FDA 510(k) Applications Received During July, 2003

FDA 510(k) Number Submission Date Device Name Applicant Contact
K032099 07/08/2003 SWISS MASTER LIGHT (EMS SA) ELECTRO MEDICAL SYSTEMS CYNTHIA J M. NOLTE
K032070 07/03/2003 ELCACAM A-DEC, INC. TOM LOUISELL
K032122 07/09/2003 AUDIT MICROCONTROLS MICROFD BNP CONTROL AALTO SCIENTIFIC LTD. ALAN J VEKICH
K032051 07/02/2003 BATTERY PACK, RECHARGEABLE, MODELS MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649P ACCESS BATTERY, INC. ALEXANDER B HENDERSON
K032159 07/15/2003 CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY ACCESS BIO INCORPORATE YOUNG HO CHOI
K032345 07/30/2003 CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY ACCURAY, INC. ANNE SCHLAGENHAFT
K032220 07/21/2003 ADEPT 1064/532 LASER ADEPT MEDICAL CONCEPTS JERRY MCFARLAND
K032218 07/21/2003 ADEPT 1064/532/755 LASER ADEPT MEDICAL CONCEPTS JERRY MCFARLAND
K032221 07/21/2003 ADEPT 1064/755 LASER ADEPT MEDICAL CONCEPTS JERRY MCFARLAND
K032030 07/01/2003 BLINK CL LUBRICANT EYE DROPS ADVANCED MEDICAL OPTICS, INC. PAUL J NOWACKI
K032034 07/01/2003 ANS AXXESS PERCUTANEOUS LEAD ADVANCED NEUROMODULATION SYSTEMS KATRYNA WARREN
K032198 07/18/2003 AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP AESCULAP, INC. MATTHEW M HULL
K032059 07/02/2003 MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM AESCULAP, INC. GEORG KELLER
K032108 07/08/2003 SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED) AESCULAP, INC. JOYCE KILROY
K032248 07/22/2003 PRECISE CARBON FIBER TABLE TOP, MODEL 11-999 AKTINA MEDICAL PHYSICS CORP. TONY SPACCAROTELLA
K032210 07/21/2003 ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM ALARA, INC. DIANE M KING
K032233 07/21/2003 MEDLEY PCA MODULE, MODEL 8120 ALARIS MEDICAL SYSTEMS, INC. STACEY L LEWIS
K032147 07/14/2003 SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES ALARIS MEDICAL SYSTEMS, INC. STACY L LEWIS
K032058 07/02/2003 MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES ALLIANCE MEDICAL CORP. MOIRA BARTON
K032278 07/24/2003 AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE AMBU, INC. SANJAY PARIKH
K032069 07/03/2003 WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER ANGIODYNAMICS, INC. TERI JUCKETT
K032257 07/22/2003 MODEL IR 1200 INSULIN PUMP ANIMAS CORP. MICHAEL J ANDREWS
K032217 07/21/2003 14G CORMARK BIOPSY SITE IDENTIFIER ARTEMIS MEDICAL, INC. LINDA GUTHRIE
K032187 07/17/2003 ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM ARTHREX, INC. SALLY FOUST
K032098 07/08/2003 ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B ARTHREX, INC. ANN WATERHOUSE
K032245 07/22/2003 ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239 ARTHREX, INC. ANN WATERHOUSE
K032072 07/03/2003 LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE ARTHROTEK, INC. TRACY J BICKEL
K032160 07/15/2003 ARTELON SURGICAL SUTURE ARTIMPLANT AB RUSS PAGANO
K032082 07/07/2003 AURORA AURORA IMAGING TECHNOLOGY, INC. JAMES R VEALE
K032144 07/14/2003 PERIFIX CATHETER CONNECTOR B. BRAUN MEDICAL, INC. AMY SMITH
K032261 07/23/2003 MODIFICATION TO TRELLIS RESERVE INFUSION SYSTEM (140CM CATHETER LENGTH, 10CM INFUSION LENGTH), TRELLIS RESERVE INFUSION BACCHUS VASCULAR, INC. GREGORY J MATHISON
