FDA 510(k) Applications Received During August, 2005

FDA 510(k) Number Submission Date Device Name Applicant Contact
K052128 08/05/2005 3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER 3M COMPANY CYNTHIA LAMANRUCCIOLA
K052235 08/17/2005 LCR 3M COMPANY KAREN O'MALLEY
K052366 08/29/2005 ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA AB BIODISK ANNE BOLMSTROM
K052247 08/18/2005 NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX ABBOTT SPINE, INC. NOAH BARTSCH
K052072 08/01/2005 THE SC-ACUFIX ANT-CER DYNAMIC CERVICAL PLATE SYSTEM SINGLE LEVEL PLATES ABBOTT SPINE, INC. NOAH BARTSCH
K052198 08/12/2005 RELIEVA SINUS BALLOON INFLATION DEVICE ACCLARENT, INC. SU-MIEN CHONG
K052325 08/25/2005 CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY ACCURAY INCORPORATED ANNE SCHLAGENHAFT
K052335 08/26/2005 ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA ACCUTRON, INC. ROBERT N CLARK
K052374 08/30/2005 RAPID PROGEAMMER 3.0 ADVANCED NEUROMODULATION SYSTEMS KATRYNA WARREN
K052087 08/02/2005 BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178 AG INDUSTRIES IAN GORDON
K052251 08/18/2005 DRYSTAR MODEL 5500 AGFA CORPORATION JEFF JEDLICKA
K052271 08/19/2005 RINSENDO AIR TECHNIQUES, INC. JOSEPH CAREY
K052340 08/26/2005 DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM ALFA TECH MEDICAL SYSTEMS, LTD. SUSAN D GOLDSTEIN-FALK
K052375 08/30/2005 ALILIFE STAND UP POWERED WHEELCHAIR, HC-300 ALILIFE TECHNOLOGICAL CO., LTD. Ke-Min Jen
K052201 08/12/2005 SOLANAS POSTERIOR STABILIZATION SYSTEM ALPHATEC SPINE, INC. ELLEN A YARNALL
K052124 08/05/2005 ACTICLOT, MODEL 824 AMERICAN DIAGNOSTICA, INC. LEIGH AYRES
K052336 08/26/2005 SPECTRAQUATTRO PULSED LIGHT SYSTEM AMJET DISTRIBUTION, LLC STEVE TRINTER
K052136 08/05/2005 GR17 DIGITAL DETECTOR ANRAD CORP. DONALD J SHERRATT
K052387 08/31/2005 ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX ARTHREX, INC. ANN WATERHOUSE
K052339 08/26/2005 ASAHI PTCA GUIDE WIRE ASAHI INTECC CO., LTD. YOSHI TERAI
K052137 08/05/2005 ASCENSION MUH ASCENSION ORTHOPEDICS, INC. GLEN NEALLY
K052085 08/02/2005 STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES ASIA-MED GMBH AND CO KG Kevin Walls
K052362 08/29/2005 BIS EEG MONITOR, MODEL A-3000 ASPECT MEDICAL SYSTEMS, INC. CHRISTINE VOZELLA
K052070 08/01/2005 ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT IN ZIRCONIA, ATLANTIS GEMEINI + ABUTMENT IN ZIRCONIA ATLANTIS COMPONENTS, INC. BETSY A BROWN
K052392 08/31/2005 HOT DOG PATIENT WARMING SYSTEM AUGUSTINE BIOMEDICAL & DESIGN, LLC JAMES D ECKLEIN
K052075 08/01/2005 PROCEDUR-10 AVANCA MEDICAL DEVICES, INC. FRANK FERGUSON
K052393 08/31/2005 B. BRAUN MODIFIED BICARBONATE DIALYSATE B. BRAUN MEDICAL, INC. CHRISTINE FORD
K052252 08/18/2005 CONTRAST MEDIA TRANSFER SETS B. BRAUN MEDICAL, INC. CHRISTINE FORD
K052352 08/29/2005 COLOR CORONIS 2MP-21 AND MFCD 2321 BARCOVIEW LIEVEN DE WANDEL
K052276 08/22/2005 NIO 2MP-20 AND E-2620 S BARCOVIEW LIEVEN DE WANDEL
K052236 08/17/2005 BARD ATLAS PTA BALLOON DILATATION CATHETER BARD PERIPHERAL VASCULAR, INC. GENEVIEVE BALUTOWSKI
K052114 08/04/2005 BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP BARD PERIPHERAL VASCULAR, INC. DENNIS SALZMANN
K052282 08/22/2005 VENAFLO II VASCULAR GRAFT BARD PERIPHERAL VASCULAR, INC. GLENN NORTON
K052242 08/17/2005 ADVIA CHEMISTRY MICROALBUMIN CONTROLS BAYER HEALTHCARE LLC ANDRES HOLLE
K052163 08/09/2005 ADVIA IMS GLUCOSE ASSAY BAYER HEALTHCARE, LLC ANDRES HOLLE
K052307 08/24/2005 BEAMER PAINLOW INFRARED LIGHT TREATMENT SYSTEM BEAMLINE CORPORATION DAVID R BALZER
K052223 08/15/2005 ACCESS EPO ASSAY BECKMAN COULTER, INC. LYNN WEIST
K052082 08/02/2005 FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 BECKMAN COULTER, INC. CAROLYN ANDERSON
K052270 08/19/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (STREP) 0.125 - 4UG/ML BECTON, DICKINSON & CO. Monica Giguere
K052250 08/18/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TOBRAMYCIN (GP) 0.5-16UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K052269 08/19/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -CIPROFLOXACIN GN BECTON, DICKINSON & CO. Monica Giguere
K052224 08/16/2005 BD PROBE TEC URINE PRESERVATIVE TRANSPORT BECTON, DICKINSON & CO. KATHRYN BABKA POWERS
K052066 08/01/2005 CEEGRAPH/SLEEPSCAN NETLINK TRAVELER BIO-LOGIC SYSTEMS CORP. NORMAN E BRUNNER
K052354 08/29/2005 OCULASE MD BIOLASE TECHNOLOGY, INC. JEFFREY W JONES
K052311 08/24/2005 VITEK 2 GRAM NEGATIVE TIGECYCLINE BIOMERIEUX, INC. JOLYN TENLLADO
K052089 08/02/2005 XR-SERIES BI-METRIC FEMORAL COMPONENTS BIOMET MANUFACTURING, INC. PATRICIA SANDBORN-BERES
K052255 08/18/2005 ARCOMXL POLYETHYLENE RX90 ACETABULAR LINERS BIOMET, INC. ALLISON K KOSKEY
K052083 08/02/2005 NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER BIOSENSE WEBSTER, INC. DIANA M THORSON
K052289 08/23/2005 DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE BIOWAVE CORPORATION MARY MCNAMARA-CULLINANE
K052122 08/05/2005 BISCO LED BISCO, INC. BENJAMIN LICHTENWALNER
K052190 08/11/2005 FETAL MONITOR, MODELS BT-300 AND BT-200 BISTOS CO., LTD. CHARLIE MACK
K052280 08/22/2005 FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM BOSTON SCIENTIFIC CORP. DEBBIE MCINTIRE
K052302 08/24/2005 HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION BOSTON SCIENTIFIC CORP. JENNIFER BOLTON
K052194 08/11/2005 SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR BOSTON SCIENTIFIC CORP. ALLYSON BARFORD
K052254 08/18/2005 MYTIS ARROW XXXX BRAINBASE CORPORATION CRAIG R BRUNS
K052220 08/15/2005 IPLAN RT FIBERTRACKING BRAINLAB AG RAINER BIRKENBACH
K052213 08/15/2005 NAVIGATION SW HIP 3.1 ON CI BRAINLAB AG RAINER BIRKENBACH
K052322 08/25/2005 BARD COLLAMEND IMPLANT, MODELS 1175101, 1175102, 1175103, 1175104, 1175105 C.R. BARD, INC. ROBIN DRAGO
K052155 08/08/2005 BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED C.R. BARD, INC. LUCINDA L FOX
K052218 08/15/2005 CRONO FIVE AND CRONO PCA 50 CANE S.R.L. CARLO MUSSO
K052219 08/15/2005 CRONO GO. CANE S.R.L. CARLO MUSSO
K052217 08/15/2005 CRONO SUPER PID CANE S.R.L. CARLO MUSSO
K052125 08/05/2005 CARBONAID GAS DIFFUSER CARDIA INNOVATION AB JEFFREY R SHIDEMAN
K052161 08/09/2005 POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A) CARDIAC SCIENCE, INC. KENNETH F OLSON
K052316 08/25/2005 POWERHEART ECD CARDIAC SCIENCE, INC. KENNETH OLSON
DEN050006 08/09/2005 CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM CARDIOMEMS INC CAROL VIERLING
K052240 08/17/2005 CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002 CARDIONET, INC JACK GAIKWAD
K052295 08/23/2005 CARDIOSOFT PC ECG, USB VERSION CARDIOSOFT, L.P. S. MORADI
K052268 08/19/2005 VISUCAM PRO NM CARL ZEISS MEDITEC AG KENT W JONES
K052290 08/23/2005 AQUASOFT ALL-DAY & ALL-DAY T (HIOXIFILCON A) DAILY WEAR CONTACT LENS CLEARLAB PTE LTD. MARTIN DALSING
K052229 08/16/2005 COLOPLAST OSTOMY ROD, MODEL 12814 COLOPLAST CORP. ELIZABETH BOOTS
K052206 08/12/2005 ZEUS MALE CONDOM APPLICATOR CONDAX LLC. ELI J CARTER
K052104 08/03/2005 ULTRACLEAN HANDCONTROLLED SUCTION COAGULATOR, MODEL 130182, 130183, 130184, 130185; ULTRACLEAN FOOTCONTROLLED SUCTION CONMED CORPORATION PAMELA VETTER
K052279 08/22/2005 COOK IRELAND ECHOBRUSH COOK IRELAND LTD EMMETT DEVEREUX
K052263 08/19/2005 MULTIPLE (TOOTH DESENSITIZER) COSMEDENT, INC. JAMES L SANDRIK
K052135 08/05/2005 CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER CYBERSONICS, INC. WILLIAM A STOLL
K052346 08/29/2005 SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS DADE BEHRING, INC. ROBERT EUSEBIO
K052303 08/24/2005 READMYHEART, MODEL RMH2.0 DAILYCARE BIOMEDICAL INC DANIEL J. H. CHANG
K052097 08/03/2005 CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE DENTSPLY INTERNATIONAL HELEN LEWIS
K052370 08/30/2005 CP BRACKET SYSTEM DENTSPLY INTERNATIONAL HELEN LEWIS
K052334 08/26/2005 CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131 DENTSPLY INTL. HELEN LEWIS
K052178 08/10/2005 DEPUY CAS HIP INSTRUMENTATION DEPUY ORTHOPAEDICS, INC. RANDA FRANKLIN
K052079 08/02/2005 PINNACLE CONSTRAINED ACETABULAR LINERS DEPUY ORTHOPAEDICS, INC. KELI K HANKEE
K052131 08/05/2005 EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS DEPUY SPINE, INC. LIZ LAVELLE
K052212 08/15/2005 MIGUE DIREX SYSTEMS CORP. LARISA GERSHTEIN
K052090 08/02/2005 SPLASH! IMPRESSION MATERIAL DEVICE DISCUS DENTAL INC. SUZANNE RIDGWAY
K052150 08/08/2005 VOLAR PLATE SYSTEM DVO EXTREMITY SOLUTIONS, LLC DINA L WEISSMAN
K052314 08/25/2005 DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE DYNAREX CORP. JAMES HURLMAN
K052343 08/26/2005 E-SAN BLUETOOTH CRADLE E-SAN LIMITED KRISTIN M ZIELINSKI
K052239 08/17/2005 EBI DYNAFIX VISION FOOTPLATE SYSTEM EBI, L.P. PETER ALLAN
K052149 08/08/2005 EDWARDS PERIPHERAL DILATION CATHETER EDWARDS LIFESCIENCES, LLC. KEVIN DRISKO
K052132 08/05/2005 MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM EDWARDS LIFESCIENCES, LLC. KEVIN DRISKO
K052344 08/26/2005 COLOR LCD MONITOR, MODEL RADIOFORCE R31 & R31-C EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K052337 08/26/2005 MONOCHROME LCD MONITOR, MODEL RADIFORCE G33 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K052071 08/01/2005 MODIFICATION TO LYSUS INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K052241 08/17/2005 DISC-FX SYSTEM ELLMAN INTERNATIONAL, INC. JOAN CARTER
K052320 08/25/2005 ENCORE CLP OFFSET TOTAL HIP SYSTEM ENCORE MEDICAL CORPORATION SAM SON
K052086 08/02/2005 ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER ENCORE MEDICAL, INC. CHRISTIE SHUMAKER
K052077 08/01/2005 G-SCAN CERVICAL SPINE COIL ESAOTE, S.P.A. CARRI GRAHAM
K052081 08/02/2005 REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA ESTECH, INC. CRAIG COOMBS
K052358 08/29/2005 ETIAM STAR PACS COMPONENTS ETIAM, S.A. CARL ALLETTO
K052233 08/17/2005 TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM ETVIEW LTD. YORAM LEVY
K052133 08/05/2005 IMMUNOSCAN RA ANTI-CCP TEST SYSTEM EURODIAGNOSTICA WILLIAM L BOTELER JR.
K052111 08/04/2005 XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382 EXCEL TECH. LTD. NICOLE LANDREVILLE
K052112 08/04/2005 XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 EXCEL TECH. LTD. NICOLE LANDREVILLE
K052103 08/03/2005 EXEL SECURE TOUCH II SAFETY SYRINGE EXELINT INTL. CO. ARMAND HAMID
K052192 08/11/2005 FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I FEMSPEC L.L.C. CARL YOUNGMANN
K052115 08/04/2005 FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY FIRST CHECK DIAGNOSTICS LLC KEVIN J GADAWSKI
K052308 08/24/2005 ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM FISHER DIAGNOSTICS M. HEATHER CAMERON
K052253 08/18/2005 MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS GAMBRO RENAL PRODUCTS FEI LAW
K052345 08/26/2005 ADVANTAGE SIM MD GE HEALTHCARE LARRY A KROGER
K052145 08/08/2005 DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES GE HEALTHCARE JOEL KENT
K052167 08/09/2005 DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIES GE HEALTHCARE JOEL C KENT
K052293 08/23/2005 GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM GE MEDICAL SYSTEMS, LLC LARRY A KROGER, PH.D.
K052157 08/08/2005 INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ GE MEDICAL SYSTEMS, LLC LARRY A KROGER
K052184 08/11/2005 GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD. SHOSHANA FRIEDMAN
K052069 08/01/2005 PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES GLOBUS MEDICAL INC. KELLY J BAKER
K052274 08/22/2005 GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000 GUIDANT CORPORATION M. LAURIE WONG
K052166 08/09/2005 MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM GUIDANT CORPORATION JULIA ANASTAS
K052165 08/09/2005 RX ACCUNET EMBOLIC PROTECTION SYSTEM GUIDANT CORPORATION JULIA ANASTAS
K052371 08/30/2005 DEPILITE EL-8B SERIES DERMO FLASH SYSTEMS HAIR INTERNATIONAL SYSTEMS USA, INC. CRAIG A MITCHELL
K052248 08/18/2005 DORSAL NAIL PLATE, ANATOMICAL HAND INNOVATIONS, LLC. ERNESTO HERNANDEZ
K052294 08/23/2005 SHOULDER NAIL PLATE HAND INNOVATIONS, LLC. ERNESTO HERNANDEZ
K052177 08/10/2005 POWDER FREE STERILE LATEX SURGICAL GLOVES HARTALEGA SDN BHD NURUL AISYAH KONG
K052120 08/04/2005 LUMIMED MONOCHROME LCD MONITOR, MODELS MM 20, MM 30 AND MM50 HEEYOUNG CO., LTD. DANIEL KAMM
K052172 08/09/2005 HHF1 MAGNETIC RESONANCE IMAGING SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K052117 08/04/2005 I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP) I-FLOW CORP. SHANE NOEHRE
K052368 08/29/2005 OLECRANONPLATE WITH ANGULAR STABILITY I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH AL LIPPINCOTT
K052319 08/25/2005 IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7 IMPEDIMED PTY LTD. NEVILLE BERTWISTLE
K052207 08/12/2005 ACCUREX GLUCOSE TEST STRIP INCLINE MEDICAL, LLC GREG HOLLAND
K052284 08/22/2005 REFORMAT GATEWAY INFINITT CO., LTD. CARL ALLETTO
K052383 08/30/2005 INNOCURE IMRT FILTER (COMPENSATORS) INNOCURE, LLC DONALD W COLLINS
K052329 08/25/2005 WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000 INNOVATIVE NEUROTRONICS INC. FAYYAZ MEMON
K052244 08/17/2005 IISIS, VERSION 1.0 INNOVISION MEDICAL TECHNOLOGIES, LLC PATRICIA L ANDREWS
K052264 08/19/2005 QUANTA LITE CCP3 IGG ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K052143 08/08/2005 QUANTA LITE GLIADIN IGA II INOVA DIAGNOSTICS, INC. BRYS C MYERS
K052142 08/08/2005 QUANTA LITE GLIADIN IGG II INOVA DIAGNOSTICS, INC. BRYS C MYERS
K052262 08/19/2005 QUANTA LITE M2 EP (MIT3) ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K052121 08/05/2005 GEM PREMIER 3000 INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K052169 08/09/2005 IMC SURGICAL DRAPES INTERNATIONAL MEDSURG CONNECTION, INC. MANNY GUPTA
K052098 08/03/2005 CONNEXUS, .5CC, MODEL 023000-005 ISOTIS ORTHOBIOLOGICS, INC PAUL DONER
K052341 08/26/2005 AJEX 9015/135H PORTABLE X-RAY JPI AMERICA, INC. ABE ELGOHARY
K052398 08/31/2005 MESA SPINAL SYSTEM K2M, LLC RICHARD W WOODS
K052214 08/15/2005 PRE-POWDERED STERILE EXAM GLOVES KANAM LATEX INDUSTRIES PVT. LTD. RAVI ABRAHAM
K052159 08/09/2005 AIDA COMPACT II SYSTEM KARL STORZ ENDOSCOPY-AMERICA, INC. PAUL LEE
K052203 08/12/2005 AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600 KIRWAN SURGICAL PRODUCTS, INC. KEVIN P PRARIO
K052347 08/29/2005 TITAN STEERABLE (PTCA) GUIDEWIRE LAKE REGION MFG., INC. KAREN MORTENSEN
K052384 08/30/2005 LANX VBR SYSTEM LANX, LLC DAVID W SCHLERF
K052245 08/17/2005 ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS LAR MFG., LLC. IAN P GORDON
K052359 08/26/2005 IBL CORTISOL LIA TEST KIT Lehnus & Associates Consulting Gary Lehnus
K052397 08/31/2005 CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML) LIFE-SHIELD PRODUCTS, INC Ke-Min Jen
K052080 08/02/2005 MATRYX INTERFERENCE SCREW LINVATEC BIOMATERIALS, INC. TUIJA ANNALA
K052129 08/05/2005 LUMENIS 1000 INTEGRATED SLIT LAMP LUMENIS, INC. KAREN L BAKER
K052119 08/04/2005 TESLAGUARD, MODEL EFT G04 MAMMENDORFER INSTITUTE FOR PHYSICS & MEDICINE GMBH ROBERT N CLARK
K052330 08/26/2005 TRU-SWAB STOCOCK MEDEGEN MEDICAL MANUFACTURING SERVICES TIM TRUITT
K052338 08/26/2005 SOLAR GI MEDICAL MEASUREMENT SYSTEMS,B.V. KARIN OGINK-SOMHORST
K052168 08/09/2005 MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K052357 08/29/2005 PATHWAY - ATS/CHEPS MEDOC LTD. ADVANCED MEDICAL SYSTEMS GEORGE J HATTUB
K052211 08/15/2005 DUREPAIR DURA REGENERATION MATRIX MEDTRONIC NEUROSURGERY JEFFREY HENDERSON
K052386 08/31/2005 MEDTRONIC M2 MAGNET ADJUSTMENT TOOL MEDTRONIC NEUROSURGERY JEFFREY HENDERSON
K052372 08/30/2005 MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C MEDTRONIC PERFUSION SYSTEMS RONALD W BENNETT
K052180 08/10/2005 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K052187 08/11/2005 MODIFICATION TO: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K052376 08/30/2005 MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K052144 08/08/2005 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K052261 08/19/2005 MODIFICATION TO: VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. RICHARD TREHARNE
K052369 08/29/2005 EXFEEL IMPLANT SYSTEM MEGAGEN CO., LTD. DAE KYU CHANG
K052288 08/23/2005 VITALOGIK MENNEN MEDICAL LTD. MICHA OESTEREICH
K052351 08/29/2005 HDR IORT SHIELDED APPLICATOR MICK RADIO-NUCLEAR INSTRUMENTS, INC. FELIX MICK
K052379 08/30/2005 MIM 3.5 (CIRCA) MIMVISTA CORP. PETER SIMMELINK
K052140 08/08/2005 SPIROLAB, SPIROLAB II MIR MEDICAL INTL. RESEARCH SRL SIMON FOWLER
K052200 08/12/2005 TEM 3000 HEAD COIL MR INSTRUMENTS INC. MARK WATSON
K052067 08/01/2005 DOPPLER GUIDED PROCTOSCOPE, MODEL 500H MULTIGON INDUSTRIES, INC. WILLIAM STERN
K052186 08/11/2005 NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P NELLCOR PURITAN BENNETT, INC. PATRICK GARVEY
K052246 08/17/2005 MODIFICATION TO EN-BLOC BIOPSY SYSTEM NEOTHERMIA CORPORATION DAVID JACOBS
K052152 08/08/2005 B-BOP PLATE NEWDEAL S.A. JUDITH E O'GRADY
K052304 08/24/2005 SUPER PORCELAIN EX-3 PRESS NORITAKE CO., INC. IVAN J WASSERMAN
K052361 08/29/2005 SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM NUCLETRON CORPORATION LISA DIMMICK
K052228 08/16/2005 SMIT SLEEVE NUCLETRON CORPORATION LISA DIMMICK
K052210 08/15/2005 NUVASIVE COROENT EXTENSURE SYSTEM NUVASIVE, INC. LAETITIA COUSIN
K052154 08/09/2005 OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC OMRON HEALTHCARE, INC. IWAO KOJIMA
K052153 08/09/2005 OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL OMRON HEALTHCARE, INC. IWAO KOJIMA
K052237 08/17/2005 SC CERAMIC BALL HEADS ORTHOPEDIC ALLIANCE LLC HARTMUT LOCH
K052173 08/10/2005 VITAGEL SURGICAL HEMOSTAT SPRAY SET ORTHOVITA, INC. GINA M NAGVAJARA
K052396 08/31/2005 OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615 OXYSURE SYSTEMS, INC. JULIAN T ROSS
K052389 08/31/2005 I-PORT PATTON MEDICAL DEVICES FRED SCHLADOR
K052349 08/29/2005 AVANTE LED CURING UNIT, MODEL N44 PENTRON CLINICAL TECHNOLOGIES GREG MOREAU
K052106 08/03/2005 SIMILE FLOW PENTRON CLINICAL TECHNOLOGIES GREG MOREAU
K052134 08/05/2005 CYSTOGLIDE DILATING INTRODUCER SHEATH PERCUTANEOUS SYSTEMS, INC. THOMAS LAWSON
K052298 08/23/2005 CYSTOGLIDE INTRODUCER SHEATH PERCUTANEOUS SYSTEMS, INCORPORATED THOMAS LAWSON
K052078 08/01/2005 ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. LYNN HARMER
K052377 08/30/2005 PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A. PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH EGON PFEIL
K052099 08/03/2005 NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ Polyganics BV JAN NIEUWENHUIS
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K052105 08/03/2005 WATER FILLED TEETHER ROYAL INDUSTRIES (THAILAND) PUBLIC CO. LTD. ANDREW SIMS
K052309 08/24/2005 DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006 SAEHAN CORP. CHARLIE MACK
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K052367 08/29/2005 SCIENT'X CEMENT RESTRICTOR SCIENT'X J.D. WEBB
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K052388 08/31/2005 SERIM PERACETIC ACID CHEMICAL INDICATOR SERIM RESEARCH CORP. PATRICIA A RUPCHOCK
K052162 08/09/2005 SHEFFIELD BRAND WARMING LUBRIGEL PERSONAL LUBRICANT SHEFFIELD LABORATORIES, DIV. OF FARIA LIMITED, LLC KATHLEEN HACKU
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K052076 08/01/2005 DAR-8000I SHIMADZU MEDICAL SYSTEMS RANDAL WALKER
K052118 08/04/2005 DOSE VERIFICATION SYSTEM SICEL TECHNOLOGIES, INC. TAMMY B CARREA
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K052202 08/12/2005 AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. GARY JOHNSON
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K052315 08/25/2005 SIMTEC IM-MAXX 2 OPTION SIEMENS MEDICAL SOLUTIONS USA, INC. CHRISTINE DUNBAR
K052216 08/03/2005 SOMATOM DEFINITION SIEMENS MEDICAL SYSTEMS, INC. GARY JOHNSON
K052096 08/03/2005 NUBIC SPINAL IMPLANT SIGNUS MEDICAL LLC. TRACY L GRAY
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K052084 08/02/2005 ENDO-EASE ENDOSCOPIC OVERTUBE SPIRUS MEDICAL, INC. PAMELA PAPINEAU
K052411 08/29/2005 HIPAX MEDICAL IMAGING SOFTWARE STEINHART MEDIZINSYSTEME GMBH MARTINA STEINHART
K052299 08/24/2005 REPROCESSED ENDOSCOPIC TROCAR STERILMED, INC. THOMAS A DOLD
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K052272 08/22/2005 STRAUMANN COMPUTER AIDED RESTORATION SERVICE STRAUMANN USA ELAINE ALAN
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K052074 08/01/2005 JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS; JSZ-WET-TREE AND JSZ-WET-OR, WETTING, SZABOCSIK AND ASSOCIATES JOHN M SZABOCSIK
K052225 08/16/2005 TEPHAFLEX ABSORBABLE SUTURE TEPHA, INC. MARY P LEGRAW
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K052185 08/11/2005 DESTINATION CAROTID GUIDING SHEATH TERUMO MEDICAL CORP. MARK UNTERREINER
K052286 08/22/2005 DEUTSCH ANTI-BLOCKAGE WOUND DRAIN THE CATHETER EXCHANGE, INC. GEORGE P TEITELBAUM
K052208 08/12/2005 GLUCOSE PILOT Tianjin New Bay Bioresearch Co., Ltd. RODBRIGO BERLIE
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K052332 08/26/2005 AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER TRUDELL MEDICAL INTL. JOHN STRAATMAN
K052204 08/12/2005 THE ELITE - ULTRA-LIGHT, COMPACT PORTABLE SCOOTER TZORA ACTIVE SYSTEMS LTD. ALEX GONOROVSKY
K052355 08/29/2005 AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS U-SYSTEMS, INC. ROBERT F LAWRENCE
K052385 08/30/2005 TANGORS POLYAXIAL SYSTEM ULRICH GMBH & CO. KG CHRISTOPH ULRICH
K052310 08/24/2005 CRYOFLOW 700, CRYOFLOW 1000 UNIPHY ELEKTROMEDIZIN GMBH & CO. KG NICO BEUN
K052175 08/10/2005 I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000 UROPLASTY, INC. MICHAEL MORRELL
K052391 08/31/2005 VISION (WITH OFF-LINE REVIEW) VARIAN MEDICAL SYSTEMS VY TRAN
K052209 08/15/2005 VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01 VASCULAR CONTROL SYSTEMS, INC KATHLEEN ROBERTS
K052232 08/17/2005 VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETER VASCULAR SOLUTIONS, INC. SARA L COON
K052258 08/19/2005 VASCULAR SOLUTIONS SKYWAY SUPPORT CATHETER VASCULAR SOLUTIONS, INC. SARA L COON
K052257 08/18/2005 VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER VASCULAR SOLUTIONS, INC. SARA L COON
K052191 08/11/2005 MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT VERIDEX, LLC DEBRA J RASMUSSEN
K052195 08/11/2005 EZ-MIO MANUAL DRIVER VIDACARE CORPORATION GREG HOLLAND
K052130 08/05/2005 VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40 VIDENT BARBARA J LEWANDOWSKI
K052196 08/11/2005 VILEX X-FIX VILEX, INC. ABRAHAM LAVI
K052348 08/29/2005 IN VISION GOLD WITH SPIN VISION, MODEL 891 SV VOLCANO CORPORATION JENNIFER M MOTTO
K052395 08/31/2005 STERILE EQUIPMENT COVERS VOLCANO CORPORATION Michelle J Badal
K052197 08/12/2005 FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST W.H.P.M., INC. FRAN WHITE
K052160 08/09/2005 ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.) WELCH ALLYN, INC. JOHN E SAWYER
K052158 08/09/2005 WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE WELCH ALLYN, INC. CHRISTOPHER KLACZYK
K052312 08/24/2005 WIDE 5MP (MAMMO) LCD MONITOR SYSTEM WIDE CORPORATION CARL ALLETTO
K052292 08/23/2005 SPIDER CERVICAL PLATING (SCP) SYSTEM X-SPINE SYSTEMS, INC. DAVID KIRSCHMAN
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K052381 08/30/2005 GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER ZERUSA LIMITED OONAGH SWEENEY
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