FDA 510(k) Decisions During September, 2006  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K062505 09/26/2006 NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES ABBOTT SPINE, INC. NOAH BARTSCH
K062458 09/15/2006 ETHMOID SINUS SPACER ACCLARENT, INC. DEBBIE COGAN
K062514 09/28/2006 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM ACCURAY INCORPORATED ANNE SCHLAGENHAFT
K062059 09/06/2006 AIE REGION OF INTEREST IMAGE ENHANCEMENT ADVANCED IMAGE ENHANCEMENT JILLIAN M REED
K062406 09/15/2006 AESCULAP NEURO PATTIES AESCULAP, INC. LISA M BOYLE
K060762 09/14/2006 AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM AESCULAP, INC. MATTHEW M HULL
K062048 09/07/2006 AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM AESTHERA CORPORATION ANNE WORDEN
K062223 09/01/2006 AGFA MODEL CR30-X AGFA CORPORATION PATRICK J LYNCH
K062390 09/18/2006 CRYSTALVIEW R200 ALARA, INC. DIANE M KING
K062504 09/05/2006 CERAMAX ALPHADENT CO., LTD. NOH HAK
K052544 09/29/2006 PULSE OXIMETER ADAPTER CABLES AMERICAN I.V. PRODUCTS, INC. GREGORY FALK
K061850 09/29/2006 MINI-YAG LASER AMERICAN LASERS, INC. DAVID K QUON
K062307 09/01/2006 XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS ANULEX TECHNOLOGIES, INC TIMOTHY MILLER
K061763 09/19/2006 ARC SURGICAL BIOTRAK SCREW ARC SURGICAL LLC. ED BOEHMER
K062365 09/29/2006 ARTHREX ASPIRATE KIT ARTHREX, INC. SALLY FOUST
K062679 09/27/2006 ARTHREX CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES ARTHREX, INC. NANCY HOFT
K062747 09/29/2006 ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM ARTHREX, INC. ANN WATERHOUSE
K061776 09/25/2006 ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE ARTHROTEK, INC. PATRICIA SANDBORN BERES
K061759 09/05/2006 REPROCESSED EXTERNAL FIXATION DEVICE ASCENT HEALTHCARE SOLUTIONS AMANDA BABCOCK
K060787 09/27/2006 TATTOOSTAR FAMILY ASCLEPION LASER TECHNOLOGIES GMBH REINHARD THIEME
K061856 09/28/2006 V-2200 INFANT INCUBATOR ATOM MEDICAL INC MARY STANIEWICZ
K062159 09/05/2006 RB12 SUCTION RECTAL BIOPSY SYSTEM AUS SYSTEMS PTY LTD. IAN P GORDON
K061422 09/25/2006 SURGICAL DRAPES AUSTIN MEDICAL, INC. PAUL DRYDEN
K060182 09/07/2006 TRUMPET VALVE HANDLE WITH 3-METRE TUBING, SINGLE SPIKE, 5MM CANNULA, TRUMPET VALVE HANDLE WITH 3-METRE TUBING, DOUBLE AUSTRALIAN SURGICAL DEVICES MARIO KUNA
K060165 09/01/2006 AXYAFLEX POLYESTER SUTURE AXYA MEDICAL, INC. Howard Schrayer
K061924 09/05/2006 CORONIS 3MP AND MDCG 3120-CB BARCOVIEW LIEVEN DE WANDEL
K061928 09/05/2006 CORONIS COLOR 2MP AND MDCC 2121 BARCOVIEW LIEVEN DE WANDEL
K061927 09/05/2006 CORONIS COLOR 3MP AND MDCC 3120-DL BARCOVIEW LIEVEN DE WANDEL
K062465 09/06/2006 ZYOPTIX XP EPI SEPARATOR SYSTEM BAUSCH & LOMB, INC. NED LUCE
K061515 09/11/2006 RENALSOFT BAXTER HEALTHCARE CORP. DAVID E CURTIN
K062457 09/21/2006 INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES BAXTER HEALTHCARE CORPORATION NANETTE HEDDEN
K062058 09/11/2006 ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080 BAYER HEALTHCARE ROGER SONNENBERG