K033006 07/25/2003 MIVD 1218 18 INCH GREYSCALE LCD DISPLAY MODULE BARCO NV BARCOVIEW FRANK FERGUSON
K032153 07/14/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML BD DIAGNOSTIC SYSTEMS KATHRYN BABKA POWERS
K032259 07/22/2003 PASCO MIC AND MIC/ID PANELS BD DIAGNOSTIC SYSTEMS LINDA K DILLON
K032162 07/15/2003 ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY BECKMAN COULTER, INC. LYNN WEIST
K032342 07/29/2003 COULTER LH 750 HEMATOLOGY ANALYZER BECKMAN COULTER, INC. STAN SUGRUE
K032287 07/24/2003 MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 BECKMAN COULTER, INC. KIM WALKER
K032035 07/01/2003 SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI BECKMAN COULTER, INC. KIM WALKER
K032131 07/11/2003 BD AUTOMATED MICROBIOLOGY SYSTEM TETRACYCLINE - GP 0.5-16 UG/ML-GRAM POSITIVE ID/AST OR AST ONLY PHOENIX PANELS BECTON, DICKINSON & CO. MONICA E GIGUERE
K032299 07/25/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM,-AMPICILLIN 0.5.-32 UG/ML BECTON, DICKINSON & CO. BRADFORD SPRING
K032275 07/23/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-IMIPENEM 1-16 UG/ML GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS BECTON, DICKINSON & CO. MICHELLE B BANDY
K032136 07/11/2003 WIROBOND C BEGO U.S.A. WILLIAM OREMUS
K032166 07/16/2003 BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 BINAX, INC. PAMELA ANGELL
K032104 07/08/2003 AMNIOLENS BIO-TISSUE, INC. DAVID J BLOCH
K032351 07/30/2003 THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT BIOHORIZONS IMPLANT SYSTEMS, INC. WINSTON D GREER
K032268 07/23/2003 MBCP BIOMATLANTE MYRIAM VINCENT
K032314 07/28/2003 VITEK 2 GRAM POSITIVE GATIFLOXACIN BIOMERIEUX, INC. Nancy Weaver
K032286 07/24/2003 CALCIGEN PSI BONE GRAFT SUBSTITUTE BIOMET ORTHOPEDICS, INC. TRACY J BICKEL
K032216 07/21/2003 BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM BIOPTRON AG Kevin Walls
K032235 07/21/2003 MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST BIOSITE INCORPORATED JEFFREY R DAHLEN
K032292 07/24/2003 BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX BIOTEQUE CORP. JENNIFER REICH
K032207 07/18/2003 COBRA COOLED SURGICAL PROBE, MODEL M004159670 BOSTON SCIENTIFIC CORP. APRIL I MALMBORG
K032183 07/17/2003 IQ HYDROPHILIC GUIDE WIRE BOSTON SCIENTIFIC CORP. ANNE V ROSSI
K032360 07/31/2003 MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM AND EXPRESS BILIARY LD UNMOUNTED STENT BOSTON SCIENTIFIC CORP. TODD KORNMANN
K032050 07/02/2003 PERIVAC KIT BOSTON SCIENTIFIC CORP. RONALD C ALLEN
K032214 07/21/2003 MEDONIC CA620/530 HEMATOLOGY ANALYZER BOULE MEDICAL AB ANDREW SWANSON
K032057 07/02/2003 TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC BRANAN MEDICAL CORP. RAPHAEL WONG
K032133 07/11/2003 BRODA MODEL 587 MANUAL WHEELCHAIR BRODA ENT., INC. PHILLIP MCTAGGART
K032325 07/28/2003 JOBST TRAVEL SOCKS BSN-JOBST, INC. ANGELO PEREIRA
K032029 07/01/2003 BTG SMARTEST GLUCOSE TEST SYSTEM BT MEDICAL DEBBIE CHENG
K032044 07/02/2003 X-PROT DUO PORT C.R. BARD, INC. JOHN C KNORPP
K032142 07/14/2003 DATACAPTOR CAPSULE TECHNOLOGIE DANIEL KAMM
