FDA 510(k) Decisions During May, 2008  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K081082 05/07/2008 U-CLIP UNI-FIRE, MODEL M65 MEDTRONIC INC. DAVID D COX
K080620 05/19/2008 MODIFICATION TO 3M TEGADERM CHG DRESSING 3M COMPANY-3M HEALTH CARE MARIA RUIZ
K063723 05/30/2008 IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM ABIOMED, INC. ROBERT T KUNG
K080401 05/09/2008 SHELL CAGE, WAVE CAGE, LOOP CAGE ADVANCED MEDICAL TECHNOLOGIES AG J.D. WEBB
K080590 05/06/2008 AOS PROXIMAL HUMERAL PLATE ADVANCED ORTHOPAEDIC SOLUTIONS, INC. PAUL DONER
K080584 05/09/2008 METHA SHORT STEM HIP SYSTEM AESCULAP IMPLANT SYSTEM, INC. KATHY A RACOSKY
K080547 05/23/2008 ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106 AESCULAP IMPLANT SYSTEM, INC. MATTHEW M HULL
K071983 05/01/2008 AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE AESCULAP IMPLANT SYSTEMS, INC. MATTHEW M HULL
K081031 05/05/2008 ENDOSCOPIC CLIP APPLIERS WITH CLIP MAGAZINE AESCULAP, INC. LISA BOYLE
K081104 05/02/2008 AESKULISA ANA HEP-2, REF 30-7115US AESKU.DIAGNOSTICS JIM RADFORD
K081251 05/13/2008 MODIFICATION TO AESKULISA DS DNA G AESKU.DIAGNOSTICS SASCHA PFEIFFER
K080994 05/16/2008 AMPLATZER TORQVUE EXCHANGE SYSTEM AGA MEDICAL CORP. MICHELLE NIVALA
K063583 05/09/2008 ALCON VISION SYSTEM ALCON TERRY J DAGNON
K072564 05/23/2008 ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM ALMA LASERS LTD. ANNE WORDEN
K072258 05/16/2008 BI-RADS COMPANION ALMEN LABORATORIES, INC. ROGER H SCHNEIDER
K080699 05/21/2008 NOVEL SPINAL SPACER SYSTEM ALPHATEC SPINE, INC. MARY STANNERS
K073078 05/30/2008 RAPID TOX CUP AMERICAN BIO MEDICA CORP. RICH REILLY
K080397 05/06/2008 AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM AMERICAN DENTAL IMPLANT CORPORATION GINA HENNON
K080400 05/13/2008 ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K081220 05/28/2008 MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER ANGIOSCORE, INC. KIMBERLEY KLINE
K080587 05/15/2008 EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE ANIMAS CORP. JENNIFER BOSLEY
K071915 05/14/2008 CPAP MASK ARCIMED LABORATORIES LLC PAUL DRYDEN
K072582 05/30/2008 PROVOX MICRON HME ATOS MEDICAL AB PAUL DRYDEN
K081154 05/23/2008 ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202 B-K MEDICAL APS JENS RASMUSSEN
K081109 05/02/2008 CORONIS 5MP MAMMO SL, MODEL MDMG 6121 BARCOVIEW, MEDICAL IMAGING SYSTEMS NEIL PHILLIPS
K063532 05/30/2008 BARD E LUMINEXX BILIARY STENT BARD PERIPHERAL VASCULAR, INC. LINDSAY K PACK
K072595 05/09/2008 OMNI-TIGHT BASIC DENTAL IMPLANT SYSTEMS, INC. RICH WEISKOPF
K073326 05/28/2008 NRG TRANSSEPTAL NEEDLE BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K080869 05/23/2008 ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC BECKMAN COULTER, INC. DAVID M IKEDA
K080998 05/12/2008 DORIPENEM 10UG BBL SENSI-DISC BECTON DICKINSON & CO. JANINE MATLAK
K080012 05/08/2008 PLATELIA LYME IGG ASSAY BIO-RAD FRAN WHITE
K080911 05/02/2008 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
K081143 05/02/2008 BIOMERS TRANSLUCENT ORTHODONTIC WIRE BIOMERS PRODUCT, LLC GEORGE ALIPHTIRAS
