FDA 510(k) Decisions During November, 2006  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K062493 11/17/2006 LAVA SOFTWARE 3M ESPE AG DENTAL PRODUCTS SABINE KRISCHER
K062855 11/22/2006 CALCIUM ABBOTT LABORATORIES LINDA MORRIS
K063173 11/03/2006 MODIFICATION TO SILVER ALGINATE II WOUND DRESSING ADVANCED MEDICAL SOLUTIONS LIMITED GRAHAME SOMERVILLE
K062135 11/07/2006 ART SHIELDED BREAST APPLICATOR ADVANCED RADIATION THERAPY, LLC RAYMOND J BRICAULT
K062510 11/17/2006 AESCULAP STERILCONTAINER SYSTEM AESCULAP MATTHEW M HULL
K062413 11/21/2006 AESCULAP PNEUMATIC KERRISON AESCULAP, INC. KATHY A RACOSKY
K062684 11/22/2006 EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD AESCULAP, INC. KATHY A RACOSKY
K062434 11/13/2006 ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528 AGAMATRIX CONNIE HERTEL
K063421 11/22/2006 DX-SI AGFA CORP. JEFFERY A JEDLICKA
K062930 11/08/2006 LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM ALCON RESEARCH, LTD. JANET G JOHNSON
K062212 11/21/2006 SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S ANACAPA TECHNOLOGIES, INC. ILA DOSHI
K062466 11/29/2006 ARTHREX INTERFERENCE SCREW ARTHREX, INC. ANN WATERHOUSE
K061601 11/17/2006 ASAHI PRECIOUS GUIDE CATHETER ASAHI INTECC CO., LTD. YOSHI TERAI
K062186 11/09/2006 ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J ASAHI INTECC CO., LTD. YOSHI TERAI
K062467 11/22/2006 AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10 AXIS-SHIELD DIAGNOSTICS, LTD. ERICA CONWAY
K061639 11/01/2006 ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON AXON SYSTEMS, INC. HOWARD BAILIN
K063280 11/17/2006 INJEKT SYRINGE B. BRAUN MEDICAL, INC. CHRISTINE FORD
K062715 11/03/2006 SYNTHETIC VINYL PATIENT EXAM GLOVES POWDER-FREE, YELLOW BAODING GUANZHONG GLOVE CO., LTD. MARY A DOUCETTE
K062131 11/17/2006 NIO 5MP-M-21" (NIO 5MP MAMMO); MDNG-5121 BB BARCOVIEW LIEVEN DE WANDEL
K062441 11/14/2006 BARRX HALO COAGULATION SYSTEM; GENERATOR, MODEL 90-9000; OUTPUT CABLE, MODEL 90-9010; FOOTSWITCH, MODEL 90-9020 BARRX MEDICAL, INCORPORATED JONATHAN S KAHAN
K062723 11/09/2006 HALO90 COAGULATION CATHETER BARRX MEDICAL, INCORPORATED VIORICA FILIMON
K062347 11/22/2006 ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM BAYER HEALTHCARE, LLC MARC HENN
K062944 11/15/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (GN) 0.5-64UG/ML BECTON, DICKINSON & CO. JANINE MATLAK
K062945 11/21/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERTAPENEM (GN) 0.25-32 UG/ML BECTON, DICKINSON & CO. VICKI L KENNEDY
K062044 11/21/2006 THE 5.0 X 6.0MM DENTAL IMPLANT BICON, INC. VINCENT J MORGAN
K062109 11/09/2006 BINAXNOW INFLUENZA A & B TEST BINAX, INC. ANGELA DRYSDALE
K061567 11/22/2006 BIOHORIZONS CERAMIC ABUTMENT BIOHORIZONS IMPLANT SYSTEMS, INC. WINSTON GREER
K061794 11/21/2006 FIDIS TM THYRO, MODEL MX002 BIOMEDICAL DIAGNOSTICS (BMD) SA CHRISTELLE COURIVAUD
