FDA 510(k) Applications Received During October, 2006

FDA 510(k) Number Submission Date Device Name Applicant Contact
K063023 10/02/2006 3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870 3M COMPANY DIANNE GIBBS
DEN060009 10/03/2006 3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR 3M COMPANY DIANNE GIBBS
K063059 10/05/2006 SORBACT WOUND DRESSING ABIGO MEDICAL AB EMALEE G MURPHY
K063078 10/10/2006 MICROENDOSCOPE ACCLARENT, INC. DEBBIE COGAN
K063173 10/19/2006 MODIFICATION TO SILVER ALGINATE II WOUND DRESSING ADVANCED MEDICAL SOLUTIONS LIMITED GRAHAME SOMERVILLE
K063080 10/10/2006 TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS ADVANCED NEUROMODULATION SYSTEMS AMY CLENDENING
K063127 10/13/2006 ENTEROCOCCUS FAECALIS PNA FISH ADVANDX, INC. Amy Aulwes
K063013 10/02/2006 PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S AEARO COMPANY ANN L PHILLIPS
K063017 10/02/2006 AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM AESCULAP, INC. MATTHEW M HULL
K063285 10/31/2006 RELIANCE CI PROCESS INDICATOR ALBERT BROWNE LTD. CYNTHIA J.M. NOLTE
K063155 10/17/2006 MONARCH III IOL DELIVERY SYSTEM ALCON MANUFACTURING, LTD. CATHERINE G GOBLE
K063015 10/02/2006 AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150 AMEDITECH, INC. JOHN WU
K063125 10/13/2006 FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME) ARC MEDICAL, INC. PAUL DRYDEN
K063244 10/26/2006 ARC SURGICAL BONE REDUCTION SCREW ARC SURGICAL LLC. ED BOEHMER
K063068 10/06/2006 FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100 ARKRAY USA, INC. TOM SPEIKERS
K063058 10/05/2006 ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS ARTHREX, INC. NANCY HOFT
K063172 10/18/2006 ARTHROCARE CAVITY SPINEWAND ARTHROCARE CORP. VALERIE DEFIESTA-NG
K063076 10/06/2006 REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER ASCENT HEALTHCARE SOLUTIONS JENN SELVEY
K063205 10/23/2006 ATLAS SPINE VERTEBRAL BODY REPLACEMENT ATLAS SPINE LLC FLOYD G LARSON
K062996 10/02/2006 DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES AXON SYSTEMS, INC. HOWARD BAILIN
K063194 10/20/2006 TUFFLEX POLYESTER SUTURE AXYA MEDICAL, INC. HOWARD L SCHRAYER
K063282 10/31/2006 CONTIPLEX STIM CONTINUOUS NERVE BLOCK SET B. BRAUN MEDICAL, INC. REBECCA STOLARICK
K063280 10/31/2006 INJEKT SYRINGE B. BRAUN MEDICAL, INC. CHRISTINE FORD
K063217 10/24/2006 VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL) B. BRAUN MEDICAL, INC. PAUL O'CONNELL
K063245 10/26/2006 ELUTIA COATED CLOSED SURGICAL WOUND DRAIN BACTERIN INTERNATIONAL INC. JOSEPH M AZARY
DEN060006 10/18/2006 COMPUTERIZED LABOR MONITORING SYSTEM BARNEV, LTD. ARAVA HACOHEN
K063231 10/25/2006 MICROBLADE SHAVER AND ACCESSORIES BAXANO, INC. SHARON ROCKWELL
K063276 10/30/2006 CLINITEK ADVANTUS, MODEL 1420 BAYER HEALTHCARE, LLC NOOR MALKI
K063196 10/20/2006 LANDLEX, MODEL S403X BESTEAM TECHNOLOGY INC. JUNNATA CHANG
K063232 10/25/2006 ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01 BIOKIT S.A. JOAN GUIXER
K063261 10/30/2006 NUCLISENS EASYQ ENTEROVIRUS SYSTEM BIOMERIEUX, INC. SANDRA PERREAND
K063243 10/26/2006 VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448 BIOMERIEUX, INC. NIKITA S MAPP
K063002 10/02/2006 ALTRA PRESS-FIT HIP SYSTEM BIOMET MANUFACTURING CORP. GARY BAKER
K062997 10/02/2006 ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS BIOMET MANUFACTURING CORP. BECKY EARL
