FDA 510(k) Decisions During September, 2007  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K063481 09/14/2007 MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM ABBOTT VASCULAR INC. NADINE SMITH
K071845 09/28/2007 RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A ACCLARENT, INC. KERI YEN
K072504 09/21/2007 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM ACCURAY INCORPORATED ANNE SCHLAGENHAFT
K071824 09/04/2007 ACME TALON PEDICLE SCREW ACME SPINE, LLC. J. D WEBB
K072167 09/06/2007 COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE ADVANCED VASCULAR DYNAMICS HERBERT J SEMLER
K071945 09/20/2007 S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS KATHY A RACOSKY
K071499 09/14/2007 COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY AESCULAP IMPLANT SYSTEMS, INC. KATHY A RACOSKY
K072357 09/18/2007 NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM AFP IMAGING CORP. MARY MCNAMARA-CULLINANE
K072413 09/27/2007 MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM AGAMATRIX CONNIE HERTEL
K071604 09/19/2007 ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM ALVEOLUS, INC DONALD V CANAL
K063658 09/12/2007 INTRAVASCULAR INTRODUCER SYSTEM APPLIED MEDICAL RESOURCES CORP. CHERYL BLAKE
K071998 09/26/2007 ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT ARROW INTL., INC. KIRSTEN STOWELL
K071887 09/18/2007 SPORTMESH OR ARTELON TISSUE REINFORCEMENT ARTIMPLANT AB TERRY S POWELL
K072431 09/26/2007 ASAHI PTCA GUIDE WIRE, X-TREME ASAHI INTECC CO., LTD. YOSHI TERAI
K072316 09/17/2007 PRECIOUS PLUS GUIDE CATHETER ASAHI INTECC CO., LTD. YOSHI TERAI
K062736 09/14/2007 SIASCOPE V ASTRON CLINICA LIMITED E.J. SMITH
K071221 09/06/2007 SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12 AUTOMEDX INC. JAMES D EVANS
K071567 09/14/2007 AUTOSAFE-REFLEX SAFETY NEEDLE, AUTOSAFE ADVANTAGE SAFETY NEEDLE AUTOSAFE-REFELX INC. JOHN D STEPHENS
K072283 09/19/2007 DORADO PTA BALLOON DILATATION CATHETER BARD PERIPHERAL VASCULAR, INC. GENEVIEVE BALUTOWSKI
K070809 09/24/2007 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K071321 09/12/2007 POCKETCPR BIO-DETEK, INC. MARK TOTMAN
K070361 09/13/2007 MRSASELECT BIO-RAD FRAN WHITE
K072389 09/18/2007 MODIFICATION TO HYPERQ SYSTEM BIOLOGICAL SIGNAL PROCESSING, LTD. GEORGE J HATTUB
K071121 09/11/2007 TRIBONE 80 BIOMATLANTE ADELINE FILLIATRE
K072038 09/12/2007 VITEK 2 GRAM NEGATIVE LEVOFLOXACIN BIOMERIEUX, INC. JOLYN TENLIADO
K072161 09/20/2007 BIOMET FEMORAL LOCKING NAIL SYSTEM BIOMET MANUFACTURING CORP. BECKY EARL
K071577 09/06/2007 BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER BIOMET MICROFIXATION, INC. KIM REED
K071816 09/20/2007 HARPOON SUTURE ANCHOR BIOMET SPORTS MEDICINE, INC. ELIZABETH WRAY
K071704 09/17/2007 SLEEVE AND BUTTON SOFT TISSUE DEVICES BIOMET SPORTS MEDICINE, INC. ELIZABETH WRAY
K071546 09/18/2007 EOS BIOSPACE MED JOHN J SMITH
K072517 09/26/2007 ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3 BOSTON SCIENTIFIC CORP. CHRISTINE DUNBAR
K070556 09/25/2007 BRAINSUITE NET BRAINLAB AG RAINER BIRKENBACH