K062980 11/22/2006 ACTIVASCREW BIORETEC LTD MARI RUOTSALAINEN
K052742 11/07/2006 HEPASPHERE MICROSPHERES BIOSPHERE MEDICAL, INC. ROSINA ROBINSON
K063060 11/29/2006 BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP BLUESHINE SRL ALICE NOVELLI
K063312 11/30/2006 MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942 BOSTON SCIENTIFIC CORP. ROBERT Z PHILLIPS
K063178 11/21/2006 BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 1175105, 1175106 C.R. BARD, INC. STEPHANIE BAKER
K063240 11/21/2006 SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR C.R. BARD, INC. LYNN M KIRCHOFF
K061705 11/21/2006 CADWELL EASYNET NASAL PRESSURE MODULE CADWELL LABORATORIES, INC. CHRIS BOLKAN
K062886 11/06/2006 ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019 CAO GROUP, INC. ROBERT K LARSEN
K062619 11/14/2006 DENLASER 800 PLUS CAO GROUP, INC. ROBERT K LARSEN
K063193 11/21/2006 MODIFICATION TO BIOMARC TISSUE MARKER CARBON MEDICAL TECHNOLOGIES, INC. ROBERT W JOHNSON
K053524 11/16/2006 C-PORT DISTAL ANASTOMOSIS SYSTEM CARDICA, INC. DAVID CASAL
K063288 11/28/2006 SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X CARDINAL HEALTH 303, INC. STACY L LEWIS
K062340 11/30/2006 CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM CARDIO-OPTICS, INC. LARRY BLANKENSHIP
K063222 11/14/2006 CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004 CARDIONET, INC JACK GAIKWAD
K062400 11/16/2006 IMPRESSIX, COLORCHANGE ALGINATE CAVEX HOLLAND B.V. RICHARD WOORTMAN
K062487 11/17/2006 APERFIX FEMORAL IMPLANT WITH INSERTER CAYENNE MEDICAL, INC. FLOYD LARSON
K063289 11/16/2006 2MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-2NC CHI LIN TECHNOLOGY CO., LTD. JUDY LIN
K063266 11/09/2006 3MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-3NC CHI LIN TECHNOLOGY CO., LTD. JUDY LIN
K063291 11/21/2006 INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22 CHOICE SMART HEALTH CARE CO. LTD. JANICE MA
K062262 11/14/2006 CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS CIBA VISION CORPORATION ALICIA M PLESNARSKI
K063079 11/07/2006 I-STOP TRANS OBTURATOR MALE SLING CL MEDICAL VINCENT GORIA
K062593 11/22/2006 CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET COMPASS BIOSCIENCE CARTER GRANDJEAN
K061814 11/30/2006 VASOPRESS DVT SYSTEM, MODEL VP500D COMPRESSION THERAPY CONCEPTS, INC. LEONARD NASS
K062548 11/01/2006 MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES CONTAMAC LTD. MARTIN DALSING
K063252 11/14/2006 ATB ADVANCED PTA DILATATION CATHETER COOK, INC. KAREN BRADBURN
K061948 11/22/2006 PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS COOPERVISION, INC. LISA HAHN
K060987 11/02/2006 OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31 CP MEDICAL BETSY CORTELLONI
K061892 11/22/2006 PROPATCH SOFT TISSUE REPAIR MATRIX CRYOLIFE, INC. JOHN D FERROS
K063102 11/09/2006 MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML) DADE BEHRING, INC. SHANNON POPSON