K081067 05/09/2008 FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) BIOMET MICROFIXATION, INC. KIM REED
K080646 05/02/2008 C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM BIOMET SPINE JACQUELYN A HUGHES
K080374 05/15/2008 BIOSYAG MEDICAL SYSTEM BIOS S.R.L. ALESSANDRO FRANCHI
K080988 05/07/2008 SCOUTPRO CS LEAD INTRODUCER SYSTEM BIOTRONIK, INC. JON BRUMBAUGH
K081253 05/15/2008 ZIRDENT CAD/CAM BLOCKS C5 MEDICAL WERKS, INC. HOMER GREGORY
K080954 05/16/2008 T34L SYRINGE DRIVER CAESAREA MEDICAL ELECTRONICS LTD. EVA PARTAS
K072456 05/08/2008 DESARA MESH SLING, MODEL CAL-DS01 CALDERA MEDICAL, INC. CHRISTINE EMANUEL
K080726 05/14/2008 CALYPSO 4D LOCALIZATION SYSTEM CALYPSO MEDICAL TECHNOLOGIES INC ERIC MEIER
K081257 05/29/2008 CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K073207 05/08/2008 OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167 CELON AG MEDICAL INSTRUMENTS LAURA STORMS-TYLER
K073213 05/28/2008 THERABOND ANTIMICROBIAL BARRIER SYSTEMS CHOICE THERAPEUTICS HOWARD M HOLSTEIN
K080452 05/15/2008 COLLAGEN TENDON WRAP COLLAGEN MATRIX, INC. PEGGY HANSEN
K080386 05/30/2008 COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE COLUMBIA SCIENTIFIC DEVELOPMENT LLC STEPHEN SHULMAN
K080752 05/14/2008 CONCEIVEX LATEX-FREE SEMEN COLLECTOR CONCEIVEX INC. BLIX WINSTON
K080936 05/12/2008 CONFORMIS TOTAL KNEE REPIAR SYSTEM (ITOTAL) TIBIAL COMPONENT: 6.0 MM THICKNESS CONFORMIS, INC. S. MICHAEL SHARP
K080946 05/20/2008 CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX CONMED ENDOSCOPIC TECHNOLOGIES, INC. BETH ZIS
K073454 05/05/2008 FINGERTIP PULSE OXIMETER, MODEL CMS-50C CONTEC MEDICAL SYSTEM CO., LTD. DIANA HONG
K080383 05/02/2008 AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C. MARILYN KONICKY
K080359 05/09/2008 EVOLUTION ESOPHAGEAL STENT SYSTEM COOK IRELAND LTD NOREEN BARRY
K080967 05/02/2008 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
K081169 05/23/2008 AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES TIM LOHNES
K080860 05/29/2008 CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM CREASPINE CYNTHIA J NOLTE
K080605 05/05/2008 SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL CURBELL ELECTRONICS INC. MICHAEL J WINTER
K080281 05/01/2008 PATHWAY CUSTOM SPINE, INC. SAAD ATTIYAH
K081181 05/05/2008 SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASER CYNOSURE, INC. GEORGE CHO
K080738 05/13/2008 DENTRON SENSOR DENTRON SYSTEMS LLC CLAUDE D BERTHOIN
K081291 05/22/2008 PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION DENTSPLY INTERNTIONAL HELEN LEWIS
K073281 05/02/2008 CAIS STAPLE DEPUY MITEK, A JOHNSON & JOHNSON COMPANY RUTH C FORSTADT
K081163 05/14/2008 SMARTSET GMV GENTAMICIN BONE CEMENT DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K081155 05/14/2008 SMARTSET MV BONE CEMENT DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K081252 05/30/2008 EXPEDIUM 4.5MM SPINE SYSTEM DEPUY SPINE, INC. CHRISTOPHER KLACZYK
K080313 05/08/2008 MODIFICATION TO EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. CHRISTOPHER KLACZYK