K062087 09/14/2006 BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 BD Biosciences CARTER NAVARRO
K061190 09/15/2006 ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 BECKMAN COULTER, INC. VALYNDA L MACHEN
K062207 09/13/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (GN) 1-64 UG/ML BECTON, DICKINSON & CO. VICKI L KENNEDY
K062206 09/08/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN (STREP) 0.0625 - 8UG/ML BECTON, DICKINSON & CO. JANINE MATLAK
K061744 09/15/2006 COCHLEA-SCAN / COCHLEA-SCAN PLUS BIO-LOGIC SYSTEMS CORP. NORMAN BRUNNER
K061311 09/22/2006 ALLOGRAN-R BIOCOMPOSITES LTD. SIMON FITZER
K061949 09/25/2006 DOUBLEPLAY SUTURE ANCHOR BIOCOMPOSITES LTD. SIMON FITZER
K062141 09/13/2006 MAMMOPAD RADIOLUCENT CUSHION BIOLUCENT, INC. SHERYL HIGGINS
K061945 09/19/2006 VITEK 2 AST-YS FLUCONAZOLE BIOMERIEUX, INC. Nancy Weaver
K061340 09/25/2006 23 MM SINGLE-PEG PATELLA COMPONENT BIOMET MANUFACTURING, INC. LESTER F PADILLA
K061787 09/21/2006 MAXFORCE TTS SINGLE-USE BALLOON DILATOR BOSTON SCIENTIFIC CORP. WING NG
K061877 09/15/2006 WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM BOSTON SCIENTIFIC CORP. ELENA BICKOFF
K061231 09/01/2006 WELLFLEX BILIARY RX STENT SYSTEM BOSTON SCIENTIFIC CORP. ALLYSON BARFORD
K062594 09/20/2006 MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM Boston Scientific Corporation SARAH PETERSON
K061884 09/06/2006 BOVIE ICON GI ELECTROSURGICAL GENERATOR, MODEL GI 120 BOVIE MEDICAL RICHARD KOZLOFF
K061764 09/06/2006 MEDIBYTE, MODEL MP8 BRAEBON MEDICAL CORP. RICHARD A BONATO
K062086 09/20/2006 NAVIVISION BRAINLAB AG RAINER BIRKENBACH
K061394 09/06/2006 SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE) BUSSE HOSPITAL DISPOSABLES, INC. MUHAMAD ANSARI
K062164 09/22/2006 RESOLUTIONMD, VERSION 1.3 CALGARY SCIENTIFIC, INC. PIERRE LEMIRE
K061528 09/22/2006 SELFCHECK GLUCO CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K061932 09/14/2006 BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE CARDIOPULMONARY CORP. JORDAN SCHRECK
K061075 09/01/2006 BOOMERANG WIRE CARDIVA MEDICAL, INC. GLENN FOY
K061960 09/05/2006 FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040 CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K062031 09/27/2006 CHASE CARDIAC ANALYSIS SYSTEM CHASE MEDICAL, LP DAVID M HERNON
K061568 09/29/2006 CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738 Codman & Shurtleff, Inc. JOCELYN RAPOSO
K061967 09/25/2006 SCD GARMENT, MODEL VP530 COMPRESSION THERAPY CONCEPTS, INC. LEN NASS
K052206 09/12/2006 ZEUS MALE CONDOM APPLICATOR CONDAX LLC. ELI J CARTER
K061972 09/18/2006 CONNECT IMAGING PACS CONNECT IMAGING, INC. PHILIP J MANLY
K060623 09/06/2006 SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE COOK IRELAND LTD EMMETT DEVEREUX
K062531 09/22/2006 ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE CORDIS CORP., A JOHNSON & JOHNSON CO. JOAN MARTIN
K060482 09/28/2006 CYTORI CELUTION CELL CONCENTRATION DEVICE CYTORI THERAPEUTICS, INC. KENNETH K KLEINHENZ