K032347 07/30/2003 BIOMARC TISSUE MARKER CARBON MEDICAL TECHNOLOGIES, INC. ROBERT W JOHNSON
K032068 07/03/2003 CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200 CARDIOVENTION, INC. TESSA YAMUT
K032116 07/09/2003 TULIP COLORSWITCH CAVEX HOLLAND B.V. RICHARD WOORTMAN
K032348 07/30/2003 CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP CENTERPULSE ORTHOPEDICS, INC. ROBERT M WOLFARTH
K032076 07/07/2003 SENOVA(R) BLOOD GLUCOSE MONITOR CHDIAGNOSTICS LLC RICHARD N PHILLIPS
K032027 07/01/2003 CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) CHOLESTECH CORP. THOMAS E WORTHY
K032113 07/09/2003 ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) CHROMA VISION MEDICAL SYSTEMS INC. DAVID DAVIS
K032074 07/07/2003 LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS CLINIQA CORPORATION CAROL RUGGIERO
K032100 07/08/2003 I-BEAM COMPUTERIZED MEDICAL SYSTEMS, INC. KATHRYN STINSON
K032223 07/21/2003 COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH COOK VASCULAR, INC. THOMAS J KARDOS
K032274 07/23/2003 COOK FIVE LUMEN CENTRAL VENOUS CATHETER COOK, INC. JENNIFER J BOSLEY
K032137 07/11/2003 PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM CORDIS CORP. SAM MIRZA
K032139 07/11/2003 REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826 CORGENIX, INC. NANCI DEXTER
K032186 07/17/2003 AUTOALIGN CORTECHS LABS, INC. ALLAN GREEN
K032169 07/16/2003 CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING) CYBERORTHOLOGY, INC. ARTHUR WARD
K032237 07/21/2003 N/T PROTEIN CONTROL DADE BEHRING, INC. KATHLEEN A DRAY-LYONS
K032338 07/29/2003 TRIO MONITOR MODEL 0998-00-0600 DATASCOPE CORP. SUSAN E MANDY
K032195 07/18/2003 DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT DENTAURUM JAN A DOORSCHODT
K032355 07/30/2003 ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW DENTSPLY GENDEX JOHN R MILLER
K032320 07/28/2003 APPOLLO 3 ALLOY DENTSPLY INTERNATIONAL P. JEFFERY LEHN
K032321 07/28/2003 CERA F ALLOY DENTSPLY INTERNATIONAL P. JEFFERY LEHN
K032319 07/28/2003 CERA R PLUS ALLOY DENTSPLY INTERNATIONAL P. JFFERY LEHN
K032318 07/28/2003 MINERVA 58 ALLOY DENTSPLY INTERNATIONAL P. JEFFERY LEHN
K032361 07/31/2003 ENDOPURE ROOT CANAL CLEANSER DENTSPLY INTL. P. JEFFERY LEHN
K032316 07/28/2003 ORION E ALLOY DENTSPLY INTL. P. JEFFERY LEHN
K032317 07/28/2003 ORION GX ALLOY DENTSPLY INTL. P. JEFFERY LEHN
K032097 07/08/2003 DEPUY ACE VERSANAIL TIBIAL NAIL DEPUY ORTHOPAEDICS, INC. TIFFANI ROGERS
K032151 07/14/2003 DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS DEPUY, INC. CHERYL HASTINGS
K032283 07/24/2003 DESIGNS FOR VISION FIBEROPTIC LIGHT DESIGNS FOR VISION, INC. MARY MCNAMARA-CULLINANE
K032040 07/01/2003 IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR DIDECO S.P.A. BARRY SALL
K032171 07/16/2003 ACCUSOFT DIREX SYSTEMS CORP. LARISA GERSHTEIN
K032358 07/30/2003 B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM) DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. JONANTHAN S KAHN
K032135 07/11/2003 SITE-RITE IV ULTRASOUND SYSTEM DYMAX CORP. CHARLES MORREALE
K032250 07/22/2003 GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200 EDWARDS LIFESCIENCES, LLC. SUSAN REYNOLDS
K032091 07/07/2003 SMART KLAMP VARIOUS BY SIZE EMERGO GROUP, INC. RENE' VAN DE ZANDE
K032105 07/08/2003 ENDOHELIX ENDARTERECTOMY DEVICE ENDARX, INC. SCOTT ADAMS
K032333 07/29/2003 CRYOCARE CS SURGICAL SYSTEM ENDOCARE, INC. EBEN GORDON
K032225 07/21/2003 EP-WORKMATE WITH RPM SYSTEM EP MEDSYSTEMS JAMES E KUHN
K032199 07/18/2003 ESA PLASMA FREE METANEPHRINE ANALYSIS KIT ESA, INC. HAROLD ASP
K032121 07/09/2003 MODIFICATION TO E-SCAN XQ ESAOTE S.P.A. COLLEEN J DENSMORE
K032272 07/23/2003 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR EST INTERNATIONAL CORPORATION ELIZABETH DENG
K032236 07/21/2003 DISPOSABLE POWERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR EST INTERNATIONAL CORPORATION ELIZABETH DENG
K032307 07/25/2003 CAP BONE SUBSTITUTE MATERIAL ETEX CORP. Kristine Canavan
K032339 07/29/2003 CARDIOVATIONS PORTABLE VIDEO SYSTEM ETHICON, INC. PETER CECCHINI
K032206 07/18/2003 PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION EV3 INC GLEN D SMYTHE
K032161 07/15/2003 PHEM-ALERT FEMTEK,LLC. JOEL S FADEN
K032208 07/18/2003 MONA LISA ASPIRATION NEEDLE FERTILITY TECHNOLOGY RESOURCES, INC. CONSTANCE W STURGEON
K032173 07/16/2003 FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS FIRST QUALITY HYGIENIC, INC. ROBERT J STAAB
K032158 07/15/2003 XIVE DENTAL IMPLANT SYSTEM MULTIPLE FRIADENT GMBH CAROL PATTERSON
K032302 07/25/2003 XIVE TG ABUTMENTS FRIADENT GMBH CAROL PATTERSON
K032284 07/24/2003 XIVE TG DENTAL IMPLANT SYSTEM FRIADENT GMBH CAROL PATTERSON
K032290 07/24/2003 FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITOR FUKUDA DENSHI USA, INC. LARRY D WALKER
K032289 07/24/2003 FIT CHECKER II GC AMERICA, INC. TERRY L JORITZ
K032045 07/02/2003 8 CHANNEL CARDIAC PHASED ARRAY COIL GE MEDICAL SYSTEMS LARRY KROGER
K032252 07/22/2003 MODEL 120 SERIES MATERNAL/FETAL MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MELISSA ROBINSON
K032346 07/30/2003 UNITY NETWORK IS PATIENT VIEWER GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES DIANA M THORSON
K032194 07/18/2003 TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS GEN-PROBE, INC. WAYNE A KVETKOSKY
K032182 07/17/2003 GE LOGIQ 7, MODEL 2354858 GENERAL ELECTRIC CO. ALLEN SCHUH
K032337 07/29/2003 HEMEDEX CRANIAL BOLT MODELS, 3601, 3602 HEMEDEX INCORPORATED DEBBIE IAMPIETRO
K032127 07/10/2003 HEMEDEX FIXATION DEVICE HEMEDEX INCORPORATED DEBBIE IAMPIETRO
K032203 07/18/2003 HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 HEMOCUE, INC. R. J SLOMOFF
K032232 07/21/2003 AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUGLAS THISTLETHWAITE
K032300 07/25/2003 ACCOLADE-J HIP STEM SERIES HOWMEDICA OSTEONICS CORP. LORRAINE MONTEMURRO
K032163 07/15/2003 DURACON TOTAL KNEE SYSTEM HOWMEDICA OSTEONICS CORP. DENISE DUCHENE
K032244 07/22/2003 GAMMA 3 NAIL SYSTEM HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K032264 07/23/2003 MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K032315 07/28/2003 IOP8 INTRA OPERATIVE PROBE HUNTLEIGH HEALTHCARE, INC. B.J. COLLEYPRIEST
K032254 07/22/2003 IBL C1Q-CIC CIA TEST IBL GMBH Gary Lehnus
K032075 07/07/2003 CONDUCTIVITY STANDARD SOLUTION-METERCARE IBP INSTRUMENTS GMBH WERNER PFINGSTMANN
K032324 07/28/2003 ECHOENCODER ICARDIOGRAM, INCORPORATED JAMES LOEHR
K032251 07/22/2003 IMMUNETECH TOTAL IGE SYSTEM IMMUNETECH CORPORATION VIVIANNE NOETZEL
K032263 07/23/2003 3I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR IMPLANT INNOVATIONS, INC. JEANNETTE G DAILEY
K032282 07/24/2003 MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM IMPLEX CORP. MARCI HALEVI
K032344 07/30/2003 THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330 IMPLEX CORP. MARCI HALEVI
K032350 07/30/2003 INFRARED SCIENCES BREASTSCAN IR SYSTEM INFRARED SCIENCES CORP. SUSAN D GOLDSTEIN-FALK
K032140 07/11/2003 5.0 X 5MM ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM INNOVA LIFE SCIENCES CORP. HOWARD M HOLSTEIN
K032145 07/14/2003 AUDICOR UPGRADE SYSTEM INOVISE MEDICAL, INC. STEVE HESLER
K032095 07/08/2003 INTERPORE CROSS CEMENT RESTRICTOR INTERPORE CROSS INTL. PROSIE REY-FESSLER
K032322 07/28/2003 CLEAR-THERM MICRO HME, MODEL 1441 INTERSURGICAL, INC. MICHAEL ZALEWSKI
K032031 07/01/2003 SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K032267 07/23/2003 R&D DESIGNATION AP-052-5 JENSEN INDUSTRIES, INC. JOHN SLANSKI
K032340 07/29/2003 VISTAKON (GALYFILCON A) SOFT CONTACT LENS JOHNSON & JOHNSON VISION CARE, INC. JACQUELINE ZIMOVAN
K032277 07/23/2003 JUSTWIN SCOOTER, MODEL JS-401 JOY RIDE TECH CO., LTD. SHU CHEN CHANG
K032081 07/07/2003 KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60 KAVO AMERICA DANIEL KAMM
K032087 07/07/2003 KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 KEELER INSTRUMENTS, INC. EUGENE VANARSDALE
K032310 07/28/2003 MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS KINETIC CONCEPTS, INC. JUDITH HARBOUR
K032134 07/11/2003 TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. HEATHER VIELE
K032212 07/21/2003 KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A KYPHON, INC. TIM REEVES
K032041 07/01/2003 DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM) LEMAITRE VASCULAR, INC. CARLOS CHAPARRO
K032365 07/31/2003 BENZODIAZEPINE ENZYME IMMUNOASSAY Lin-Zhi International, Inc. CHENG-I LIN
K032291 07/24/2003 TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM LINDE MEDICAL SENSORS AG JEAN-PIERRE PALMA
K032323 07/28/2003 BROTHERS POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW LONG FIRST (XIAMEN) PLASTICS CO., LTD. CHIEN LIN
K032298 07/25/2003 MODIFICATION TO OUTBACK CATHETER LUMEND, INC. MICHAEL A DANIEL
K032357 07/30/2003 NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES LUMENIS, INC. KAREN BAKER
K032191 07/17/2003 OMNILIGHT FLUORESCENT PULSED LIGHT SYSTEM LUXSANO AB Connie Hoy
K032335 07/29/2003 MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL MEDICAL ANALYSIS SYSTEMS, INC. PENNY M LAYMAN
K032055 07/02/2003 MEDS-4-INF+ MEDICAL EQUIPMENT DEVICE SPECIALISTS C. A. TEKLINSKI
K032170 07/16/2003 TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000 MEDICAL INDUSTRIES AMERICA, INC. ANNE B CARLSON
K032094 07/07/2003 PASSMED SPINAL SYSTEM MEDICREA J.D. WEBB
K032362 07/31/2003 UP-GRADE FOREHEAD THERMOMETER MEDISIM LTD. DALIA GIVONY