K071449 09/14/2007 BRM3 BRAIN MONITOR BRAINZ INSTRUMENTS LTD. CHRIS MANDER
K070156 09/26/2007 BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100 CARDIODYNAMICS INTERNATIONAL CORP. PAUL L SHAFFER
K072297 09/12/2007 BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM CARDIVA MEDICAL, INC. KIT CARIQUITAN
K072514 09/21/2007 VISULAS TRION CARL ZEISS MEDITEC AG KENT W JONES
K062028 09/07/2007 CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01 CELERA DIAGNOSTICS VICTORIA MACKINNON
K071854 09/07/2007 AQUADEX FLEXFLOW SYSTEM CHF SOLUTIONS, INC. CHRIS SCAVOTTO
K071272 09/12/2007 TROJAN THINTENSITY BRAND MALE LATEX CONDOM CHURCH & DWIGHT CO., INC. STEPHEN C KOLAKOWSKY
K070339 09/26/2007 DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES CINCINNATI SUB-ZERO PRODUCTS, INC DAN WITTMER
K071614 09/11/2007 FIDUCIAL MARKERS CIVCO JIM LEONG
K061539 09/20/2007 GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE CLINICAL INNOVATIONS, LLC WM DEAN WALLACE
K071196 09/06/2007 DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS COEUR, INC. DEBRA F MANNING
K072368 09/20/2007 CONFORMIS METAL BACKED TIBIAL COMPONENT CONFORMIS, INC. MICHAEL SHARP
K071962 09/26/2007 VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER) CORDIS NEUROVASCULAR, INC. AMARILYS MACHADO
K071533 09/28/2007 FITMATE SERIES COSMED S.R.L. ROBERT SCHIFF
K072539 09/13/2007 CURE CATHETER CURE MEDICAL LLC. JAMES SMITH
K071980 09/11/2007 DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H DADE BEHRING, INC. ANNA MARIE ENNIS
K072304 09/19/2007 FIBRINOGEN CALIBRATOR KIT DADE BEHRING, INC. RADAMES RIESGO
K071805 09/25/2007 NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX DATASCOPE CORP. KATHLEEN KRAMER
K071817 09/04/2007 OSTEOGRAF/N-300 DENTSPLY INTERNTIONAL HELEN LEWIS
K071379 09/11/2007 DELTA XTEND REVERSE SHOULDER MODULAR STEM DEPUY ORTHOPAEDICS, INC. NATALIE S HECK
K070554 09/11/2007 DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS DEPUY ORTHOPAEDICS, INC. KATHY HARRIS
K071830 09/28/2007 DEPUY DELTA TS CERAMIC FEMORAL HEADS DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K071016 09/04/2007 DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT DEPUY ORTHOPAEDICS, INC. KATHY HARRIS
K070387 09/18/2007 EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. CHRISTOPHER KLACZYK
K063675 09/24/2007 DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT DIAGNOSTIC HYBRIDS, INC. GAIL GOODRUM
K063798 09/21/2007 DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000 DIAGNOSTIC HYBRIDS, INC. GAIL GOODRUM
K071971 09/17/2007 DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL DIAZYME LABORATORIES CHARLES YU
K071431 09/21/2007 GLOBUS GENESY 1100 STIMULATOR DOMINO S.R.L. GIOVANNI M CIRIANI
K072023 09/12/2007 ELLIPSE JUVIA, MODEL 9EJU7465 ELLIPSE A/S OLE KOFOD
K070282 09/06/2007 ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM ENDIUS, INC. REGINA WAGNER
K071651 09/14/2007 EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES ENDOGASTRIC SOLUTIONS, INC. MICHAEL A DANIEL
K072355 09/26/2007 OSSIFUSE BONE SUBSTITUTE MATERIAL ETEX CORP. PAMELA W ADAMS