K063099 11/01/2006 MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML) DADE BEHRING, INC. MAY MORISHIMA
K063101 11/01/2006 MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML DADE BEHRING, INC. MAUREEN MENDE
K063299 11/27/2006 MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN DADE BEHRING, INC. MAY MORISHIMA
K062938 11/20/2006 MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH NITROFURANTOIN (2 - 256 UG/ML DADE BEHRING, INC. ROBERT EUSEBIO
K062754 11/02/2006 GAS MODULE SE, MODEL 0998-00-0481-02 DATASCOPE CORP. KATHLEEN KRAMER
K062469 11/03/2006 VOYAGER 12 DEL MAR REYNOLDS MEDICAL, LTD. GEORGE MYERS
K063188 11/30/2006 DEL-IMS DEL MEDICAL IMAGING CORP. WILLIAM J ENGEL
K062733 11/09/2006 TOMAS PIN SD 6, 8, AND 10 MM DENTAURUM CHARLES R BELL
K062828 11/27/2006 MOUTHGUARD AND ALIGNER MATERIALS DENTSPLY INTL., INC. HELEN LEWIS
K063273 11/22/2006 PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR DEPUY MILTEK, A JOHNSON & JOHNSON CO. KRISTINE CHRISTO
K062748 11/30/2006 MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD DEPUY ORTHOPAEDICS, INC. ANNE M SCHULER
K062174 11/02/2006 MODIFICATION TO EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. MARY GRAY
K063156 11/22/2006 MODIFICATION TO EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. CHRISTOPHER KLACZYK
K061101 11/20/2006 D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT DIAGNOSTIC HYBRIDS, INC. GAIL R GOODRUM
K063067 11/03/2006 CONFIDENCE FENESTRATED INTRODUCER NEEDLE DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. JONATHAN S KAHAN
K063146 11/27/2006 ACCU-CHEK LINKASSIST DISETRONIC MEDICAL SYSTEMS AG SCOTT THIEL
K063029 11/02/2006 EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 E-Z-EM, INC. TRACEY CAMPBELL
K061696 11/13/2006 IQQA-LIVER SOFTWARE EDDA TECHNOLOGY, INC. XIAOLAN ZENG
K063120 11/09/2006 COLOR LCD MONITOR, RADIFORCE, MODEL RX210 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K062507 11/22/2006 MICRO-INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K063448 11/30/2006 EMG AC/DC SUCTION UNIT EMG TECHNOLOGY CO., LTD. SALLY CHUANG
K063257 11/22/2006 FMP COATED SPIKED ACETABULAR CUP; HEMISPHERICAL ACETABULAR CUP; FLARED RIM ACETABULAR CUP; METAL/METAL ACETABULAR INSERT ENCORE MEDICAL, L.P. TEFFANY HUTTO
K063277 11/30/2006 MAPMATE EP MEDSYSTEMS, INC. LARRY PICCIANO
K063207 11/09/2006 S-SCAN MRI SYSTEM ESAOTE, S.P.A. CARRI GRAHAM
K063204 11/14/2006 SPIDERFX EMBOLIC PROTECTION DEVICE EV3 INC DAVID WORRELL
K063279 11/29/2006 NOVATION SPLINED RDD FEMORAL STEMS EXACTECH, INC. MARITZA ELIAS
K062440 11/07/2006 GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 GEN-PROBE, INC. E JOSEPH MCMULLEN
K063006 11/02/2006 GE LOGIQ WORKS GENERAL ELECTRIC CO. ALLEN SCHUH
K063162 11/02/2006 GOLDEN LITEWAY GOLDEN TECHNOLOGIES, INC. GENE R KULON
K062721 11/21/2006 GREENTON ECOLITE IPL SYSTEM GREENTON (LONDON) LTD. ROBERT T HANDREN
