FDA 510(k) Applications Received During April, 2008

FDA 510(k) Number Submission Date Device Name Applicant Contact
K080960 04/03/2008 PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS ABBOTT DIABETES CARE INC. TAMMY WHARTON
K080925 04/02/2008 FOX PLUS PTA CATHETER ABBOTT VASCULAR INC. Ivalee Cohen
K081127 04/21/2008 ACCIN TOTAL KNEE SYSTEM ACCELERATED INNOVATION, LLC MICHAEL KVITNITSKY
K081208 04/29/2008 CINCH ANCHOR, MODEL 1194 ADVANCED NEUROMODULATION SYSTEMS PENNY HOUSTON
K080992 04/07/2008 AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM AESCULAP IMPLANT SYSTEMS, INC. Lisa Boyle
K081031 04/11/2008 ENDOSCOPIC CLIP APPLIERS WITH CLIP MAGAZINE AESCULAP, INC. Lisa Boyle
K081104 04/18/2008 AESKULISA ANA HEP-2, REF 30-7115US AESKU.DIAGNOSTICS JIM RADFORD
K080995 04/07/2008 MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM Affymetrix, Inc. MAUREEN J MENDE
K080994 04/07/2008 AMPLATZER TORQVUE EXCHANGE SYSTEM AGA MEDICAL CORP. MICHELLE NIVALA
K081092 04/17/2008 MODIFICATION TO MAMMAPRINT AGENDIA Guido Brink
K081062 04/14/2008 AIRSONNETT AIRSHOWER AIR 3 AIRSONETT, INC. CONSTANCE G BUNDY
K081158 04/23/2008 ZODIC POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC. MARY STANNERS
K081220 04/30/2008 MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER ANGIOSCORE, INC. KIMBERLEY KLINE
K080966 04/04/2008 HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM AOTI LTD. ROBBIE WALSH
K081011 04/09/2008 AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45 AREX USA ELLEN HOKANSON
K080997 04/08/2008 ASCENSION PYROCARBON LUNATE ASCENSION ORTHOPEDICS, INC. DEBBIE STEARNS
K081160 04/23/2008 AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES AVITA CORPORATION JENNIFER REICH
K081154 04/23/2008 ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202 B-K MEDICAL APS JENS RASMUSSEN
K081109 04/18/2008 CORONIS 5MP MAMMO SL, MODEL MDMG 6121 BARCOVIEW, MEDICAL IMAGING SYSTEMS NEIL PHILLIPS
K081213 04/30/2008 BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 BD Biosciences NOBUKO NAKAJIMA
K080998 04/07/2008 DORIPENEM 10UG BBL SENSI-DISC BECTON DICKINSON & CO. JANINE MATLAK
K080933 04/02/2008 HANDHELD ECG MONITOR, MODEL MD100 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. Diana Hong
K081125 04/21/2008 WRIST PULSE OXIMETER MD300W BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. LEI WANG
K081212 04/29/2008 MRSASELECT - EXTENDED INCUBATION BIO-RAD FRAN WHITE
K080911 04/02/2008 VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI J.B BARTILSON
K080910 04/01/2008 PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS BIOIMAGENE, INC. INDU LAKSHMAN
K081015 04/09/2008 CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 BIOLITEC, INC. JONATHAN S KAHAN
K080931 04/02/2008 VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY BIOMERIEUX, INC. NIKITA S MAPP
K081143 04/22/2008 BIOMERS TRANSLUCENT ORTHODONTIC WIRE BIOMERS PRODUCT, LLC GEORGE ALIPHTIRAS
K081172 04/24/2008 COMPOSITE HITCH SUTURE ANCHOR BIOMET MANUFACTURING CORP. BECKY EARL
K080979 04/07/2008 STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT BIOMET MANUFACTURING CORP. GARY BAKER
K081067 04/15/2008 FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) BIOMET MICROFIXATION, INC. KIM REED
K081149 04/22/2008 BIOPRO GO-EZ SCREW BIOPRO, INC. DAVID MRAK
K080988 04/07/2008 SCOUTPRO CS LEAD INTRODUCER SYSTEM BIOTRONIK, INC. Jon Brumbaugh