K072203 09/25/2007 HARMONIC 10CM COMBINATION HOOK BLADE ETHICON ENDO-SURGERY, LLC ELIZABETH MILLER
K071951 09/05/2007 COMFY SERIES: EV-804, EV-805 & EV-806 EVERYWAY MEDICAL INSTRUMENTS CO., LTD. JAY MANSOUR
K070640 09/13/2007 ARCHITECT STAT TROPONIN-1; MYOGLOBIN FISHER DIAGNOSTICS HEATHER CAMERON
K071744 09/25/2007 AVIAFIT PULSATING LEGBAND FLOWMEDIC LTD. AHAVA STEIN
K071510 09/24/2007 HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950 FOCUS DIAGNOSTICS, INC. CONSTANCE BRIDGES
K070822 09/28/2007 ARCHITECT SIROLIMUS ASSAY FUJIREBIO DIAGNOSTICS, INC. DIANA LYN DICKSON
K072232 09/07/2007 GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL GAMBRO RENAL PRODUCTS, INC. KAE MILLER
K071982 09/21/2007 MODIFICATION TO: UNITY NETWORK ID GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES LISA M BAUMHARDT
K072439 09/14/2007 GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA JAMES P RASKOB
K072224 09/21/2007 ZIP'R PC GLOBAL FABTECH WHEEL CHAIR (SHANGHAI) CO., LTD. JUNNATA CHANG
K072320 09/14/2007 GREINER VACUETTE QUICKSHIELD COMPLETE GREINER BIO-ONE NORTH AMERICA, INC. JUDI SMITH
K071910 09/06/2007 NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK) HARTALEGA SDN BHD NURUL AISYAH KONG BT ABDULLAH
K072279 09/21/2007 MAGNETIC RESONANCE DIAGNOSTIC DEVICE HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K072272 09/07/2007 HONEYWELL HOMMED CENTRAL STATION 4.0 HONEYWELL HOMMED, LLC MICHAEL LEIGH
K071471 09/10/2007 CORIN ADAPTOR SLEEVE HOWMEDICA OSTEONICS CORP KAREN ARIEMMA
K071082 09/13/2007 STRYKER MODULAR HIP SYSTEM HOWMEDICA OSTEONICS CORP VIVIAN KELLY
K071255 09/07/2007 ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A HYPHEN BIOMED OLA ANDERSON
K070979 09/19/2007 PULL TAB SQUEEZE FLUSH ICU MEDICAL, INC TRACY BEST
K071346 09/24/2007 IMMULISA INTRINSIC FACTOR ANTIBODY ELISA IMMCO DIAGNOSTICS, INC. KEVIN LAWSON
K071911 09/07/2007 CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR INNOVISION A/S RICHARD O WOOD
K071966 09/05/2007 1.5T MRGFUS PELVIC COIL INSIGHTEC-TXSONICS, INC. NADIR ALIKACEM
K071357 09/26/2007 P.004 NC ANATOMIC ABUTMENTS INSTITUT STRAUMANN AG PAIGE SWEENEY
K072497 09/26/2007 P.004 NC GOLD ABUTMENT FOR CROWNS INSTITUT STRAUMANN AG ELAINE ALAN
K070927 09/17/2007 HEMOSIL D-DIMER HS INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K072208 09/07/2007 MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS INTEGRA LIFESCIENCES CORPORATION HELDER A SOUSA
K071428 09/17/2007 INQU ISTO TECHNOLOGIES, INC. PATSY J TRISLER
K071118 09/07/2007 GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE IVES EEG SOLUTIONS, INC. JOHN R IVES
K072338 09/21/2007 CERVITEC PLUS IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K072152 09/07/2007 JUNIPER CLN1 DERMAL COOLING DEVICE JUNIPER MEDICAL INC. DONALD V JOHNSON
K072387 09/13/2007 KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES KARL STORZ ENDOSCOPY-AMERICA, INC. SUSIE CHEN
K071437 09/12/2007 MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C KARL STORZ ENDOSCOPY-AMERICA, INC. CRYSTAL DIZOL