K061933 11/16/2006 HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER HAGER WORLDWIDE, INC. JAMES DELANEY
K063046 11/17/2006 NITRILE POWDER FREE EXAMINATION GLOVES (GREEN) HARTALEGA SDN BHD NURUL A KONG
K062515 11/22/2006 RETENTION FLOW OPAQUE HERAEUS KULZER GMBH CHERYL V ZIMMERMAN
K061993 11/03/2006 EQUIVITAL, MODEL EQ-01 HIDALGO LIMITED JUSTIN PISANI
K061608 11/22/2006 MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER HITACHI MEDICAL CORP. DOUG THISTLETHWAITE
K062999 11/03/2006 OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN HOSPIRA, INC. DIANE RENNPFERD
K062419 11/15/2006 TRIDENT LARGE DIAMETER ACETABULAR INSERTS HOWMEDICA OSTEONICS CORP TIFFANI ROGERS
K061848 11/08/2006 HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1 HYPERMED, INC. CHAS BURR
K063234 11/21/2006 ON-Q INTRODUCERS I-FLOW CORP. SHANE NOEHRE
K063246 11/22/2006 XPLORER 1500 DIGITAL RADIOGRAPHIC SYSTEM WITH STAND IMAGING DYNAMICS COMPANY LTD. SHIRANTHA SAMARAPPULI
K063247 11/22/2006 XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAND IMAGING DYNAMICS COMPANY LTD. SHIRANTHA SAMARAPPULI
K063039 11/02/2006 XPLORER 2200 DIGITAL RADIOGRAPHIC SYSTEM IMAGING DYNAMICS COMPANY LTD. SHIRANTHA SAMARAPPULI
K062985 11/22/2006 IVUS ENHANCER INDEC SYSTEMS, INC. CAROL HUBLER
K062782 11/09/2006 INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001 INION OY KATI MARTTINEN
K061718 11/13/2006 INNOVACON SPECTRUM II TEST CARD INNOVACON, INC. EDWARD TUNG
K063422 11/21/2006 BIOAGGREGATE INNOVATIVE BIOCERAMIX INC. QUANZU YANG
K062589 11/30/2006 SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM INOLASE 2002, LTD. GEORGE J HATTUB
K062369 11/08/2006 IRIDEX OCULIGHT TX IRIDEX CORP. JOHN JOSSY
K062074 11/14/2006 IRIDEX WIRELESS FOOTSWITCH IRIDEX CORP. JOHN JOSSY
K062384 11/09/2006 CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE ISORAY, INC DAVID J SWANBERG
K062713 11/02/2006 ADHESIVE DC ACTIVATOR IVOCLAR VIVADENT, INC. ANDERJEET S GULATI
K062740 11/02/2006 JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU JINDELL MEDICAL INSTRUMENTS CO., LTD. KE-MIN JEN
K062614 11/01/2006 VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) JOHNSON & JOHNSON VISION CARE, INC. SUSAN MORRIS
K060907 11/09/2006 KARL STORZ VIDEO GASTROSCOPES KARL STORZ ENDOSCOPY-AMERICA, INC. PAUL S LEE
K062412 11/06/2006 CRYOMATIC KEELER INSTRUMENTS, INC. EUGENE R VANARSDALE
K062671 11/03/2006 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE) KENDALL KEITH MARTIN
K061749 11/22/2006 ECLIPSE TOTAL ANKLE IMPLANT KINETIKOS MEDICAL, INC. JOHN G STAMPINATO
K062857 11/22/2006 KLS MARTIN QUICK DISC KLS MARTIN L.P. JENNIFER DAMATO
K062021 11/01/2006 KOWA VX-10I KOWA CO. LTD. RICHARD PHILLIPS
K062409 11/08/2006 K-ETCHANT GEL KURARAY MEDICAL INC. KOJI NISHIDA
K063031 11/02/2006 PRISM VIEW, MODEL KYRON CLINICAL IMAGING, INC. JAMES L REUSS, PH.D.
