FDA 510(k) Applications Received During October, 2000

FDA 510(k) Number Submission Date Device Name Applicant Contact
K003185 10/11/2000 FS ACTIVATOR III ACTIVATOR METHODS INTERNATIONAL, LTD ARLAN W FUHR
K003305 10/20/2000 PEDIATRIC INGESTASCAN ADAMS ELECTRONICS, INC. ROBERT E ADAMS
K003134 10/06/2000 FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING ADRI/TECHNAM GEORGE H SCHERR
K003107 10/04/2000 M2376A DEVICELINK SYSTEM AGILENT TECHNOLOGIES, INC. MIKE HUDON
K003330 10/24/2000 AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC) AKTINA MEDICAL PHYSICS CORP. JOAN ZACHAROPOULOS
K003370 10/30/2000 JAMSHIDI MARROW ACQUISITION CRADLE ALLEGIANCE HEALTHCARE CORP. LAVENIA FORD
K003109 10/04/2000 COMPLETE BRAND LUBRICATING AND REWETTING DROPS ALLERGAN, INC. PAUL J NOWACKI
K003252 10/17/2000 COMPLETE BRAND MULTI-PURPOSE SOLUTION ALLERGAN, INC. PAUL J NOWACKI
K003202 10/12/2000 FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & II ALTUS MEDICAL MICHAEL LEVERNIER
K003368 10/30/2000 ACROTHERM AQUARIUS MEDICAL CORP. CHRISTINA M FLEMING
K003227 10/16/2000 BIO-ABSORBABLE CORKSCREW MODEL AR-1920B ARTHREX, INC. VERNON BROWN
K003187 10/11/2000 VACUCATH I.V. CATHETER INTRODUCTER AUTO/CATH VASCULAR ACCESS, INC. ANIL BHALANI
K003193 10/12/2000 DUPLOGRIP BAXTER HEALTHCARE CORP. ARLENE VIDOR
K003245 10/17/2000 HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML BAXTER HEALTHCARE CORP. LINDA COLEMAN
K003225 10/16/2000 SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE BAXTER HEALTHCARE CORP. MARY ELLEN SNYDER
K003291 10/20/2000 BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY BAYER DIAGNOSTICS CORP. WILLIAM J PIGNATO
K003062 10/02/2000 BACTEC MGIT 960 SIR KITS BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC DENNIS R MERTZ
K003259 10/18/2000 ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479 BECKMAN COULTER, INC. DENISE THOMPSON
K003098 10/03/2000 ACCESS ULTRASENSITIVE HGH CALIBRATORS BECKMAN COULTER, INC. MARA CALER
K003196 10/12/2000 SYNCHRON SYSTEMS AMMONIA REAGENT BECKMAN COULTER, INC. LUCINDA STOCKERT
K003239 10/17/2000 LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506 BIO-RAD ELIZABETH PLATT
K003242 10/17/2000 LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623 BIO-RAD ELIZABETH PLATT
K003280 10/19/2000 VARIANT II TOTAL GHB BIO-RAD JACKIE BUCKLEY
K003176 10/11/2000 BIOEMG II AND BIOJVA BIO-RESEARCH ASSOCIATES, INC. JOHN C RADKE
K003385 10/31/2000 TWILITE, TWILITE WHITE BIOLASE TECHNOLOGY, INC. IOANA M RIZOIU
K003240 10/17/2000 BIOMET EXTERNAL WRIST PLATE BIOMET, INC. TRACY J BICKEL
K003294 10/20/2000 BIOMET LATERAL TROCH PLATE BIOMET, INC. TRACY J BICKEL
K003296 10/20/2000 BIOMET SCK KNEE SYSTEM BIOMET, INC. TRACY J BICKEL
K003253 10/17/2000 BIOMET'S MINIMALLY CONSTRAINED ELBOW BIOMET, INC. SARA A BAILEY
K003281 10/19/2000 LACTOSORB RAPIDFLAP BIOMET, INC. CAROL LAUSTER
K003273 10/18/2000 LACTOSORB SCREW ANCHOR BIOMET, INC. MARY VERSTYNEN
K003363 10/27/2000 M2A 32MM TAPER SYSTEM BIOMET, INC. MICHELLE L MCKINLEY
K003131 10/06/2000 MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT BIOMET, INC. CAROL LAUSTER
K003077 10/03/2000 SMARTSCREW MODEL 222006...227510 BIONX IMPLANTS, LTD. GERARD S CARLOZZI
K003105 10/04/2000 BIOSPHERE MEDICAL INFUSION CATHETER BIOSPHERE MEDICAL JOHN BONASERA