K072384 09/21/2007 MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE KENSEY NASH CORP. JENNIFER J BOSLEY
K071429 09/10/2007 TI2200 TRANSILLUMINATION CABLE KERR CORPORATION COLLEEN BOSWELL
K071067 09/14/2007 BACTRACK LCD ALCOHOL DETECTOR KHN SOLUTIONS, LLC DANIEL KAMM
K071877 09/17/2007 LANX SPINAL FIXATION SYSTEM LANX, LLC JANICE M HOGAN
K071472 09/21/2007 PLANET 55 LARSEN & TOUBRO LIMITED HARRY P GUGNANI
K062003 09/19/2007 NEURO WAVE 6 LHASA OMS, INC. MARK W SHEEHAN
K071578 09/27/2007 BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, BSIX-15, BSIX-17 LIFESCIENCE PLUS, INC. AUDREY VITALE
K071773 09/12/2007 CPAP NASAL MASK WITH PILLOWS LIFESOURCE PAUL DRYDEN
K063297 09/20/2007 LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR LIGHTMED CORP. DENNIS DOWELL
K072246 09/14/2007 VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601 MAINE STANDARDS CO. HOLLY CRESSMAN
K071575 09/10/2007 SANDMAN INTRO MALLINCKRODT DEVELOPPEMENT FRANCE JAMES BONDS
K071612 09/11/2007 MODUS TRILOCK 2.0/2.3/2.5 MEDARTIS AG LINDA SCHULZ
K072542 09/25/2007 MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR MEDEGEN MEDICAL MANUFACTURING SYSTEM ALEX MAZZA
K071832 09/18/2007 MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM MEDICAL SCIENTIFIC, INC. PAUL NARDELLA JR
K071133 09/21/2007 APEXNRG-BLUE ELECTRONIC APEX LOCATOR MEDICNRG LTD. GEORGE J HATTUB
K070276 09/21/2007 MODIFICATION TO PASSMED SPINAL SYSTEM MEDICREA TECHNOLOGIES J. D WEBB
K070291 09/21/2007 MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX MEDIX I.C.S.A. JAMES H KNAUSS
K072315 09/18/2007 MIDAS REX CURVED BUR MEDTRONIC POWERED SURGICAL SOLUTIONS JEFFREY HENDERSON
K072429 09/28/2007 MODIFICATION TO TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK LEE GRANT
K070742 09/14/2007 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK LEE GRANT
K072317 09/18/2007 MODIFICATION TO:TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. LEE GRANT
K071348 09/07/2007 EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM MENNEN MEDICAL LTD. MICHA OESTEREICH
K062644 09/11/2007 FLEXWARMER, MODELS KZ-1 AND KZ-2 MERLYN ASSOCIATES, INC. KAREN CHEN
K070897 09/17/2007 BONEMEDIK, AND BONEMEDIK-S META BIOMED CO., LTD. TAE-HOON KIM
K070590 09/11/2007 MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT19S1R MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K070816 09/19/2007 PERIPHERAL GUIDING SHEATH MICRUS DESIGN TECHNOLOGY, INC. MARIANNE GRUNWALDT, MS, CQE
K071741 09/24/2007 TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM MIGADA PLANT YOSSI SHACHAR
K070694 09/10/2007 CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS) MIKE MINER MIKE MINER
K071964 09/26/2007 MIM 4.1 (SEASTAR) MIMVISTA CORP. PETER SIMMELINK
K070812 09/14/2007 DISPOSABLE LAPAROSCOPIC INSTRUMENT MODERN MEDICAL EQUIPMENT MFG., LTD. ROBERT STILLMAN
K071414 09/10/2007 BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) MOLNLYCKE HEALTH CARE US, LLC STEVEN DOWDLEY
K071565 09/10/2007 BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT MOLNLYCKE HEALTH CARE US, LLC STEVEN DOWDLEY