K032329 07/29/2003 SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM MEDISON AMERICA, INC. A. ROBERT DEPALMA
K032308 07/25/2003 BLOOD PRESSURE MONITOR, MODEL M100 MEDITEK TECHNOLOGY, INC. TONY C.S. CHANG
K032065 07/03/2003 MEDLINE BAND BAGS AND EQUIPMENT COVERS MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K032164 07/15/2003 DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333 MEDTRONIC MINIMED GERDA P RESCH
K032037 07/01/2003 CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE) MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K032033 07/01/2003 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K032265 07/23/2003 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K032312 07/28/2003 ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM MEDTRONIC VASCULAR KRISTINA MOLLNER
K032138 07/11/2003 MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER MEDTRONIC VASCULAR DEBORAH KIDDER
K032231 07/21/2003 MEDX1100 CONSOLE & MEDX 100T AND DUOLIGHT LASER ACCESSORIES, MEDX 100 PORTABLE LASER MEDX ELECTRONICS, INC. ANITA SALTMARCHE
K032222 07/21/2003 IMMUNOCARDSTAT HPSA MERIDIAN BIOSCIENCE, INC. SUSAN ROLIH
K032143 07/14/2003 LIQUID OXYGEN SYSTEM MICRO TECHNOLOGY SERVICES, INC. TOMMY BUIE
K032364 07/31/2003 MICROLIFE DIGITAL UNDERARM ELECTRONIC THERMOMETER, MODEL MT 18E1 (V932) MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K032175 07/16/2003 DESENS-IONOMER MILTON HODOSH, M.D. MILTON HODOSH
K032167 07/16/2003 BIO-INTRAFIX TIBIAL SCREW AND SHEATH MITEK WORLDWIDE KAREN K SYLVIA
K032078 07/07/2003 MITEK MICRO QUICKANCHOR MITEK WORLDWIDE SERGIO J GADALETA
K032234 07/21/2003 MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K MK-DENT GMBH MARTINA GUNDEROTH
K032327 07/28/2003 MODERN MEDICAL BIPOLAR FORCEPS MODERN MEDICAL EQUIPMENT MFG., LTD. DAVID LOU
K032090 07/07/2003 NEUROVASCULAR ARRAY COIL, MODEL NVA-127-8 MRI DEVICES CORP. TOM SCHUBERT
K032301 07/25/2003 NEOGEN ONE, CLOSED WOUND DRAIN SYSTEM, PART NUMBER: NG9900 NEOGEN TECHNOLOGIES, INC LYDIA B BIGGIE
K032238 07/21/2003 TWISTER SUPERELASTIC LIGATING CLIP AND APPLIER NEUROSEL (MEDICAL) LIMITED PETER GIBSON
K032196 07/18/2003 NBD DISPOSABLE RF CANNULAE NEW BUSINESS DEVELOPMENT, LLC TIMOTHY B LUSBY
K032188 07/17/2003 NICHOLS ADVANTAGE ALDOSTERONE ASSAY NICHOLS INSTITUTE DIAGNOSTICS JIMMY WONG
K032085 07/07/2003 GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 NIDEK, INC. CAROL PATTERSON
K032256 07/22/2003 QUASAR-QUASAR PLUS-QUASAR TORIC (HYBUFOCON A, HEXAFOCON A, PAFLUFOCON B) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT LE NO 7 CONTACT LENS LABORATORY LTD. MARTIN DALSING
K032209 07/18/2003 NOMOS CORVUS 5.0M NOMOS CORP. FRANCIS X DOBSCHA
K032309 07/25/2003 NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY NOVELENS, INC. RICHARD E LIPPMAN
K032180 07/17/2003 NUVASIVE CEMENT RESTRICTOR NUVASIVE, INC. LAETITIA BERNARD
K032083 07/07/2003 NUVASIVE NEUROVISION JJB SYSTEM NUVASIVE, INC. LAETITIA BERNARD
K032356 07/30/2003 NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS NXSTAGE MEDICAL, INC. NORMA LEMAY
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