K063161 11/21/2006 SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL LEONHARD LANG GMBH ELAINE DUNCAN
K062643 11/16/2006 KINETIC ANTERIOR CERVICAL PLATE LIFE SPINE ERIN MALLOY
K062876 11/01/2006 PRIMACONNEX CERAMIC ABUTMENTS LIFECORE BIOMEDICAL, INC. BRIAN SMEKAL
K062571 11/21/2006 LONGPORT EPISCAN, MODEL-I-200 LONGPORT, INC. MICHAEL G FARROW
K061375 11/17/2006 RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730 LOUIS M. GERSON CO., INC. ROBERT BRUNELL
K053225 11/06/2006 CELLU M6 KEYMODULE I LPG ONE, INC JAY MANSOUR
K062871 11/14/2006 LUMACARE LC-122M NON-COHERENT LIGHT SOURCE LYNTON LASERS LIMITED ANDREW J BERRY
K050263 11/21/2006 MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU M.O.C.O.M. SRL DANIELE TOSI
K063333 11/21/2006 M3 MAVIG GMBH CHRISTIAN STOIAN
K062474 11/09/2006 SMITHWICK CAROTID SHUNT MCPHERSON ENTERPRISES, INC. WILLIAM MCPHERSON
K061905 11/08/2006 HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.0 MEDCON LTD. JONATHAN S KAHAN
K062127 11/08/2006 MEDIC4ALL TELEMEDICINE SYSTEM, MODEL VMS-01 (NIBP) MEDIC4ALL (ISRAEL) LTD. JONATHAN S KAHAN
K062662 11/21/2006 TELEMEDICINE SYSTEM MODEL VMS-01 MEDIC4ALL (ISRAEL) LTD. JONATHAN S KAHAN
K062746 11/20/2006 FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 MEDICON HELLAS S.A. GEORGE PSICHAS
K062482 11/03/2006 VENTED VIAL ADAPTER TRANSFER DEVICE MEDIMOP MEDICAL PROJECTS, LTD. ARI Y SOBEL
K062984 11/13/2006 MEDLINE HYPODERMIC NEEDLES MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K061316 11/02/2006 MEDLINE SURGICAL SPONGE SCANNER MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K063342 11/30/2006 MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS MEDRAD, INC. LISA A EWING
K063117 11/03/2006 MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX MEDTRONIC NEUROSURGERY JEFFERY HENDERSON
K063083 11/06/2006 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. EDWARD S CHIN
K062807 11/06/2006 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. EDWARD CHIN
K063305 11/29/2006 STIMULATING BUR GUARD MEDTRONIC XOMED, INC. ANTOINE KOUCHAKJY
K063327 11/22/2006 ORTHOVIEW MERDIAN TECHNIQUE, LTD. ANTHONY THORNE
K062906 11/17/2006 ENA HFO COMPOSITE SYSTEM MICERIUM S.P.A. EUGENIO MICELI
K062153 11/21/2006 PORTABLE OXYGEN GENERATOR SYSTEM MOLECULAR PRODUCTS LTD. PAUL DRYDEN
K062677 11/15/2006 ELI 350 ELECTROCARDIOGRAPH MORTARA INSTRUMENT, INC. HARLAN VAN MATRE
K061829 11/17/2006 ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES NEW LEAF MEDICAL, INC. RICHARD T NOCK
K062749 11/29/2006 SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL 33699, SFB 15 ESTHETIC ABUTMENT 1MM RP, MODEL 33701, CFB 15 ESTHETIC ABUTMENT 2MM NOBEL BIOCARE AB HERBERT CRANE
K062241 11/09/2006 ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR NORTH AMERICAN SCIENTIFIC, INC. LEIGH SPOTTEN
K061830 11/01/2006 STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ NOVA BIOMEDICAL CORP. PAUL W MACDONALD
K062500 11/21/2006 FLEXPEN NEEDLE NOVO NORDISK INC. RICK SPRING
K062581 11/29/2006 OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM OLYMPUS AMERICA, INC. DAVID DAVIS
K063141 11/29/2006 OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBER OMNIGUIDE, INC. DOUGLAS W WOODRUFF
K062043 11/07/2006 BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500 OMRON HEALTHCARE, INC. DONNA DJINOVICH
K060054 11/21/2006 ONCOBIONIC SYSTEM ONCOBIONICS, INC. LAURIE A CLARKE
K063177 11/30/2006 RAPID STRAND RX ONCURA INC. SUBHASH PATEL
K062416 11/17/2006 RETINAL FUNCTIONAL IMAGER (RFI) OPTICAL IMAGING LTD. JONATHAN S KAHAN
K063144 11/13/2006 VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM ORTHO-CLINICAL DIAGNOSTICS, INC. SARAH C PARSONS
K062077 11/22/2006 VITROS CHEMISTRY PRODUCTS AMPH REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS ORTHO-CLINICAL DIAGNOSTICS, INC. MARLENE A HANNA
K062123 11/16/2006 VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV ORTHO-CLINICAL DIAGNOSTICS, INC. MICHAEL M BYRNE
K062637 11/22/2006 VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V ORTHO-CLINICAL DIAGNOSTICS, INC. DARLENE J PHILLIPS
K062094 11/22/2006 VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V ORTHO-CLINICAL DIAGNOSTICS, INC. DARLENE J PHILLIPS
K063330 11/22/2006 ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY ORTHOCON, INC. HOWARD L SCHRAYER
K062920 11/13/2006 ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP ORTHOFIX SRL CANDACE F CEDERMAN
K063033 11/01/2006 MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT ORTHOPEDIC SCIENCES, INC JAMES BRANNON M.D.
K062908 11/13/2006 ORTHROPRO HEMI TOE ORTHOPRO LLC J.D. WEBB
K062051 11/01/2006 SS SYSTEM OSSTEM IMPLANT CO.,LTD CATHRYN N CAMBRIA
K062030 11/02/2006 US SYSTEM OSSTEM IMPLANT CO.,LTD CATHRYN N CAMBRIA
K062851 11/17/2006 OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED OSTEOMED L.P. PIEDAD PENA
K052716 11/16/2006 RAPIRUN H. PYLORI ANTIBODY DETECTION KIT OTSUKA PHARMACEUTICAL CO., LTD. CYNTHIA A SINCLAIR
K062403 11/14/2006 IMAX CEPH DIGITAL X-RAY SENSOR OWANDY CLAUDE D BERTHOIN
K063003 11/28/2006 AURORA PARKELL, INC. DANIEL R SCHECHTER
K062300 11/27/2006 OX-SOX, MODEL C, D, E, PATTIENT SAFETY INNOVATIONS, LLP ERIK STALHANDSKE
K062271 11/30/2006 M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE J.00 (FOR M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170) PHILIPS MEDICAL SYSTEMS DAVID OSBORN
K062455 11/03/2006 PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL PHILIPS MEDICAL SYSTEMS RICH MCCLEARY
K062605 11/09/2006 PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T PHILIPS MEDICAL SYSTEMS RICH MCCLEARY
K062233 11/22/2006 HEARTSTART MRX MONITOR/DEFIBRILLATOR PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. MICHAEL J DOYLE
K063315 11/20/2006 INTELLIVUE PATIENT MONITORS, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH ANDREAS SUCHI
K063344 11/28/2006 CAAS QCA 3D PIE MEDICAL IMAGING B.V. CARLA DE VRIES
K061944 11/03/2006 POLY-CHEM CREATININE POLYMEDCO, INC. HELEN LANDICHO
K062155 11/09/2006 DIGITAL MXR-D FLOWMETER PORTER INSTRUMENT CO., INC. CYNTHIA J.M. NOLTE
K061951 11/22/2006 ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120 POSSIS MEDICAL, INC. FRANK B FREEDMAN
K063075 11/02/2006 NATURAL ORIFICE LINEAR CUTTER DIGITAL LOADING UNITS POWER MEDICAL INTERVENTIONS, INC. BARBARA J WHITMAN
K062166 11/21/2006 ENAMEL PRO PREMIER DENTAL PRODUCTS CO. VINCE D'ALESSANDRO
K062683 11/21/2006 ENAMEL PRO VARNISH PREMIER DENTAL PRODUCTS CO. VINCE D'ALESSANDRO
K063389 11/17/2006 GO GO ELITE TRAVELLER PLUS 4 WHEEL SCOOTER, MODEL SC54 PRIDE MOBILITY PRODUCTS CORP. THOMAS SCHAPPERT
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