K071465 09/11/2007 BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT MOLNLYCKE HEALTHCARE, US LLC STEVEN DOWDLEY
K071700 09/11/2007 BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT MOLNLYCKE HEALTHCARE, US LLC STEVEN DOWDLEY
K071798 09/17/2007 MONDEAL DISTAL RADIUS SYSTEM MONDEAL MEDICAL SYSTEMS GMBH JAY EVANS
K071797 09/17/2007 MONDEAL HAND CONTOUR SYSTEM MONDEAL MEDICAL SYSTEMS GMBH JAY EVANS
K070804 09/17/2007 VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST NANOSPHERE, INC SUE KENT
K071553 09/18/2007 ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR NDO SURGICAL, INC. JOHN J VOZELLA
K072021 09/12/2007 NEOPIP INFANT RESUSCITATOR NEOFORCE GROUP, INC. MONICA FERRANTE
K061519 09/28/2007 MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM NIKKISO CO. LTD. FUMIAKI KANAI
K071145 09/07/2007 NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE NIPRO MEDICAL CORPORATION JESSICA OSWALD
K060676 09/07/2007 NES REPROCESSED ENDOSCOPIC TROCAR NORTHEAST SCIENTIFIC, INC. CRAIG ALLMENDINGER
K071056 09/28/2007 NEUTROPHASE WOUND CLEANSER NOVABAY PHARMACEUTICALS LUANA STAIGER
K072222 09/07/2007 SPY FLUORESCENT IMAGING SYSTEM NOVADAQ TECHNOLOGIES, INC. ALLISON MANNERS
K072150 09/13/2007 DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL NOVOCOL, INC. STEVE RUDOLPH
K072445 09/14/2007 INTEGRATED BRACHYTHERAPY UNIT - DIGITAL NUCLETRON CORP. LISA DIMMICK
K070937 09/21/2007 MULTIPLE BRAND MALE LATEX CONDOM NULATEX SDN. BHD. KIM L LEE
K063259 09/14/2007 OLYMPUS CAPSULE ENDOSCOPE SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K071762 09/27/2007 OMNIWAVE ENDOVASCULAR SYSTEM OMNISONICS MEDICAL TECHNOLOGIES ANNE M KULIS
K071250 09/28/2007 CA, MODEL: CAM OPTOVUE, INC. JAY WEI
K072515 09/20/2007 EMBRACE GEL ORISON CORPORATION AL SANDY
K072443 09/24/2007 VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY ORTHO-CLINICAL DIAGNOSTICS, INC. MARLENE HANNA
K072440 09/20/2007 VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208) ORTHO-CLINICAL DIAGNOSTICS, INC. MARLENE HANNA
K071929 09/19/2007 NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL ORTHOSOFT, INC. CHRISTOPHER MCLEAN
K072184 09/18/2007 VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE ORTHOVITA, INC. GINA M NAGVAJARA
K063861 09/21/2007 GS SYSTEM OSSTEM IMPLANT CO.,LTD CATHRYN N CAMBRIA
K071650 09/12/2007 C350 POWERED WHEELCHAIR PERMOBIL AB JAN ASTROM
K071391 09/07/2007 PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521 PHILIPS MEDICAL SYSTEMS, INC. PAUL SCHRADER
K071800 09/27/2007 PHILIPS AVALON FETAL MONITORS FM20 AND FM30 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN MICHAEL ASMALSKY
K072318 09/21/2007 POWRSYRINGE INJECTOR PINYONS MEDICAL TECHNOLOGY, INC. SHAWN P FOJTIK
K072345 09/21/2007 POWRSYRINGE MONITOR PINYONS MEDICAL TECHNOLOGY, INC. SHAWN P FOJTIK
K072244 09/21/2007 PLANMECA PROONE PLANMECA OY LARS MORING
K071507 09/10/2007 PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS POLYMER TECHNOLOGY SYSTEMS, INC. MARGO ENRIGHT