K062998 10/02/2006 COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG) BIOMET MANUFACTURING CORP. JING XIE
K062994 10/02/2006 LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS BIOMET MANUFACTURING CORP. PATRICIA S BERES
K062995 10/02/2006 M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT BIOMET MANUFACTURING CORP. PATRICIA S BERES
K063139 10/16/2006 SPINAL STABILIZING SPHERE SYSTEM BIOMET SPINE PATRICIA SANDBORN BERES
K063107 10/11/2006 3DNET SUITE BIOTRONICS3D, LTD. HARALAMBOS HATZAKIS
K063237 10/26/2006 THERACAL LC BISCO, INC. BENJAMIN LICHTENWALNER
K063060 10/05/2006 BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP BLUESHINE SRL ALICE NOVELLI
K063098 10/10/2006 STATIC CRANIOPLASTY ORTHOSIS BOSTON BRACE INTL., INC. JAMES WYNNE
K063236 10/25/2006 BETA-POWDER BRAINBASE CORPORATION SATOSHI NOAKE
K063028 10/02/2006 VECTORVISION HIP SR BRAINLAB, AG RAINER BIRKENBACH
K063018 10/02/2006 GLASS LOSS OF RESISTANCE SYRINGE BUSSE HOSPITAL DISPOSABLES, INC. MUHAMAD ANSARI
K063118 10/11/2006 BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE C.R. BARD, INC. SUSAN SCOTT
K063178 10/19/2006 BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 1175105, 1175106 C.R. BARD, INC. STEPHANIE BAKER
K063240 10/26/2006 SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR C.R. BARD, INC. LYNN M KIRCHOFF
K063074 10/06/2006 CANDELA 3630 LASER SYSTEM CANDELA CORP. JEFFREY ROBERTS
K063073 10/06/2006 CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS CANDELA CORP. JEFFERY ROBERTS
K063072 10/06/2006 CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS: 532 AND 1064 ND:YAG HANDPIECE ACCESSORIES CANDELA CORP. JEFFERY ROBERTS
K063193 10/20/2006 MODIFICATION TO BIOMARC TISSUE MARKER CARBON MEDICAL TECHNOLOGIES, INC. ROBERT W JOHNSON
K063222 10/24/2006 CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004 CARDIONET, INC JACK GAIKWAD
K063087 10/10/2006 MODIFICATION TO MODEL 750 SERIES MONITOR CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K063070 10/06/2006 APERFIX TIBIAL IMPLANT WITH INSERTER CAYENNE MEDICAL, INC. Floyd Larson
K063037 10/03/2006 CENTARISONE RIS/PACS CENTARISONE, LLC SCOTT SHANNON
K063266 10/30/2006 3MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-3NC CHI LIN TECHNOLOGY CO., LTD. JUDY LIN
K063269 10/30/2006 5MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2010-5NC CHI LIN TECHNOLOGY CO., LTD. JUDY LIN
K063079 10/10/2006 I-STOP TRANS OBTURATOR MALE SLING CL MEDICAL VINCENT GORIA
K063114 10/11/2006 DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES COEUR, INC. DEBRA F MANNING
K063030 10/03/2006 COMFORT SCOOTER MODEL LY-EW406 COMFORT ORTHOPEDIC CO. LTD. Ke-Min Jen
K063032 10/03/2006 COMFORT SCOOTER, MODEL LY-EW415 COMFORT ORTHOPEDIC CO. LTD. Ke-Min Jen
K063227 10/24/2006 CONCEIVEX CONCEPTION KIT CONCEIVEX INC. BLIX WINSTON
K063271 10/30/2006 AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED ANTIMICROBIAL DRESSING CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, LLC. MARILYN KONICKY
K063252 10/27/2006 ATB ADVANCED PTA DILATATION CATHETER COOK, INC. KAREN BRADBURN
K063223 10/24/2006 MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS COOPERSURGICAL, INC. JOSEPH AZARY
K063254 10/27/2006 THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM CORDIS NEUROVASCULAR, INC. Amarilys Machado
K063133 10/13/2006 CRANIAL SOLUTION ORTHOSIS CRANIAL SOLUTIONS KIRK A LUCYK
K063106 10/11/2006 REVOIS IMPLANT SYSTEM CURASAN AG ERIC WEICHERT