K081177 04/25/2008 BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM BLACKSTONE MEDICAL, INC. WHITNEY G TORNING
K081021 04/10/2008 KINETIX GUIDEWIRE, PLUS GUIDEWIRE BOSTON SCIENTIFIC CORP. CHRISTINE THOMAS
K081048 04/14/2008 PINNACLE PELVIC FLOOR REPAIR KIT II BOSTON SCIENTIFIC CORP. MICHELLE BARRY
K080982 04/07/2008 STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS BOSTON SCIENTIFIC CORP. MARK MURPHY
K081130 04/21/2008 BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER BRIDGEPOINT MEDICAL MICHAEL A DANIEL
K081187 04/28/2008 BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001 BRIDGEPOINT MEDICAL MICHAEL A DANIEL
K080987 04/07/2008 BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES BRIDGEPOINT MEDICAL MICHAEL A DANIEL
K081168 04/24/2008 BRIT PACS SYSTEMS BRIT SYSTEMS, INC. ROBERT MURRY
K081042 04/11/2008 MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES BSD MEDICAL SYSTEMS CORP. PHIL TRIOLO
K080944 04/03/2008 X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER C.R. BARD, INC. TERRI MORRIS
K080954 04/03/2008 T34L SYRINGE DRIVER CAESAREA MEDICAL ELECTRONICS LTD. EVA PARTAS
K081157 04/23/2008 ACCUFRAME CAGENIX INC. LINDA K SCHULZ
K081225 04/30/2008 CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM CARDICA, INC. ISKRA MRAKOVIC
K080906 04/01/2008 CDB CLIP CDB CORPORATION JENS RUMSFELD
K081088 04/16/2008 MYRAY SKYVIEW CEFLA S.C. BERTHOIN CLAUDE
K081176 04/25/2008 FLOCHANNEL CHAD THERAPEUTICS, INC. KEVIN MCCULLOH
K080921 04/01/2008 SPIRO-MASTER PC-10 SPIROMETRY SYSTEM CHEST M.I., INC. FUMIAKI KANAI
K081017 04/09/2008 TEMPLATE AND COUNTER-FIT CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. JEANETTE SMITH
K080973 04/04/2008 CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC CLINIQA CORPORATION CAROL RUGGIERO
K080956 04/03/2008 MODIFICATION TO VF GEL PLUS COAPT SYSTEMS, INC. LINDA RUEDY
K081151 04/23/2008 COMPUMEDICS NEUVO COMPUMEDICS USA, LTD. DAVID CARDONA
K080936 04/02/2008 CONFORMIS TOTAL KNEE REPIAR SYSTEM (ITOTAL) TIBIAL COMPONENT: 6.0 MM THICKNESS CONFORMIS, INC. S. MICHAEL SHARP
K080946 04/03/2008 CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX CONMED ENDOSCOPIC TECHNOLOGIES, INC. BETH ZIS
K081178 04/25/2008 OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES CONTAMAC LTD. MARTIN DALSING
K081113 04/18/2008 COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS COOK, INC. SUSANNE GALIN
K080967 04/04/2008 TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT CORDIS NEUROVASCULAR, INC. Amarilys Machado
K081060 04/14/2008 FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 CORE ESSENCE ORTHOPAEDICS, LLC SHAWN T HUXEL
K081169 04/24/2008 AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES TIM LOHNES
K081049 04/14/2008 FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12 CRYOCATH TECHNOLOGIES, INC. FRED MILDER
K081181 04/25/2008 SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASER CYNOSURE, INC. GEORGE CHO
K081161 04/24/2008 DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST DADE BEHRING, INC. HELEN M LEE
K081010 04/09/2008 BARD 3DMAX MESH DAVOL INC., SUB. C.R. BARD, INC. STEPHANIE BAKER
K080918 04/01/2008 DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0 Depuy Mitek KRISTINE CHRISTO
K080991 04/07/2008 DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM DEPUY ORTHOPAEDICS, INC. DAWN SINCLAIR
K080990 04/07/2008 DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER DEPUY ORTHOPAEDICS, INC. DAWN SINCLAIR