K072269 09/08/2007 ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552 POSSIS MEDICAL, INC. MIKE BURNSIDE
K071708 09/27/2007 I45, I45S, I60, AND I60S POWER MEDICAL INTERVENTIONS, INC. BARBARA J WHITMAN
K063735 09/19/2007 PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112 PRESYM, INC. TAMIM HAMID
K071827 09/20/2007 ALWAYS MENSTRUAL PADS PROCTER & GAMBLE, INC. LENORE FAULHABER
K072364 09/19/2007 PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES PULSION MEDICAL SYSTEMS AG JAMIE SULLEY
K072034 09/20/2007 DIODE MEDICAL LASER FAMILY, MODELS 4, 6, 30 QUANTA SYSTEM, S.P.A. ISABELLA CARRER
K071457 09/25/2007 MODIFICATION TO RADIUS SNARE RADIUS MEDICAL TECHNOLOGIES, INC. MAUREEN FINLAYSON
K072242 09/11/2007 COR ANALYZER II, MODEL V1.7 RCADIA MEDICAL IMAGING LTD. DAN LAOR
K063637 09/27/2007 RELIANCE VBS SYSTEM RELIANCE MEDICAL SYSTEMS, LLC BRET M BERRY
K071688 09/07/2007 RELIANCE S.E.P. RELIANCE ORTHODONTIC PRODUCTS, INC. PAUL GANGE
K072418 09/12/2007 OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER RESPIRONICS NEW JERSEY, INC. LAUREN ZIEGLER
K071486 09/10/2007 RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053 RESTORATIVE THERAPIES INC. ANDREW BARRISKILL
K072394 09/12/2007 PORTRAIT STAND-OFF RHYTEC INCORPORATED ROBERT ZOLETTI
K071239 09/14/2007 TOTAL PROTEIN URINE/CSF GEN.3 ROCHE DIAGNOSTICS CORINA HARPER
K071644 09/12/2007 ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 ROCHE DIAGNOSTICS CORP. DIMITRIS DEMIRTZOGLOU
K071922 09/18/2007 INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC RSB SPINE LLC. KAREN E WARDEN
K070670 09/18/2007 EYETRACKER/IDEAS S.A. INSTRUMENTATION DIFRA GUIDO PAGNACCO
K070881 09/26/2007 LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 SAPI MED S.P.A E.J. SMITH
K071965 09/10/2007 I-SURGE SATELEC STEVE SALESKY
K072181 09/19/2007 MINI LED AUTOFOCUS SATELEC STEVE SALESKY
K071891 09/13/2007 STATIS DENTAL HANDPIECES SCICAN LTD. BRENDA MURPHY
K072541 09/25/2007 SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM SENORX, INC.
K071672 09/12/2007 SENTEC DIGITAL MONITORING SYSTEM SENTEC AG STEPHEN H GORSKI
K072164 09/05/2007 DC-6 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD LI DONGLING
K063609 09/12/2007 RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER SHL TELEMEDICINE INTERNATIONAL LTD. GEORGE J HATTUB
K072392 09/25/2007 OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. KIM RENDON
K072090 09/14/2007 SIEMENS DIAGNOSTIC ULTRASOUND SYSTEMS SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI KRISTEN DORROUGH
K071541 09/10/2007 SBI TWISTOFIX SMALL BONE INNOVATIONS INC. ROBERT HOEHN
K071170 09/14/2007 POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGEL SMART GLOVE CORP. SDN BHD FOO KHON PU
K071071 09/19/2007 CROSSLINKED POLYETHYLENE ARTICULAR INSERTS SMITH & NEPHEW, INC. RISHI SINHA
K072322 09/18/2007 ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS SMITH & NEPHEW, INC. JULIE ACKER
K071418 09/04/2007 DANA 3CC SYRINGE INSULIN RESERVOIR SOOIL DEVELOPMENT CO., LTD. CYNTHIA NOLTE, PH.D
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