K063235 10/25/2006 CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT CYTORI THERAPEUTICS, INC. KENNETH K KLEINHENZ
K063272 10/30/2006 DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K063206 10/23/2006 DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH DADE BEHRING, INC. KATHLEEN DRAY- LYONS
K063102 10/10/2006 MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML) DADE BEHRING, INC. SHANNON POPSON
K063099 10/10/2006 MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML) DADE BEHRING, INC. MAY MORISHIMA
K063101 10/10/2006 MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML DADE BEHRING, INC. MAUREEN MENDE
K063064 10/06/2006 MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML) DADE BEHRING, INC. MAUREEN MENDE
K063053 10/04/2006 MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML) DADE BEHRING, INC. SHANNON POPSON
K063065 10/06/2006 MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML) DADE BEHRING, INC. MAUREEN MENDE
K063188 10/20/2006 DEL-IMS DEL MEDICAL IMAGING CORP. WILLIAM J ENGEL
K063273 10/30/2006 PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR DEPUY MILTEK, A JOHNSON & JOHNSON CO. KRISTINE CHRISTO
K063156 10/17/2006 MODIFICATION TO EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. CHRISTOPHER KLACZYK
K063208 10/23/2006 MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 DIAGNOSTIC CHEMICALS LTD. DEBBIE M MURRAY
K063045 10/04/2006 IMMULITE 2000, IMMULITE 2500 VANCOMYCIN DIAGNOSTIC PRODUCTS CORP. DEBORAH L MORRIS
K063057 10/05/2006 IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP DIAGNOSTIC PRODUCTS CORPORATION DEBORAH L MORRIS
K063067 10/06/2006 CONFIDENCE FENESTRATED INTRODUCER NEEDLE DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. JONATHAN S KAHAN
K063146 10/16/2006 ACCU-CHEK LINKASSIST DISETRONIC MEDICAL SYSTEMS AG Scott Thiel
K063029 10/02/2006 EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 E-Z-EM, INC. TRACEY CAMPBELL
K063120 10/12/2006 COLOR LCD MONITOR, RADIFORCE, MODEL RX210 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K063152 10/16/2006 CLAROS DENTAL LASER SYSTEM ELEXXION AG JOHANNES MUELLER
K063151 10/16/2006 HUMAPEN LUXURA HD ELI LILLY AND CO. LEEANN CHAMBERS
K063257 10/27/2006 FMP COATED SPIKED ACETABULAR CUP; HEMISPHERICAL ACETABULAR CUP; FLARED RIM ACETABULAR CUP; METAL/METAL ACETABULAR INSERT ENCORE MEDICAL, L.P. TEFFANY HUTTO
K063182 10/19/2006 ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX ENPATH MEDICAL, INC. JAMES JENKINS
K063113 10/11/2006 EP-WORKMATE EP MEDSYSTEMS LARRY PICCIANO
K063277 10/31/2006 MAPMATE EP MEDSYSTEMS, INC. LARRY PICCIANO
K063207 10/23/2006 S-SCAN MRI SYSTEM ESAOTE, S.P.A. CARRI GRAHAM
K063050 10/04/2006 CAP PLUS ETEX CORP. FRANCES A FLORENCE
K063192 10/20/2006 HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIP ETHICON ENDO-SURGERY, LLC ELIZABETH MILLER, MST
K063204 10/23/2006 SPIDERFX EMBOLIC PROTECTION DEVICE EV3 INC David Worrell
K063213 10/23/2006 EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES EVER LIGHT PLASTIC PRODUCTS CO., LTD. KATHY LIU
K063214 10/23/2006 EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES EVER LIGHT PLASTIC PRODUCTS CO., LTD. KATHY LIU
K063215 10/23/2006 EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES EVER LIGHT PLASTIC PRODUCTS CO., LTD. KATHY LIU
K063154 10/16/2006 FACIAL RECONSTRUCTIVE MESH (FRM) EVERA MEDICAL, INC. RANDY KESTEN