K081163 04/24/2008 SMARTSET GMV GENTAMICIN BONE CEMENT DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K081155 04/23/2008 SMARTSET MV BONE CEMENT DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K081162 04/24/2008 TEMPTOUCH DERMAL THERMOMETER DIABETICA SOLUTIONS, INC. J.S. ALLINSON
K081164 04/24/2008 D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT DIAGNOSTIC HYBRIDS, INC. GAIL R GOODRUM
K080959 04/03/2008 DORNIER MEDILAS D 30 LASER, MEDILAS D 1064 DORNIER MEDTECH AMERICA, INC. THERON GOBER
K081047 04/14/2008 TRANSPOSAL ULTRA SYSTEMS DORNOCH MEDICAL SYSTEMS, INC. ANTHONY MARTINI
K081093 04/17/2008 3-D IMAGING WORKSTATION EIGEN LLC MARK A HOFFMAN
K080968 04/04/2008 S-SCAN, G-SCAN, DYNAMIC MRI SOFTWARE FOR C-SCAN, E-SCANXQ & E-SCAN OPERA ESAOTE S.P.A. CARRI GRAHAM
K080972 04/04/2008 ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP ETHICON ENDO-SUGERY, LLC RUTH A WOOD
K081146 04/22/2008 ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT) ETHICON ENDO-SURGERY, LLC Abhilasha Mukherjee
K080980 04/07/2008 EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS EXACTECH, INC. XAVIER SARABIA
K080904 04/01/2008 FEEL-FINE INSULIN PEN NEEDLE FEEL TECH DANIEL KAMM
K081029 04/11/2008 SLEEPSTYLE 200 AUTO SERIES HC254 FISHER & PAYKEL HEALTHCARE, LTD. JAMES THOMPSON
K080974 04/04/2008 TLS FIXATION SYSTEM FOURNITURES HOSPITALIERES INDUSTRIE PATRICIA DONNARD
K080964 04/04/2008 FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE FRESENIUS MEDICAL CARE NORTH AMERICA JANET C KAY
K080945 04/03/2008 FCR GO PORTABLE DIGITAL X-RAY SYSTEM FUJIFILM MEDICAL SYSTEMS U.S.A., INC. DEBBIE PEACOCK
K081041 04/11/2008 GPS, G SURGICAL PEDICLE SYSTEM G SURGICAL CO., LTD. DONALD GRAFTON
K081105 04/18/2008 GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0) GE HEALTHCARE ANDREW MENDEN
K081091 04/16/2008 PRECISION 500D R&F X-RAY SYSTEM GE HEALTHCARE MICHAEL PETROWSKI
K081028 04/11/2008 SIGNA 3.0T MR750 SYSTEM GE MEDICAL SYSTEMS, LLC MARK STAUFFER
K081054 04/14/2008 GISH ARTERIAL FILTER WITH HA COATING GISH BIOMEDICAL, INC. HARVEY KNAUSS
K081200 04/28/2008 DENTAL PORCELAIN (GLASS POWDER), TOP-CERAM T-1, T1, T2, T3, T4 GLOBAL TOP, INC. CLAUDE YANG
K081195 04/28/2008 REVERE UNIPLANAR SCREWS GLOBUS MEDICAL INC. KELLY J BAKER
K080937 04/02/2008 POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE GX CORPORATION SDN BHD FOO K PU
K081159 04/14/2008 HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 SERIES HARVARD MEDICAL DEVICES LTD. PAUL AYLETT
K081061 04/14/2008 HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES HARVARD MEDICAL DEVICES LTD. PAUL AYLETT
K081198 04/28/2008 ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL MR-RBC-150N HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K081179 04/25/2008 MAMMOSITE CAVITY EVALUATION DEVICE HOLOGIC, INC. RANDALL J COVILL
K081044 04/14/2008 REJUVENATE MODULAR HIP SYSTEM HOWMEDICA OSTEONICS CORP DENISE DAUGERT
K081171 04/24/2008 TRITANIUM ACETABULAR SHELL SYSTEM HOWMEDICA OSTEONICS CORP KIMBERLY LANE
K081152 04/23/2008 T2 FEMORAL NAIL HOWMEDICA OSTEONICS CORP. DANIELLE HILLMAN
K081217 04/30/2008 HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM HYCOR BIOMEDICAL, INC. P. NARAYAN NAYAK
K080923 04/02/2008 CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MODEL GM505C; CARESENS POP METER, MODEL GM505EA OR GM505EB i-SENS, Inc. HYUN JOON OH
K080989 04/07/2008 UNIVERSAL VIAL ACCESS SPIKE ICU MEDICAL, INC TRACY BEST