K061825 09/06/2006 DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K062316 09/06/2006 DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE DADE BEHRING, INC. LORRAINE H PIESTRAK
K061852 09/22/2006 DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K061802 09/11/2006 DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K062334 09/22/2006 DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130 DADE BEHRING, INC. VICTOR M CARRIO
K061990 09/19/2006 DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K061795 09/11/2006 DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR DADE BEHRING, INC. PAMELA A JUNGA
K062034 09/06/2006 DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410) DADE BEHRING, INC. VICTOR M CARRIO
K062199 09/06/2006 DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430) DADE BEHRING, INC. VICTOR M CARRIO
K062162 09/14/2006 DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510) DADE BEHRING, INC. VICTOR M CARRIO
K062182 09/14/2006 DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 DADE BEHRING, INC. VICTOR M CARRIO
K062585 09/19/2006 MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN DADE BEHRING, INC. SHANNON POPSON
K062290 09/01/2006 MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML) DADE BEHRING, INC. SHANNON POPSON
K062596 09/19/2006 MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID DADE BEHRING, INC. SHANNON POPSON
K052532 09/05/2006 IMAX 9.5 STERILIZERS DENTAL X SRL CYNTHIA J.M. NOLTE
K061658 09/18/2006 SPIRIT, MODEL M, U; DOCPORTMACRO, MODEL M, U, L DENTALL CORP. EDWIN FIRST
K061648 09/11/2006 DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) DEPUY ORTHOPAEDICS, INC. NANCY FRIDDLE
K062654 09/29/2006 DEPUY SIGMA CRUCIATE RETAINING POROCOAT FEMORAL COMPONENTS DEPUY ORTHOPAEDICS, INC. NANCY FRIDDLE
K062196 09/11/2006 SFX SNAP-FIT CROSS CONNECTOR DEPUY SPINE, INC. MARY GRAY
K052536 09/13/2006 ALGICELL AG DERMA SCIENCES CANADA, INC. DELA SHARMINI ATHERAY
K062234 09/11/2006 MODIFICATION TO DIADEXUS PLAC TEST DIADEXUS, INC. ROBERT L WOLFERT
K060333 09/08/2006 DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM DIALYSIS SERVICES, INC. MIKE STERLING
K061797 09/01/2006 SM IMPLANT SYSTEMS DIO DEPARTMENT DSI, INC. DAE KYU CHANG
K062758 09/27/2006 OWL URF-3AP DIROS TECHNOLOGY, INC. GEORGE DARMOS
K062424 09/14/2006 CONFIDENCE EX HIGH VISCOSITY BONE CEMENT DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. JONATHAN S KAHAN
K061864 09/15/2006 DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560 DUKAL CORP. PATRICK J LAMB
K062404 09/08/2006 TRANSEAR BONE CONDUCTION HEARING AID EAR TECHNOLOGY CORP. RICK GILBERT
K062429 09/27/2006 MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH EDWARDS LIFESCIENCES RESEARCH MEDICAL KAREN JONES
K061134 09/01/2006 EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES EFS EBERLE FEINWERKTECHNISCHE SYSTEME GERALD GOIGITZER
K060329 09/11/2006 ENDOFAST RELIANT SYSTEM ENDOGUN MEDICAL SYSTEMS YORAM LEVY