K063279 10/31/2006 NOVATION SPLINED RDD FEMORAL STEMS EXACTECH, INC. MARITZA ELIAS
K063111 10/11/2006 FINOMETER MODEL-2 WITH ACCESSORIES FINAPRES MEDICAL SYSTEMS BV GERAD J LANGEWOUTERS
K063036 10/03/2006 OPUS HC482 DIRECT NASAL MASK FISHER & PAYKEL HEALTHCARE, LTD. JAYANTI KARANDIKAR
K063183 10/19/2006 PRISMA M10 PRE SET GAMBRO RENAL PRODUCTS, INC. JEFFREY R SHIDEMAN
K063006 10/02/2006 GE LOGIQ WORKS GENERAL ELECTRIC CO. ALLEN SCHUH
K063121 10/12/2006 PORTABLE X-RAY SYSTEM, MODEL PORT-X II GENORAY CO., LTD. CHARLIE MACK
K063224 10/24/2006 GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL GENTRIS CORPORATION DEBORAH N KLOOS
K063042 10/03/2006 CARDIOMEM CM 3000-12BT GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG SID MATHUR
K063162 10/18/2006 GOLDEN LITEWAY GOLDEN TECHNOLOGIES, INC. GENE R KULON
K063046 10/04/2006 NITRILE POWDER FREE EXAMINATION GLOVES (GREEN) HARTALEGA SDN BHD NURUL A KONG
K063191 10/20/2006 HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT HEIDELBERG ENGINEERING GERHARD ZINSER
K063062 10/05/2006 HKBOND 2006 HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K063034 10/03/2006 AIR-FLEX WITH AUTO-DISTRACTION HILL LABORATORIES CO. BRADY ALLER
K063180 10/19/2006 ISECURE SYRINGE CARTRIDGE HOLDER HOSPIRA, INC. DIANE RENNPFERD
K063239 10/26/2006 LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526 HOSPIRA, INC. DIANE RENNPFERD
K062999 10/02/2006 OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN HOSPIRA, INC. DIANE RENNPFERD
K063225 10/24/2006 METAIZEAU NAILING SYSTEM HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K063112 10/11/2006 REVLITE Q-SWITCHED ND:YAG LASER HOYA CONBIO, INC DONNA K TEMPLEMAN
K063268 10/30/2006 CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235 HSINER CO., LTD. TOM SHANKS
K063234 10/25/2006 ON-Q INTRODUCERS I-FLOW CORP. SHANE NOEHRE
K063166 10/18/2006 I.T.S. PELVIC RECONSTRUCTION SYSTEM I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH AL LIPPINCOTT
K063246 10/26/2006 XPLORER 1500 DIGITAL RADIOGRAPHIC SYSTEM WITH STAND IMAGING DYNAMICS COMPANY LTD. SHIRANTHA SAMARAPPULI
K063247 10/26/2006 XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAND IMAGING DYNAMICS COMPANY LTD. SHIRANTHA SAMARAPPULI
K063039 10/03/2006 XPLORER 2200 DIGITAL RADIOGRAPHIC SYSTEM IMAGING DYNAMICS COMPANY LTD. SHIRANTHA SAMARAPPULI
K063203 10/23/2006 ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4) IMC-HEARTWAY, LLC MICHAEL CHEN
K063286 10/31/2006 OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE IMPLANT INNOVATIONS, INC. JACQUELYN A HUGHES
K063238 10/26/2006 ULTRACLIP II WING AND ULTRACLIP II COIL INRAD MELISSA LALOMIA
K063020 10/02/2006 INTAI BONE PLATE AND BONE SCREW SYSTEM; INTAI DHS/DCS PLATE SYSTEM INTAI TECHNOLOGY INC. PIEWEN LIN
K063124 10/13/2006 INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS INTEGRA LIFESCIENCES CORP. DIANA M BORDON
K063230 10/25/2006 INTEGRA RADIONICS IMAGEFUSION 3 INTEGRA RADIONICS, INC. KEVIN J O'CONNELL
K062992 10/02/2006 SPINAL SPHERES INTERBODY INNOVATIONS LLP J D WEBB
K063220 10/24/2006 DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000 INTUITIVE SURGICAL, INC. MICHAEL H YRAMATEGUI
K063228 10/25/2006 SURFACE COAT KURARAY AMERICA, INC. KOJI NISHIDA
K063071 10/06/2006 DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B KYPHON, INC. CINDY DOMECUS
K063031 10/03/2006 PRISM VIEW, MODEL KYRON CLINICAL IMAGING, INC. JAMES L REUSS, PH.D.