K073562 05/15/2008 MODIFICATION TO VIPER SPINE SYSTEM DEPUY SPINE, INC. CHRISTOPHER KLACZYK
K080568 05/01/2008 X-MESH EXPANDABLE CAGE SYSTEM DEPUY SPINE, INC. HANDE TUFAN
K081162 05/08/2008 TEMPTOUCH DERMAL THERMOMETER DIABETICA SOLUTIONS, INC. J.S. ALLINSON
K070104 05/07/2008 PROLYTE ELECTROLYTE ANALYZER DIAMOND DIAGNOSTICS, INC. RANDOLPH QUINN
K072290 05/29/2008 PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS DIMA ITALIA SRL LEWIS WARD
K073070 05/16/2008 DIO BIOTITE-H IMPLANT SYSTEM DIO DEPARTMENT DSI, INC. STEVE CHANG
K080129 05/30/2008 SECURE IMPLANT SYSTEM (2.5/3.0MM) DIO DEPARTMENT DSI, INC. HYUNGICK KIM
K080128 05/14/2008 SM-EXTRA WIDE (RBM) IMPLANT SYSTEM DIO DEPARTMENT DSI, INC. HYUNGICK KIM
K080479 05/21/2008 DENTAL CERAMIC DMG USA, INC. PAMELA PAPINEAU
K080480 05/30/2008 NANOCOMPOSITE RESTORATIVE KIT DMG USA, INC. PAMELA PAPINEAU
K080385 05/13/2008 CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR E1 ENT., INC. JACK CHENG
K073415 05/23/2008 NEMUS SYSTEM; NEMUS PC PERIPHERAL EB NEURO, S.P.A. ALLISON SCOTT
K073711 05/30/2008 MUCOGRAFT COLLAGEN MATRIX ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE PETER S REICHERTZ
K072399 05/23/2008 DEL SOL RED LIGHT THERAPY SYSTEM EDGE SYSTEMS, INC. GARY MOCNIK
K081093 05/01/2008 3-D IMAGING WORKSTATION EIGEN LLC MARK A HOFFMAN
K080250 05/13/2008 LEKSELL SURGIPLAN, MODEL 1006947 ELEKTA INSTRUMENT AB PETER LOWENDAHL
K072536 05/07/2008 ESA BIOSCIENCES INC. VITAMIN D HPLC TEST ESA BIOSCIENCES INC. HAROLD ASP
K080839 05/21/2008 ECHELON GRAY CARTRIDGE, MODEL ERC45M ETHICON ENDO-SURGERY, LLC RUTH ANN WOOD
K071512 05/15/2008 GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS ETHICON, INC. BRYAN A LISA
K081274 05/28/2008 SURESKIN SILVER BANDAGES EUROMED, INC. SUBHASH CHANDER
K080980 05/06/2008 EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS EXACTECH, INC. XAVIER SARABIA
K073675 05/08/2008 T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP GAYMAR INDUSTRIES, INC. BETHANY J GILBERT
K071889 05/19/2008 DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE GE HEALTHCARE JOEL C KENT
K081105 05/09/2008 GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0) GE HEALTHCARE ANDREW MENDEN
K073543 05/02/2008 OEC 9900 ELITE GE OEC MEDICAL SYSTEMS MARIA C FRAME
K080662 05/15/2008 GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR GENZYME CORPORATION ERIC LAWSON
K081195 05/28/2008 REVERE UNIPLANAR SCREWS GLOBUS MEDICAL INC. KELLY J BAKER
K080937 05/23/2008 POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE GX CORPORATION SDN BHD FOO K PU
K080093 05/02/2008 PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK GYRUS ACMI, INC. TERRENCE E SULLIVAN
K080818 05/15/2008 HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING HEMCON MEDICAL TECHNOLOGIES, INC. KEVIN HAWKINS
K081179 05/09/2008 MAMMOSITE CAVITY EVALUATION DEVICE HOLOGIC, INC. RANDALL J COVILL
K081278 05/29/2008 OMEGA 3 TROCHANTERIC STABILIZING PLATE HOWMEDICA OSTEONICS CORP. ANDREA DWYER