K080909 04/01/2008 ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000 IKONISYS INC SYED ATAULLAH
K081101 04/17/2008 SPECTRA-SYSTEM ABUTMENTS 2008 IMPLANT DIRECT LLC THOMAS GOTTENBOS
K080908 04/01/2008 INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM INNERCOOL THERAPIES, INC.- A DELAWARE CORPORATION JENNIFER SPINELLA
K080917 04/01/2008 IROOT SP INNOVATIVE BIOCERAMIX INC. QUANZU YANG
K081136 04/21/2008 LYRIC HEARING AID INSOUND MEDICAL INC. SUSAN WHICHARD
K081186 04/28/2008 CONCAVE RN HEALING CAP INSTITUT STRAUMANN AG ELAINE ALAN
K081005 04/08/2008 P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS INSTITUT STRAUMANN AG ELAINE ALAN
K081057 04/14/2008 INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL INTACT MEDICAL CORPORATION DOUGLAS MACARTHUR
K081070 04/15/2008 INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM INTERLACE MEDICAL, INC. RON ADAMS
K081207 04/29/2008 INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WITH DA VINCI CONNECT AND ONSITE INTUITIVE SURGICAL, INC. JERRY TSUTSUMI
K081137 04/21/2008 INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000 INTUITIVE SURGICAL, INC. KAREN UYESUGI
K081112 04/18/2008 FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM ISODOSE CONTROL B.V. HUB VAN DE BERGH
K081218 04/30/2008 BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST IT-V MEDIZINTECHNIK, GMBH CORNELIA DAMSKY
K081037 04/11/2008 WATCH-PAT 200I (WP200I) ITAMAR MEDICAL JOHATHAN S KAHAN
K081064 04/14/2008 GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF IVD RESEARCH, INC. MICHAEL WIENHOLT
K081122 04/21/2008 FUSION MEDICAL CANNULATED SCREW SYSTEM JOHN RICCIO JOHN RICCIO
K081107 04/18/2008 CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS K2M, INC. RICHARD W WOODS
K080975 04/07/2008 FENCER 308 EXCIMER LASER SYSTEM KERA HARVEST/LASER MAX MEDICAL TECHNOLOGIES CORP PAUL Y FANG
K080949 04/03/2008 KERATEC WOUND DRESSINGS KERATEC LIMITED MARY MCNAMARA-CULLINANE
K081120 04/21/2008 FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS KETTENBACH GMBH & CO KG MICHAELA ZINKE
K081089 04/16/2008 KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM KIMBERLY-CLARK CORP. RICHARD V WOLFE
K081027 04/10/2008 KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE) KIMBERLY-CLARK CORP. RICHARD W WOLFE
K081215 04/30/2008 VOLUMINA KJAYA MEDICAL, LLC KOVALAN MUNIANDY
K081133 04/21/2008 KYMCO FORU, MODEL EQ40 KWANG YANG MOTOR CO., LTD. JUNNATA CHANG
K081221 04/30/2008 LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE LEVITRONIX LLC. SUSAN HAMANN
K081008 04/10/2008 BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS Lin-Zhi International, Inc. MARIE LIN
K080902 04/02/2008 FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058 LORENZ BIOTECH S.P.A. ROSINA ROBINSON
K080932 04/02/2008 MOSAIC LASER SYSTEM LUTRONIC CORPORATION MAUREEN O'CONNELL
K081023 04/10/2008 EVOLIS TOTAL KNEE SYSTEM MEDACTA INTERNATIONAL, SA NATALIE J KENNEL
K080969 04/04/2008 HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510 MEDI NUCLEAR CORP., INC. JERRY SCHOEN
K081066 04/15/2008 BRACHYTHERAPY SOURCE DEVICE, MODEL 9011 MEDI-PHYSICS, INC., DBA GE HEALTHCARE DAVID RISLEY
K081082 04/16/2008 U-CLIP UNI-FIRE, MODEL M65 MEDTRONIC INC. DAVID D COX
K081038 04/11/2008 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM MEDTRONIC SOFAMOR DANEK CHRIS MCKEE
K081080 04/16/2008 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK MELISA LANSKY