K063001 10/02/2006 SLIM EVOLUTION FAMILY OF CO2 LASERS AND DELIVERY DEVICE ACCESSORIES LASERING S.R.L. ALLEN R HOWES
K063161 10/17/2006 SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL LEONHARD LANG GMBH ELAINE DUNCAN
K063024 10/02/2006 LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. MARIE LIN
K063025 10/02/2006 LINA POWERBLADE, MODEL 5005,5005-E,5005-C,5005-150,5000-C-150,5005-E-C-150,5005-420,5005-C-420,5005-E-420,5005-E-C-420, LINA MEDICAL APS WALT BRITTLE
K063140 10/16/2006 RAINBOW ADHESIVE CO-OXIMETRY SENSORS MASIMO CORPORATION JAMES J CRONIN
K063103 10/10/2006 AG-EDGE, MODEL 91200 MEDEL S.P.A. TERRENCE O'BRIEN
K063047 10/04/2006 MEDHOT MTI 2000 THERMAL IMAGING SYSTEM MEDHOT THERMAL IMAGING, INC. SID MATHUR
K063249 10/26/2006 BEAMAX MEDIC SHARPLIGHT LTD. DAN LAOR
K063063 10/06/2006 SILVACIDE SKIN & WOUND MOISTURIZING SOLUTION MEDICAL MOLECULAR THERAPUETICS LLC ARTHUR B FLICK
K063069 10/06/2006 SILVAKLENZ SKIN AND WOUND CLENSER SOLUTION MEDICAL MOLECULAR THERAPUETICS LLC ARTHUR B FLICK
K063175 10/19/2006 IPUP 200 (INTELLIGENT PRESSURE ULCER PREVENTION) MEDICAL TECHNOLOGY SYSTEMS, INC. ELLIS K NAM
K063090 10/10/2006 MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY MEDRAD, INC. TROY A JACK
K063119 10/12/2006 LIFEPAK 20 DEFIBRILLATOR/ MONITOR MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. MICHELLE ACKERMANN
K063210 10/23/2006 ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488 MEDTRONIC INC., CARDIAC RHYTHM MANAGEMENT MICHELLE NIVALA
K063117 10/12/2006 MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX MEDTRONIC NEUROSURGERY JEFFERY HENDERSON
K063248 10/26/2006 ARCUATE VERTEBRAL AUGMENTATION SYSTEM MEDTRONIC SOFAMOR DANEK CHRISTINE SCIFERT
K063100 10/10/2006 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, TRANSLATIONAL PLATE MEDTRONIC SOFAMOR DANEK, INC. CHRISTINE SCIFERT
K063083 10/10/2006 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. EDWARD S CHIN
K063216 10/24/2006 RESCUE INTERNAL IMPLANT SYSTEM MEGAGEN CO., LTD. SUN HAHM
K063148 10/16/2006 SOCK IT! ORAL PAIN GEL MERLIN GROUP DBA MCMERLIN DENTAL COMPANY EILEEN VENNUM
K063157 10/17/2006 MERRIES K-PHATE BONE GRAFT SUBSTITUTE MERRIES INTERNATIONAL INC. SOPHIA LEE
K063170 10/18/2006 TENDER FIBER MICERIUM S.P.A. EUGENIO MICELI
K063043 10/03/2006 SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP MODERN HEALTHCARE CORP. JEN KE-MIN
K062847 10/04/2006 BIOGEL ECLIPSE INDICATOR UNDERGLOVE MOLNLYCKE HEALTH CARE US, LLC STEVEN DOWDLEY
K063044 10/04/2006 CARDIOBELT ELECTRODE BELT MONEBO TECHNOLOGIES, INC. DALE J MISCZYNSKI
K063135 10/16/2006 SONIC-STIM NAIMCO, INC. JULIE CREASMAN
K063066 10/06/2006 AXIS-V MONOCHROME 5 MP DISPLAY NATIONAL DISPLAY SYSTEMS RON HANSON