K081217 05/22/2008 HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM HYCOR BIOMEDICAL, INC. P. NARAYAN NAYAK
K080424 05/28/2008 HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861 HYGIA HEALTH SERVICES, INC. JEROME JAMES
K080007 05/13/2008 GRADUATED ADAPTER WITH CLAVE ICU MEDICAL, INC TRACY BEST
K080989 05/02/2008 UNIVERSAL VIAL ACCESS SPIKE ICU MEDICAL, INC TRACY BEST
K080762 05/15/2008 IB NEURO, VERSION 1.0 IMAGING BIOMETRICS, LLC MICHAEL SCHMAINDA
K080713 05/16/2008 REACTIVE DENTAL IMPLANT SYSTEM IMPLANT DIRECT LLC THOMAS GOTTENBOS
K081347 05/28/2008 ILUMA VISION IMTEC CORP. BRAD VANCE
K073217 05/14/2008 INCLUSIVE IMPLANT ABUTMENTS INCLUSIVE DENTAL SOLUTIONS KEITH D ALLRED
K081136 05/08/2008 LYRIC HEARING AID INSOUND MEDICAL INC. SUSAN WHICHARD
K081186 05/23/2008 CONCAVE RN HEALING CAP INSTITUT STRAUMANN AG ELAINE ALAN
K081005 05/02/2008 P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS INSTITUT STRAUMANN AG ELAINE ALAN
K073377 05/04/2008 ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K072863 05/23/2008 ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES INTERNACIONAL FARMACEUTICA, S.A. DE C.V. ALLAN P SCHWARTZ
K072859 05/23/2008 ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES INTERNACIONAL FARMACEUTICA, S.A. DE C.V. ALAN P SCHWARTZ
K080598 05/21/2008 MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS INTRA-LOCK INTERNATIONAL JEFFREY SAKOFF
K080575 05/13/2008 CORRIDOR4DM INVIA F. DAVID ROTHKOPF
K080427 05/23/2008 WATCH-PAT MODEL 100S-2 ITAMAR MEDICAL JONATHAN KAHAN
K080618 05/23/2008 DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID JAS DIAGNOSTICS, INC. SAMUEL BURGOS
K080759 05/12/2008 THERMOFLASH LX-26 JXB CO. LTD GUANGZHOU (CHINA) TRAY CUI
K072410 05/09/2008 KSEA CLEARVISION II, MODEL 40334120 KARL STORZ ENDOSCOPY-AMERICA, INC. CRYSTAL DIZOL
K081120 05/01/2008 FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS KETTENBACH GMBH & CO KG MICHAELA ZINKE
K080159 05/22/2008 KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. HEATHER VIELE
K080140 05/09/2008 LAURIMED SPINAL INJECTION SYSTEM LAURIMED LLC NANCY LINCE
K080158 05/02/2008 LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM LB MEDICAL L.L.C. TERRY SHERIDAN POWELL
K080728 05/29/2008 LDR SPINE ROI-C IMPLANT LDR SPINE USA NOAH BARTSCH
K080569 05/07/2008 LDR SPINE ROI-T IMPLANT LDR SPINE USA NOAH BARTSCH
K080612 05/09/2008 LEICA FL800 LEICA MICROSYSTEMS (SCHWEIZ) AG COLLEEN BOSWELL
K080767 05/21/2008 CONQUEST SPINAL SYSTEM LIFE SPINE REBECCA M BROOKS
K080411 05/15/2008 PLATEAU SPACER SYSTEM LIFE SPINE REBECCA M BROOKS
K073411 05/13/2008 LITEDUO LIGHT INSTRUMENTS YORAM LEVY
K080029 05/16/2008 MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM MAKO SURGICAL CORP. WILLIAM F TAPIA
K080439 05/16/2008 SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE MALLINCKRODT DEVELOPPEMENT FRANCE TINA DREILING
K073592 05/07/2008 OPTISTAR ELITE INJECTION SYSTEM MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS DALE MOORE
K080238 05/12/2008 MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER MASIMO CORPORATION MARQUERITE THOMLINSON
