FDA 510(k) Applications Received During December, 2001

FDA 510(k) Number Submission Date Device Name Applicant Contact
K014142 12/17/2001 UNITE BONDING ADHESIVE 3M UNITEK L. MARLYN SCHEFF
K014201 12/21/2001 AARON REUSABLE ELECTROSURGICAL ELECTRODE AARON MEDICAL INDUSTRIES RICHARD A KOZLOFF
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
K013972 12/03/2001 H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005 ACKARD LABORATORIES RICHARD HETTENBACH
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
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
K014101 12/13/2001 RAPIDONE-OXY TEST AMERICAN BIO MEDICA CORP. HENRY WELLS
K014023 12/06/2001 BABY TEETHER, MODEL 20104 ANGELINA TRADING, INC. JOHN CHANG
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
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
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
K014102 12/13/2001 PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251 ATOS MEDICAL AB EDDY ABERG
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
K014174 12/20/2001 HARVEY PV DRY STERILIZER, MODEL # ST127325; ST127320; ST127320-33 BARNSTEAD/THERMOLYNE CORP. MIA M WARE
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
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
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
K013971 12/03/2001 BD VACUTAINER SAFETY COAGULATION TUBE BECTON DICKINSON & CO. KEITH SMITH
K014123 12/17/2001 BACTEC MGIT 960 SIRE KITS BECTON, DICKINSON & CO. JODY J HOFFMANN
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
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
K014247 12/26/2001 TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002 BIOSITE INCORPORATED JEFFREY R DAHLEN
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
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
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
K014212 12/21/2001 BARD CONQUEST PTA BALLOON DILATATION CATHETER C.R. BARD, INC. CAROL VIERLING
K014128 12/17/2001 CANDELA SMOOTHBEAM LASER SYSTEM CANDELA CORP. LORRAINE NELSON
K014028 12/06/2001 CARESIDE APTT CARESIDE HEMOTOLOGY, INC. KENNETH B ASARCH
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
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
K014035 12/07/2001 "COOLTOUCH" AND "COOLTOUCH-II" ND:YAG LASER SYSTEMS COOLTOUCH CORP. DONALD V JOHNSON
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
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
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
K013984 12/03/2001 IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
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
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
K014218 12/21/2001 OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210' DOLPHIN MEDICAL INC. JON WERNER
K014137 12/17/2001 MODIFICATION TO EBI OMEGA 21 SYSTEM EBI, L.P. FREDERIC TESTA
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
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
K014107 12/13/2001 ENDIUS CERVICAL PLATE SYSTEM ENDIUS, INC. GENE DIPOTO
K014090 12/11/2001 ENDIUS SPINAL FIXATION SYSTEM ENDIUS, INC. GENE DIPOTO
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
K014289 12/28/2001 ORTHOSS RESORBABLE BONE VOID FILLER GEISTLICH-PHARMA PETER S REICHERTZ
K014206 12/21/2001 LOGIQBOOK GENERAL ELECTRIC CO. ALLEN SCHUH
K014058 12/10/2001 ENTEGRA PE PERSONAL DIGITAL ASSISTANT GENERAL ELECTRIC MEDICAL SYSTEMS D. DUERSTELER
K014108 12/13/2001 MAC 5000 ECG ANALYSIS SYSTEM GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN LISA LEE MICHELS
K014104 12/13/2001 VACUETTE EDTA K2 TUBES GREINER VACUETTE NORTH AMERICA, INC. JUDI SMITH
K014250 12/26/2001 7MM EXTENDED LENGTH ENDOSCOPE,DISSECTION TIPS, MODELS VH-1111, VH-1114 GUIDANT CORP. ANNE SCHLAGENHAFT
K014007 12/05/2001 DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM GUIDANT CORP. SABA MODJARRAD
K014184 12/20/2001 MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM GUIDANT CORP. SABA MODJARRAD
K014013 12/05/2001 H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM H & W TECHNOLOGY, LLC CHARLES O HANCOCK
K014083 12/11/2001 HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM HAEMONETICS CORP. JOHN SOKOLOWSKI
K014164 12/19/2001 GREAT TOE IMPLANT SYSTEM HARMOS ORTHOPAEDICS, INC. RICHARD W WOODS
K014122 12/17/2001 HL168E HEALTH & LIFE CO., LTD. SUSAN CHEN
K014094 12/12/2001 MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM HILL-ROM MANUFACTURING, INC. CINDY L CROSBY
K014240 12/26/2001 PRONTO HITACHI MEDICAL SYSTEMS AMERICA, INC. ROBERT MCCARTHY
K014074 12/10/2001 HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI-LEVEL PLUS, SCALAR, SCALAR PLUS; CPAP WITH HUMIDIFIER OPTION HOFFRICHTER GMBH STEPHEN H GORSKI
K014025 12/06/2001 HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READER HOMMED LLC. TOMMIE J MORGAN
K014229 12/26/2001 MODIFICATION TO OPUS SPINAL SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K014199 12/21/2001 SURGICAL SIMPLEX P WITH TOBRAMYCIN HOWMEDICA OSTEONICS CORP. WILLIAM J CYMBALUK
K014220 12/26/2001 T2 FEMORAL NAIL SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K014226 12/26/2001 UNITRAX MODULAR UNIPOLAR SYSTEM HOWMEDICA OSTEONICS CORP. JENNIFER A DAUDELIN
K014022 12/06/2001 MRI LINE MARKER I.Z.I. CORP. HELEN ZINREICH
K014130 12/17/2001 NLITE SYSTEM ICN PHOTONICS LTD. IAN MORTIMER
K014018 12/06/2001 CHOLESTEROL 1, 2, 3 IMI THOMAS M TSAKERIS
K014235 12/26/2001 OSSEOTITE NT DENTAL IMPLANTS & ACCESSORIES IMPLANT INNOVATIONS, INC. JEANNETTE G DAILEY
K014239 12/26/2001 MEDSURG EQUIPMENT COVERS INTERNATIONAL MEDSURG CONNECTION MICHELE H VOVOLKA
K014145 12/18/2001 MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODEL 8130, 8131 INTERPORE CROSS INTL. LYNN M RODARTI
K014079 12/11/2001 DR. HAYS BITE GUARD INVENTIVE RESOURCES, INC. DAVID W SCHLERF
K014008 12/05/2001 HEMOCHRON JR. CITRATE APTT CUVETTE ITC, INC. JOHN CLAY
K014082 12/11/2001 D.SIGN 53, MODEL NA1012204 IVOCLAR VIVADENT, INC. DONNA M HARTNETT
K014042 12/07/2001 D.SIGN 84 IVOCLAR VIVADENT, INC. ANDERJEET S GULATI
K014183 12/20/2001 AFB (ABSORBABLE FOAM BUTTRESS) J&J CORPORATE BIOMATERIALS CENTER DAVID A DALESSANDRO
K014300 12/31/2001 SAFETOUCH JAMES D RUSIN MD, MBA JAMES D RUSIN
K014129 12/17/2001 PROMOGRAN MATRIX WOUND DRESSING JOHNSON & JOHNSON MEDICAL, LTD. SERGIO J GADALETA
K014303 12/31/2001 JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE JOSTRA AG KATHLEEN JOHNSON
K014204 12/21/2001 ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822 K-JUMP HEALTH CO., LTD. JONATHAN S KAHAN
K014293 12/28/2001 K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET KAMIYA BIOMEDICAL CO. COLIN GETTY
K014277 12/27/2001 KSEA DEPLOYABLE CARDIOVASCULAR CLAMP KARL STORZ ENDOSCOPY-AMERICA, INC. JAMES A LEE
K014179 12/20/2001 DEMETRON LC KERR CORP. COLLEEN BOSWELL
K014027 12/06/2001 OPTIBOND SOLO PLUS 4 KERR DENTAL MATERIALS CENTER COLLEEN BOSWELL
K013982 12/03/2001 KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT KINAMED, INC. VINEET SARIN
K013994 12/04/2001 MODIFICATION TO VIEWSEND MEDICAL KLT TELECOM, INC. KEN LOGSDON, JR.