K061597 09/27/2006 EPOC BLOOD ANALYSIS SYSTEM EPOCAL, INC. ROY LAYER
K061992 09/19/2006 EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014 EPS BIO TECHNOLOGY CORP. Y C LEI
K061770 09/25/2006 ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM ETHICON ENDO-SURGERY, INC. TOM BOSTICCO
K062000 09/25/2006 HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCH ETHICON ENDO-SURGERY, INC. CAROL WALSH
K060700 09/08/2006 EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT. EUROIMMUN US LLC KATHRYN KOHL
K061668 09/12/2006 OPTECURE +CCC EXACTECH, INC. MARITZA ELIAS
K060734 09/05/2006 FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE) FRESENIUS MEDICAL CARE NORTH AMERICA JANET C KAY
K062576 09/29/2006 DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES GE HEALTHCARE JOEL KENT
K062393 09/01/2006 GE VANTAGE PET NEURO SOFTWARE GE HEALTHCARE D. DUERSTELER
K061741 09/15/2006 MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM GE HEALTHCARE ALLEN TABOR
K061942 09/29/2006 TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233; WITHOUT FOAM MODEL M1024237 GE HEALTHCARE JOEL C KENT
K062039 09/11/2006 BIOPSY DIGIT-AM GIOTTO USA, LLC Allison Scott
K061735 09/08/2006 INFIBRA, MODEL 1200 GLOBAL DENTAL PRODUCTS, INC. JERRY BARTICK
K062407 09/06/2006 GATEWAY THORACOLUMBAR PLATE SYSTEM GLOBUS MEDICAL, INC. KELLY J BAKER
K062385 09/27/2006 BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES Grace Medical, Inc. JEFF COBB
K061690 09/15/2006 SURGICAL HEADLIGHT GULF MEDICAL FIBEROPTICS MARCELINO AFANADOR
K061611 09/11/2006 BOSWORTH DENTIN RESIN HARRY J. BOSWORTH CO. MILDRED M GOLDSTEIN
K062448 09/20/2006 LYRA ACUPUNCTURE NEEDLES HELIO MEDICAL SUPPLIES, INC. ERIC CHENG
K060765 09/06/2006 HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712 HEMOCUE AB ALLEN WHITE
K061138 09/29/2006 ABX PENTRA 400 : CRP HORIBA ABX TIM LAWTON
K061432 09/11/2006 HOSPIRA ENTERAL FEEDING SET, MODEL 20640 HOSPIRA, INC. DIANE RENNPFERD
K061573 09/19/2006 TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT HOSPIRA, INC. THOMAS KOZMA
K062488 09/19/2006 IQ-SYSTEM PACS SYSTEM IMAGE INFORMATION SYSTEMS, LTD. CARL ALLETTO
K062417 09/15/2006 XPLORER 1100 IMAGING DYNAMICS COMPANY LTD. SHIRANTHA SAMARAPPULI
K062405 09/13/2006 XPLORER 1590 IMAGING DYNAMICS COMPANY LTD. SHIRANTHA SAMARAPPULI
K062586 09/29/2006 XPLORER 1600 PLUS IMAGING DYNAMICS COMPANY LTD. SHIRANTHA SAMARAPPULI
K061979 09/22/2006 MODIFICATION TO MYALLERGY TEST IMMUNETECH CORPORATION NANCY BENSON
K061319 09/29/2006 SPECTRA SYSTEM IMPLANT DIRECT LLC LESLIE TERRY
K061974 09/15/2006 GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K061598 09/22/2006 HEMOSIL HOMOCYSTEINE AND CONTROLS INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K062431 09/01/2006 HEMOSIL LIQUID ANTITHROMBIN INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K062430 09/01/2006 HEMOSIL PROTEIN C INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K062599 09/27/2006 MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS INTEGRA LIFESCIENCES CORPORATION DARLENE M WELSH