K063012 10/02/2006 NCONTACT COAGULATION SYSTEM KIT, MODEL CSK NCONTACT SURGICAL, INC. JANE RICUPERO
K063095 10/10/2006 HUMERUS LOCKING PLATING SYSTEM NEWCLIP TECHNICS J.D. WEBB
K063221 10/24/2006 MEDWEB ADVANCED 3D WEB PACS NEXSYS ELECTRONICS, INC. GARY J ALLSEBROOK
K063190 10/20/2006 SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC NOBLE FIBER TECHNOLOGIES, INC. PATRICIA DAVIDSON
K063274 10/30/2006 ACCULOC BREAST LOCALIZATION SYSTEM NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC. LEE MYERS
K063153 10/16/2006 NOVAPACS NOVARAD CORP. PAUL SHUMWAY
K063026 10/02/2006 OK METER BLOOD GLUCOSE MONITORING SYSTEM OK BIOTECH CO., LTD. Ke-Min Jen
K063259 10/30/2006 OLYMPUS CAPSULE ENDOSCOPE SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K063141 10/16/2006 OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBER OMNIGUIDE, INC. DOUGLAS W WOODRUFF
K063177 10/19/2006 RAPID STRAND RX ONCURA INC. SUBHASH PATEL
K063144 10/16/2006 VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM Ortho-Clinical Diagnostics, Inc. SARAH C PARSONS
K063164 10/18/2006 VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV Ortho-Clinical Diagnostics, Inc. MICHAEL M BYRNE
K063143 10/16/2006 VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS Ortho-Clinical Diagnostics, Inc. CHARLOTTE BAKER
K063033 10/03/2006 MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT ORTHOPEDIC SCIENCES, INC JAMES BRANNON M.D.
K063233 10/25/2006 DELTACUT (APPARATUS AND CANNULA) PAJUNK GMBH MEDIZINTECHNOLOGIE CHRISTIAN QUASS
K063003 10/02/2006 AURORA PARKELL, INC. DANIEL R SCHECHTER
K063137 10/16/2006 PHARMASMART PUBLIC USE BLOOD PRESSURE MONITOR, MODELS PS-1000/PS-1500/PS-2000 PHARMASMART, INC. IAN GORDON
K063167 10/18/2006 EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG) PHASEIN AB DAVID WEISSBURG
K063278 10/31/2006 PORTLAND COBALT CHROME FEMORAL HEAD PORTLAND ORTHOPAEDICS LIMITED ELAINE DUNCAN
K063075 10/06/2006 NATURAL ORIFICE LINEAR CUTTER DIGITAL LOADING UNITS POWER MEDICAL INTERVENTIONS, INC. BARBARA J WHITMAN
K063009 10/02/2006 FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES) PRAESIDIA S.R.L. GEORGE HAAR
K063096 10/10/2006 PRECISION OXYGEN MONITOR PRECISION MEDICAL, INC. JAMES PARKER
K063202 10/20/2006 PRODERMA LIQUID BANDAGE PROCUREMENT TECHNOLOGY SYSTEMS, LLC WILLIAM J GRISWOLD
K063159 10/17/2006 STERILOX LIQUID CHEMICAL STERILANT SYSTEM PURICORE, INC. HOWARD MANN
K063185 10/20/2006 RII INFRARED EAR THERMOMETER, MODELS TH5XY SERIES RADIANT INNOVATION, INC. FRANK LIN
K063229 10/25/2006 REST ASSURED NITE PROTECTOR RANIR LLC CHRISTOPHER PREDKO
K063038 10/02/2006 FRAXEL III SR LASER SYSTEM AND ACCESSORIES RELIANT TECHNOLOGIES, INC. HEATHER TANNER MACFALLS
K063011 10/02/2006 MIRAGE LIBERTY FULL FACE MASK RESMED LTD. DAVID D'CRUZ
