FDA 510(k) Applications Received During February, 2001

FDA 510(k) Number Submission Date Device Name Applicant Contact
K014142 12/17/2001 UNITE BONDING ADHESIVE 3M UNITEK L. MARLYN SCHEFF
K010510 02/21/2001 BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1 A & A MEDICAL, INC. JIHAD (JAY) MANSOUR
K014201 12/21/2001 AARON REUSABLE ELECTROSURGICAL ELECTRODE AARON MEDICAL INDUSTRIES RICHARD A KOZLOFF
K010363 02/07/2001 ETEST MEROPENEM AB BIODISK ANNE BOLMSTROM
K010553 02/26/2001 PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY ABBOTT LABORATORIES JANET CONNOLLY
K014118 12/14/2001 MODIFICATION TO SUPERCROSS CATHETER ABBOTT VASCULAR INC. SEVRINA CIUCCI
K014203 12/21/2001 ABX MICROS 60 HEMATOLOGY ANALYZER ABX DIAGNOSTICS TOM M PHILLIPS
K010390 02/09/2001 ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS ACIST MEDICAL SYSTEMS, INC. CARL M BEAURLINE
K013972 12/03/2001 H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005 ACKARD LABORATORIES RICHARD HETTENBACH
K010582 02/27/2001 ACON STREP A RAPID TEST STRIP ACON LABORATORIES CO. ROBERT HUDAK
K010587 02/27/2001 ACTIVEECG ACTIVE CORP. KAREN SIEGEL
K014185 12/20/2001 AOS CANNULATED BONE SCREW SYSTEM ADVANCED ORTHOPAEDIC SOLUTIONS, INC. PAUL DONER
K013987 12/04/2001 REPROCESSED DISPOSABLE TROCARS ADVEN MEDICAL MARK W ALDANA
K014172 12/20/2001 NELSON ELECTROSURGICAL UNIT, MODEL GN640 AESCULAP, INC. LISA MILLINGTON
K014149 12/18/2001 PAEDISCOPE, MODEL # P010A AND PF011A AESCULAP, INC. GEORG KELLER
K014207 12/21/2001 REPOSABLE INSTRUMENT SYSTEM, MODELS MF001-MF083 AESCULAP, INC. LISA MILLINGTON
K014144 12/18/2001 EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804 AFP IMAGING CORP. DAVID VOZICK
K010571 02/26/2001 ADC QS/IPD WORKSTATION AGFA CORP. T. WHIT ATHEY
K010453 02/15/2001 M2376A DEVICELINK SYSTEM AGILENT TECHNOLOGIES, INC. MIKE HUDON
K010342 02/05/2001 M2376A DEVICELINK SYSTEM, MODEL M2376A AGILENT TECHNOLOGIES, INC. MIKE HUDON
K014081 12/11/2001 AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGES AKTINA MEDICAL PHYSICS CORP. JOAN KACHAROPOULOS
K014202 12/21/2001 COMPLETE BRAND MULTI-PURPOSE SOLUTION ALLERGAN, INC. PAUL J NOWACKI
K014071 12/10/2001 PMX DISPOSABLE BAG MASK RESUSCITATOR ALLIED HEALTHCARE PRODUCTS, INC. VERNON TRIMBLE
K014241 12/26/2001 COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D ALSIUS CORP. KEN COLLINS
K014040 12/07/2001 FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS ALTUS MEDICAL, INC. KATHY MAYNOR
K010583 02/27/2001 AMBU GEL, HYDROGEL BURN DRESSING AMBU, INC. SANJAY PARIKH
K014101 12/13/2001 RAPIDONE-OXY TEST AMERICAN BIO MEDICA CORP. HENRY WELLS
K010503 02/21/2001 AMIGO WHEELCHAIR AMIGO MOBILITY INTL., INC. MIKE LABRAKE
K010605 02/28/2001 ATLAST DATA MANAGEMENT SOFTWARE (DMS) AMIRA MEDICAL, INC. NINA PELED
K014023 12/06/2001 BABY TEETHER, MODEL 20104 ANGELINA TRADING, INC. JOHN CHANG
K010544 02/23/2001 VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE APEX DENTAL MATERIALS, INC. SCOTT LAMERAND
K010547 02/23/2001 VERTEX SEALAND L/C ORTHODONTIC SEALANT APEX DENTAL MATERIALS, INC. SCOTT LAMERAND
K014005 12/05/2001 APPLE MEDICAL MOBIUS ELASTIC RETRACTOR APPLE MEDICAL CORP. JOHN C PULFORD
K014047 12/07/2001 APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE APPLIED MEDICAL RESOURCES CORP. ANIL BHALANI
K010592 02/28/2001 AQUA WATER TREATMENT FOR HEMODIALYSIS AQUA WATER TREATMENT, INC. ANTHONY WEATHERS
K010330 02/02/2001 ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U ARROW INTL., INC. WILLIAM PAQUIN
K010525 02/22/2001 ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM ARTHREX, INC. VERNON BROWN
K010457 02/16/2001 ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924 ARTHREX, INC. VERNON BROWN
K014155 12/19/2001 OPENING/CLOSING WEDGE OSTETOMY PLATES ARTHREX, INC. ANN WATERHOUSE
K014222 12/26/2001 ARTHROCARE CONTROLLER, PATIENT CABLE, FOOT CONTROL, POWER CORD ARTHROCARE CORP. BRUCE PROTHRO
K010568 02/26/2001 ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM ARTHROCARE CORP. BETTY M JOHNSON
K014290 12/28/2001 ENTEC PLASMA WANDS ARTHROCARE CORP. BRUCE PROTHRO
K014305 12/31/2001 RESORBABLE LACTOSORB-L ACL CROSSPIN ARTHROTEK, INC. SARA B SHULTZ