K081153 04/23/2008 NOVEL SPINAL SYSTEM MEDYSSEY CO., LTD. JUNG BAE BANG
K080981 04/07/2008 EAR THERMOMETER, MODELS ST66 AND ST67 MESURE TECHNOLOGY CO.,LTD. JOHN CHEN
K081039 04/11/2008 LIPO CANNULA MILLENNIUM MEDICAL TECHNOLOGIES, INC. GREGORY M MILES
K081033 04/11/2008 MIROXI MIR MEDICAL INTL. RESEARCH SRL SIMON FOWLER
K081180 04/25/2008 SKINSENSE POLYISOPRENE UNDERGLOVE MOLNLYCKE HEALTH CARE US, LLC STEVEN DOWDLEY
K080941 04/03/2008 BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM N.I. MEDICAL, LTD. JAMES COLLIE
K081075 04/16/2008 PAINSHIELD MD NANO VIBRONIX LTD. ELI ORBACH
K080976 04/07/2008 NEXUS I.V. FLUID TRANSFER DEVICE NEXUS MEDICAL, LLC LARRY SMITH
K081123 04/21/2008 NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISTRATION SETS NEXUS MEDICAL, LLC LARRY SMITH
K081210 04/29/2008 NIPRO SAFETOUCH HUBER INFUSTION SET NIPRO MEDICAL CORP. JESSICA OSWALD
K081128 04/21/2008 MOLAR IMPLANT NOBEL BIOCARE AB THUONG NGUYEN SON
K081118 04/21/2008 NORAS MR-BI320-PA 1.5T NORAS MRI PRODUCTS GMBH MARTIN HEMPEL
K081191 04/28/2008 TCM ENDO 20 NOUVAG AG ERICH FORSTER
K081009 04/08/2008 NEUTROPHASE NOVABAY PHARMACEUTICALS SHEILA W PICKERING
K080929 04/01/2008 ONCENTRA GYN NUCLETRON CORPORATION LISA DIMMICK
K080934 04/02/2008 VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET NUCLETRON CORPORATION LISA DIMMICK
K081043 04/14/2008 LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT NXSTAGE MEDICAL, INC. MARY LOU STROUMBOS
K080919 04/01/2008 NXSTAGE PUREFLOW SL NXSTAGE MEDICAL, INC. MICHAEL DOYLE
K081140 04/22/2008 VISENSIA OBS MEDICAL WAYNE NETHERCUTT
K081185 04/25/2008 MOBLVAC W.C. OHIO MEDICAL CORPORATION DAVID PLATT
K081094 04/17/2008 OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 OLYMPIC MEDICAL CORP. STEVE HESLER
K081173 04/24/2008 ENDOSCOPIC CO2 REGULATION UNIT UCR OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K080948 04/03/2008 HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K081097 04/17/2008 ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM ORTHOPEDIATRICS, LLC GARY BARNETT
K081052 04/14/2008 OCCLUSION BALLOON CATHETER, MODEL VENOS Oscor Inc. MILA DOSKOCIL
K081078 04/16/2008 NT/IT SYSTEM OSSTEM IMPLANT CO.,LTD MINJOO KIM
K081227 04/30/2008 PLEXUR M OSTEOTECH, INC. CHRIS TALBOT
K081035 04/11/2008 AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2 OSYPKA MEDICAL, INC. MARKUS OSYPKA
K080950 04/03/2008 STIWELL MED4 OTTO BOCK, AUSTRIA GMBH WILLIAM F JACKSON
K080963 04/04/2008 DSS STABILIZATION SYSTEM PARADIGM SPINE JUSTIN EGGLETON
K081073 04/15/2008 HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F PAUSCH LLC JUSTIN TICE
K080999 04/08/2008 PAGEWRITER CARDIOGRAPH PHILIPS MEDICAL SYSTEMS PAUL SCHRADER
K080927 04/02/2008 BRIGHTVIEW VCT IMAGING SYSTEM PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. COLEEN A COLEMAN
K081135 04/21/2008 GEMINI CONDOR PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. MELINDA NOVATNY
K081203 04/28/2008 OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00 PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH MICHAEL ASMALSKY
K080961 04/04/2008 NM APPLICATION SUITE PHILIPS NUCLEAR MEDICINE, INC LORI R PETERSON
K081053 04/14/2008 PIVOT ASSIST PIVOT ASSIST, LLC JOHN QUIGLEY
K081030 04/11/2008 MODIFICATION TO PROFLU+ ASSAY PRODESSE, INC. KAREN HARRINGTON
K081040 04/11/2008 POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE PT. SHAMROCK MANUFACTURING CORP. EMMY TJOENG