K080764 05/06/2008 SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100 MAX ENDOSCOPY INC. RICHARD M WOLF
K073467 05/23/2008 SPINEASSIST SYSTEM MAZOR SURGICAL TECHNOLOGIES LTD. AHAVA STEIN
K080742 05/09/2008 VERISUITE 1.6, VERISUITE-PARTICLE 1.6 MEDCOM GMBH STEFAN WALTER
K081066 05/05/2008 BRACHYTHERAPY SOURCE DEVICE, MODEL 9011 MEDI-PHYSICS, INC., DBA GE HEALTHCARE DAVID RISLEY
K071642 05/02/2008 MEDIAID M960 SERIES, VITAL SIGNS MONITOR AND MEDIAID M900 SERIES, PULSE OXIMETER MEDIAID INC. JAYESH PATEL
K080582 05/15/2008 MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA MEDICATECH USA DANIEL KAMM
K073051 05/30/2008 MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY MEDRAD, INC. LESLIE S O'NAN
K080509 05/05/2008 CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE MEDTRONIC INC. PREETI JAIN
K080824 05/07/2008 BIO-CONSOLE 560 MEDTRONIC PERFUSION SYSTEMS PREETI JAIN
K080462 05/13/2008 PROGENIX DBM PUTTY MEDTRONIC SOFAMOR DANEK MICHELLE OBENAUER
K073285 05/15/2008 PEEK PREVAIL CERVICAL INTERBODY DEVICE MEDTRONIC SOFAMOR DANEK USA, INC. MICHAEL SCOTT
K080257 05/22/2008 MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS MEDTRONIC XOMED, INC. JAYME WILSON
K072251 05/08/2008 MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM MERETE MEDICAL GMBH DONNA COLEMAN
K080556 05/02/2008 ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES MERZ DENTAL GMBH RICHARD G HUNTER, M.S., RAC
K080981 05/02/2008 EAR THERMOMETER, MODELS ST66 AND ST67 MESURE TECHNOLOGY CO.,LTD. JOHN CHEN
K080655 05/09/2008 CHRYSALIS META IMAGING SOLUTIONS, LLC ROBERT J STAAB
K080337 05/13/2008 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MQ1-2D MICROLIFE CORP. SUSAN D GOLDSTEIN-FALK
K080437 05/08/2008 MICRUS MICROCOIL SYSTEM, "DELTAPAQ 10 CERECYTE", MODEL CDF MICRUS ENDOVASCULAR CORPORATION PATRICK LEE
K080328 05/14/2008 MPS ACACIA ENTERAL FEEDING TUBE MPS ACACIA FERGIE FERGUSON
K080168 05/16/2008 SHUNTCHECK - CSF SHUNT FLOW DETECTOR NEURO DIAGNOSTIC DEVICES FREDERICK J FRITZ
K072259 05/06/2008 OPHTHALMOSCOPE F-10 NIDEK CO., LTD. PAUL SUMNER
K080177 05/09/2008 WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV NIHON SEIMITSU SOKKI CO., LTD. KOJI KOBO
K080255 05/23/2008 NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER NONIN MEDICAL, INC. LORI M ROTH
K081118 05/02/2008 NORAS MR-BI320-PA 1.5T NORAS MRI PRODUCTS GMBH MARTIN HEMPEL
K080515 05/16/2008 FMRI HARDWARE SYSTEM NORDICNEUROLAB STIAN SCISLY SAGEVIK
K081009 05/20/2008 NEUTROPHASE NOVABAY PHARMACEUTICALS SHEILA W PICKERING
K080009 05/06/2008 NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT NOVABONE PRODUCTS, LLC DAVID M GAISSER
K081281 05/20/2008 OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY) NUCLETRON CORPORATION LISA DIMMICK
K080934 05/28/2008 VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET NUCLETRON CORPORATION LISA DIMMICK
K080115 05/30/2008 I-MINI DENTAL IMPLANT OCO BIOMEDICAL KEVIN WALLS
K081185 05/02/2008 MOBLVAC W.C. OHIO MEDICAL CORPORATION DAVID PLATT