K014057 12/10/2001 DERMASTAR ER:YAG LASER SYSTEM ASCLEPION-MEDITEC AG WILLIAM KELLEY
K010514 02/21/2001 BREASTVIEW VISUAL MAPPING SYSTEM ASSURANCE MEDICAL HOWARD M HOLSTEIN
K010473 02/20/2001 SPARROWHAWK DISPOSABLE ATC TECHNOLOGIES, INC. PAUL KIERCE
K014102 12/13/2001 PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251 ATOS MEDICAL AB EDDY ABERG
K010517 02/22/2001 ADVANTA SST GRAFT (<6MM) ATRIUM MEDICAL CORP. KAREN HALL
K010516 02/22/2001 ADVANTA SST GRAFT (>_6MM) ATRIUM MEDICAL CORP. KAREN HALL
K010477 02/20/2001 AUTO-LOCK AUTO-LOCK DIETRICH W GRABIS
K014210 12/21/2001 PALMO THERMOREGULATION INTERFACE ACCESSORY AVACORE TECHNOLOGIES, INC. CRAIG COOMBS
K014246 12/26/2001 AVID-NIT NERVE STIMULATION NEEDLES AVID N.I.T., INC. SCOTT HENDERSON
K010462 02/16/2001 AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) AVITA CORPORATION ALLEN REICH
K010485 02/20/2001 VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER B BRAUN PAUL O'CONNELL
K014174 12/20/2001 HARVEY PV DRY STERILIZER, MODEL # ST127325; ST127320; ST127320-33 BARNSTEAD/THERMOLYNE CORP. MIA M WARE
K010566 02/26/2001 COLLEAGUE VOLUMETRIC INFUSION PUMP BAXTER HEALTHCARE CORP. JENNIFER M PAINE
K014088 12/12/2001 DUPLOREACH BAXTER HEALTHCARE CORP. ARLENE VIDOR
K014075 12/11/2001 BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145 BAYLIS MEDICAL CO., INC. KRIS SHAH
K010429 02/13/2001 ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345 BECKMAN COULTER, INC. BRENT TABER
K010428 02/13/2001 ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349 BECKMAN COULTER, INC. BRENT TABER
K014034 12/07/2001 MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) BECKMAN COULTER, INC. ANNETTE HELLIE
K013978 12/03/2001 SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT BECKMAN COULTER, INC. MARY BETH TANG
K010597 02/28/2001 SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT BECKMAN COULTER, INC. ANNETTE HELLIE
K014103 12/13/2001 SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR BECKMAN COULTER, INC. MARY BETH TANG
K014173 12/20/2001 SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR BECKMAN COULTER, INC. MARY BETH TANG
K010358 02/06/2001 VIGIL SEROLOGY CONTROL LEVEL C BECKMAN COULTER, INC. ANNETTE HELLIE
K013971 12/03/2001 BD VACUTAINER SAFETY COAGULATION TUBE BECTON DICKINSON & CO. KEITH SMITH
K010572 02/26/2001 BD VISIDRAPE OPHTHALMIC DRAPES; BD VISIFLEX INCISE DRAPE BECTON DICKINSON AND CO. JAMES STAFFIERA
K014123 12/17/2001 BACTEC MGIT 960 SIRE KITS BECTON, DICKINSON & CO. JODY J HOFFMANN
K010523 02/22/2001 MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST BINAX, INC. PAMELA S ANGELL
K014019 12/06/2001 NEUROTECH MEDISTIM PLUS, TYPE 291 BIO-MEDICAL RESEARCH, LTD. MICHELLE SAWYER
K014020 12/06/2001 NT MEDITENS PLUS, TYPE 290 BIO-MEDICAL RESEARCH, LTD. MICHELLE SAWYER
K010335 02/02/2001 SLENDERTONE FLEX, MODEL, 512 BIO-MEDICAL RESEARCH, LTD. ROBERT DORMER
K010458 02/16/2001 THE MAESTRO SYSTEM BIOHORIZONS IMPLANT SYSTEMS, INC. STEVEN BOGGAN
K010550 02/26/2001 VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 BIOMERIEUX, INC. Nancy Weaver
K020870 12/28/2001 VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN BIOMERIEUX, INC. Nancy Weaver
K020871 12/28/2001 VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN BIOMERIEUX, INC. Nancy Weaver
K010560 02/26/2001 PORTRAIT FEMORAL COMPONENT BIOMET, INC. MICHELLE L MCKINLEY
K010348 02/05/2001 TANTALUM BEADS - RADIOGRAPHIC MARKER BIOMET, INC. LONNIE WITHAM
K010554 02/26/2001 MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA2000A BIONX IMPLANTS, INC. TUIJA ANNALA
K014247 12/26/2001 TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002 BIOSITE INCORPORATED JEFFREY R DAHLEN
K010405 02/12/2001 7230 ULTRASOUND IMAGING SYSTEM WITH TEI BIOSOUND ESAOTE, INC. COLLEEN HITTLE
K014168 12/19/2001 AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION) BIOSOUND ESAOTE, INC. COLLEEN H DENSMORE
K014000 12/04/2001 VISTITOME 20-10 MICROKERATOME BIOVISION AG DAVID S FERNQUIST
K014169 12/19/2001 WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS BOB J. JOHNSON & ASSOC., INC ROBERT SNYDER