K014087 12/11/2001 LATEXX MANUFACTURING NON-CHLORINATED, POLYMER COATED, POWDER-FREE RUBBER LATEX EXAMINATION GLOVE LATEXX MANUFACTURING SDN.BHD. YOLANDA SMITH
K014162 12/19/2001 MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND LOBOB LABORATORIES, INC. DANIEL J MANELLI
K013999 12/04/2001 LODOX, MODEL BASELINE LODOX SYSTEMS (PTY) LTD. BRADLEY SACKS
K014117 12/14/2001 MODIFICATION TO OUTBACK CATHETER LUMEND, INC. PHIL HOPPER
K013985 12/03/2001 MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX MACHNET BV DANIEL KAMM
K013995 12/04/2001 MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL MEDICAL ANALYSIS SYSTEMS, INC. PENNY M LAYMAN
K014294 12/28/2001 MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414 MEDICAL DATA ELECTRONICS GREGORY ALKIRE
K014036 12/07/2001 MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030. MEDTRADE PRODUCTS LTD. JONATHAN D RANFIELD
K014205 12/21/2001 MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM ("BRIDGE SE") MEDTRONIC AVE, INC. KEVIN DRISCO
K014269 12/27/2001 POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102 MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S TOVE KJAER
K014223 12/26/2001 MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM MEDTRONIC PERCUSURGE, INC. MATT MOON
K014296 12/31/2001 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD W TREHARNE
K014267 12/27/2001 BUTTERFLY PLATE FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K013962 12/03/2001 EQUATION FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K014076 12/11/2001 MODIFICATION TO TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K013963 12/03/2001 MODEL 9210 DELIVERY CATHETER, MODEL 9210 MEDTRONIC VASCULAR MARY E BEST
K014165 12/19/2001 STIMULUS - DISSECTION INSTRUMENTS MEDTRONIC XOMED, INC. MARTIN D SARGENT
K014225 12/26/2001 BREATHTEK - UBIT UBT FOR H. PYLORI MERETEK DIAGNOSTICS, INC. DENISE E SPELLMAN
K014301 12/31/2001 MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS MERITS HEALTH PRODUCTS CO., LTD. LEE LEICHTER
K014060 12/10/2001 MICROAIRE 1000E SYSTEM MICROAIRE SURGICAL INSTRUMENTS, INC. CARL ANGLES
K014272 12/27/2001 PERIOLASE ND:YAG DENTAL LASER SYSTEM MILLENNIUM DENTAL TECHNOLOGIES, INC. DAVID M HARRIS
K013988 12/04/2001 MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R MILLIPORE CORP. THOMAS BORROWS
K014016 12/05/2001 ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER MINNTECH CORP. LYNN LUCDERS
K014282 12/27/2001 BACSTOP FILTER,BACSTOP FILTER/HME MUNKTELL FILTER AB PAUL DRYDEN
K014281 12/27/2001 GARD FILTER, COMBIGARD FILTE / HME MUNKTELL FILTER AB PAUL DRYDEN
K014121 12/17/2001 WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860 NELLCOR PURITAN BENNETT, INC. ANTHONY MULLIN
K013992 12/04/2001 NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY NICHOLS INSTITUTE DIAGNOSTICS ROBERT SCHMIDT
K014274 12/27/2001 NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000 NIDEK, INC. CAROL PATTERSON
K014114 12/14/2001 GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX NIPRO DIABETES SYSTEMS, INC. KAELYN B HADLEY
K014044 12/07/2001 MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT) NOTAL VISION, INC. RICHARD E LIPPMAN
K014295 12/28/2001 STAT PROFILE PHOX ANALYZER NOVA BIOMEDICAL CORP. PAUL W MAC DONALD
K014251 12/26/2001 NTERO HOTROD SYSTEM NTERO SURGICAL, INC. BOMMI BOMMANNAN
K014124 12/17/2001 NUMED COEFFICIENT PTV CATHETERS NUMED, INC. NICHELLE R LAFLASH
K014152 12/18/2001 NXSTAGE CARTRIDGE EXPRESS NXSTAGE MEDICAL, INC. NORMA LEMAY
K014170 12/20/2001 STAURENGHI WIDE FIELD SCANNING LASER LENS OCULAR INSTRUMENTS, INC. RAYMOND GRAHAM
K014015 12/05/2001 OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA OLYMPUS AMERICA, INC. MICHAEL CAMPBELL
K014032 12/06/2001 OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA OLYMPUS AMERICA, INC. MICHAEL CAMPBELL