K053540 09/06/2006 INTERMEDIC DIODE LASER FAMILY 810NM AND 980NM (AND THE DELIVERY ACCESSORIES THAT ARE USED WITH THEM TO DELIVER LASER ENE INTERMEDIC ARFRAN, S.A. KLAUS SIVEC
K062402 09/21/2006 EASYSTAND EVOLV INVACARE CORP. RONALD CLINES
K061874 09/05/2006 INVACARE'S TWILIGHT II NASAL MASKS INVACARE CORP. JANICE BROWNLEE
K062252 09/27/2006 MOLTENO3 IOP, INC. JASON MALECKA
K061781 09/05/2006 MULTILINK SPRINT IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K060882 09/01/2006 EXCEL BOND DC, MODEL 28-200100 J. MORITA USA, INC. HOWARD ROWE
K061664 09/08/2006 FORMCORE DC, MODEL 28-700100 J. MORITA USA, INC. TAKESHI INOUE
K062462 09/29/2006 NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L JAWON MEDICAL CO., LTD. W. H PARK
K062522 09/08/2006 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES JIANGSU JAYSUN GLOVE CO., LTD. CHU XIAOAN
K062401 09/28/2006 MODIFICATION TO LUCAS JOLIFE AB HOWARD M HOLSTEIN
K060917 09/22/2006 KENSEY NASH BONE VOID FILLER KENSEY NASH CORPORATION JENNIFER J BOSLEY
K062275 09/20/2006 RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135 KERBEROS PROXIMAL SOLUTIONS, INC. TOM MASON
K052870 09/29/2006 INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 KIMBERLY-CLARK CORP. TIERNEY NORSTED
K051165 09/07/2006 KLS MARTIN STERNAL TALON KLS-MARTIN L.P. JENNIJER DAMATO
K061507 09/21/2006 SONICWELD RX ENDOBROW FIXATION KLS-MARTIN L.P. JENNIFER DAMATO
K062356 09/27/2006 KOWA NONMYD ALPHA-D KOWA CO. LTD. SATOHIKO TAKANASHI
K061906 09/28/2006 CLEARFIL CERAMIC PRIMER KURARAY MEDICAL INC. KOJI NISHIDA
K062382 09/27/2006 CLEARFIL DC BOND KURARAY MEDICAL INC. KOJI NISHIDA
K062410 09/26/2006 CLEARFIL ESTHETIC CEMENT & DC BOND KURARAY MEDICAL INC. KOJI NISHIDA
K061860 09/18/2006 CLEARFIL MAJESTY ESTHETIC KURARAY MEDICAL INC. KOJI NISHIDA
K060153 09/29/2006 ACUMED LASER, MODEL 1000 LASER THERA, LLC SHELLY HENRY
K061871 09/20/2006 LEICA MODEL FL800 LEICA MICROSYSTEMS, INC. MAX STURGIS
K061023 09/20/2006 THERMOSUIT SYSTEM LIFE RECOVERY SYSTEMS HD, LLC PAUL A TENTHOREY
K061364 09/05/2006 PILOT POSTERIOR LUMBAR PLATING SYSTEM LIFE SPINE ERIN MALLOY
K061966 09/27/2006 LITETOUCH DENTAL LASER SYSTEM LIGHT INSTRUMENT LTD YORAM LEVY
K062242 09/29/2006 METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. MARIE LIN
K062483 09/08/2006 MINI POWER CHAIR, MODEL MN 5000 LINE IND.(SHANGHAI) CO., LTD. SID MATHUR
K061742 09/06/2006 URYXXON RELAX URINE ANALYZER MACHEREY-NAGEL GMBH & CO., KG. ARMOND WELCH
K060847 09/26/2006 MAGSTIM 200-2 MAGSTIM COMPANY US, LLC. REZA JALINOUS
K062501 09/29/2006 VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901 MAINE STANDARDS CO. HOLLY CRESSMAN
K061473 09/21/2006 SURGI-WRAP MAST BIORESORBABLE SHEET MAST BIOSURGERY USA INC. KENNETH K KLEINHENZ
K061502 09/15/2006 MEDIC4ALL TELEMEDICINE SYSTEM VMS-01 MEDIC4ALL (ISRAEL) LTD. JONATHAN S KAHAN
K062229 09/11/2006 CTC WORKSTATION, MODEL 2200 MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. JAMES M BENSON