K003380 10/31/2000 BIOTEQUE VAGINAL DILATOR BIOTEQUE AMERICA, INC. DENIS DORSEY
K003072 10/03/2000 PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES BIOTRONIK, INC. JON BRUMBAUGH
K003317 10/24/2000 RENEW LS-1 BISCO, INC. CINDY ORIS
K003361 10/27/2000 RENEW LS-2 BISCO, INC. CYNDY ORIS
K003251 10/17/2000 BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690 BLEASE MEDICAL EQUIPMENT LTD. ART WARD
K003362 10/27/2000 ASTRONOMER+WITH SLD BOSTON SCIENTIFIC CORP. ANDREA J BOUMIS
K003100 10/03/2000 WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM BOSTON SCIENTIFIC CORP. RON BENNETT
K003285 10/19/2000 EXAC TRAC 2.0 (NOVALIS BODY MODULE) BRAINLAB, AG STEFAN VILSMELIER
K003268 10/18/2000 Z-TOUCH BRAINLAB, AG
K003186 10/11/2000 BARD MEMOTHERM ENDOSCOPIC BILIARY STENT C.R. BARD, INC. BETH A ZIS
K003289 10/20/2000 BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED); BARDEX LUBRI-SIL TEMPERATURE-SENSING FOLEY CATHETER (LU C.R. BARD, INC. GEORGE C ABERNATHY
K003220 10/16/2000 PERSONAL ECG TRANSMITTER, MODEL CG-6550 CARD GUARD SCIENTIFIC SURVIVAL, LTD. LEONID TRACHTENBERG
K003238 10/17/2000 SOLID STATE X-RAY IMAGING DEVICES CARES BUILT, INC. TIMOTHY D TELYMONDE
K003301 10/20/2000 DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER CELLAVISION AB CONSTANCE G BUNDY
K003345 10/25/2000 AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K003071 10/02/2000 GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR CIBA VISION CORPORATION TERRINA WILDER
K003322 10/24/2000 CODMAN BACTISEAL CATHETERS CODMAN & SHURTLEFF, INC. JAMES M FLAHERTY
K003057 10/02/2000 AUTOSTAT II ENA-4 PROFILE ELISA COGENT DIAGNOTICS LTD. DANIELLE KNIGHT
K003054 10/02/2000 AUTOSTAT II ENA-6 PROFILE ELISA COGENT DIAGNOTICS LTD. DANIELLE KNIGHT
K003339 10/25/2000 COLLAGEN PERIODONTAL MEMBRANE COLLAGEN MATRIX, INC. SHU-TUNG LI
K003175 10/10/2000 COMPUMEDICS SIESTA SYSTEM COMPUMEDICS LIMITED CONSTANCE BUNDY
K003217 10/13/2000 HERMES PORT EXPANDER COMPUTER MOTION, INC. DAVID U THOMAS
K003222 10/16/2000 MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER COMPUTER MOTION, INC. DAVID U THOMAS
K003085 10/03/2000 CONCENTRIC GUIDE CATHETER, MODELS 90018, 90020 CONCENTRIC MEDICAL, INC. LINDA BRADLEY
K003084 10/03/2000 CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012 CONCENTRIC MEDICAL, INC. LINDA BRADLEY
K003086 10/03/2000 CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008 CONCENTRIC MEDICAL, INC. LINDA BRADLY
K003213 10/13/2000 ALMATEX POWDER-FREE LATEX EXANINATION GLOVES WITH PROTIEN LABELING CLAIM 50 MICROGRAMS OR LESS CONCEPT RUBBER PRODUCTS SDN BHD TEOH HUN LIM
K003159 10/10/2000 CORDIS SLALOM PTA BALLOON CATHETER CORDIS CORP. CHUCK RYAN
K003336 10/25/2000 MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM CORDIS CORP. ELENA S JUGO
K003365 10/27/2000 S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS) CORDIS CORP. SAM MIRZA
K003050 10/02/2000 CRYOSURGICAL UNIT AND ACCESSORIES CRYOGEN, INC. CHERYL L SHEA
K003241 10/17/2000 ECAT PET SCANNER CTI PET SYSTEMS, INC. WILLIAM SKREMSKY
K003485 10/18/2000 CARE PROVIDER STATION ADDITION OF WEIGHT SCALE CYBERCARE TECHNOLOGIES, INC. GORDON J PETERS
K003257 10/18/2000 EHC400 DESKTOP PATIENT STATION; ECH600 CARE PROVIDER STATION CYBERCARE TECHNOLOGIES, INC. GORDON J PETERS
K003209 10/13/2000 URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A DADE BEHRING, INC. CATHY P CRAFT
K003323 10/24/2000 COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 DAVOL, INC. PAULA E BULGER
K003286 10/20/2000 SYMPHONY GRAFT DELIVERY SYSTEM DEPUY ACROMED FRANK MAAS
K003235 10/17/2000 PE.R.I. II KNEE FRACTURE SYSTEM DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K003182 10/11/2000 ORTHOGENESIS LPS SYSTEM DEPUY, INC. JANET G JOHNSON
K003146 10/10/2000 CLINIFLO INCENTIVE SPIROMETER DHD HEALTHCARE CORP. LAWRENCE WEINSTEIN
K003093 10/03/2000 ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30 DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K003372 10/30/2000 IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP DIAGNOSTIC PRODUCTS CORP. EDWARDS M LEVINE
K003212 10/13/2000 FIXION INTRAMEDULLARY NAILING SYSTEM ("FIXION IM NAIL") DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. JOHNATHAN S KAHAN
K003215 10/13/2000 MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM ("FIXION IM NAIL") DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. JONATHAN S KAHAN
K003272 10/18/2000 FLO-BOOT DISCOVERY GROUP LLC. RICHARD J FREER
K003067 10/02/2000 CALEO DRAGER MEDIZINTECHNIK GMBH JIM BRENNAN
K003068 10/02/2000 SAVINA DRAGER MEDIZINTECHNIK GMBH JIM BRENNAN
K003154 10/10/2000 MIZAR, BASIS BE, SANDMAN DIGITAL EB NEURO, S.P.A. COLLEEN HITTLE
K003126 10/05/2000 BIPOLAR TRIGGER-FLEX PROBE ELLMAN INTL., INC. FRANK LIN
K003250 10/17/2000 FMP METAL/METAL ACETABULAR INSERT ENCORE ORTHOPEDICS, INC. DEBBIE DE LOS SANTOS
K003324 10/24/2000 PLASMA SPRAYED SHOULDER ENCORE ORTHOPEDICS, INC. JOANNA DROEGE
K003151 10/10/2000 MICROPOBE SERIES OF LASERS AND ACCESSORIES ENDO OPTIKS, INC. KEITH HERTZ
K003348 10/26/2000 E.N.S.I. RETRACTABLE SAFETY SYRINGE ENSI-MED INTERNATIONAL PTY. LTD. NAP CURIE
K003352 10/26/2000 ESCREEN SYSTEM ESCREEN, INC. JONATHAN S KAHAN
K003170 10/10/2000 RYTHMIC AND RYTHMIC UV ESSILOR INTL. CHRISTINE MOENCH
K003297 10/20/2000 MAMMOTOME HAND HELD PROBE, MODEL MHH8 ETHICON ENDO-SURGERY, INC. DENNIS HAHN
K003070 10/02/2000 ETHIBOND EXCEL VALVE LOOP SUTURE ETHICON, INC. GREGORY R JONES
K003060 10/02/2000 PLASMAKINETIC GENERATOR EVEREST MEDICAL CORP. DAVID KAY
K003133 10/06/2000 MULTIPLE-VINYL EXAM GLOVE, POWDERED EXCELLENCE ENT. CO., LTD. JANNA P TUCKER
K003122 10/05/2000 SMARTFLOW, MODEL SFIP 2000 FLORENCE MEDICAL LTD. SHOSHANA FREIDMAN, RAC
K003326 10/24/2000 FUNET AMY MAMA BODY THERMOMETER FUNAI RADIO & COMMUNICATIONS CORP. JOHN LIN
K003065 10/02/2000 SEEDNET, MODEL EP6T5, EP5E5 GALIL MEDICAL LTD. JONATHAN S KAHAN
K003264 10/18/2000 QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION GE MEDICAL SYSTEMS F.I. HAIFA DAN LAOR
K003223 10/16/2000 GEON DIGITAL CLINICAL THERMOMETER GEON CORP. ALLEN REICH
K003063 10/02/2000 GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE FINGERTIP PROTECTION GIMBEL GLOVE CO., LLC. GORDON P PARDY
K003195 10/12/2000 GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC GREER LABORATORIES, INC. GERALD FRIESEN
K003214 10/13/2000 SMITH & NEPHEW PISTONS GYRUS ENT L.L.C. JEFFREY W COBB
K003219 10/16/2000 HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST HARALD NORDIN S.A JAMES DELANEY
K003221 10/16/2000 HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST HARALD NORDIN S.A JAMES DELANEY
K003359 10/27/2000 COLOSCREEN-ES HELENA LABORATORIES PAT FRANKS
K003335 10/25/2000 RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER HILL-ROM AIR-SHIELDS LARRY W KRASLEY
K003231 10/17/2000 HMS NEUROMUSCULAR STIMULATOR, MODEL HMS 3 HOME MEDICAL SERVICES C.A. TEKLINSKI
K003258 10/18/2000 MS-ONE, MODEL MS-1 HOME WELLNESS WEST C.A. TEKLINSKI
K003180 10/11/2000 HOMMED OBSERVER, MODEL I HOMMED LLC. TOMMIE J MORGAN
K003211 10/13/2000 HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K003391 10/31/2000 OSTEONICS ALUMINA C-TAPER HEAD HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K003379 10/31/2000 V-40/C-TAPER ADAPTER SLEEVE HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K003366 10/30/2000 MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL IGC-MEDICAL ADVANCES, INC. MICHAEL J LEIGH
K003205 10/13/2000 TRANSFX ANGLED RODS IMMEDICA, INC. ROY BOGERT
K003181 10/11/2000 IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX-YYY-ZZZZ IMPLEX CORP. JOHN SCHALAGO
K003271 10/18/2000 MODIFICATION TO ITI DENTAL IMPLANT SYSTEM INSTITUT STRAUMANN AG CAROLYN BITETTI
K003229 10/10/2000 BIOPATCH ANTIMICROBIAL DRESSING INTEGRA LIFESCIENCES CORP. WILLIAM GOELLER
K003338 10/25/2000 BIO-EYE II ORBITAL IMPLANT INTEGRATED ORBITAL IMPLANTS, INC. FLOYD G LARSON
K003204 10/13/2000 BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT INTRACEL CORP. SHANE WARD
K003278 10/19/2000 COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922 IRVINE SCIENTIFIC SALES CO., INC. WENDELL LEE
K003293 10/20/2000 EXCITE DSC IVOCLAR NORTH AMERICA, INC. ANDY GULATI
K003377 10/30/2000 FERMIT N PLUS IVOCLAR NORTH AMERICA, INC. ANDY GULATI
K003374 10/30/2000 FERMIT PLUS IVOCLAR NORTH AMERICA, INC. ANDY GULATI
K003373 10/30/2000 PROCAD ADD-ON IVOCLAR NORTH AMERICA, INC. ANDY GULATI
K003327 10/24/2000 ALBUMIN JAS DIAGNOSTICS, INC. DAVID JOHNSTON
K003247 10/17/2000 CREATININE JAS DIAGNOSTICS, INC. DAVID JOHNSTON
K003197 10/12/2000 VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES, YELLOW KAOHSIUNG BROTHERS PRODUCTS CORP. STONE CHEN
K003113 10/04/2000 KSEA SCB-RUI SCO KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN KENNAN
K003325 10/24/2000 KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM KARL STORZ IMAGING, INC. TERRY FERNANDEZ
K003228 10/16/2000 K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A KATECHO, INC. WARREN R WALTERS
K003347 10/25/2000 ORTHOPILOT KINAMED, INC. JOEL SLOMOFF
K003056 10/01/2000 OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218 LABOTECT LABOR-TECHNIK GOTTINGEN ANGELIKA ALBRECHT
K003147 10/10/2000 LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION) LASERSCOPE PAUL HARDIMAN
K003161 10/10/2000 ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (CLEAR AND TINT LES LABORATOIRES BLANCHARD JOHN M SZABOCSIK
K003369 10/30/2000 LIFECARE COMPACT TENS DEVICE LIFECARE LTD. AHAVA STEIN
K003226 10/16/2000 THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM LIFECORE BIOMEDICAL, INC. CAROLYN ANDERSON
K003191 10/10/2000 MIS IMPLANT SYSTEM DECIVE M.I.S. IMPLANTS TECHNOLOGIES LTD. AHAVA STEIN
K003075 10/03/2000 KNIGHTSTAR 330 VENTILATOR MALLINCKRODT, INC. ANTHONY MULLIN
K003315 10/23/2000 SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA MALLINCKRODT, INC. JAMES C KEEVEN
K003167 10/10/2000 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES MASIMO CORP. JAMES J CRONIN
K003244 10/17/2000 MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES MASIMO CORP. JAMES J CRONIN
K003110 10/04/2000 MEDCOMP BIO-CATH CATHETER LINE MEDCOMP FLORENCE A CAIKOSKI
K003144 10/10/2000 MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL MEDICAL ADVANCES, INC. THOMAS E TYNES
K003207 10/13/2000 MEDCOMP ULTRA-FLOW CATHETER MEDICAL COMPONENTS, INC. JEANNE M CUSH
K003344 10/25/2000 MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2 MEDICAL DEPOT, INC. ART WARD
K003156 10/10/2000 BLASTASSIST SYSTEM MEDICULT A/S RONALD G LEONARDI
K003163 10/10/2000 SYNVITRO FLUSH MEDICULT A/S RONALD G LEONARDI
K003121 10/05/2000 MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS MEDISON AMERICA, INC. GARY J ALLSEBROK
K003332 10/24/2000 MEDITHERM MED2000 MEDITHERM, INC. PETER LEANDO
K003353 10/26/2000 MEDLINE ALOE TOUCH STERILE NITRILE EXAMINATION GLOVES WITH ALOE VERA MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K003055 10/02/2000 MEDLINE STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K003091 10/03/2000 MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOW MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K003201 10/12/2000 STEALTHSTATION TREATMENT GUIDANCE PLATFORM MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES RONALD K SMITH
K003078 10/03/2000 MERIT DRAINAGE DEPOT MERIT MEDICAL SYSTEMS, INC. CHESTER MCCOY
K003387 10/31/2000 AUROFILM NP METALOR DENTAL USA CORP. KENNETH A PUTNEY
K003260 10/18/2000 VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460 METRON MEDICAL AUSTRALIA PTY LTD ROB HOPKINS
K003308 10/23/2000 MICROLIFE DIGITAL INFRARED EAR THERMOMETER, IR1DAI, IR1DB1, IR1DD1 MICROLIFE CORP. SUSAN D GOLDSTEIN-FALK
K003090 10/03/2000 MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM MIDMARK CORP. MIKE SNYDER
K003097 10/03/2000 BRAIN COIL, MODEL 9800GE-64 MIDWEST R.F. LLC. RALPH S HASHOIAN
K003386 10/31/2000 SPECIAL PROCEDURES HEAD COIL; MODEL # 1100GE-64 MIDWEST R.F. LLC. RALPH S HASHOIAN
K003143 10/10/2000 MILLENNIUM BLADES, MODEL MB101 MILLENNIUM BIOMEDICAL, INC. JERRY KAENI
K003254 10/17/2000 CORTEZ NEEDLE FREE IV CONNECTOR, MODEL MMD-001 MISSION MEDICL DEVICES DONALD V CANAL
K003076 10/03/2000 MITEK CUFFTACK MITEK PRODUCTS CHRISTINE KUNTZ-NASSIF
K003340 10/25/2000 OBC-149 BREAST ARRAY COIL MRI DEVICES CORP. THOMAS SCHUBERT
K003331 10/24/2000 QWH-149 WRIST ARRAY COIL MRI DEVICES CORP. THOMAS SCHUBERT
K003349 10/26/2000 ALLON 2001 MODIFIED MTRE ADVANCED TECHNOLOGY LTD. PAUL DRYDEN
K003287 10/20/2000 MODEL K7 EVALUATION DEVICE MYOTRONICS-NOROMED, INC. FRAY ADIB
K003302 10/20/2000 IM-5A INJECTOR NARISHIGE CO., LTD. MITSUKO YONEYAMA
K003303 10/20/2000 IM-5B MICROINJECTOR NARISHIGE CO., LTD. MITSUKO YONEYAMA
K003304 10/20/2000 IM-6 MICROINJECTOR NARISHIGE CO., LTD. MITSUKO YONEYAMA
K003300 10/20/2000 MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR NARISHIGE CO., LTD. MITSUKO YONEYAMA
K003298 10/20/2000 MO-202U THREE-AXIS JOYSTICK HYDRAULIC MICROMANIPULATOR NARISHIGE CO., LTD. MITSUKO YONEYAMA
K003190 10/11/2000 EN BLOC BIOPSY SYSTEM NEOTHERMIA CORP. SHERRIE COVAL-GOLDMSITH
K003299 10/20/2000 OPD-SCAN, MODELS ARK-10000 AND ARK-9000 NIDEK CO., LTD. CAROL PATTERSON
K003270 10/18/2000 PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067 NUCLETRON CORP. ROBERT APPLEBAUM
K003114 10/05/2000 NUMED TYSHAK AND Z-MED PTV CATHETERS NUMED, INC. NICHELLE R LAFLESH
K003052 10/02/2000 NUMED TYSHAK II AND Z-MED II PTV CATHETERS NUMED, INC. NICHELLE R LAFLESH
K003320 10/24/2000 PTA-OS SIZING BALLOON, MODEL 360 NUMED, INC. NICHELLE LAFLESH
K003276 10/19/2000 TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107 NUMED, INC. NICHELLE R LAFLESH
K003136 10/06/2000 OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENS OCULAR SCIENCES PUERTO RICO, INC. RICHARD E LIPPMAN
K003198 10/12/2000 VULCAN TAC PROBES, MODEL 911XXX ORATEC INTERVENTIONS, INC. LARAINE PANGELINA
K003256 10/17/2000 PCCR DIGITAL IMAGING DEVICE OREX COMPUTED RADIOGRAPHY LTD ROSINA ROBINSON
K003145 10/10/2000 ORIGEN BLADDER HOLDER ORIGEN BIOMEDICAL, INC. RICHARD MARTIN
K003288 10/20/2000 ORIGEN DUAL LUMEN CATHETER ORIGEN BIOMEDICAL, INC. RICHARD MARTIN
K003112 10/04/2000 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS ORTHO-CLINICAL DIAGNOSTICS, INC. SUSAN WERNER
K003316 10/23/2000 OTI CERAMIC FEMORAL HEAD SYSTEM OSTEOIMPLANT TECHNOLOGY, INC. SAM SON
K003199 10/12/2000 TRIAD II MODULAR TOTAL HIP SYSTEM OSTEOIMPLANT TECHNOLOGY, INC. SAM SON
K003384 10/31/2000 VERSALINK TITANIUM ROD-TO-ROD COUPLERS OSTEOTECH, INC. KIM THURMAN
K003155 10/10/2000 VERTEBRAL BODY REPLACEMENT OSTEOTECH, INC. KIM THURMAN
K003350 10/26/2000 HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE COATED (BLUE) PAMITEX INDUSTRIES SDN BHD SAID AWANG
K003318 10/24/2000 PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X PARADIGM MEDICAL INDUSTRIES, INC. TRACY S BEST
K003141 10/10/2000 UBM PLUS, MODEL P45 PARADIGM MEDICAL INDUSTRIES, INC. TRACY S BEST
K003102 10/04/2000 PARE ENDOSCOPIC SUTURING SYSTEM PARE SURGICAL, INC. RICHARD P FLEENOR
K003292 10/20/2000 260 CORVUS PIE MEDICAL COLLEEN J HITTLE
K003274 10/18/2000 LPC-PLUS ACETABULAR CUP PLUS ORTHOPEDICS HARTMUT LOCH
K003277 10/19/2000 SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33 POWERMED, INC. MICHELE LUCEY
K003284 10/19/2000 PHLEBOPUMP, MODEL 1000 PREVENT PRODUCTS, INC. CAROL A GARCIA
K003058 10/02/2000 LASER 3 SPSC300 PRIDE MOBILITY PRODUCTS CORP. GENE R KULON
K003059 10/02/2000 LASER 4SPSC340 PRIDE MOBILITY PRODUCTS CORP. GENE R K ULON
K003206 10/13/2000 GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005 PROXIMA THERAPEUTICS, INC. DEBORAH J MOORE
K003249 10/17/2000 PST ELECTROSURGICAL GENERATOR, MODEL 2150, PST BIPOLAR FORCEPS, MODEL EBF 1228 PST, INC. WILLIAM NADEL
K003096 10/03/2000 FASTPACK CALIBRATORS QUALIGEN, INC. DOROTHY DEINZER
K003095 10/03/2000 FASTPACK CONTROL QUALIGEN, INC. DOROTHY DEINZER
K003094 10/03/2000 FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER QUALIGEN, INC. DOROTHY DEINZER
K003069 10/02/2000 ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM QUEST INTL., INC. ROBERT A CORT
K003208 10/13/2000 R & D 3K RETIC R & D SYSTEMS, INC. KENNETH T EDDS
K003346 10/25/2000 RANDOX GLUCOSE (GOD/PAP) RANDOX LABORATORIES, LTD. P. ARMSTRONG
K003236 10/17/2000 RETINADX REGULATORY ASSOCIATES, INC. KEVIN WALLS
K003142 10/10/2000 MICROMANIPULATOR RESEARCH INSTRUMENTS LTD. BEN MURDOCK
K003164 10/10/2000 TROCARS "TROTEC" WITH AUTOMATIC PROTECTIVE MECHANISM RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K003232 10/17/2000 RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE) RIVERSTONE RESOURCES SDN. BHD. CHONG CHU MEE
K003233 10/17/2000 RS NITRILSTST MEDICAL EXAMINATION GLOVES, POWDERED (NON STERILE) BLUE RIVERSTONE RESOURCES SDN. BHD. CHONG CHU MEE
K003261 10/18/2000 CREATININE PLUS ROCHE DIAGNOSTICS CORP. PRISCILLA A HAMILL
K003174 10/10/2000 ELECSYS DHEA-S ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K003178 10/11/2000 ELECSYS HCG AND BETA TEST SYSTEM ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K003120 10/05/2000 MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K003158 10/10/2000 ROCHE DIAGNOSTICS CK-MB ROCHE DIAGNOSTICS CORP. KAY A TALOR
K003064 10/02/2000 TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323 ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K003382 10/31/2000 SARSTEDT NEEDLE PROTECTOR SARSTEDT, INC. PETER RUMSWINKEL
K003282 10/19/2000 FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H SEIN ELECTRONICS CO., LTD. WON KY KIM
K003321 10/24/2000 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR SHANGHAI ANTARES INDUSTRIES, INC. JOHN LAI
K003392 10/31/2000 CARDIO MONITOR CENTER VISION; MODEL S-CV7-00 SHL TELEMEDICINE INTERNATIONAL LTD. ALROY IRIT
K003130 10/06/2000 REGUTHERM 952 THERMOGRAPHIC SYSTEM SIE-MED, INC. CHARLES H KYPER
K003192 10/12/2000 MAGNETIC CONCERTO SIEMENS MEDICAL SOLUTIONS USA, INC. JAMIE YIEH
K003243 10/17/2000 SIEMENS INFINITY MODULAR MONITORS MODEL SC 8000; SC 7000; SC 9000XL SIEMENS MEDICAL SOLUTIONS USA, INC. PENELOPE H GRECO
K003248 10/17/2000 SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER SIEMENS MEDICAL SOLUTIONS USA, INC. PENELOPE H GRECO
K003246 10/17/2000 SIEMENS MULTI VIEW WORKSTATION WITH VENT VIEWER OPTION SIEMENS MEDICAL SOLUTIONS USA, INC. PENELOPE H GRECO
K003179 10/11/2000 SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. PENELOPE H GRECO
K003266 10/18/2000 SIREMOBIL ISO-C 3D SIEMENS MEDICAL SOLUTIONS USA, INC. AMY SHAW HOSLER
K003152 10/10/2000 SOMATOM SMILE SIEMENS MEDICAL SOLUTIONS USA, INC. KATHLEEN RUTHERFORD
K003125 10/05/2000 SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. JUDI HOFFMAN
K003328 10/24/2000 ACCUCLOT CONTROL I, MODEL A4089 SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT
K003267 10/18/2000 SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT II
K003329 10/24/2000 SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT
K003358 10/26/2000 QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT) SMV AMERICA PAULA MCLEAN
K003079 10/03/2000 SPECIALTY TINT SOFT CONTACT LENS SPECIALTY TINT ROBERT BREECE
K003351 10/26/2000 PARSFIX CABLE-SCREW SYSTEM SPINAL CONCEPTS, INC. DAVID M HOOPER
K003367 10/30/2000 ORION PLATINUM SRS MEDICAL SYSTEMS, INC. LEE BRODY
K003127 10/06/2000 REGAIN DESKTOP SRS MEDICAL SYSTEMS, INC. LEE BRODY
K003194 10/12/2000 STACKHOUSE LENS HOOD, MODEL SA-700/FS STACKHOUSE, INC. TOM GUTIERREZ
K003169 10/10/2000 VASCULAR CLOSURE DEVICE STD MFG., INC. STEPHEN M PALUMBO