K014187 12/21/2001 AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM BOEHRINGER LABORATORIES JOHN KARPOWICZ
K013976 12/03/2001 BOEHRINGER MRI SUCTION REGULATORY BOEHRINGER LABORATORIES JOHN KARPOWICZ
K010479 02/20/2001 MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR BONUTTI RESEARCH, INC. PATRICK BALSMANN
K014297 12/31/2001 ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT; ENDOVIVE LOW PROFILE BUTTON REPLACEMENT GASTROSTOMY TUBE; SECURI-T INITIAL P BOSTON SCIENTIFIC CORP. PAIGE SWEENEY
K014195 12/21/2001 KAYAK HYDROPHILIC GUIDE WIRES BOSTON SCIENTIFIC CORP. MARK MURPHY
K014109 12/14/2001 IN-TIME RETRIEVAL DEVICE BOSTON SCIENTIFIC, TARGET SETH A SCHULMAN
K014256 12/26/2001 KOLIBRI IGS SYSTEMS BRAINLAB AG STEFAN VILSMEIER
K010602 02/28/2001 VECTORVISION HIP BRAINLAB, AG RAINER BIRKENBACH
K010505 02/21/2001 TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY BRENTWOOD MEDICAL TECHNOLOGY CORP. RUOMEI ZHANG
K014280 12/27/2001 LATEX EXAMINATION GLOVE (POWDERED) BRIGHTWAY GLOVES PVT. LTD. N. PARAMASIVAN
K014279 12/27/2001 LATEX EXAMINATION GLOVES (POWDER FREE) BRIGHTWAY GLOVES PVT. LTD. N. PARAMASIVAN
K014283 12/27/2001 LATEX SURGEONS GLOVE (POWDER FREE) BRIGHTWAY GLOVES PVT. LTD. N. PARAMASIVAN
K014278 12/27/2001 LATEX SURGEONS GLOVE (POWDERED) BRIGHTWAY GLOVES PVT. LTD. N. PARAMASIVAN
K010343 02/05/2001 BMR DENTAL IMPLANT SYSTEM, MODEL 3.3XX, EITHER HA OR TPS COATED, 3.308, 3.310,3.312, 3.314 3.316 BUCK MEDICAL RESEARCH REBECCA ELLIS
K010444 02/14/2001 ADVANTAGE SINGLE-USE ELECTROSURGICAL ATTACHMENT-J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, BALL TIP, NEEDLE TIP C.R. BARD, INC. KERRY CHUNKO
K014212 12/21/2001 BARD CONQUEST PTA BALLOON DILATATION CATHETER C.R. BARD, INC. CAROL VIERLING
K010567 02/26/2001 OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR C.R. BARD, INC. PEGGY KEIFFER
K014128 12/17/2001 CANDELA SMOOTHBEAM LASER SYSTEM CANDELA CORP. LORRAINE NELSON
K010552 02/26/2001 CG-900P FETAL/MATERNAL MONITOR CARD GUARD SCIENTIFIC SURVIVAL, LTD. LEONID TRACHTENBERG
K010396 02/09/2001 C. NET 2100 CARDIONETICS, LTD. BARRY SALL
K010393 02/08/2001 APOLLO MOBILE C ARM SYSTEM CARES BUILT, INC. TIMOTHY TELYMONDE
K010392 02/08/2001 ATHENA REMOTE CONTROLLED RF SYSTEM CARES BUILT, INC. TIMOTHY TELYMONDE
K010391 02/09/2001 ATLAS MULTI-PURPOSE DSA SYSTEM CARES BUILT, INC. TIMOTHY TELYMONDE
K014028 12/06/2001 CARESIDE APTT CARESIDE HEMOTOLOGY, INC. KENNETH B ASARCH
K010349 02/05/2001 DUAL LUMEN MIDLINE CATHETER CATHETER INNOVATIONS, INC. ROGER L RICHINS
K013960 12/03/2001 APATIGHT HA-BONE GRAFT SUBSTITUTE CERABIO, LLC JAMES J CASSIDY
K013966 12/03/2001 APATIGHT-TCP BONE GRAFT SUBSTITUTE CERABIO, LLC JAMES J CASSIDY
K010389 02/09/2001 CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411 CHAD THERAPEUTICS, INC. KEVIN MCCULLOH
K014048 12/07/2001 CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS CLINICON CORP. SEAN M CURRY
K014236 12/26/2001 CLINICON WAVEGUIDE PLATFORM WITH INTERCONNECT FOR LUXAR ACCESSORIES CLINICON CORP. SEAN M CURRY
K014063 12/11/2001 TASK FORCE MONITOR 3040 CNSYSTEMS MEDIZINTECHNIK GMBH CHRISTIAN WAGNER
K014153 12/18/2001 COAPT SYSTMES ENDOTINE DEVICE COAPT SYSTEMS, INC. JUDE PAGANELLI
K014234 12/26/2001 MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER CONTINUUM ELECTRO-OPTICS, INC. RONALD KOHLHARDT
K014160 12/19/2001 PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES) COOK UROLOGICAL, INC. DEBBIE SCHMITT
K010601 02/28/2001 FANELLI BILIARY STENT COOK, INC. LISA HOPKINS
K010450 02/15/2001 LIVER TAMPONADE BALLOON COOK, INC. LISA HOPKINS
K014035 12/07/2001 COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS COOLTOUCH CORP. DONALD V JOHNSON
K010316 02/02/2001 COOLTOUCH VARIA ND:YAG LASER SYSTEM; COOLTOUCH VARIA-II ND:YAG LASER SYSTEM COOLTOUCH CORP. DONALD V JOHNSON
K010411 02/12/2001 PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM CORDIS CORP. CHARLES J RYAN
K010445 02/14/2001 PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM CORDIS CORP. SAM MIRZA
K014041 12/07/2001 TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM CORDIS NEUROVASCULAR ALINA CARABALLO