K014166 12/19/2001 UHI-3 HIGH FLOW INSUFFLATION UNIT OLYMPUS OPTICAL CO., LTD. LAURA STORMS-TYLER
K014078 12/11/2001 ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM ON SITE GAS SYSTEMS, INC. C. BARTON GULLONG
K014286 12/27/2001 SALUTE, MODEL 3022 ONUX MEDICAL, INC. RUTHANN DEPIETRO
K014100 12/13/2001 OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND OPUSDENT LTD. ARAVA HACOHEN
K014001 12/04/2001 DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3 ORAL OSTEODISTRACTION, L.P. ARTHUR WARD
K014189 12/21/2001 ODI TALON INTRAMEDULLARY HIP NAIL ORTHOPEDIC DESIGNS, INC. JOHN SODEIKA
K014209 12/21/2001 PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS PADPRO LLC. DANIEL KAMM
K014253 12/26/2001 DERMACHILLER 4 PARADIGM TREX, LLC NIKOLAI TANKOVICH
K014268 12/27/2001 NORAPAD PLAIN; NORAPAD TA PERLEI MEDICAL, INC. ART WARD
K014157 12/19/2001 HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A PHILIPS MEDICAL SYSTEMS TAMARA YOUNT
K014191 12/21/2001 M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540 PHILIPS MEDICAL SYSTEMS STEVE SINGLAR
K014181 12/20/2001 M2376A DEVICELINK SYSTEM, MODEL M2376A PHILIPS MEDICAL SYSTEMS, INC. MIKE HUDON
K014159 12/19/2001 PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM; PHILLIPS V24/V26 PATIENT MONITOR PHILIPS MEDICAL SYSTEMS, INC. DAVE OSBORN
K014261 12/27/2001 ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0 PHILIPS MEDICAL SYSTEMS, INC. DAVE OSBORN
K014302 12/31/2001 UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM PISHARODI SURGICALS, INC. MADHAVEN PISHARODI
K014167 12/19/2001 LIBERTY BLOOD GLUCOSE MONITORING SYSTEM POLYMEDICA PHARMACEUTICALS, U.S.A., INC.] PATRICIA COLLINS
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
K013996 12/03/2001 LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE PT. MAJA AGUNG LATEXINDO EMMY T JOENG
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
K014126 12/17/2001 SANIDAD HEALTH-UP TENS MP-73725 ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY JEN KE-MIN
K014139 12/17/2001 DIABETES ASSISTANT SOFTWARE ROCHE DIAGNOSTICS CORP. SCOTT THIEL
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
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
K014055 12/10/2001 NON-STERILE POWDERED LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM ON LABELING SEAL POLYMER INDUSTRIES BHD. CHUN C FONG
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
K013989 12/04/2001 ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER SMITH & NEPHEW, INC. JANET JOHNSON GREEN
K014116 12/14/2001 HAND-CARRIED ULTRASOUND SYSTEM SONOSITE,INC. MICHAEL 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
K014105 12/13/2001 SPECTRAL'S TROPONIN I SPECTRAL DIAGNOSTICS, INC. NISAR A SHAIKH
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
K014062 12/10/2001 SIMPLICITY EASY ACCESS INFUSION SET STERLING MEDIVATIONS, INC. JOEL S DOUGLAS
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
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
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
K014197 12/21/2001 SYNTHES HIGH TIBIAL OSTEOTOMY PLATE SYNTHES (USA) MATTHEW M HULL
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)
K014182 12/20/2001 TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCERS TETRAD CORP. CHARLES F HOTTINGER
K014270 12/27/2001 MININEPH HUMAN B2-MICROGLOBULIN KIT THE BINDING SITE, LTD. JAY H GELLER
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
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
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
K014148 12/18/2001 SELF-DRILLING RADIOGRAPHIC MARKER WALTER LORENZ SURGICAL, INC. KIM REED
K013983 12/03/2001 WIENER LAB. ALP 405 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
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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