K081095 04/17/2008 PROLITE III TOWER AND PR AND HR HANDPIECE QUANTEL S.A. MICHAEL JOHNSON
K080905 04/01/2008 QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI QUANTUM MEDICAL IMAGING, LLC. PAMELA PAPINEAU
K080915 04/02/2008 FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES RELIANT TECHNOLOGIES, INC. HEATHER MACFALLS
K081025 04/10/2008 ISOELASTICU REMI SCIENCES, INC. SANJIV H NAIDU
K081206 04/29/2008 HOMELOX RESPIRONICS, INC. ZITA A YURKO
K080977 04/07/2008 3 CCD ENDOCAM 5550 RICHARD WOLF MEDICAL INSTRUMENTS CORP. NIELS SCHMIDT
K081138 04/21/2008 SAFEFLO VENA CAVA FILTER RMT MEDICAL TECHNILOGIES INC. JANICE M HOGAN
K081032 04/11/2008 TR-USB TELEPHONIC STETHOSCOPE RNK PRODUCTS, INC. CHARLES R ABBRUSCATO
K081193 04/28/2008 COBAS INTEGRA 400/800 BILIRUBIN TOTAL Roche Diagnostics JENNIFER TRIBBETT
K080914 04/01/2008 ULTRASHARP CONCENTRIC NEEDLES ROCHESTER ELECTRO MEDICAL, INC. CHARLES C BERKINS
K081194 04/28/2008 INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD) RSB SPINE LLC. KAREN E WARDEN
K080922 04/01/2008 SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR SALTER LABS, DIVISION OF REGULATORY AFFAIRS DUANE KAZAL
K081219 04/30/2008 APOLLO MINI IPL SYSTEM SANDSTONE MEDICAL TECHNOLOGIES, LLC MARK ROHRER
K081142 04/22/2008 AUTO-BAND LIGATOR SCANDIMED INTERNATIONAL SALAH CHAMI
K080916 04/02/2008 CAPILLARYS URINE SEBIA KAREN ANDERSON
K081079 04/16/2008 CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY SENORX, INC. EBEN GORDON
K081170 04/24/2008 PROSTATE TISSUE MARKER SENORX, INC. EBEN GORDON
K081085 04/16/2008 STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS SENORX, INC. EBEN GORDON
K081110 04/18/2008 SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS BOB LEIKER
K081182 04/25/2008 MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBLE CLINDAMYCIN SIEMENS LIBBY WARRINER
K081013 04/09/2008 MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN SIEMENS HEALTHCARE DIAGNOSTICS LIBBY WARRINER
K081074 04/16/2008 DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691 Siemens Healthcare Diagnostics Inc. YUK-TING LEWIS
K081103 04/18/2008 LOCI THYROID CALIBRATOR WITH MODEL RC610 Siemens Healthcare Diagnostics Inc. YUK-TING LEWIS
K081018 04/10/2008 SYNGO DYNAMICS VERSION 7.0 SIEMENS MEDICAL SOLUTIONS
K081022 04/10/2008 SOMATOM DEFINITION, MODEL AS/AS+ SIEMENS MEDICAL SOLUTIONS USA, INC. CORRINE MCLEOD
K081121 04/21/2008 MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI MARTINA VOGT
K081148 04/22/2008 SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI SHEILA PICKERING
K081108 04/18/2008 MONOPOLY PEDICLE SCREW SYSTEM SIGNUS MEDICAL LLC. RICHARD JANSEN
K081226 04/30/2008 SIMPACT IMPLANT SYSTEM SIMPACT LLC ALAN LOMBARDO
K081098 04/17/2008 ENDOBUTTON CONTINUOUS LOOP (CL) SMITH & NEPHEW INC., ENDOSCOPY DIVISION CHRISTINA FLORES
K081111 04/18/2008 LEGION HINGE KNEE SYSTEM SMITH & NEPHEW, INC. NICHOLAS B TABRIZI
K081124 04/21/2008 MDF REVISION HIP SYSTEM SMITH & NEPHEW, INC. RISHI SINHA
K081106 04/18/2008 PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS LOCKING PLATE FOR THE UPPER EXTREMITY-ASTM F139 SMITH & NEPHEW, INC. LAURA SEJNOWSKI
K081016 04/09/2008 SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM SMITH & NEPHEW, INC. JASON SELLS
K081086 04/16/2008 PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.0 SMITHS MEDICAL ASD, INC. JOHN TULLETT