K010511 02/21/2001 MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES CORDIS NEUROVASCULAR, INC. Amarilys Machado
K014262 12/27/2001 COSMED QUARK C12/QUARK T12 COSMED S.R.L. ROBERT SCHIFF
K013975 12/03/2001 CP-SLEEVE CP MEDICAL MARY ANN GREENWALT
K013964 12/03/2001 MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS CP MEDICAL MARY ANN GREENWALT
K014012 12/05/2001 DOC BAND CRANIAL TECHNOLOGIES, INC. TIMOTHY R LITTLEFIELD
K014156 12/19/2001 CERASORB ORTHO CURASAN AG ERIC WIECHERT
K014216 12/21/2001 SECCA SYSTEM CURON MEDICAL, INC. JONATHAN S KAHAN
K010314 02/02/2001 DIMENSION CTNI CALIBRATOR DADE BEHRING, INC. GEORGE PLUMMER
K010313 02/02/2001 DIMENSION CTNI FLEX REAGENT CARTRIDGE DADE BEHRING, INC. GEORGE PLUMMER
K010418 02/12/2001 DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS DADE BEHRING, INC. CYNTHIA VAN DUKER
K010494 02/20/2001 SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 DADE BEHRING, INC. RADAMES RIESGO
K010395 02/09/2001 E-POWER DALTON MEDICAL CORP. WILL RIDGWAY
K010463 02/16/2001 DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES DATEX-OHMEDA, INC. JOEL C KENT
K014238 12/26/2001 DELSONIC 2000 DELDENT LTD. ALAN EDEL
K014249 12/26/2001 JETPOLISHER DELDENT LTD. ALAN EDEL
K014245 12/26/2001 JETSONIC 2000 DELDENT LTD. ALAN EDEL
K014252 12/26/2001 JETSTREAM DELDENT LTD. ALAN EDEL
K013969 12/03/2001 MINIBLASTER DELDENT LTD. ALAN EDEL
K014188 12/21/2001 NEW PROPHY POWDER DENTSPLY INTL. P. JEFFERY LEHN
K014053 12/10/2001 CONDUIT TCP GRANULES DEPUY ACROMED KAREN F JURCZAK
K010320 02/02/2001 MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM DEPUY ACROMED KAREN F JURCZAK
K010576 02/27/2001 MONARCH SPINE SYSTEM DEPUY ACROMED FRANK MAAS
K010367 02/07/2001 MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM DEPUY ORTHOPAEDICS, INC. ARLENE C SAULL
K013984 12/03/2001 IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K010350 02/05/2001 STA -CALIBRATOR HBPM/LMWH KIT DIAGNOSTICA STAGO, INC. ANDREW LOC B. LE
K010324 02/02/2001 STA-QUALITY HBPM/LMWH KIT DIAGNOSTICA STAGO, INC. ANDREW LOC B. LE
K014120 12/17/2001 TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) DIAGNOSTICS BIOCHEM CANADA, INC. G. R. DUMONT
K014030 12/06/2001 1,25-DIHYDROXYVITAMIN D125I RIA DIASORIN, INC. DAVID IKEDA
K010399 02/09/2001 DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM) DIATEK, INC. TODD CASSIDY
K010478 02/20/2001 DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR DIDECO LYNNE LEONARD
K014080 12/11/2001 APEX ADULT HOLLOWE FIBER OXYGENATOR DIDECO S.P.A. BARRY S SALL
K014141 12/17/2001 DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11 DIGIBIO TECHNOLOGY CORP. ERIC LUO
K014072 12/10/2001 FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH) DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. JONATHAN S KAHAN
K010595 02/28/2001 DJ ORTHOPEDICS INTERFERENCE SCREW DJ ORTHOPEDICS, LLC JAMAL D RUSHDY
K010594 02/28/2001 DJ ORTHOPEDICS POST SCREW DJ ORTHOPEDICS, LLC JAMAL D RUSHDY
K014218 12/21/2001 OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210' DOLPHIN MEDICAL INC. JON WERNER
K010386 02/08/2001 DUO-DENT DENTAL IMPLANT DUO-DENT DENTAL IMPLANT SYSTEMS LLC. MICHAEL H VOVOLKA
K010565 02/26/2001 DYNATRON STS DYNATRONICS CORP. JOHN S RAMEY
K010551 02/26/2001 EBI DYNAFIX VS OSTEOTOMY SYSTEM EBI, L.P. PATRICIA FLOOD
K014137 12/17/2001 MODIFICATION TO EBI OMEGA 21 SYSTEM EBI, L.P. FREDERIC TESTA
K010437 02/13/2001 MODIFICATION TO EBI XFIX DFS RAIL SYSTEM EBI, L.P. PATRICIA FLOOD
K014276 12/27/2001 MODIFICATION TO EBI XFIX DFS SYSTEM EBI, L.P. FREDERIC TESTA
K014194 12/21/2001 MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM EBI, L.P. PATRICIA M FLOOD
K010482 02/20/2001 ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1 ECHOCATH, INC. DAVID LYONS
K014052 12/10/2001 EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL EDWARDS LIFESCIENCES, LLC. JASON SMITH
K014054 12/10/2001 EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL EDWARDS LIFESCIENCES, LLC. JASON SMITH
K013990 12/03/2001 LIFESTITCH SUTURING DEVICE EDWARDS LIFESCIENCES, LLC. LUCINDA STOCKERT