K003283 10/19/2000 SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103) STERLING MEDIVATIONS, INC. JOEL DOUGLAS
K003333 10/25/2000 STICK STICK TECH LTD. WILLIAM M TROETEL
K003334 10/25/2000 STICK NET STICK TECH LTD. WILLIAM M TROETEL
K003111 10/04/2000 STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES STRYKER INSTRUMENTS NICOLE PETTY
K003269 10/18/2000 UNICONDYLAR INTERPOSITIONAL SPACER SULZER ORTHOPEDICS, INC. MITCHELL A DHORITY
K003123 10/05/2000 RENAX A.V. FISTULA NEEDLE SETS SUNDER BIOMEDICAL TECH. CO., LTD. TONY HUNG
K003061 10/02/2000 SYNTHES USS (10.0MM SIDE OPENING SCREWS) SYNTHES JONATHAN GILBERT
K003275 10/19/2000 SYNTHES SYNMESH SPACER SYSTEM SYNTHES (USA) JONATHAN GILBERT
K003341 10/25/2000 EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS SYVA CO., DADE BEHRING, INC. PAUL L ROGER
K003306 10/20/2000 C. DIFFICILE TOX A/B II TECHLAB, INC. DAVID M LYERLY
K003375 10/30/2000 CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX TECNILATEX S.A. JOSE M VAZQUEZ MARTIN
K003371 10/30/2000 PUMP TUBING WITH X-COATING TERUMO CORP. GARRY A COURTNEY
K003265 10/18/2000 CLEANAIR/ CLEANWATER UNIT, MODEL 1600 TEXAS INSTITUTE FOR CONSERVATIVE DENTISTRY H.O. PIPKIN
K003128 10/06/2000 MODIFICATION TO RELIEF BRIEF THE JM KOHN CO. CHARLES L MORIN
K003313 10/23/2000 FILAC FAS TEMP ELECTRONIC THERMOMETER THE KENDALL COMPANY KELLY J ROWLAND
K003183 10/11/2000 THERMAGE THERMACOOL II SYSTEM THERMAGE, INC. KEITH MULLOWNEY
K003381 10/31/2000 SHIELDING NEEDLE HOLDER U.S. SAFETY SYRINGES CO., INC. DAVID A HOINES
K003383 10/31/2000 PALMLIGHT ULTRADENT PRODUCTS, INC. MARKUS R GEE
K003237 10/17/2000 U2 HIP STEM, TI POROUS COATED UNITED ORTHOPEDIC CORP. MELLEN LIU
K003173 10/10/2000 ASPIRE COVERED STENT AND DELIVERY CATHETER VASCULAR ARCHITECTS, INC. KEVIN F MACDONALD
K003230 10/16/2000 V SCORE WITH AUTO GATE MODEL TBD VITAL IMAGES, INC. ROBERT C SAMEC
K003364 10/27/2000 VIVO 200 DPS VIVOSCAN VIVOSONIC, INC. RICHARD KEEN
K003115 10/02/2000 ACTIS ADJUSTABLE CONSTRICTION LOOP VIVUS, INC. CAROL D KARP
K003092 10/03/2000 MODIFICATION TO VNUS CLOSURE SYSTEM VNUS MEDICAL TECHNOLOGIES, INC. SAM NANAVATI
K003153 10/10/2000 SOLOBOND PLUS VOCO GMBH EVAN DICK
K003311 10/23/2000 NUTRISAFE PUR ENTERAL FEEDING TUBE VYGON CORP. ROBERT SCHIFF
K003342 10/25/2000 WAKO CRP-UL, CRP-UL CALIBRATOR SET WAKO CHEMICALS, USA, INC. TONYA MALLOY
K003337 10/25/2000 HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240 WECK CLOSURE SYSTEMS BRIAN YOUNG
K003376 10/30/2000 WELCH ALLYN 11800 OPTHALMOSCOPE WELCH ALLYN, INC. COLIN WOLFF
K003132 10/06/2000 DERMAGRIP POWDER FREE BLUE POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAM OR LESS OF TOTAL WA WRP SPECIALTY PRODUCTS SDN. BHD. MOHD HAIZAN HUSSEIN
K003309 10/23/2000 DERMAGRIP POWDER FREE GREEN POLYMER COATED EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE WRP SPECIALTY PRODUCTS SDN. BHD. MOHD HAIZAN HUSSEIN
K003307 10/23/2000 DERMAGRIP POWDER FREE PINK POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL W WRP SPECIALTY PRODUCTS SDN. BHD. MOHD HAIZAN HUSSEIN
K003184 10/11/2000 RS BIOTECH GALAXY 'R' CO2 INCUBATOR ZANDER MEDICAL SUPPLIES, INC. FRIEDEL MW ZANDER
K003118 10/05/2000 Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 ZCV ,INC. JING ZHANG


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