K081229 04/30/2008 SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G, 25G SAF-T WING SMITHS MEDICAL ASD, INC. BRIAN FARIAS
K081156 04/23/2008 CADD MEDICATION CASSETTE RESERVOIR SMITHS MEDICAL MD, INC. DAVID H SHORT
K081126 04/21/2008 PARIETEX COMPOSITE MONO PM MESH SOFRADIM PRODUCTION SHARON ALEXANDER
K081050 04/14/2008 PARIETEX PROGRIP MESH SOFRADIM PRODUCTION SHARON ALEXANDER
K081145 04/22/2008 MODIFICATION TO 4CIS VANE SPINE SYSTEM SOLCO BIOMEDICAL CO., LTD. SAEYOUNG AHN
K081166 04/24/2008 LIGHTSTREAM LOW LEVEL LASER SOLICA CORPORATION CARLA WINSLOW
K081196 04/28/2008 SPINAL USA VBR SYSTEM SPINAL USA JEFFREY JOHNSON
K080971 04/04/2008 SPINESMITH CIMPLICITY SPINAL SYSTEM SPINE SMITH PARTNERS L.P. ROBERT JONES
K081132 04/21/2008 SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM SPINE SMITH PARTNERS L.P. ROBERT JONES
K081051 04/14/2008 SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE SPINE VIEW, INC. ROY CHIN
K081228 04/30/2008 CAPSURE PS (R) SPINE SYSTEM SPINE WAVE, INC. ROAIDA RIZKALLAH
K081165 04/24/2008 ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM SPINEART FRANCK PENNESI
K081026 04/10/2008 BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5 SPORT-ELEC S.A. SHARON SCANNELL
K080924 04/02/2008 MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI COLLEEN CANAN
K081004 04/08/2008 PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL STRYKER GI TIFFANI ROGERS
K080928 04/02/2008 XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS STRYKER SPINE CURTIS TRUESDALE
K080985 04/07/2008 QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO) SURGICAL SPECIALTIES CORP. TRUDY D ESTRIDGE
K081129 04/21/2008 ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL SURGRX, INC. LINDA OLESON
K081002 04/08/2008 MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE SUTURES INDIA PVT., LTD. L.G. CHANDRASEKHAR
K081001 04/08/2008 PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE SUTURES INDIA PVT., LTD. L.G. CHANDRASEKHAR
K081003 04/08/2008 TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE SUTURES INDIA PVT., LTD. L.G. CHANDRASEKHAR
K081034 04/11/2008 SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PS Synergeyes, Inc. RICHARD E LIPPMAN
K081205 04/29/2008 SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS SYNTHES (USA) KARL J NITTINGER
K080943 04/03/2008 SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS SYNTHES (USA) SHERI L MUSGNUNG
K081071 04/15/2008 SYNTHES 6.5MM MIDFOOT FUSION BOLT SYNTHES (USA) KARL J NITTINGER
K081144 04/22/2008 CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243 TaiDoc Technology Corporation Yuhua Chen
K081099 04/17/2008 TEPHAFLEX ABSORBABLE SUTURE TEPHA, INC. MARY P LEGRAW
K081045 04/14/2008 DESTINATION RENAL GUIDING SHEATH TERUMO MEDICAL CORP. MARK UNTERREINER
K081046 04/14/2008 PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH TERUMO MEDICAL CORP. MARK UNTERREINER
K081083 04/16/2008 CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS Thermo Fisher Scientific JACK ROGERS
K080962 04/04/2008 LITE WAND II THOMPSON SURGICAL INSTRUMENTS, INC. STEPHANIE A ZALUCHA
K080940 04/03/2008 ESTELITE SIGMA QUICK TOKUYAMA DENTAL CORPORATION KEITH BARRITT
K080978 04/07/2008 WALGREEN'S PERSONAL LUBRICATING JELLY TOPCO SALES LORELEI CHAVEZ
K081059 04/14/2008 AEQUALIS REVERSED SHOULDER PROSTHESIS TORNIER DAMIEN GUILLAUD
K081065 04/15/2008 APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION 2.2 TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K080952 04/03/2008 15-INCH (38 CM) COLOR LCD MONITOR CDL1576A TOTOKU ELECTRIC CO., LTD MIKIO HASEGAWA
K080951 04/03/2008 19-INCH (48CM) 1.3M COLOR LCD MONITOR CDL1909A TOTOKU ELECTRIC CO., LTD MIKIO HASEGAWA
K081055 04/14/2008 21.3 (54CM) 2M COLOR LCD MONITOR CCL254I2 (CDL2125A) TOTOKU ELECTRIC CO., LTD. MIKIO HASEGAWA
K081056 04/14/2008 21.3 (54CM) 3M COLOR LCD MONITOR CCL354I2 (CDL2126A) TOTOKU ELECTRIC CO., LTD. MIKIO HASEGAWA
K081183 04/25/2008 WOUNDSTAT TRAUMACURE INC. CAMPBELL HUTTON
K081230 04/30/2008 TRAUSON INTRAMEDULLARY NAIL TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD. Diana Hong
K081063 04/14/2008 SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K080926 04/02/2008 AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER TRUDELL MEDICAL INTL. DARRYL FISCHER
K081150 04/23/2008 RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST TURKLAB MEDICAL DEVICES INC HILDA CIL
K080930 04/02/2008 MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS U-SYSTEM, INC. LISA SCOTT
DEN080006 04/11/2008 ULTHERA SYSTEM, MODEL 8850-0001 ULTHERA, INC. RANDALL E MILLER
K080935 04/02/2008 SONIX MDP ULTRASOUND SCANNER UltraSonix Medical Corporation ALAN REMFRY
K081201 04/28/2008 WBR XPRESS3.CARDIAC ULTRASPECT LTD. DAN LAOR
K080970 04/04/2008 USHIFU STEPPER USHIFU DEVELOPMENT COMPANY, LLC MARE RYAN
K081036 04/11/2008 4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS) VARIAN MEDICAL SYSTEMS, INC. VY TRAN
K081188 04/28/2008 TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE VARIAN MEDICAL SYSTEMS, INC. VY TRAN
K081147 04/22/2008 ISOFLOW INFUSION CATHETER VASCULAR DESIGNS INC. GRACE HOLLAND
K081076 04/16/2008 VELOCITYAIS, VELOCITY AI, VELOCITYVX, VELOCITYRT, V-RESPONSE VELOCITY MEDICAL SOLUTIONS, LLC PAUL SUMNER
K080983 04/07/2008 PROVENT NASAL CANNULA VENTUS MEDICAL, INC. CINDY DOMECUS
K081102 04/17/2008 VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM VISIONSENSE, LTD. GERARD J PRUD'HOMME
K081114 04/18/2008 G-1 V5 VITROLIFE SWEDEN AB KJELL KJORK
K081117 04/18/2008 G-2 V5 VITROLIFE SWEDEN AB KJELL KJORK
K081116 04/18/2008 G-IVF G5 SERIES VITROLIFE SWEDEN AB KJELL KJORK
K081115 04/18/2008 G-MOPS G5 SERIES VITROLIFE SWEDEN AB KJELL KJORK
K080939 04/03/2008 SURGICAL HANDPIECES, MIKRO SAW HANDPIECES W & H DENTALWERK BUERMOOS GMBH GABRIELE WIENBECK
K081184 04/25/2008 GORE VIABIL BILILARY ENDOPROSTHESIS W.L. GORE & ASSOCIATES INC, MEDICAL PRODUCTS DIV. Michael Ivey
K081069 04/15/2008 GORE INFINIT MESH W.L. GORE & ASSOCIATES,INC MICHAEL J TITUS
K081014 04/09/2008 SOYALA GEL VENTED WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG RALF EGENOLF
K080955 04/03/2008 ZEN PROGRAM (MIND 440 HEARING AID) WIDEX HEARING AID CO., INC. FRANCIS KUK
K081090 04/16/2008 PROFEMUR LX 5/8 COATED HIP STEM WRIGHT MEDICAL TECHNOLOGY, INC. RYAN ROSS
K081141 04/22/2008 COMBOCARE 2000 XANACARE TECHNOLOGIES, LLC ROBERT N CLARK
K081214 04/30/2008 STYLA MICROLASER AND STYLAORTHO ZAP LASERS, LLC JAY GOBLE
K081084 04/16/2008 COLORISE RIGID ZHERMACK S.P.A. GERALD W SHIPPS
K081007 04/08/2008 ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM ZIMMER, INC. BENJAMIN C CURSON
K080903 04/01/2008 ZOLL E SERIES WITH INTIBATION ASSIST OPTION ZOLL MEDICAL CORPORATION EILEEN M BOYLE
K081081 04/16/2008 ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS EILEEN M BOYLE


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