K010488 02/20/2001 ATAC PAK AST REAGENT KIT ELAN HOLDINGS, INC. WYNN STOCKING
K010526 02/22/2001 MODIFICATION TO THE GRIP ELCARE INNOVATIONS, INC. ELROY T CANTRELL
K010465 02/16/2001 DENSTAT ELMED, INC. WERNER HAUSNER
K014107 12/13/2001 ENDIUS CERVICAL PLATE SYSTEM ENDIUS, INC. GENE DIPOTO
K014090 12/11/2001 ENDIUS SPINAL FIXATION SYSTEM ENDIUS, INC. GENE DIPOTO
K010535 02/23/2001 TRIFIX SPINAL FIXATION SYSTEM ENDIUS, INC. SUSAN FINNERAN
K010339 02/05/2001 ENDOCARE PERCUTANEOUS ACCESS SET ENDOCARE, INC. VINCENT CUTARELLI
K010356 02/05/2001 LATEX EXAMINATION GLOVES-POWDER FREE ENZYMIC TECHNOLOGIES SDN BHD LEE HONG YEN
K010347 02/05/2001 LATEX EXAMINATION GLOVES-POWDERED, NONSTERILE ENZYMIC TECHNOLOGIES SDN BHD LEE HONG YEN
K010311 02/01/2001 LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICE EUROMI SA JOSEPH M AZARY
K010434 02/13/2001 OPTETRAK B-SERIES TOTAL KNEE SYSTEM EXACTECH, INC. Lisa Simpson
K010404 02/12/2001 EXEL I.V. ADMINISTRATION SET EXELINT INTL. CO. ARMAND HAMID
K010562 02/26/2001 ALPHA DX SYSTEM FIRST MEDICAL, INC. GREG HOLLAND
K014024 12/06/2001 MODIFICATION TO ALPHA DX SYSTEM FIRST MEDICAL, INC. GREG HOLLAND
K013977 12/03/2001 ECHO-SCREEN T, TA, TD, TDA, TC FISCHER-ZOTH AUDIOLOGIC SYSTEMS, INC. MICHAEL SOERENSEN
K014284 12/27/2001 NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE AND YELLOWISH WHITE FORMOSA GLOVE INDUSTRIAL CO., LTD. TIANG S CHANG
K014285 12/27/2001 NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE, PURPLE FORMOSA GLOVE INDUSTRIAL CO., LTD. TIANG S CHANG
K014002 12/04/2001 ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 FORTUNE MEDICAL INSTRUMENT CORP. ABE WANG
K013997 12/04/2001 UNIFIL BOND GC AMERICA, INC. TERRY L JORITZ
K014097 12/12/2001 GE LOGIQ 5 GE MEDICAL SYSTEMS ALLEN SCHUH
K014255 12/26/2001 DINAMAP PROCARE SERIES MONITOR; MODEL 100, 200, 300, 400 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES THOMAS ENGLISH
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K014167 12/19/2001 LIBERTY BLOOD GLUCOSE MONITORING SYSTEM POLYMEDICA PHARMACEUTICALS, U.S.A., INC.] PATRICIA COLLINS
K010456 02/16/2001 BIOSCANNER CREATININE TEST STRIPS POLYMER TECHNOLOGY SYSTEMS, INC. MARGO ENRIGHT
K014099 12/13/2001 BIOSCANNER PLUS POLYMER TECHNOLOGY SYSTEMS, INC. MARGO ENRIGHT
K014115 12/14/2001 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX PORTEX, INC. TIMOTHY J TALCOTT
K014073 12/10/2001 HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE PORTEX, INC. BRAIN E FARIAS
K013970 12/03/2001 PRIME-DENT HEMA DESENSITIZER PRIME DENTAL MANUFACTURING, INC. ROLANDO MARASIGAN
K014084 12/11/2001 NYCOCARD CRP CONTROL PRIMUS CORP. JIM NOFFSINGER
K014069 12/10/2001 LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC PRINCETON BIOMEDITECH CORP. JEMO KANG
K014067 12/10/2001 LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC PRINCETON BIOMEDITECH CORP. JEMO KANG
K014193 12/21/2001 LIFESIGN DOA 4 (THC/OPI/COC/MET) PRINCETON BIOMEDITECH CORP. JEMO KANG
K014192 12/21/2001 LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET PRINCETON BIOMEDITECH CORP. JEMO KANG
K014066 12/10/2001 LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC PRINCETON BIOMEDITECH CORP. JEMO KANG
K010454 02/15/2001 THE ALBERTA LENS SM2, SULFOCON B PROGRESSIVE OPTICAL RESEARCH LTD. NICK NOVICKY
K010400 02/12/2001 VACUUM ASSISTED CORE BIOPSY DEVICE PROMEX, INC. JOSEPH L MARK
K013996 12/03/2001 LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE PT. MAJA AGUNG LATEXINDO EMMY T JOENG
K010486 02/20/2001 POLYMER COATED POWDER-FREE GREY COLOR POLYCHLOROPRENE PATIENT EXAMINATION GLOVES PT. MEDISAFE TECHNOLOGIES ANIL TANEJA
K010483 02/20/2001 POWDERFREE COLORED LATEX EXAMINATION GLOVES (PINK, BLUE, GREEN, AND WHITE) WITH PROTEIN CONTENT LABELING CLAIM (50 MICR0 PT. MEDISAFE TECHNOLOGIES ANIL TANEJA
K014133 12/17/2001 PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE PULPDENT CORP. KENNETH J BERK
K014059 12/10/2001 PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE PULPDENT CORP. KENNETH J BERK
K014138 12/17/2001 PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT PULPDENT CORP. KENNETH J BERK
K010337 02/05/2001 LIPOPRINT SYSTEM, LDL SUBFRACTIONS QUANTIMETRIX CORP. GEBHARD NEYER
K010598 02/28/2001 SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL QUANTIMETRIX CORP. EVA LASZLO
K010461 02/16/2001 ADVIA RETIC PLUS R & D SYSTEMS, INC. KENNETH T EDDS
K010409 02/12/2001 CBC-SF R & D SYSTEMS, INC. KENNETH T EDDS
K010470 02/20/2001 R & D 4K RETIC R & D SYSTEMS, INC. KENNETH T EDDS
K010548 02/26/2001 MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP KEVIN J O'CONNELL
K010538 02/23/2001 PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PARSET NEEDLELESS SECONDARY SET WITH BLUNT CANNULA, A14003E RD MEDICAL MFG., INC. CARLOS A RODRIGUEZ-GARCIA
K010436 02/13/2001 TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011 REMOTE DIAGNOSTIC TECHNOLOGIES LTD. CHRIS HANNAN
K014126 12/17/2001 SANIDAD HEALTH-UP TENS MP-73725 ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY JEN KE-MIN
K010362 02/06/2001 ACCU-CHEK COMFORT CURVE TEST STRIP ROCHE DIAGNOSTICS CORP. MIKE FLIS
K014139 12/17/2001 DIABETES ASSISTANT SOFTWARE ROCHE DIAGNOSTICS CORP. Scott Thiel
K010588 02/27/2001 ELECSYSCA 15-3 II ASSAY ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K010498 02/21/2001 WRISTWATCH BLOOD PRESSURE MONITOR A46 ROSSMAX INTERNATIONL LTD. MICHAEL YEH
K010596 02/28/2001 RUSCH BRONCHUS BLOCKER KIT RUSCH INTL. KARENANN J BROZOWSKI
K010420 02/12/2001 RUSCH MMG/O'NEIL CATHETER RUSCH, INC. WILLIAM SLEVIN
K014208 12/21/2001 SSIR SYSTEM RUSSIAN-AMERICAN TECHNOLOGY ASSOCIATES, INC. JOYCE HEINRICH
K014273 12/27/2001 ACUSTIM S.H.P. INTL. PTY., LTD. E.D. RICHARDS
K010593 02/28/2001 SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT SA SCIENTIFIC, INC. ARBI A SHADFAN
K010522 02/22/2001 SUREVUE URINE HCG SA SCIENTIFIC, INC. HARBI A SHADFAN
K010502 02/21/2001 MODEL THERMO TEK QUICKCARE SAAT LTD. E. J SMITH
K013980 12/03/2001 SAFE SHIELD PRE-POWDERED LATEX EXAMINATION GLOVES SAFE SHIELD CO. LTD SUSAN D GOLDSTEIN-FALK
K014056 12/10/2001 SALTER LABS MODIFIED NEBUTECH NEBULIZER SALTER LABS DUANE KAZAL
K010559 02/26/2001 SAUFLON MULTI LENS CARE SYSTEM SAUFLON PHARMACEUTICALS, LTD. LIGIA DELACRUZ
K010519 02/22/2001 MAGNUM FLOW IRRIGATION SYSTEM SCION VALLEY, INC. C. KENNETH FRENCH
K014055 12/10/2001 NON-STERILE POWDERED LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM ON LABELING SEAL POLYMER INDUSTRIES BHD. CHUN C FONG
K010382 02/08/2001 100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I SENSIDYNE, INC. GEORGE MASON
K014038 12/07/2001 PYLORITEK VP TEST KIT 5140VP SERIM RESEARCH CORP. PATRICIA RUPUCHOCK
K013998 12/04/2001 POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES SHEEN MORE ENT. CO., LTD. JANNA P TUCKER
K014077 12/11/2001 POWDER FREE (BLUE) NITRILE PATIENT EXAMINATION GLOVES SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT JAMES CHU
K014112 12/14/2001 SATARI LATEX PATIENT EXAMINATION POWDERED GLOVE SINGLE SIDE POLYMER COATED, NON STERILE, 200 MG OR LESS OF TOTAL WATER E SIAM SEMPERMED CORP. LTD. JAY MANSOUR
K014110 12/14/2001 SATARI POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) POLYMER COATED WHIT SIAM SEMPERMED CORP. LTD. JAY MANSOUR
K014113 12/14/2001 ENDOMAP SIEMENS MEDICAL SOLUTIONS USA, INC. SANDRA ROBINSON
K014213 12/21/2001 SIEMENS INFINITY GATEWAY SUITE SIEMENS MEDICAL SOLUTIONS USA, INC. PENELOPE H GRECO
K010426 02/13/2001 PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER SIMS DELTEC, INC. LISA J STONE
K010489 02/20/2001 DYONICS VISION 111 MOBILE VIDEO UNIT SMITH & NEPHEW, INC. STEVEN JACKSON
K010555 02/26/2001 JAX SMITH & NEPHEW, INC. KIM P KELLY
K010557 02/26/2001 JAX GRANULES BONE VOID FILLER SMITH & NEPHEW, INC. TRUDE C MCLEAN
K013989 12/04/2001 ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER SMITH & NEPHEW, INC. JANET JOHNSON GREEN
K010509 02/21/2001 CEDARS-SINAI BPGS AND MOCO SMV AMERICA PAULA MCLEAN
K014116 12/14/2001 HAND-CARRIED ULTRASOUND SYSTEM SONOSITE,INC. MICHAEL HOFFMAN
K010374 02/07/2001 SONOSITE HAND-CARRIED ULTRASOUND SYSTEM SONOSITE,INC. MICHAEL A HOFFMAN
K014299 12/31/2001 SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH SORBA MEDICAL SYSTEMS, INC. JILL BARNEY
K014211 12/21/2001 OXYARM CO2 SOUTHMEDIC, INC. PAUL E DRYDEN
K010415 02/12/2001 ISODAN SPECIALITES SEPTODONT PETER S REICHERZ
K014105 12/13/2001 SPECTRAL'S TROPONIN I SPECTRAL DIAGNOSTICS, INC. NISAR A SHAIKH
K010563 02/26/2001 END-TO-END AND SIDE-BY-SIDE CONNECTORS SPINAL CONCEPTS, INC. DAVID M HOOPER
K013979 12/03/2001 SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM SPINAL CONCEPTS, INC. DAVID M HOOPER
K014200 12/21/2001 OPTIMESH SPINEOLOGY, INC. PAMELA R SNYDER
K014037 12/07/2001 SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE) ST. JUDE MEDICAL, INC. WILLIAM MCKELVEY
K014161 12/19/2001 SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE) ST. JUDE MEDICAL, INC. WILLIAM MCKELVEY
K014049 12/10/2001 EPOCA CODR STEM AND HEAD STELKAST COMPANY DONALD A STEVENS
K013993 12/04/2001 NEOCALEX STEPHEN M KORAL, DMD STEPHEN M KORAL
K010534 02/23/2001 CROSS-CHECKS DUAL, MODEL CI 125 STERITEC PRODUCTS, INC. LINDA NELSON
K014062 12/10/2001 SIMPLICITY EASY ACCESS INFUSION SET STERLING MEDIVATIONS, INC. JOEL S DOUGLAS
K010373 02/07/2001 SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND MINIMED MEDICATION RESERVOIRS (MODEL MMT-103) STERLING MEDIVATIONS, INC. JOEL DOUGLASS
K014061 12/10/2001 SIMPLICITY STARPLUS SOFT INFUSION SET STERLING MEDIVATIONS, INC. JOEL S DOUGLAS
K014091 12/12/2001 STRYKER PAINPUMP STRYKER CORP. NICOLE PETTY
K014263 12/27/2001 NEWGEN/UNIVERSAL MANDIBULAR SYSTEM STRYKER INSTRUMENTS ROBIN L ROWE
K014050 12/10/2001 HEX-LOCK TEMPORARY ABUTMENT SULZER DENTAL, INC. SEAN HARIRI
K014175 12/20/2001 SULZER DENTAL CERAMIC SYSTEM-HEXLOCK SULZER DENTAL, INC. SEAN HARIRI
K014214 12/21/2001 SULZER DENTAL CERAMIC SYSTEM-SPLINE SULZER DENTAL, INC. SEAN HARIRI
K014136 12/17/2001 MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY SULZER INTRATHERAPEUTICS, INC. MARIA E BRITTLE
K014089 12/11/2001 VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES SUN BIOMEDICAL LABORATORIES, INC. MING SUN
K010449 02/15/2001 IVD (IN VIVO DOSIMETER), MODEL 1131 SUN NUCLEAR CORP. NOEL M DOWNEY
K014140 12/17/2001 RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET SUNDER BIOMEDICAL TECH. CO., LTD. TONY HUNG
K014134 12/17/2001 POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G) SUPERGRADE HEALTHCARE PRODUCTS SDN. BHD. JANNA P TUCKER
K014230 12/26/2001 STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) SUPERMAX GLOVE MANUFACTURING SDN BHD STANLEY THAI
K010371 02/07/2001 LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT SURETEX, LTD. LON D MCILVAIN
K010542 02/23/2001 SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION SURGICAL NAVIGATION SPECIALISTS, INC. CAROL NAKAGAWA
K014021 12/06/2001 SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED SURGICAL SPECIALTIES CORP. ELIZABETH LAZARO
K014033 12/07/2001 EMORY CARDIAC TOOLBOX 2.1 EXECUTING ON NUCLEAR MEDICINE COMPUTERS SYNTERMED, INC. KENNETH F VAN TRAIN
K010344 02/05/2001 ADJUSTABLE LARGE FIXATOR SYSTEM SYNTHES (USA) BONNIE J SMITH
K010321 02/02/2001 MODULAR FOOT SYSTEM - 2.7 MM MODULE SYNTHES (USA) THOMAS M MAGUIRE
K010527 02/22/2001 SYNTHES (USA) IMF SCREWS SYNTHES (USA) THOMAS M MAGUIRE
K010499 02/21/2001 SYNTHES (USA) MIDFACE DISTRACTOR SYNTHES (USA) THOMAS M MAGUIRE
K010518 02/22/2001 SYNTHES ANTEROLATERAL CALCANEAL PLATE SYNTHES (USA) THOMAS M MAGUIRE
K014197 12/21/2001 SYNTHES HIGH TIBIAL OSTEOTOMY PLATE SYNTHES (USA) MATTHEW M HULL
K010578 02/27/2001 TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017 TAGA MEDICAL TECHNOLOGIES, INC. GARY AUSTIN
K014198 12/21/2001 BIOTECH B990K VIVI WHEELCHAIR TAIWAN ARMADA ENTERPRISE CO., LTD. Ke-Min Jen
K014009 12/05/2001 TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE TANITA CORP. OF AMERICA CAROL ALLOIAN (BENSON)
K010412 02/12/2001 FLEXIBLE ENDOSCOPIC SCISSORS TELEMED SYSTEMS, INC. MICHAEL CARROLL
K010383 02/08/2001 TEMP SCAN TENGHI CO. LTD TONY C S. CHANG
K010438 02/13/2001 MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS) TERANG NUSA SDN BHD CHIN-GUAN LOW
K010439 02/12/2001 MAXITEX DUPLEX STERILE LATEX POWDERED SURGEON GLOVES WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS) TERANG NUSA SDN BHD CHIN-GUAN LOW
K010443 02/14/2001 CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING TERUMO CARDIOVASCULAR SYSTEMS CORP. GARRY A COURTNEY
K014182 12/20/2001 TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCERS TETRAD CORP. CHARLES F HOTTINGER
K010441 02/13/2001 FREELITE KAPPA FREE KIT THE BINDING SITE, LTD. JAY H GELLER
K010440 02/13/2001 FREELITE LAMBDA FREE KIT THE BINDING SITE, LTD. JAY H GELLER
K014270 12/27/2001 MININEPH HUMAN B2-MICROGLOBULIN KIT THE BINDING SITE, LTD. JAY H GELLER
K010401 02/12/2001 TRI-PLEX ADAPTER THE MEDICAL DEVICE GROUP, INC. E.J. Smith
K010466 02/16/2001 TETHER ACFS THEKEN SURGICAL,LLC ROBERT THEKEN
K010472 02/20/2001 PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50 THOMSON & NIELSEN ELECTRONICS, LTD. ANDREW HARTSHORN
K014260 12/27/2001 TISSUELINK SOLID CYLINDER MONOPOLAR DEVICE TISSUELINK MEDICAL, INC. VICKI ANASTASI
K014258 12/26/2001 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K014259 12/26/2001 SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K010545 02/23/2001 TBW TRI-MED, INC. ROBERT J MEDOFF
K014243 12/26/2001 BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050 TRIAGE MEDICAL INC BRAD CULBERT
K014304 12/31/2001 BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S TRIAGE MEDICAL INC BRAD CULBERT
K013974 12/03/2001 RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A TRIMEDYNE, INC. SUSAN H GAMBLE
K014233 12/26/2001 CAPTIAM SYPHILIS-G ASSAY TRINITY BIOTECH, PLC FIONA CAMPBELL
K014248 12/26/2001 DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER UROGYN LTD. EREZ ADIV
K014086 12/11/2001 CTL BODY / SPINE ARRAY COIL USA INSTRUMENTS, INC. RONY THOMAS
K014011 12/05/2001 CANVAS N-VAS-D 2.0 VASSOL, INC. LYNETTE L HOWARD
K014127 12/17/2001 KARMA DISCOVERY, MODEL KP40 VESTIL MANUFACTURING CORP. RICH MICHAEL
K014224 12/26/2001 PRECISION PLUS TUNA OFFICE SYSTEM VIDAMED, INC. YI CHEN
K014154 12/18/2001 VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00 VILEX, INC. ABRAHIM LAVI
K013973 12/03/2001 ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOC VISTAKON JAMES W PARZIALE
K010507 02/21/2001 VISTAKON (METHAFILCON A) CONTACT LENSES VISTAKON MICHAEL J TERSAK
K014111 12/14/2001 REBILDA SC VOCO GMBH EVAN DICK
K014068 12/10/2001 ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115 W & H DENTALWERK BUERMOOS GMBH RALF BENDA
K014215 12/21/2001 VIABIL BILIARY ENDOPROSTHESIS W.L. GORE & ASSOCIATES,INC JACQUELINE KALBACH
K010326 02/02/2001 WAKO AUTOKIT C3 WAKO CHEMICALS, USA, INC. TONYA MALLORY
K010325 02/02/2001 WAKO AUTOKIT C4 WAKO CHEMICALS, USA, INC. TONYA MALLORY
K010332 02/02/2001 WAKO IMMUNOASSAY CALIBRATOR SET WAKO CHEMICALS, USA, INC. TONYA MALLORY
K010334 02/02/2001 WAKO LIPID CALIBRATOR WAKO CHEMICALS, USA, INC. TONYA MALLORY
K010427 02/13/2001 LORENZ FIDUCAIL SCREW WALTER LORENZ SURGICAL, INC. KIM REED
K014148 12/18/2001 SELF-DRILLING RADIOGRAPHIC MARKER WALTER LORENZ SURGICAL, INC. KIM REED
K010447 02/13/2001 MODIFICATION TO ACTICOAT FOAM DRESSING WESTAIM BIOMEDICAL, INC. Steve Chartier
K013983 12/03/2001 WIENER LAB. ALP 405 WIENER LABORATORIES S.A.I.C. VIVIANA CETOLA
K010421 02/12/2001 WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105 WIENER LABORATORIES S.A.I.C. VIVIANA CETOLA
K014158 12/19/2001 ENDOSCOPIC CAMERA TC804/C4 WORLD OF MEDICINE LEMKE GMBH SUSANNE RAAB
K014171 12/20/2001 ADVANCE UNICONDYLAR KNEE SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K010532 02/23/2001 OSTEOSET BVF KIT WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K014288 12/28/2001 DERMGRIP POWDER FREE POLYMER COATED LATEX SURGEON'S GLOVES,STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM ORS WRP SPECIALTY PRODUCTS SDN. BHD. MOHD H HUSSEIN
K014119 12/17/2001 WU'S 3-WHEELED NEO SCOOTER, WT-M3 WU'S TECH CO., LTD. Ke-Min Jen
K014147 12/18/2001 80 CHANNEL EEG XLTEK SONJA MARKEZ
K014146 12/18/2001 84 CHANNEL EEG XLTEK SONJA MARKEZ
K014070 12/10/2001 EPOCH HIP PROSTHESIS, MODEL 4075 SERIES ZIMMER, INC. KAREN CAIN
K013991 12/04/2001 PROLONG HIGHLY CROSSLINKED POLYETHTYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS ZIMMER, INC. STEPHEN H MCKELVEY


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