K061731 09/06/2006 MEDGRAPHICS ULTIMA SYSTEM MEDICAL GRAPHICS CORP. LYNN BROSIOUS
K062611 09/20/2006 IGUIDE SYSTEM MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA MICHAEL WOLFF
K062639 09/21/2006 MODIFICATION TO HEXAPOD RT COUCH TOP MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA MICHAEL WOLFF
K061339 09/19/2006 HIERSPEC SPECULUM MEDICAL PRODUCTS DIV. THOMAS W COPELAND
K062119 09/22/2006 HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100 MEDICAL PRODUCTS MFG., LLC ROSINA ROBINSON
K060681 09/15/2006 MEDTRONIC PS MEDICAL STRATA TYPE VALUE MEDTRONIC NEUROSURGERY JEFFREY HENDERSON
K062348 09/08/2006 TIMESH SELF DRILLING SCREW MEDTRONIC NEUROSURGERY JEFFREY HENDERSON
K062606 09/25/2006 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK EDWARD S CHIN
K061635 09/05/2006 MSD BIPOLAR FORCEPS MEDTRONIC SOFAMOR DANEK RICHARD W TREHARNE
K062427 09/12/2006 VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK EDWARD CHIN
K061591 09/08/2006 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K062133 09/26/2006 MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SPINAL AND BIOLOGICS DIV LEE GRANT
K062420 09/08/2006 5F SHERPA ACTIVE NX GUIDE CATHETER MEDTRONIC VASCULAR MARK PUOPOLO
K061958 09/05/2006 MEDTRONIC EXPORT XT CATHETER MEDTRONIC VASCULAR KAREN A BROZOWSKI
K061557 09/15/2006 FUSION MEDWAVE, INC. DONNA R LUNAK
K061809 09/13/2006 ARTEGRAL IMCROWN MERZ DENTAL GMBH RICHARD G HUNTER
K061471 09/11/2006 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MC1-PC MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K061092 09/13/2006 BAXTER DUPLOSPRAY MIS APPLICATOR MICROMEDICS, INC. THOMAS LOPAC
K062163 09/22/2006 MIMVIEWER MIMVISTA CORP. PETER SIMMELINK
K052492 09/05/2006 AIRNERGY+STREAM NATURAL ENERGY SOLUTIONS AG MARTINA GUNDEROTH
K062451 09/28/2006 NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM NEUSOFT MEDICAL SYSTEMS CO., LTD. TIAN YANFANG
K062210 09/25/2006 COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160 NEW STAR LASERS, INC. DONALD V JOHNSON
K061618 09/25/2006 COOLTOUCH, MODEL CTEV NEW STAR LASERS, INC. DONALD V JOHNSON
K060644 09/18/2006 AHMED GLAUCOMA VALVE, MODEL M4 NEW WORLD MEDICAL, INC. A. MATEEN AHMED
K061768 09/28/2006 MP-1 MICROPERIMETER NIDEK TECHNOLOGIES SRL ALDO COCCHIGLIA
K062020 09/05/2006 LIFESOUND ESOPHAGEAL STETHOSCOPE NOVAMED, LLC PAUL DRYDEN
K062317 09/01/2006 MODIFICATION TO NUVASIVE SPHERX II SYSTEM NUVASIVE, INC. LAETITIA COUSIN
K062610 09/28/2006 CARE-E-VAC 3 OHIO MEDICAL CORPORATION HOBY CHAE
K062049 09/22/2006 EVIS EXERA II 180 SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K062423 09/21/2006 OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM OMNIGUIDE, INC. DOUGLAS W WOODRUFF
K061524 09/26/2006 ISS INTEGRATED SPINE SYSTEM ORTHO DEVELOPMENT CORP. WILLIAM J GRIFFIN
K060770 09/15/2006 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS Ortho-Clinical Diagnostics, Inc. SARAH PARSONS
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