K080187 05/09/2008 OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS OLSEN MEDICAL JOHN P WATERS
K080586 05/06/2008 OLYMPUS XCHF TYPE B180Y1 OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K080403 05/20/2008 XTJF TYPE Q160VF1 OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORM-TYLER
K080065 05/02/2008 OSFERION OLYMPUS TERUMO BIOMATERIALS CORPORATION LAURA STORMS-TYLER
K080842 05/23/2008 APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES] OMNI LIFE SCIENCE, INC. WILLIAM MCCALLUM
K080202 05/08/2008 ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT ONCOBIONICS, INC. PAUL MIKUS
K080631 05/23/2008 CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER ORAL HEALTH TECHNOLOGIES, LLC ROBERT E TRICCA
K080648 05/07/2008 TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE ORE-MEDIX, LLC DONALD F GRABARZ
K080694 05/15/2008 OSTEOMED MODULAR LOCKING FIXATION SYSTEM OSTEOMED L.P. PIEDAD PENA
K081035 05/30/2008 AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2 OSYPKA MEDICAL, INC. MARKUS OSYPKA
K080654 05/08/2008 PAJUNK'S KIT FOR BALLOON AIDED LAPAROSCOPY PAJUNK GMBH MEDIZINTECHNOLOGIE CHRISTIAN QUASS
K080674 05/09/2008 PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM PAJUNK GMBH MEDIZINTECHNOLOGIE CHRISTIAN QUASS
K081416 05/29/2008 PALOMAR ASPIRE LASER PLATFORM PALOMAR MEDICAL PRODUCTS, INC. SHARON TIMBERLAKE
K080963 05/02/2008 DSS STABILIZATION SYSTEM PARADIGM SPINE JUSTIN EGGLETON
K073362 05/23/2008 MROPEN PARAMED SRL MICHAEL A DOUGLAS
K080549 05/13/2008 DURAFINISH ALL-CURE, MODEL S296 PARKELL, INC. DANIEL R SCHECHTER, ESQ
K080161 05/29/2008 PASPORT OPTICAL TROCAR, VORTEX SEAL, BLUNT TIP TROCAR, SHIELDED TROCAR, CANNULA ANCHOR PATTON SURGICAL CORP. MICHAEL PATTON
K072300 05/16/2008 POWDER FREE NATURAL RUBBER LOW MODULUS LATEX PATIENT EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM PERUSAHAAN PELINDUNG GETAH (M) SDN BHD THOMAS N TILLOTSON
K080999 05/09/2008 PAGEWRITER CARDIOGRAPH PHILIPS MEDICAL SYSTEMS PAUL SCHRADER
K081203 05/28/2008 OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00 PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH MICHAEL ASMALSKY
K073477 05/09/2008 PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS PHOTONOVA OFSWEDEN AB CONNIE HOY
K073177 05/13/2008 PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM PIONEER SURGICAL TECHNOLOGY JONATHAN M GILBERT
K080165 05/14/2008 SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY) PLATINUM GLOVE INDUSTRIES SDN.BHD. SO SOON CHEAW
K081030 05/02/2008 MODIFICATION TO PROFLU+ ASSAY PRODESSE, INC. KAREN HARRINGTON
K081040 05/20/2008 POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE PT. SHAMROCK MANUFACTURING CORP. EMMY TJOENG
K080256 05/09/2008 PULMODYNE CHF FLOW GENERATOR SYSTEM PULMODYNE PAUL DRYDEN
K080307 05/01/2008 PROCHEM INDICATOR TAPE RAVEN LABORATORIES WENDY ROYALTY-HANN
K070412 05/21/2008 ELEXOMA MEDIC REDPLANE AG JAEN LABUSCHAGNE
K070463 05/07/2008 REVERA WOUND CARE, MODEL MDW0060 REVALESIO CORPORATION GREG J ARCHAMBEAU
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