K063122 10/12/2006 MIRAGE QUATTRO FULL FACE MASK RESMED LTD. DAVID D'CRUZ
K063093 10/10/2006 SECTRA WORKSTATION, VERSION 11.1 SECTRA IMTEC AB CARL ALLETTO
K063283 10/30/2006 DEFINIUM 5000 X-RAY SYSTEM SEDECAL S.A. DANIEL KAMM
K063110 10/11/2006 CST61 HIGH SPEED TURBINE HANDPIECE SHANGHAI DENTAL INSTRUMENT FACTORY JAY MANSOUR
K063055 10/05/2006 VS-800 VITAL SIGNS MONITOR SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN D GOLDSTEIN-FALK
K063138 10/16/2006 MODIFICATION TO ACUSON ANTARES ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. SHEILA W PICKERING PH.D.
K063085 10/10/2006 MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. SHEILA W PICKERING
K063877 10/12/2006 SYNGO LUNG CAD SIEMENS MEDICAL SOLUTIONS USA, INC. MORTEZA MINAEE
K063160 10/17/2006 ALLERGEAZE PATCH TEST CHAMBERS SMART PRACTICE KIM SULLIVAN
K063467 10/24/2006 SMITH & NEPHEW RF CANNULAE SMITH & NEPHEW, INC. MINNIE MILDWOFF
K063253 10/27/2006 RCHIVE PACS SOBHA RENAISSANCE INFORMATION TECHNOLOGY PVT LTD CARL ALLETTO
K063126 10/13/2006 DANA DIABECARE IIS SOOIL DEVELOPMENT CO., LTD. JEREMY KIM
K063255 10/27/2006 D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED SORIN GROUP ITALIA S.R.L BARRY SALL
K063136 10/16/2006 NEEDLELESS SLING SPECIALITIES REMEEX INTERNATIONAL, S.L. JEFFREY R SHIDEMAN
K063010 10/02/2006 REGEN BIOCEMENT STEINER LABORATORIES GREGORY GENE STEINER
K063211 10/23/2006 PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT STELKAST COMPANY DAVID J STUMPO
K063267 10/30/2006 ISITE PACS, V 4. X STENTOR INC., A PHILIPS MEDICAL SYSTEMS CO. DEANA WISEMAN
K063218 10/24/2006 E-CHECK (XE) Streck KERRIE OETTER
K063005 10/02/2006 STRYKER T6 HOODS AND TOGAS STRYKER INSTRUMENTS PAULETTE D JOHNSON
K063021 10/02/2006 PROFILER 2 SUN NUCLEAR CORP. NOEL DOWNEY
K063097 10/10/2006 ENSEAL PTC TISSUE SEALING DEVICE SURGRX, INC. LINDA OLESON
K063116 10/12/2006 DEMETRON A.2 SYBRON DENTAL SPECIALTIES COLLEEN BOSWELL
K063181 10/19/2006 SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM SYNTHES (USA) DEBORAH L JACKSON
K063049 10/04/2006 SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM SYNTHES (USA) DEBORAH L JACKSON
K063158 10/17/2006 SYNTHES ANTEGRA SYSTEM SYNTHES SPINE CO.LP SUSAN LEWANDOWSKI
K063149 10/16/2006 ORTHODONTIC TAADS (TEMPORARY ANATOMICAL ANCHOR DEVICE SYSTEM) T.O.A.D.S., LLC. DAVID BAUGHMAN
K063212 10/23/2006 CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM TaiDoc Technology Corporation PI-SHIOU LI
K063275 10/30/2006 DISTAL CLAVICULAR FRAGMENT IMMOBILIZATION PLATE LEFT, MODEL 1810-116_126-03 (05,07) RIGHT 1811-116_126-03 (05,07) TERRAY CORP. STEVEN WILLIS
K063131 10/13/2006 CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS THERMO ELECTRON OY PAIVI SORMUNEN
