000545 02/18/2000 SENTRY EXPANDING INTRODUCER SHEATH (EIS) APPLIED MEDICAL RESOURCES ANIL BHALANI
K003871 12/15/2000 LAPAROSCOPIC HAND PORT APPLIED MEDICAL RESOURCES CORP. ANIL BHALANI
K000539 02/17/2000 NYLON NONABSORBABLE SURGICAL SUTURES, USP ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. RICHARD KUO
K000542 02/17/2000 PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. RICHARD KUO
K000540 02/17/2000 POLYESTER NONABSORBABLE SURGICAL SUTURES, USP ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. RICHARD KUO
K000537 02/17/2000 POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. RICHARD KUO
K000541 02/17/2000 SILK NONABSORBABLE SURGICAL SUTURES, USP ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. RICHARD KUO
K000508 02/15/2000 THERMOFLEX SYSTEM ARGOMED, INC. RICHARD B KLEIN
K004015 12/27/2000 BEAM BLOCK TRAYS ARPLAY MEDICAL S.A. RICHARD BORGI
K003778 12/07/2000 BREAST-BOARD (MULTIPLE) ARPLAY MEDICAL S.A. RICHARD BORGI
K003779 12/07/2000 IMMOBILIZATION SYSTEM FOR ENT ARPLAY MEDICAL S.A. RICHARD BORGI
K004023 12/27/2000 INTRA OPERATIVE RADIATION THERAPY ARPLAY MEDICAL S.A. RICHARD BORGI
K003777 12/07/2000 CARIS SITE MARKER ARTEMIS MEDICAL, INC. ROBIN BUSH
K003988 12/26/2000 UROSCOPE, ARTES MEDICAL, USA ARTES MEDICAL USA, INC. WILLIAM KIRKPATRICK
K003816 12/11/2000 ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM, ARTHREX TITANIUM CORKSCREW 6.5MM ARTHREX, INC. VERNON C BROWN
K000506 02/15/2000 BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B ARTHREX, INC. VERNON BROWN
K000511 02/16/2000 MODIFICATION TO ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINE WANDS ARTHROCARE CORP. BRUCE PROTHRO
K010303 12/05/2000 ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE ARTSCAN MEDICAL INNOVATIONS ROBERT ANTHONY
K000499 02/15/2000 ADVANTA SUPER SOFT GRAFT ATRIUM MEDICAL CORP. KAREN HALL
K000504 02/15/2000 ADVANTA SUPER SOFT GRAFT ATRIUM MEDICAL CORP. KAREN HALL
K000632 02/24/2000 0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE AVITRO LLC. JOHN BRDA
K003971 12/22/2000 AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR AXYA MEDICAL, INC. HOWARD L SCHRAYER
K000567 02/22/2000 ULTRASOUND SCANNER TYPE 2102 B & K MEDICAL A/S VILLY BRAENDER
K003986 12/26/2000 ULTRASOUND SCANNER TYPE 2102 B-K MEDICAL A/S VILLY BRAENDER
K000495 02/15/2000 BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES BALLARD MEDICAL PRODUCTS E. MARTIN CHAMBERLAIN
K003749 12/04/2000 100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN BANTA HEALTHCARE YOLNDA SMITH
K003975 12/22/2000 BAUMER CEMENTED HIP PROSTHESIS BAUMER S.A. BRENO C FARAGO
K003976 12/22/2000 BAUMER MULLER HIP PROSTHESIS BAUMER S.A. BRENO C FARAGO
K003747 12/04/2000 C1-INHIBITOR MICROTITER ASSAY DEVICE BAXTER HEALTHCARE CORP. ARLENE VIDOR
K003730 12/04/2000 CHEMO-AIDE DISPENSING PIN BAXTER HEALTHCARE CORP. JUDY KANNENBERG
K000657 02/28/2000 LUER ACCESS UNIVERSAL VIAL ADAPTER BAXTER HEALTHCARE CORP. MARY ELLEN SNYDER
K000664 02/28/2000 VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS BAXTER HEALTHCARE CORP. PAULA A TORRIANNI
K003796 12/08/2000 ADVIA 120 HEMATOLOGY BAYER CORP. FREDRICK CLERIE
K000611 02/23/2000 STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER BD BIOSCIENCES JO-ANN E FABILA
K000687 02/29/2000 THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST BEACON BIOLOGICALS, INC. KANTI DAYA
K000494 02/15/2000 SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT BECKMAN COULTER, INC. GAIL LEFEBVRE
K000410 02/08/2000 SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS BECKMAN COULTER, INC. LUCINDA STOCKERT
K000606 02/23/2000 SYNCHRON SYSTEMS AMPHETAMINE REAGENT BECKMAN COULTER, INC. LUCINDA STOCKERT
K003861 12/13/2000 BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WEAR CONTACT LENS (LATHE-CUT) BENZ RESEARCH AND DEVELOPMENT CORP. MARTIN DALSING
K000650 02/28/2000 BETEL POWDER FREE LATEX EXAM GLOVES BETELCARE SDN BHD K.B. SIAH
K000652 02/28/2000 BETEL POWDER FREE LATEX EXAM GLOVES, CHLORINATED, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) BETELCARE SDN BHD KENG BENG SIAH
K003896 12/18/2000 LYMPHA VISION-EXPERT BEXLEY TRADING, INC. MICHAEL ZMUDA
K003827 12/11/2000 PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION BIO-PLEXUS, INC. PAUL A TENTHOREY
K003851 12/12/2000 BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119 BIOCHECK, INC. ROBIN J HELLEN
K003954 12/21/2000 STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT BIOCOMPOSITES LTD. J. STEPHEN BRATT
K003948 12/21/2000 EPI-DERM SILICONE GEL SHEETING BIODERMIS CORP. JEFF S SCHLEUING
K003867 12/12/2000 EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET) BIOFILM, INC. ROBERT L DE ARMOND
K003908 12/19/2000 SEROJET BIOJECT, INC. NANCY J GERTLAR
K003795 12/08/2000 BIOLUCENT MAMMOGRAPHY CUSHION BIOLUCENT, INC. STEVE GEX
K003856 12/13/2000 EZ-HCG URINE(PREGNANCY TEST) BIOMERICA, INC. JAY SINGH
K000334 02/03/2000 IMPACT MODULAR TOTAL HIP SYSTEM BIOMET, INC. FRED MCCLURE
K000335 02/03/2000 MALLORY-HEAD MODULAR CALCAR TOTAL HIP SYSTEM BIOMET, INC. FRED MCCLURE
K000538 02/17/2000 MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL BIOMET, INC. DALENE T BINKLEY
K000683 02/29/2000 MODIFIED SINGLE AXLE TOTAL ELBOW BIOMET, INC. FRED MCCLURE
K000318 02/01/2000 BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM BIONOSTICS, INC. KATHLEEN STORRO
K003756 12/06/2000 BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES BIONX IMPLANTS, INC. DAVID W ANDERSON
K003970 12/22/2000 CONTOUR LABRAL NAIL, MODEL 533520A BIONX IMPLANTS, INC. TUIJA ANNALA
K000616 02/24/2000 SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828 BIONX IMPLANTS, LTD. TUIJA ANNALA
K003757 12/06/2000 THERMOFX MESH BIONX IMPLANTS, LTD. TUIJA ANNALA
K003752 12/05/2000 BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH) BIOSAFE LABORATORIES, INC. JACK A MAGGIORE
K000332 02/03/2000 NOGA CARDIAC NAVIGATION SYSTEM BIOSENSE WEBSTER, INC. AMY WALTERS
K000681 02/28/2000 AU5, AU6 BIOSOUND ESAOTE, INC. COLLEEN HITTLE
K000438 02/10/2000 MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER BIOSURGICAL CORP. TERRY LAAS
K003770 12/06/2000 BIRD TBIRD LEGACY VENTILATOR BIRD PRODUCTS CORP. TOM GUTIERREZ
K000426 02/09/2000 VIP- VARIABLE INTENSITY POLYMERIZER BISCO, INC. KATHRYN B PATTERSON
K003735 12/04/2000 BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR BLACKSTONE MEDICAL, INC. ALAN LOMBARDO
K000633 02/25/2000 SYNTHETIC GLASS BONE GRAFT MATERIAL BLUE SKY BIO RITA GIEBEL
K000510 02/15/2000 ART-M1, MODEL M1-1-ART-A1 BONART CO. LTD. BANKSON TSAI
K000570 02/22/2000 BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA BOSTON SCIENTIFIC CORP. TERRY A MCGOVERN
K003839 12/12/2000 CENTRAL VENOUS CATHETER BOSTON SCIENTIFIC CORP. THERESA A MCGOVERN
K003782 12/07/2000 CONSTELLATION CATHETER, MODEL 8031 BOSTON SCIENTIFIC CORP. ANDREA BOUMIS
K000409 02/08/2000 MODIFICATION TO T-REX BIOPSY FORCEPS BOSTON SCIENTIFIC CORP. JOCELYN KERSTEN
K003929 12/20/2000 NIROYAL BILIARY PREMOUNTED STENT SYSTEM BOSTON SCIENTIFIC CORP. JODI L GREENIZEN
K000397 02/07/2000 SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL BOSTON SCIENTIFIC CORP. ABBY LIPMAN
K000308 02/01/2000 WALLSTENT BILIARY ENDOPROSTHESIS BOSTON SCIENTIFIC CORP. LISA M QUAGLIA
K004022 12/27/2000 M3 (MIRCO-MULTILEAF COLLIMATOR BRAINLAB AG STEFAN VILSMEIER
K004034 12/28/2000 MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12 BRANAN MEDICAL CORP. RAPHAEL WONG
K003732 12/04/2000 BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES BRAUN GMBH FRED SCHLADOR
K000520 02/16/2000 C-IT BREGAS AB PAUL KRILL
K000519 02/16/2000 GLUCANPRO BRENNEN MEDICAL, INC. PHIL LAWIN
K000518 02/16/2000 MACROPRO GEL BRENNEN MEDICAL, INC. PHIL LAWIN
K003917 12/19/2000 MODIFICATION TO FLUOROTEX II SURGICAL MESH BRIDGER BIOMED, INC. BRUCE G RUEFER
K003906 12/19/2000 MODIFICATION TO FLUROTEX SURGICAL MESH BRIDGER BIOMED, INC. BRUCE G RUEFER
K003828 12/11/2000 VASO PRESS DVT FOOT GARMENT #VP 520 BRITT CORP., INC. J J BRITTON
K000639 02/25/2000 VISIONARY 2000 BURTON MEDICAL PRODUCTS CORP. DORIAN SWARTZ
K003956 12/21/2000 BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595 C.R. BARD, INC. BETH A ZIS
K003793 12/08/2000 BARD LUMINEXX BILIARY STENT C.R. BARD, INC. CAROL VIERLING
K003876 12/15/2000 US SENSOR #CG-930P; TOCO SENSOR CG-940P CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K000609 02/23/2000 CARDTEL, MODEL NT-100 CARDIAC TELECOMMUNICATIONS J. HARVEY KNAUSS
K003707 12/01/2000 CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A CARDIONET DONALD CANAL
K003885 12/15/2000 VISULAS YAG II CARL ZEISS, INC. SCOTT A MARGOLIN
K000512 02/16/2000 OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010 CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K003791 12/08/2000 CAVEX TEMPORARY CEMENT CAVEX HOLLAND B.V. RICHARD WOORTMAN
K000686 02/29/2000 KROM-ALGINATE AND ALGINATE PLUS CAVEX HOLLAND B.V. RICHARD WOORTMAN
K000685 02/29/2000 CHARTER MEDICAL NEONATAL SYRINGE SET CHARTER MEDICAL, LTD. K. ALICE PREVILLE
K003927 12/20/2000 Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02 CHEEN HOUNG ENT. CO. LTD. JAY WANG
K003826 12/11/2000 FOCUS DAILIES PROGRESSIVES CIBA VISION CORPORATION ALICIA M PLESNARSKI
K000607 02/23/2000 SOLO-CARE BRAND HARD SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K003833 12/11/2000 SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENSES FOR DAILY WEAR CLEARLAB PTE LTD. JOHN M SZABOCSIK
K000388 02/07/2000 CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL) CLEARWATER COLON HYDROTHERAPY, INC. STUART K BAKER
K000368 02/04/2000 EYECAP IMAGING SYSTEM CLEMENT CLARKE INTL., LTD. M.J. WILKINSON
K003958 12/21/2000 COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE COALESCENT SURGICAL MICHAEL A DANIEL
K004046 12/29/2000 COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K000311 02/01/2000 PARAPOST FIBER WHITE COLTENE/WHALEDENT INC. H.J. VOGELSTEIN
K003880 12/15/2000 CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F) CONCENTRIC MEDICAL, INC. SAM LAZZARA
K003716 12/01/2000 CONFORMANCE CHEMISTRY CONTROL C3 CONSOLIDATED TECHNOLOGY RUSTY SEWELL
K000543 02/18/2000 CONTEMPRO-MIST CONTEMPORARY PRODUCTS, INC. BARRY A SCHWARTZ
K000651 02/28/2000 DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM COOK, INC. LISA WEBB
K003781 12/07/2000 COOLTOUCH "VARIA-II" ND:YAG LASER SYSTEM COOLTOUCH CORP. DONALD V JOHNSON
K003715 12/01/2000 COOLTOUCH ND:YAG LASER SYSTEM, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH II COOLTOUCH CORP. DONALD V JOHNSON
K000384 02/07/2000 FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX COOPERVISION, INC. BONNIE TSYMBAL
K003920 12/19/2000 CORDIS M3 PTA DILATATION CATHETER CORDIS CORP. CHARLES (CHUCK) J RYAN
K000564 02/22/2000 CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY CORDIS CORP. KAREN WILK
K000579 02/22/2000 TEMPO AQUA ANGIOGRAPHIC CATHETER CORDIS CORP. ARIEL MACTAVISH
K003964 12/22/2000 TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B CORDIS CORP. KAREN WILK
K003925 12/20/2000 PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS CORDIS NEUROVASCULAR, INC. AMARILYS MACHADO
K000634 02/25/2000 ROD TO ROD CROSS BRACES CORIN U.S.A. JOEL BATTS
K000500 02/14/2000 DINAMAP ADVANCED NIBP MODULE CRITIKON COMPANY, L.L.C. THOMAS J ENGLISH
K004039 12/29/2000 CYNOSURE PHOTOGENICA NEO-V CYNOSURE, INC. GEORGE CHO
K000490 02/15/2000 CYNOSURE PHOTOGENICA VLS-STAR CYNOSURE, INC. GEORGE CHO
K003963 12/22/2000 DIMENSION PSA FLEX REAGENT CARTRIDGE DADE BEHRING, INC. GEORGE M PLUMMER
K000649 02/28/2000 SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 DADE BEHRING, INC. RADAMES RIESGO
K003870 12/15/2000 THROMBOREL S DADE BEHRING, INC. REBECCA S AYASH
K000460 02/11/2000 URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A DADE BEHRING, INC. JUDY MCINNIS-BERGER
K000459 02/11/2000 URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A DADE BEHRING, INC. JUDY MCINNIS-BERGER
K000458 02/11/2000 URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A DADE BEHRING, INC. JUDY MCINNIS-BERGER
K000461 02/11/2000 URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A DADE BEHRING, INC. JUDY MCINNIS-BERGER
K000467 02/11/2000 URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A DADE BEHRING, INC. JUDY MCINNIS-BERGER
K000466 02/11/2000 URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A DADE BEHRING, INC. JUDY MCINNIS-BERGER
K000464 02/11/2000 URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A DADE BEHRING, INC. JUDY MCINNIS-BERGER
K000462 02/11/2000 URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A DADE BEHRING, INC. JUDY MCINNIS-BERGER
K003998 12/26/2000 FLEXVIEW CLINICAL MONITORING SYSTEM DATA CRITICAL CORP. TERESA DAVIDSON
K000647 02/28/2000 DATEX-OHMEDA NETWORK AND CENTRAL DATEX-OHMEDA, INC. JOEL KENT
K003790 12/08/2000 DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005 DAVOL, INC. LUCINDA L FOX
K004031 12/28/2000 NT SWIFT; TITEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES DENTAL POWER, INC. JOHN SCHOEFFEL
K003921 12/20/2000 DYRACT CEM LCI COMPOMER DENTSPLY INTL. P. JEFFREY LEHN
K003822 12/11/2000 ISOLA CLOSED DUAL ROD CONNECTOR DEPUY ACROMED FRANK MAAS
K003797 12/08/2000 ACE AIM TTC FUSION NAIL DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K003800 12/08/2000 AML HIP PROSTHESIS DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K000658 02/28/2000 ERS RADIAL HEAD REPLACEMENT DEPUY ORTHOPAEDICS, INC. LYNNETTE WHITAKER
K000575 02/22/2000 GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K000306 02/01/2000 PINNACLE ACETABULAR SYSTEM DEPUY ORTHOPAEDICS, INC. LYNNETTE WHITAKER
K000432 02/09/2000 RESPONSE 2000 CEMENTED HIP STEM DEPUY ORTHOPAEDICS, INC. ARLENE C SAULL
K000392 02/07/2000 RESPONSE 2000 HIP STEM DEPUY ORTHOPAEDICS, INC. ARLENE C SAULL
K003875 12/15/2000 TI-REPLICA HIP STEM DEPUY ORTHOPAEDICS, INC. ARLENE C SAULL
K004002 12/26/2000 IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600) DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K000463 02/11/2000 IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
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K000489 02/14/2000 ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST HELIX DIAGNOSTICS, INC. VIRGINIA CAPPEL
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K004013 12/27/2000 IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YYYYY IMPLEX CORP. JOHN SCHALAGO
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K004011 12/27/2000 IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS IMPRA, INC. LORI CHAVEZ
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K003854 12/13/2000 INTRAVASCULAR ADMINISTRATION SET INFUSION DEVICES, INC. PAUL E DRYDEN
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K003783 12/07/2000 MEDICAL DEPOT-WHEELCHAIRS, MODEL SENTRA,ASTAIRE AND VIPER MEDICAL DEPOT, INC. ART WARD
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K000641 02/25/2000 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
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K003718 12/04/2000 TITANIUM CEMENT RESTRICTOR (TCR) MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
K003928 12/20/2000 TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
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K004005 12/26/2000 MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED) MENTOR CORP. DONNA A CRAWFORD
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K003794 12/08/2000 ELISA TEST, SEROLOGY MICRO DETECT, INC. MEDHI ALEM
K000477 02/14/2000 MDI DS-DNA TEST MICRO DETECT, INC. MEHDI ALEM
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K000355 02/04/2000 3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR MINNESOTA MINING AND MFG. CO. GRETCHEN KEENAN
K000690 02/29/2000 3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE MINNESOTA MINING AND MFG. CO. LINDA JOHNSON
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K004017 12/27/2000 H-SCRIBE MORTARA INSTRUMENT, INC. HARLAN L VAN MATRE
K003899 12/18/2000 IFIS-SA INTEGRATED FUCTIONAL IMAGING SYSTEM MRI DEVICES CORP. WILLIAM DINEHART
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K000604 02/23/2000 NATURE'S CHEMIST PAIN RELIEF OINTMENT AND THERAPEUTIC ULTRASOUND COUPLING AGENT NATUROPATHIC LABORATORIES INTERNATIONAL, INC. EMALEE G MURPHY
K000565 02/22/2000 MODIFICATION TO NC-STAT NEUROMETRIX, INC. CYNTHIA J.M. NOLTE
K000517 02/16/2000 LIFE SCOPE EC, MODEL BSM-1102 NIHON KOHDEN AMERICA, INC. BONNIE BISHOP
K000338 02/03/2000 VITAPORT 3 NIHON KOHDEN AMERICA, INC. BONNIE BISHOP
K003804 12/08/2000 SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801 NIKO MEDICAL PRODUCTS RICHARD A HAMER
K000643 02/25/2000 INPLANT ORTHODONTIC ANCHOR SYSTEM NOBEL BIOCARE UAS INC JEFF HAUSHEER
K000404 02/07/2000 PC ECG 1200 NORAV MEDICAL LTD. STEVE SPRINGROSE
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K000393 02/07/2000 NOVA CORDLESS CURING LIGHT NOVA/DA VINCI SYSTEMS, INC. ALAN A CREAMER
K003902 12/19/2000 MULTITRACK ANGIOGRAPHIC CATHETER NUMED, INC. NICHELLE R LAFLESH
K003972 12/22/2000 NUMED GHOST II PTA CATHETERS NUMED, INC. NICHELL LAFLESH
K003820 12/11/2000 DISPOSABLE CB-PE MICROKERATOME BLADES OASIS MEDICAL, INC. YVONNE FERNANDEZ
K004000 12/26/2000 OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT OCU-EASE OPTICAL PRODUCTS, INC. CHARLES R VERMETTE
K003996 12/26/2000 OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR OCU-EASE OPTICAL PRODUCTS, INC. CHARLES R VERMETTE
K003721 12/04/2000 MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER OLYMPUS AMERICA, INC. MICHAEL CAMPBELL
K003824 12/11/2000 OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI OMNISONICS MEDICAL TECHNOLOGIES DOUG CHARLAND
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K000415 02/08/2000 OIS-2500 DIAGNOSTIC ULTRASOUND SYSTEM OPTIMAL IMAGING SYSTEMS, INC. JORGE MILLAN
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K004021 12/27/2000 F1 DIODE LASER SYSTEM OPUS MEDICAL, INC. CONNIE WHITE-HOY
K000399 02/07/2000 STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 ORASURE TECHNOLOGIES, INC. R. SAM NEIDBALA
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K000378 02/07/2000 BACT/ALERT MB CULTURE BOTTLE ORGANON TEKNIKA CORP. REBECCA A RIVAS
K000492 02/15/2000 MDA D-DIMER ORGANON TEKNIKA CORP. RON SANYAL
K000321 02/02/2000 HEMISPHERE MODULAR CUP SYSTEM ORTHO DEVELOPMENT CORP. CAROL FREASIER
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K003733 12/04/2000 SCS CLOSED SCREW ORTHOTEC, L.L.C. PATRICK BERTRANOU
K003823 12/11/2000 SCS DT-02 TRANSVERSE CONNECTOR ORTHOTEC, L.L.C. PATRICK BERTRANOU
K003918 12/19/2000 OSCOR PERMANENT PACING LEAD RZ MODEL SERIES OSCOR INC. MILA DOSKOCIL
K000602 02/23/2000 PROTEGE WHEELCHAIR OTTO BOCK ORTHOPEDIC INDUSTRY, INC. JOHN HENDRICKSON
K000678 02/29/2000 RAEBBITT/EVOLUTION POWERED WHEELCHAIR OTTO BOCK ORTHOPEDIC INDUSTRY, INC. WILLIAM JACKSON
K000497 02/15/2000 VOYAGER/VIPER WHEELCHAIR OTTO BOCK ORTHOPEDIC INDUSTRY, INC. JOHN HENDRICKSON
K000482 02/14/2000 MODIFICATION TO AUTOJECT MINI OWEN MUMFORD, LTD. ROBERT SHAW
K000679 02/29/2000 THROMBOSTRATE CONTROL PLASMAS PACIFIC HEMOSTASIS LAURA A WORFOLK
K003886 12/18/2000 PALOMAR SPALIGHT PULSED LIGHT SYSTEM PALOMAR MEDICAL TECHNOLOGIES, INC. MARCY MOORE
K003951 12/21/2000 PECTOFIX STERNAL REPAIR WIRE PECTOFIX, INC. ERIC BANNON
K003775 12/06/2000 PORTABLE BREAST COMPRESSION DEVICE PEM TECHNOLOGIES T. WHIT ATHEY
K003992 12/26/2000 PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM PERCUSURGE, INC. MATTHEW J MOON
K003737 12/04/2000 POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMSPER OR LESS) PERUSAHAAN GETAH ASAS SDN BHD TAN KONG CHANG
K003858 12/13/2000 MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175 PHAMATECH CARL A MONGIOVI
K000447 02/10/2000 QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225 PHAMATECH CARL A MONGIOVI
K000312 02/01/2000 VARELISA SM ANTIBODIES PHARMACIA & UPJOHN CO. KAREN MATIS
K003853 12/12/2000 INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. DUANE PRASCHAN
K000310 02/01/2000 VOYAGER 6.0 SOFTWARE OPTION PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. ELAINE K KEELER
K000514 02/16/2000 RUMBAR DRAINAGE SYSTEM PHOENIX BIOMEDICAL CORP. COURTNEY SMITH
K003705 12/01/2000 XTRAC EXCIMER LASER SYSTEM, MODEL AL7000 PHOTO MEDEX, INC. AL MEMMOLO
K003725 12/04/2000 240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS PIE MEDICAL COLLEEN J HITTLE
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K000428 02/09/2000 DIXI 2 PLANMECA OY LARS MORING
K000666 02/28/2000 TC-PLUS SOLUTION KNEE PLUS ORTHOPEDICS HARTMUT LOCH
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K000586 02/22/2000 BIOSCANNER TRIGLYCERIDES TEST STRIPS POLYMER TECHNOLOGY SYSTEMS, INC. MARGO ENRIGHT
K003842 12/12/2000 PRESCOTT'S SURGICAL SPEAR PRESCOTT'S, INC. PAUL REDNER
K000444 02/10/2000 MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM PRISM ENTERPRISES, INC. JUDITH A HARBOUR
K003909 12/19/2000 PROACT 1 PROACT CO. JEAN ROZINT
K003843 12/12/2000 ENVIVE MINIFORMS PROCTER & GAMBLE CO. KATHLEEN C BLIEZNER
K000667 02/28/2000 POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER LABEL CLAIM PROTECTION GLOVES SDN. BHD. THIRUNAVUKARASU PEARIASAMY
K000668 02/28/2000 POWDER-FREE NON-VHLORINATED POLYMER COATED LATEX EXAMINATION GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRA PROTECTION GLOVES SDN. BHD. THIRUNAVUKARASU PEARIASAMY
K000653 02/28/2000 AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002 PULMONOX MEDICAL CORP. PAULA TOMAT
K003904 12/19/2000 POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES PURNABINA SDN BHD LIEW YOON FONG
K000554 02/18/2000 POCKET ULTRASONIC OPHTHALMIC PACHYMETER, BIOMETRY TRANSDUCER FOR POCKET QUANTEL MEDICAL GEORGE MYERS
K003874 12/15/2000 CBC-4K HEMATOLOGY CONTROL R & D SYSTEMS, INC. KENNETH EDDS
K003991 12/26/2000 CD-CAL PLUS CALIBRATOR R & D SYSTEMS, INC. KENNETH T EDDS
K000443 02/10/2000 REMOTE FETAL MEDICINE ULTRASOUND SYSTEM R4 TELEMEDICINE, INC. THOMAS B SMITH
K000483 02/14/2000 RANDOX ALBUMIN RANDOX LABORATORIES, LTD. P ARMSTRONG
K000375 02/07/2000 RANDOX CALCIUM RANDOX LABORATORIES, LTD. P. ARMSTRONG
K000469 02/11/2000 RANDOX COMPLEMENT C3 RANDOX LABORATORIES, LTD. R ARMSTRONG
K000468 02/11/2000 RANDOX COMPLEMENT C4 RANDOX LABORATORIES, LTD. P ARMSTRONG
K000662 02/28/2000 RANDOX FERRITIN RANDOX LABORATORIES, LTD. P. ARMSTRONG
K000661 02/28/2000 RANDOX PREALBUMIN RANDOX LABORATORIES, LTD. P ARMSTRONG
K003809 12/08/2000 RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS RAPID DIAGNOSTICS, INC. CHARLES C.F. YU
K004040 12/29/2000 REDTECH GIPC 2000 RED-TECH, INC. GARY MOCNIK
K000418 02/08/2000 PDT DOSECALCULATOR, MODEL 80000 RETINALABS.COM FRANK TIGHE
K000420 02/08/2000 SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003 RETINALABS.COM FRANK TIGHE
K000416 02/08/2000 TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001 RETINALABS.COM FRANK TIGHE
K000457 02/11/2000 VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES RETINALABS.COM FRANK TIGHE
K000336 02/03/2000 RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E RHIGENE, INC. DAVE KOLESAR
K000406 02/07/2000 RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE RHINOMETRICS A/S HOWARD M HOLSTEIN
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K003745 12/04/2000 LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET RLN SYSTEMS, INC. J. LEE REA
K000365 02/04/2000 ACCU-CHEK ADVANTAGE METER ROCHE DIAGNOSTICS CORP. MIKE FLIS
K004010 12/26/2000 ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS ROCHE DIAGNOSTICS CORP. LUANN OCHS
K000364 02/04/2000 ACCU-CHEK COMPLETE METER ROCHE DIAGNOSTICS CORP. MIKE FLIS
K003846 12/12/2000 ACCU-CHEK INFORM METER ROCHE DIAGNOSTICS CORP. MIKE FLIS
K003967 12/22/2000 CA 125 II CALCHECK ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K003865 12/13/2000 COBAS INTEGRA AMPHETAMINES ROCHE DIAGNOSTICS CORP. JENNIFER TRIBBETT
K000534 02/17/2000 COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K003969 12/22/2000 ELECSYS CA 125 II CALSET ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K000576 02/22/2000 ELECSYS CORTISOL CALCHECK ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
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K000568 02/22/2000 HDL CHOLESTEROL PLUS ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
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K000656 02/28/2000 EMBRYON GIFT TRANSFER CATHETERS/SETS ROCKET MEDICAL PLC LES TODD
K000340 02/03/2000 HYSTALOG HSG CATHETER ROCKET MEDICAL PLC L. TODD
K003734 12/04/2000 SERUM PROTEIN SUBSTITUTE SAGE BIOPHARMA GRACE HOLLAND
K003916 12/19/2000 DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM SCANDIA MANUFACTURING LTD. RONALD E BERGLUND
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K003711 12/01/2000 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P SEIN ELECTRONICS CO., LTD. WON-KY KIM
K000583 02/22/2000 FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM SELFCARE, INC. CAROL A ADILETTO
K003934 12/20/2000 POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) SELTOM PACIFIC SDN. BHD. S. SEAGARAN
K003701 12/01/2000 SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800) SENTECH MEDICAL SYSTEMS, INC. LYDIA BIGGIE
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K000390 02/07/2000 VITAL SHIELD GOLD POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) SGMP CO., LTD. JANNA P TUCKER
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K000584 02/22/2000 POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) SHASTA ASIA PARTNERS GLOVES MANUFACTURING CO LTD. JANNA P TUCKER
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K000323 02/02/2000 NITRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDER FREE, NON STERILE SIAM SEMPERMED CORP. LTD. JOY LANCASTER
K000330 02/02/2000 NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR), POWDER FREE, NON STERILE SIAM SEMPERMED CORP. LTD. JOY LANCASTER
K000329 02/02/2000 NITRILE PATIENT EXAMINATION GLOVE POWDER FREE, NON STERILE SIAM SEMPERMED CORP. LTD. JOY LANCASTER
K003945 12/21/2000 OPDIMA SIEMENS MEDICAL SOLUTIONS USA, INC. PRAVEEN NADKARNI
K000528 02/17/2000 ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT
K000527 02/17/2000 ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT
K000628 02/24/2000 WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733 SIMS PORTEX LTD. GILES BISHOP
K000672 02/28/2000 HELIODENT VARIO SIRONA DENTAL SYSTEMS GMBH SHEILA HEMEON-HEYER
K003710 12/01/2000 DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048; DYONICS AUTOCLAVABLE CAMERA COUPLER MODEL 7207905 SMITH & NEPHEW, INC. JANICE HASELTON
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K003990 12/26/2000 SOFRADIM PARIETEX SURGICAL MESHES SOFRADIM PRODUCTION MARY MCNAMARA-CULLINANE
K000501 02/15/2000 ELECTROSURGICAL GENERATOR, MODEL S1 SOMNUS MEDICAL TECHNOLOGIES, INC. STEVEN J OJALA
K000424 02/09/2000 S51D DIGITAL ENDOSCOPY CAMERA SOPRO PIERRE MONTILLOT
K000423 02/09/2000 S52D DIGITAL VIDEO LAPAROSCOPE SOPRO PIERRE MONTILLOT
K000422 02/09/2000 S57D DIGITAL OPERATING ROOM CAMERA SOPRO PIERRE MONTILLOT
K003789 12/08/2000 SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR; SPECIALITY 56 UV TORIC (HEFILCON C) SOFT SPECIALTY ULTRAVISION, INC. DEBBIE MCINTIRE
K000376 02/07/2000 SPECIALTY 42 (HEFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR, SPECIALTY T-42 TORIC (HEFILCON A) HYDROPHILIC CONTACT SPECIALTY ULTRAVISION, INC. GAROLD L EDWARDS
K000421 02/08/2000 BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE SSL AMERICAS, INC. (REGENT MEDICAL) BRADLEY L PUGH
K003729 12/04/2000 ULTIMUM EV HEMOSTASIS INTRODUCER (14F), ULTIMUM EV HEMOSTASIS INTRODUCER (16F), ULTIMUM EV HEMOSTASIS INTRODUCER (18F), ST. JUDE MEDICAL ANGELA BYLAND
K000605 02/23/2000 STACKHOUSE LENS HOOD, MODEL SA-700/F STACKHOUSE, INC. TOM GUTIERREZ
K000608 02/23/2000 SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM STD MFG., INC. JIM LOUSARARIAN
K000411 02/08/2000 CHILI VIDEO, CHILI VIDEOPRO STEINBEIS-TRANSFERZENTRUM MEDIZINISCHE INFORMATIK JIM DOYLE
K003857 12/13/2000 STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES STERILMED, INC. PATRICK FLEISCHHACKER
K000502 02/15/2000 STEAM/EO RECORD CARD, MODEL CI 121 STERITEC PRODUCTS MFG. CO., INC. LINDA NELSON
K003983 12/26/2000 STIMUPLEX HNS-11 STOCKERT GMBH DOMINIKA SCHULER
K003792 12/08/2000 STRYKER HEATED INSUFFLATOR TUBE SET STRYKER CORP. MICHAEL BAYCURA
K000493 02/15/2000 STRYKER IRRIGATION TUBE SET STRYKER ENDOSCOPY MARK KUIPER
K004027 12/27/2000 STRYKER REMOTE SURGICAL PLANNING SYSTEM STRYKER INSTRUMENTS NICOLE PETTY
K000348 02/03/2000 COLORADO MICRODISSECTION NEEDLE STRYKER LEIBINGER KRISTYN R KELLEY
K000594 02/22/2000 LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE STRYKER LEIBINGER ROBIN L ROWE
K000349 02/03/2000 MOTORIZED MICRO MULTILEAF COLLIMATOR STRYKER LEIBINGER KRISTYN R KELLEY
K003758 12/06/2000 ALLOFIT ACETABULAR SYSTEM SULZER ORTHOPEDICS, INC. MITCHELL A DHORITY
K003801 12/08/2000 ANATOMICAL PRESS-FIT HUMERAL STEM SULZER ORTHOPEDICS, INC. MITCHELL A DHORITY
K003832 12/11/2000 SULZER ORTHOPEDICS ANATOMICAL SHOULDER CEMENTED HUMERAL STEM SULZER ORTHOPEDICS, INC. MITCHELL A DHORITY
K000644 02/25/2000 SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVES SUPERMAX GLOVE MANUFACTURING SDN BHD STANLEY THAI
K000408 02/08/2000 LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM SURETEX PROPHYLACTICS LTD. LON D MCINVAIN
K003748 12/04/2000 TIANXIE SUZHOU TIANYI ACUPUNCTURE INSTRUMENTS CO., LTD. HENRY WOO
K000530 02/17/2000 BELLEGLASS HP ENAMEL SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K000436 02/10/2000 BELLEGLASS HP TRANSLUCENT DENTIN SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K003808 12/08/2000 TAKE 1 SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K003836 12/12/2000 SYNTHES SYNEX SPACER SYSTEM SYNTHES JONATHAN GILBERT
K000684 02/29/2000 SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM SYNTHES (USA) ANGELA J SILVESTRI
K003786 12/08/2000 SMF RESORBABLE MESHES AND SHEETS SYNTHES (USA) THOMAS M MAGUIRE
K000560 02/18/2000 SYNTHES (USA) RESORBABLE TACK SYSTEM SYNTHES (USA) BONNIE J SMITH
K000558 02/18/2000 SYNTHES (USA) WRIST FUSION PLATES (WFP) SYNTHES (USA) SHERI L MUSGNUNG
K003700 12/01/2000 SYNTHES HAMSTRING LOOP SYNTHES (USA) THOMAS M MAGUIRE
K000682 02/29/2000 SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM SYNTHES (USA) ANGELA J SILVESTRI
K003743 12/04/2000 SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM SYNTHES (USA) ANGELA J SILVESTRI
K003788 12/08/2000 SYNTHES RESORABLE MESHES AND SHEETS SYNTHES (USA) THOMAS M MAGUIRE
K000450 02/11/2000 MODIFICATION TO SYNTHES USS SYNTHES SPINE JONATHAN GILBERT
K000536 02/16/2000 SYNTHES ANTERIOR CSLP SYSTEM SYNTHES SPINE JONATHAN GILBERT
K000600 02/23/2000 SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS SYVA CO., DADE BEHRING, INC. PAUL L ROGERS
K003703 12/01/2000 TAUT-INSUFFLATION NEEDLE TAUT, INC. RONALD KENSETH
K003987 12/26/2000 URS-1K (KETONE TESST) TECO DIAGNOSTICS DINDO CARRILLO
K000555 02/18/2000 TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN & POWDER LABEL CLAIM CONTAINS 70MGM OR LESS O TEKMEDIC (M) SDN BHD KOK-KEE HON
K003717 12/04/2000 INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE ENDODCOPIC INSTRUMENTS 5 MM, 10MM (HANDLE, SHAF TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO. HARALD JUNG
K003911 12/19/2000 TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE) TERRAY CORP. STEVE WANG
K000387 02/07/2000 TERUMO NEEDLE WITH LOCKING SHEATH TERUMO MEDICAL CORP. YUK-TING LEWIS
K000665 02/28/2000 TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER TFX MEDICAL, INC. KARENANN J BROZOWSKI
K004019 12/27/2000 ANA EIA DIAGNOSTIC TEST KIT THE BINDING SITE, LTD. JAY H GELLER
K000343 02/03/2000 NAC Y-ADP THE KIPP GROUP GARY WERSCHMIDT
K000529 02/17/2000 LIFESTYLE MV2 (TM) TORIC (POLYMACON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR (CLEAR OR TINTED) THE LIFESTYLE CO., INC. MARTIN RIEHM
K000577 02/22/2000 YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL CAMERA THE YOSHIDA DENTAL MFG. CO., LTD. KIYOSHI YOSHIDA
K004026 12/27/2000 BRAIDED GUIDING INTRODUCER THOMAS MEDICAL PRODUCTS, INC. PETER J RAPP
K003731 12/04/2000 SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE THOMAS MEDICAL PRODUCTS, INC. PETER J RAPP
K004025 12/27/2000 SPLITTABLE SHEATH INTRODUCER KIT THOMAS MEDICAL PRODUCTS, INC. KIMBERLY A FISCHER
K004048 12/29/2000 SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) TILLOTSON HEALTHCARE CORP. F.W. PERRELLA
K000317 02/01/2000 SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM TISSUE MEDICAL LASERS, INC. DWIGHT ZURAWSKI
K003818 12/11/2000 TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS TITAN IMPLANTS LYNETTE L HOWARD
K003936 12/20/2000 PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING TOMTEC IMAGING SYSTEMS, GMBH FLORIAN EISENBERGER
K004018 12/27/2000 SKINGARD POLYCOAT GLOVE TOP QUALITY MFG., INC. ART WARD
K003728 12/04/2000 MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM TORNIER DAVID W SCHLERF
K000549 02/18/2000 OPART, MODEL MRT-600 TOSHIBA AMERICA MRI, INC. KEN NEHMER
K003834 12/12/2000 SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K003868 12/14/2000 SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K004045 12/29/2000 SUSCEPTIBILITY TEST PANEL TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K000572 02/22/2000 E.N.S.I. SYRINGE TRI-JECT INTL. CORP. PETER G LEMIN
K000333 02/03/2000 STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED BALL, MODIFIED STANDARD & EXTENDED BLADE, MOD TRIAD SURGICAL TECHNOLOGIES, INC. BRIAN MCGAVIN
K003995 12/26/2000 SPECULITE/ORALLITE TRYLON CORP. MARTIN LONKY
K003890 12/18/2000 VHF ULTRASONIC ARC-SCAN SYSTEM ULTRALINK, LLC. GEORGE D WISEMAN
K003709 12/01/2000 SURGICAL DYNAMICS MESH CAGE SYSTEM UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC JENNIFER E SCHUCK
K003753 12/05/2000 GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE URESIL CORP. CHARLES P GILL
K000507 02/15/2000 CAVERMAP SURGICAL AID UROMED CORP. FREDERICK TOBIA
K000437 02/10/2000 INTERVENTIONAL BODY COIL USA INSTRUMENTS, INC. RONY THOMAS
K000401 02/07/2000 VAPOTHERM, MODEL 2000I VAPOTHERM, INC. WILLIAM NILAND
K003719 12/04/2000 VASCULAR ARCHITECTS PERISCOPE DEVICE VASCULAR ARCHITECTS, INC. JEAN M CAILLOUETTE
K000597 02/22/2000 VITA RESPONSE VIDENT BARBARA J LEWANDOWSKI
K000412 02/08/2000 VISION R/F TILTING TABLE VILLA SISTEMI MEDICALI S.P.A. JEFFERY N MOELLER
K000327 02/02/2000 WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 VISX, INCORPORATED DAVID M PATINO
K000441 02/10/2000 BODYGUARD VITAL SIGNS, INC. ANTHONY MARTINO
K000599 02/22/2000 VITALOGRAPH BASE STATION VITALOGRAPH, INC. PHIL HEMES
K000557 02/18/2000 MEDVIZER PACS, MODEL RELEASE 2000 VITEL NET ALLEN IZADPANAH
K000623 02/17/2000 SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1 VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB GARY Y YINGLING
K000625 02/17/2000 SCANDINAVIAN IVF SCIENCES AB, G1.2 VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB GARY Y YINGLING
K000619 02/17/2000 SCANDINAVIAN IVF SCIENCES AB, G2.2 VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB GARY L YINGLING
K000626 02/17/2000 SCANDINAVIAN IVF SCIENCES AB, GAMETE-100 VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB GARY L YINGLING
K000627 02/17/2000 SCANDINAVIAN IVF SCIENCES AB, HYBASE-1 VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB GARY L YINGLING
K000621 02/17/2000 SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100 VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB GARY L YINGLING
K000618 02/17/2000 SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1 VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB GARY L YINGLING
K000356 02/04/2000 C.T.M. MOBILITY SCOOTER, MODEL H2-686, HS-740, HS-580 WAREPALMY ENTERPRISE LLC (USA) ROBERT S MCQUATE
K000354 02/04/2000 C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570 WAREPALMY ENTERPRISE LLC (USA) ROBERT S MCQUATE
K003773 12/06/2000 CLEAN SCRAPE WEBB RESEARCH II, INC. STEVEN KRUPNICK
K000439 02/10/2000 DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 2 (PHEMFILCON A) SHERICAL ( HYDROPHILIC)C WESLEY JESSEN CORP. JOSEPH F FOOS
K000574 02/22/2000 IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE) WR MEDICAL ELECTRONICS CO. PATRICK J ANDERSON
K004043 12/29/2000 METAL TRANSCEND ARTICULATION SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K004032 12/28/2000 PERFECTA AND EXTEND WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K000313 02/01/2000 TEARAWAY INTRODUCER SHEATH XENTEK MEDICAL, INC. JIM EDDINGS
K000363 02/04/2000 MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K000362 02/04/2000 MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K003910 12/19/2000 NEXGEN COMPLETE KNEE SOLUTION CROSS-LINKED POLYETHYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS ZIMMER, INC. STEPHEN MCKELVEY


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