K063150 10/16/2006 COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL THERMO ELECTRON OY PAIVI SORMUNEN
K063209 10/23/2006 HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL THERMO ELECTRON OY PAIVI SORMUNEN
K063145 10/16/2006 PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS THERMO ELECTRON OY PAIVI SORMUNEN
K063086 10/10/2006 TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS THERMO ELECTRON OY PAIVI SORMUNEN
K063081 10/10/2006 AEQUALIS SHOULDER SYSTEM TORNIER Mireille Lemery
K063241 10/26/2006 CSTC-002A, EXTENDED FIELD OF VIEW SOFTWARE OPTION TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K063184 10/20/2006 MODEL CVV-001A VESSEL VIEW SOFTWARE OPTION TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K063189 10/20/2006 TSX-301A, AQUILION ONE CT SYSTEM TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K063130 10/13/2006 APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K063200 10/20/2006 20.1-INCH (51CM) COLOR LCD MONITOR CDL2010A (CCL204) TOTOKU ELECTRIC CO., LTD MIKIO HASEGAWA
K063197 10/20/2006 21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2118A (ME355I2) TOTOKU ELECTRIC CO., LTD MIKIO HASEGAWA
K063199 10/20/2006 21.3-INCH (54CM) COLOR LCD MONITOR CDL2120A (CCL252I2) TOTOKU ELECTRIC CO., LTD MIKIO HASEGAWA
K063198 10/20/2006 21.3-INCH (54CM) MONOCHROME LCD MONITOR MDL2121A (ME253I2) TOTOKU ELECTRIC CO., LTD MIKIO HASEGAWA
K063048 10/04/2006 TRANS-CATHETER EXTRACTOR TRAN PA-C, INC. TOM TRAN
K063091 10/10/2006 PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0601 TYRX PHARMA, INC. MASON W DIAMOND
K063195 10/20/2006 LIGASURE ADVANCE LAPAROSCOPIC SEALER/DIVIDER WITH DISSECTING ELECTRODE, MODELS LF5034 AND LF5044 VALLEYLAB CHARLES COPPERBERG
K063270 10/30/2006 RPM RESPIRATORY GATING SYSTEM VARIAN MEDICAL SYSTEMS, INC. VY TRAN
K063061 10/05/2006 CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 VIASYS MEDSYSTEMS STEPHANIE WASIELEWSKI
K063142 10/16/2006 MANUAL PD-IO; POWERED PD-IO VIDACARE CORPORATION GRACE HOLLAND
K063262 10/30/2006 AMX4-50 AND AMX4-31 MOBILE DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS VIRTUAL IMAGING DANIEL KAMM
K063052 10/04/2006 LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES WALTER LORENZ SURGICAL, INC. KIM REED
K063007 10/02/2006 POWERTOME PERIOTOME WESTPORT MEDICAL, INC. RALPH WELLS
K063128 10/13/2006 ADVANCE SPIKED POROUS TIBIAL BASE WRIGHT MEDICAL TECHNOLOGY, INC. THERESA LEISTER
K063008 10/02/2006 HEALTH CHECK KIOSK XPEREX CORPORATION GEORGE MYERS
K063186 10/20/2006 ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM ZEUS SCIENTIFIC, INC. EWA NADOLCZAK
K063251 10/27/2006 ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY ZIMMER, INC. DALENE T BINKLEY


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact