FDA 510(k) Decisions During August, 2007  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K071852 08/29/2007 AAP APS SYSTEM AAP IMPLANTATE AG MARC SEEGERS
K071531 08/22/2007 MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM ACCURAY INCORPORATED ANNE SCHLAGENHAFT
K071944 08/09/2007 ACUMED SMALL BONE LOCKING SYSTEM II ACUMED LLC ED BOEHMER
K070158 08/23/2007 R-PORT LAPAROSCOPIC ACCESS DEVICE ADVANCED SURGICAL CONCEPTS TANYA KAVANAGH
K070981 08/21/2007 SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (PLASMAPORE) AESCULAP IMPLANT SYSTEMS, INC. LISA BOYLE
K071699 08/15/2007 AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022 AGA MEDICAL CORP. JODI L RAUS
K071682 08/15/2007 CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER) ALARA, INC. ROBERT LUNDBERG
K062865 08/23/2007 SMALL VOLUME SYRINGE ALCON LABORATORIES SEAN P GRIFFIN
K072285 08/30/2007 ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM ALOKA CO., LTD. RICHARD J CEHOVSKY
K071380 08/20/2007 MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM ALPHATEC SPINE, INC. PAULA MORGAN
K072234 08/23/2007 THERMOGARD XP THERMAL REGULATION SYSTEM ALSIUS CORP. KENNETH A COLLINS
K071213 08/10/2007 CAMLOG LOGFIT PROSTHETIC SYSTEM ALTATEC GMBH FLOYD G LARSON
K063323 08/15/2007 SPECTROLYSE PAI-1, MODEL 101201 AMERICAN DIAGNOSTICA, INC. DAVID TEICHER
K071902 08/24/2007 AMS MINIARC SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC. BRAD ONSTAD
K072196 08/27/2007 ANGIODYNAMICS, INC MORPHEUS PICC AND PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K071959 08/01/2007 ANGIODYNAMICS, INC.NEVERTOUCH 600UM FIBER AND VENACURE PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K063771 08/09/2007 GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM ARKRAY FACTORY USA, INC. TOM SPEIKERS
K071538 08/30/2007 ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER ARROW INTERNATIONAL, INC. KIRSTEN STOWELL
K071032 08/20/2007 ARTHREX UNIVERS II SHOULDER PROSTHESIS ARTHREX, INC. NANCY HOFT
K071978 08/15/2007 MINI TIGHTROPE FT REPAIR KIT ARTHREX, INC. SALLY FOUST
K071176 08/03/2007 MODIFICATION TO: ARTHREX INTERFERENCE SCREW ARTHREX, INC. ANN WATERHOUSE, RAC
K072089 08/17/2007 ARTHROCARE SPINEWAND ARTHROCARE CORP. VALERIE DEFIESTA-NG
K071709 08/07/2007 ARTHROCARE SYSTEM 12000 ARTHROCARE CORP. VALERIE DEFIESTA-NG
K071963 08/07/2007 MODIFICATION TO: ARTHROCARE ARTHROWANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K071374 08/02/2007 OPUS TWINLOCK KNOTLESS FIXATION DEVICE ARTHROCARE CORP. LAURA N KASPEROWICZ
K070034 08/17/2007 REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES ASCENT HEALTHCARE SOLUTIONS KATIE BRAY
K070036 08/17/2007 REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES ASCENT HEALTHCARE SOLUTIONS KATIE BRAY
K071451 08/01/2007 TATTOOSTAR Y ASCLEPION LASER TECHNOLOGIES GMBH ANTJE KATZER
K070795 08/31/2007 SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM ATCOR MEDICAL PTY. LTD EVAN P PHELPS
K071923 08/14/2007 PTFE FLIXENE GRADUATED WALL GRAFT ATRIUM MEDICAL CORP. KAREN HALL
K071459 08/16/2007 B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES B. BRAUN MEDICAL, INC. CHRISTINE FORD
K071518 08/17/2007 DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS B. BRAUN MEDIZINTECHNOLOGIE GMBH SUSAN OLINGER
K071793 08/03/2007 CONVERTIBLE I-SERIES POSITIONING AND TRANSFER CHAIR BARTON MEDICAL CORP. LAWRENCE W SWOL
K071266 08/15/2007 BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS BAUSCH & LOMB, INC. MICHAEL A SANTALUCIA
K071043 08/02/2007 BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES BAUSCH & LOMB, INC. DEBRA KETCHUM
K070163 08/03/2007 SWABBABLE CAP, MODEL 60205 BAXA CORP. KIMBERLY ZIZIK
K071623 08/20/2007 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, AMPICILLIN-SULBACTAM (GN) 1/0.5-32/16 UG/ML BECTON, DICKINSON & CO. VICKI K WHITLEY
K070371 08/13/2007 FINGERTIP PULSE OXIMETER MD300C BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. DIANA HONG
K062854 08/06/2007 BENZ-G 4X HIOXIFILCON D BENZ RESEARCH AND DEVELOPMENT CORP. ARTHUR J WARD
K072127 08/31/2007 DOMINATOR BIOCOMPOSITES LTD. SIMON FITZER
K071952 08/14/2007 GRAFTLOCK SCREW, ST SCREW BIOCOMPOSITES LTD. SIMON FITZER
K072106 08/30/2007 150W CERALAS D 980NM DIODE LASER BIOLITEC, INC. JONATHAN S KAHAN
K071551 08/30/2007 QUICKBRIDGE TM CYLINDER AND CAP BIOMET 3I, INC. DIANA TAYLOR
K071377 08/06/2007 POLARIS BE RODS BIOMET SPINE DEBRA BING
K070389 08/09/2007 PEEK KNOTLESS ANCHORS BIOMET SPORTS MEDICINE, INC. SUSAN ALEXANDER
K071863 08/31/2007 ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS) BIORETEC LTD MARI RUOTSALAINEN
K071328 08/31/2007 VISUALASE THERMAL THERAPY SYSTEM BIOTEX, INC. MATTHEW FOX
K070002 08/17/2007 BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER BOSTONSCIENTIFIC NICHOLAS CONDAKES
K070201 08/01/2007 BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001 C.R. BARD, INC. MICHELLE GUDITH
K071469 08/15/2007 INOLASE SERENITY PSF ( PNEUMATIC SKIN FLATTENING) SYSTEM CANDELA CORP. JEFFREY ROBERTS
K071648 08/22/2007 EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS CANTERBURY SCIENTIFIC LTD. MAURICE OWEN
K072119 08/10/2007 AIRLIFE NEBULIZER CAP CARDINAL HEALTH SHARON NICHOLS
K071350 08/22/2007 DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM CARDIOVASCULAR SYSTEMS, INC. MICHAEL J KALLOK
K071427 08/30/2007 DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS CARDIOVASCULAR SYSTEMS, INC. CINDY SETUM
K072210 08/24/2007 CHISON, MODEL 8300 CHISON MEDICAL IMAGING CO., LTD. DIANA HONG
K070627 08/02/2007 OPACIDEN SOLUTION CIDEN TECHNOLOGIES LLC LISA S JONES
K071496 08/15/2007 ICATH, STERILESURE COLORADO CATHETER COMPANY, INC. DOUG WILSON
K071172 08/22/2007 MODIFIED MERCI RETRIEVER, MODEL 90060 CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K070376 08/20/2007 CONMED LINVATEC 300W XENON LIGHT SOURCE CONMED LINVATEC ELIZABETH M PAUL
K070780 08/21/2007 CONMED LINVATEC XO BUTTON CONMED LINVATEC JOY LOVETT
K071461 08/21/2007 MODEL 300D HOME OXYGEN LIQUEFIER COPD PARTNERS, INC. PAUL DRYDEN
K071520 08/10/2007 RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X CORE ESSENCE ORTHOPAEDICS, LLC SHAWN T HUXEL
K071477 08/15/2007 REVERTO 55 AND 37 SHAPE MEMORY STAPLES CORE ESSENCE ORTHOPAEDICS, LLC SHAWN T HUXEL
K070918 08/22/2007 4DDOME COUSIN BIOTECH PAUL DRYDEN
K070272 08/03/2007 NEUROPORT ELECTRODE CYBERKINETICS NEUROTECHNOLOGY SYSTEMS, INC. GARY SYRING
K071767 08/04/2007 DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A DADE BEHRING, INC. PAMELA A JURGA
K071811 08/24/2007 ETOH FLEX REAGENT CARTRIDGE (DF22) DADE BEHRING, INC. VICTOR M CARRIO
K071317 08/20/2007 MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-GENTAMICIN SYNERGY SCREEN DADE BEHRING, INC. ROBERT EUSEBIO
K071316 08/20/2007 MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN DADE BEHRING, INC. ROBERT EUSEBIO
K071247 08/08/2007 N LATEX RF KIT DADE BEHRING, INC. HELEN LEE
K071834 08/17/2007 STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM DADE BEHRING, INC. GEORGE M PLUMMER
K072147 08/30/2007 DEN TEK COMFORT FIT NIGHTGUARD DEN TEK ORAL CARE, INC. HOWARD HOLSTEIN, ESQ.
K072052 08/08/2007 OSTEOGRAF/D-300 DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K072056 08/06/2007 OSTEOGRAF/D-700 DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K072057 08/06/2007 OSTEOGRAF/LD-300 DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K072058 08/03/2007 MODIFICATION TO: OSTEOGRAF/N-700 DENTSPLY INTERNTIONAL HELEN LEWIS
K071481 08/09/2007 HEALIX ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON COMPANY RUTH FORSTADT
K070267 08/17/2007 DEPUY GCK TIBIAL COMPONENTS DEPUY ORTHOPAEDICS, INC. NANCY FRIDDLE
K071417 08/02/2007 DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K071860 08/01/2007 MODIFICATION TO: VIPER SPINE SYSTEM DEPUY SPINE, INC. CHRISTOPHER KLACZYK
K070206 08/30/2007 DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 DIAGNOSTIC HYBRIDS, INC. GAIL GOODRUM
K071039 08/08/2007 MISSION OLYMPUS AU ISE CALIBRATORS DIAMOND DIAGNOSTICS, INC. KATHRYN THORSEN
K071299 08/31/2007 IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP DIGITAL HEALTHCARE, LTD. GERRY SKEWS
K070117 08/06/2007 SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC DOLOMITE BIOTECH SDN BHD TIMOTHY LIEW
K072353 08/30/2007 PORTABLE ECSCOPE DYANSYS CORP SRINI NAGESHWAR
K071168 08/31/2007 THE PORTABLE ANSISCOPE DYANSYS, INC. MICHAEL A DANIEL
K071080 08/31/2007 ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL EP 211M E SURGICAL, LLC HANS J RICHTER
K071722 08/10/2007 DEEP BLUE E.M.S. ELECTRO MEDICAL SYSTEMS S.A. CYNTHIA J.M. NOLTE
K063620 08/06/2007 EKOS MICRO-INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K071933 08/10/2007 ENDOWAVE INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K063453 08/30/2007 VERTEFIX PEDICLE SCREW SPINAL SYSTEM ELITE SURGICAL SUPPLIES (PTY) LTD. CHARISE DE BARRIOS
K060980 08/16/2007 VENDYS MODEL 5000 B/BC ENDOTHELIX, INC. DOUGLAS BLAKELY
K071996 08/03/2007 MYLAB30, MODEL 7300 ESAOTE S.P.A. ALLISON SCOTT
K070151 08/15/2007 INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER ETHICON ENDO-SURGERY, LLC KIMBERLY SHOEMAKER
K071320 08/17/2007 EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311 EVERLIFE MEDICAL EQUIPMENT CO., LTD. JEN KE-MIN
K071738 08/15/2007 EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER EXACTECH, INC. AMNON TALMOR
K071775 08/07/2007 DASH EZSURGICAL KEVIN WALLS
K063447 08/16/2007 INSIGHT DISCOVERY FASSTECH LEE BRODY
K070209 08/08/2007 FB-100U SERIES DIGITAL BLOOD PRESSURE MONITOR FEGO PRECISION INDUSTRIAL CO; LTD JENNIFER REICH
K070135 08/16/2007 VITRIFREEZE MEDIUM; VITRITHAW MEDIUM FERTI PRO N.V. GRACE HOLLAND
K071858 08/31/2007 DENTAL MATRIX BAND FLY CAST TECHNOLOGIES, INC. MICHELE H VOVOLKA
K070820 08/01/2007 ARCHITECT TACROLIMUS: MODEL 1L77 FUJIREBIO DIAGNOSTICS, INC. DIANA DICKSON
K071079 08/02/2007 SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200 GAMBRO BCT, INC. PATTI L ARNDT
K071674 08/09/2007 GC-ZIRCONIA GC AMERICA, INC. TERRY L JORITZ-LYONS
K071828 08/06/2007 LULLABY GE HEALTHCARE CLINICAL SYSTEMS THALIA BRINE
K071985 08/17/2007 GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND GENERAL ELECTRIC CO. ALLEN SCHUH
K072075 08/29/2007 MODIFICATION TO GE LOGIQ A3 GENERAL ELECTRIC CO. ALLEN SCHUH
K071274 08/24/2007 GSO GS1 SPACER GOLD STANDARD ORTHOPEDICS LLC DAVID BAUGHMAN
K071908 08/23/2007 DOCTOR'S LIGHT LED DENTAL CURING LIGHT GOOD DOCTORS CO., LTD. IAN P GORDON
K070419 08/31/2007 OPACIDEN OPA REAGENT STRIPS HACH COMPANY DAVID A MORRIS
K070630 08/31/2007 HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION SET WITH CHECK VALVE HEALTH LINE INTERNATIONAL CORPORATION (HLIC) DENICE WROE
K072104 08/17/2007 HEARTWAY POWER MOBILITY SCOOTER, PF6 HEARTWAY MEDICAL PRODUCTS CO., LTD. HSIANG-PIN HUANG
K071519 08/06/2007 HEMCON CHITOFLEX-SURGICAL DRESSING HEMCON, INC. KEVIN HAWKINS
K071207 08/07/2007 MASTER GUARD NITRILE BLUE POWDERED EXAMINATION GLOVES HIGH MOMENTUM SDN BHD HUE K FAH
K071806 08/28/2007 ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUGLAS THISTLETHWAITE
K071991 08/15/2007 MODIFICATION TO SCORPIO NRG KNEE SYSTEM HOWMEDICA OSTEONICS CORP PATRICIA SETTI-LAPERCH
K071894 08/16/2007 XEBRA DICOM IMAGE BROWSER HX TECHNOLOGIES, INC. CARL ALLETTO
K071470 08/31/2007 IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX IMPLANTECH ASSOCIATES INC. STEPHEN MEADE
K071464 08/03/2007 INION HEXALON BIODEGRADABLE ACL/PCL SCREW INION OY KATI MARTTINEN
K071225 08/31/2007 INNOVASA STAT*SEAL TOPICAL HEMOSTAT INNOVASA, INC. ROBERTA HINES
K071943 08/10/2007 SERENITY PRO PSF SYSTEM INOLASE 2002, LTD. GEORGE J HATTUB
K072071 08/15/2007 STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPS INSTITUT STRAUMANN AG ELAINE ALAN
K070549 08/31/2007 STRAUMANN P.004 RC GOLD ABUTMENT INSTITUT STRAUMANN AG ELAINE ALAN
K071771 08/02/2007 INSTRUMED RETRACTORS INSTRUMED INTERNATIONAL, INC. MICHAEL MASSONG
K070005 08/15/2007 HEMOSIL RECOMBIPLASTIN 2G INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K072207 08/23/2007 DURAGEN XS DURAL REGENERATION MATRIX INTEGRA LIFESCIENCES CORP. PETER ALLAN
K071505 08/06/2007 MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM INTEGRA LIFESCIENCES CORPORATION JON CAPAROTTA
K071669 08/17/2007 INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP INTEGRA RADIONICS, INC. KEVIN J O'CONNELL
K071035 08/13/2007 IFS BONE FIXATION DEVICES INTERNAL FIXATION SYSTEMS, INC. STEVE HERNANDEZ
K071637 08/03/2007 INTRINSIC THERAPEUTICS FIXATION STAPLE INTRINSIC THERAPEUTICS INCORPORATED KRISHNA UPPUGONDURI
K061880 08/15/2007 ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC ISOTIS NV ELAINE SCHUTTE
K071848 08/30/2007 IPS INLINE POM SYSTEM IVOCLAR VIVADENT, INC. DONNA M HARTNETT
K071636 08/09/2007 CODIAGNOSTIX (R) 5.72 IVS SOLUTIONS AG FRANK STOCKMANN
K071190 08/17/2007 ROOT ZX II J. MORITA USA, INC. ROBERT A SILVERMAN
K071884 08/09/2007 BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900 JAWON MEDICAL CO., LTD. HL JUNG
K071857 08/08/2007 DELTA SPINAL FUSION SYSTEM JEMO SPINE, LLC PATRICK MOORE
K071710 08/14/2007 BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) JOHNSON & JOHNSON CONSUMER PRODUCTS, INC. DAGMAR OETTE
K071530 08/24/2007 KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM KARL STORZ ENDOSCOPY-AMERICA, INC. SUSIE CHEN
K070579 08/30/2007 STORZ SLX-F2 STORM TOUCH KARL STORZ ENDOSCOPY-AMERICA, INC. PAUL S LEE
K072195 08/23/2007 THROMCAT THROMBECTOMY CATHETER SYSTEM KENSEY NASH CORP. CINDY R VARUGHESE
K070360 08/07/2007 KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601 KIRWAN SURGICAL PRODUCTS, INC. KEVIN P PRARIO
K070828 08/15/2007 KD-595 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., LIU YI
K070826 08/15/2007 KD-795 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., LIU YI
K072027 08/20/2007 FORU KV10HB KWANG YANG MOTOR CO., LTD. JUNNATA CHANG
K071685 08/06/2007 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES LANGFANG HUILONG PLASTIC PRODUCT CO., LTD. CHU XIAOAN
K071686 08/22/2007 POWDERED VINYL PATIENT EXAMINATION GLOVES LANGFANG HUILONG PLASTIC PRODUCT CO., LTD. CHU XIAOAN
K071633 08/15/2007 LANX DEFORMITY SYSTEM LANX, LLC JANICE HOGAN
K070341 08/08/2007 LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM LDR SPINE USA JAMES BURROWS
K072132 08/30/2007 LDR SPINE ROI-T SYSTEM LDR SPINE USA JAMES BURROWS
K071367 08/29/2007 FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05 LEMAITRE VASCULAR, INC. MINNIE MILDWOFF
K072037 08/08/2007 CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML LIFE-SHIELD PRODUCTS, INC ROSINA ROBINSON
K071751 08/27/2007 LIFESYNC ADAPTER, MODEL LS-302 LIFESYNC CORPORATION DIANE SUDDUTH
K071761 08/03/2007 LLOYD LINDEN, MODEL E04 LLOYD LINDEN, INC. JUNNATA CHANG
K061828 08/24/2007 LORENZ BIOTECH APTIVA, VERSION 2.13 LORENZ BIOTECH S.P.A. ROSINA ROBINSON
K071529 08/10/2007 XTRACT CATHETER SYSTEM LUMEN BIOMEDICAL, INC. MARIA E BRITTLE
K062974 08/13/2007 TESLA NIBP MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN GMBH ROBERT N CLARK
K072172 08/31/2007 JOSTRA PEDIATRIC ARTERIAL PREFUSION CANNULAE MAQUET CARDIOPULMONARY AG KATRIN SCHWENGLENKS
K070625 08/01/2007 PELVIMESH / HERMESH 7 MARKETING SOLUTIONS INC. LORENA TRABUCCO
K063607 08/23/2007 SPINEASSIST SYSTEM MAZOR SURGICAL TECHNOLOGIES LTD. AHAVA STEIN
K070057 08/30/2007 EASYRA CLINICAL CHEMISTRY ANALYZER MEDICA CORP. PHOTIOS MAKRIS
K072079 08/14/2007 IGUIDE SYSTEM MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA MICHAEL WOLFF
K071094 08/13/2007 MODIFICATION TO SOLAR GI MEDICAL MEASUREMENT SYSTEMS,B.V. KARIN OGINK-SOMHORST
K072040 08/03/2007 C-JAWS CERVICAL COMPRESSIVE MINI FRAME MEDICREA TECHNOLOGIES J.D. WEBB
K071167 08/31/2007 FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560 MEDIGROUP, INC. JOHN A NAVIS
K071960 08/03/2007 MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05 MEDITECH KFT. BENNY ARAZY
K071341 08/03/2007 MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 MEDIVANCE, INC. LYNNE ARONSON
K063836 08/16/2007 RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715 MEDTRONIC NEUROSURGERY JEFFREY HENDERSON
K071033 08/14/2007 T2 XVBR SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK CHRISTINE SCIFERT
K072205 08/29/2007 VISAGE PACS/CS, RELEASE VERSION 5.0 MERCURY COMPUTER SYSTEMS, INC MARTIN GABLER
K071548 08/21/2007 WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED MERZ DENTAL GMBH RICHARD G HUNTER
K071137 08/01/2007 SONICATOR PLUS 940, MODEL ME940 METTLER ELECTRONICS CORP. ROB FLEMING
K070023 08/15/2007 MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-100 MICROSURGEON, INC. DUDLEY HARRIS
K063671 08/16/2007 REBOUND HRD MINNESOTA MEDICAL DEVELOPMENT, INC. ELAINE DUNCAN
K071298 08/08/2007 HF JUNIOR HEMOFILTER MINNTECH CORP. LYNN LUEDERS
K072047 08/29/2007 MHI-TM2000 LINEAR ACCELERATOR SYSTEM MITSUBISHI HEAVY INDUSTRIES, LTD. TAKASHI YAMAKAWA
K063066 08/03/2007 AXIS-V MONOCHROME 5 MP DISPLAY NATIONAL DISPLAY SYSTEMS RON HANSON
K070622 08/14/2007 NEOGUIDE ENDOSCOPY SYSTEM NEOGUIDE SYSTEMS, INC. JORGE L PORRAS
K071308 08/16/2007 MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM NEUSOFT MEDICAL SYSTEMS CO., LTD. TIAN YANFANG
K072217 08/30/2007 ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M NIHON KOHDEN AMERICA, INC. JACK COGGAN
K072060 08/17/2007 QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V NIHON KOHDEN AMERICA, INC. JACK COGGAN
K071370 08/03/2007 NOBELACTIVE INTERNAL CONNECTION IMPLANT NOBEL BIOCARE AB PHUONG NGUYEN SON
K063190 08/21/2007 SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC NOBLE FIBER TECHNOLOGIES, INC. PATRICIA DAVIDSON
K071415 08/08/2007 DIGITAL PULSE OXIMETER, MODEL 7500FO NONIN MEDICAL, INC. LORI M ROTH
K071329 08/08/2007 NUVASIVE HELIX ACP SYSTEM NUVASIVE, INC. LAETITIA COUSIN
K071435 08/06/2007 NUVASIVE OCT SYSTEM NUVASIVE, INC. LAETITIA COUSIN
K071263 08/24/2007 NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500 NXSTAGE MEDICAL, INC. NORMA LEMAY
K071606 08/31/2007 BIOSIGN CENTRAL STATION OBS MEDICAL WAYNE NETHERCUTT
K072157 08/27/2007 MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) OHMEDA MEDICAL AGATA SMIEJA
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K070970 08/17/2007 NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F PENUMBRA, INC. THERESA BRANDNER-ALLEN
K071281 08/03/2007 UNIRING - ANNULOPLASTY RING WITH SIZERS PETERS SURGICAL ROBERT RENAULT
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K071913 08/24/2007 IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01 PHADIA AB KARL-ERIK BACKLUND
K070623 08/31/2007 PHARMAPAC LUBRICATING JELLY PHARMAPAC LLC TOM OTTO
K070185 08/21/2007 TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001 PHAROS LIFE CORPORATION PHIL CUSCUNA
K071564 08/31/2007 MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921 PHILIPS MEDICAL SYSTEMS RICK SCHUL
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K070928 08/01/2007 CERAMIC BALL HEADS, 28, 32 AND 36 MM PLUS ORTHOPEDICS AG PAMELA J WEAGRAFF
K071756 08/15/2007 ENDOHUB- 1.0 ENDOSCOPIC VIDEO CAMERA SYSTEM WITH VIDEO CAPTURE POINTE CONCEPTION MEDICAL, INC WILLIAM C HAACK
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K072010 08/07/2007 QUANTUM DIREX SYSTEM QUANTUM MEDICAL IMAGING, LLC. MARK CAMIRAND
K072096 08/20/2007 CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04 R & D SYSTEMS, INC. NANCY C RING
K071361 08/20/2007 R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005 R4 VASCULAR, INC. MICHAEL SARAJIAN
K070338 08/28/2007 RAINBOW, RAINBOW LIGHT,RAINBOW BLUE, RAINBOW PLUS RAINBOW COMMUNICATIONS, INC LEON E JEW
K071509 08/08/2007 BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP ZITA A YURKO
K071422 08/22/2007 15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET REX MEDICAL SUSAN D GOLDSTEIN-FALK
K071492 08/28/2007 FIRSTVIEW RIVERAIN MEDICAL GROUP,LLC JENNIFER STEINKE
K070999 08/02/2007 BC (BODY COMPOSITION SOFTWARE) RJL SYSTEMS, INC. BARRY CALLAHAN
K071953 08/08/2007 RTX3370 RTX HEALTHCARE A/S NIELS O ANDERSON
K070913 08/10/2007 SELF-LIGHT DISPOSABLE ANOSCOPE SAPIMED S.P.A. E J SMITH
K071424 08/24/2007 PMAX NEWTRON XS SATELEC-ACTEON GROUP STEVE SALESKY
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K063310 08/02/2007 TRUEFIELD ANALYZER SEEING MACHINES LIMITED ALAN DONALD
K071584 08/31/2007 OASIS RELEASE 1.0 SEGAMI CORPORATION PHILIPPE BRIANDET
K070987 08/02/2007 SENTINEL LITHIUM ASSAY SENTINEL CH SPA FABIO ROTA
K071072 08/30/2007 SHANGHAI CHINA STAR CORP. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE SHANGHAI CHINA STAR CORP ROMIL RAMBHIA
K072006 08/31/2007 DAR-9400F SHIMADZU CORP. DON KARLE
K070988 08/23/2007 SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G) SHINCHANG MEDICAL CO., LTD. JAN J FRANK
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K070727 08/03/2007 ADVIA CHEMISTRY ENZYMATIC CREATININE_2 SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS PHILIP LIU
K072266 08/29/2007 ACUSON P50 DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. SHEILA PICKERING
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K071925 08/14/2007 MAGNETOM ESSENZA SIEMENS MEDICAL SOLUTIONS USA, INC. JUDITH CAMPBELL
K071656 08/27/2007 SBI ARTFIX SMALL BONE INNOVATIONS INC. ROBERT HOEHN
K071549 08/07/2007 SBI RHEAD PLATING SYSTEM SMALL BONE INNOVATIONS INC. ROBERT HOEHN
K071479 08/02/2007 SBI STAFIX SMALL BONE INNOVATIONS INC. ROBERT HOEHN
K071540 08/08/2007 SBI TITANIUM THREADED PIN SMALL BONE INNOVATIONS INC. ROBERT HOEHN
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K071586 08/17/2007 BIORAPTOR 2.3 PK SUTURE ANCHOR SMITH & NEPHEW INC., ENDOSCOPY DIVISION JULIE ACKER
K063835 08/03/2007 ALLEVYN AG DRESSING SMITH & NEPHEW, INC. TERRY MCMAHON
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K070911 08/10/2007 STD MED PRIMO PORT STD MED, INC. PAMELA PAPINEAU
K071029 08/24/2007 CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS) STEREOTAXIS, INC. DENNIS POZZO
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K071989 08/06/2007 QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL SURGICAL SPECIALTIES CORP. KEVIN BENTLEY
K071703 08/22/2007 ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC SWISS AMERICAN PRODUCTS, INC. ERIC LUO
K071872 08/22/2007 VELASHAPE SYNERON MEDICAL LTD. YONI IGER
K071476 08/24/2007 SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP SYNTHES (USA) ANGELA SILVESTRI
K071245 08/02/2007 TALON AND REVERE TALON ACRYLICS, INC. SHERMAN WATSON
K072001 08/15/2007 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD CHU XIAOAN
K063729 08/21/2007 DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 TECHNOMED EUROPE MAURICE ROOST
K072108 08/31/2007 MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES TECNIMED S.R.L. MARIA F GRIFFIN
K071807 08/06/2007 ORTHOMEND SOFT TISSUE MATRIX TEI BIOSCIENCES INC. KENNETH JAMES
K063759 08/15/2007 HEATMARKER TIME TEMPERATURE INDICATOR TEMPTIME CORPORATION RICHARD PHILLIPS
K071410 08/15/2007 ARGEN PEARL BRAND ZIRCONIA THE ARGEN CORPORATION PAUL CASCONE
K070962 08/22/2007 CORAL PEDICLE SCREW SYSTEM THEKEN SPINE LLC DALE DAVISON
K063086 08/08/2007 TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS THERMO ELECTRON OY PAIVI SORMUNEN
K071126 08/16/2007 CRYOSEAL FS APPLICATOR SYSTEM THERMOGENESIS CORP. JOHN CHAPMAN
K070787 08/24/2007 LATITUDE ELBOW PROTHESIS TORNIER MIREILLE LEMERY
K072066 08/14/2007 1.3M MONOCHROME LCD MONITOR MDL1908A TOTOKU ELECTRIC CO., LTD MIKIO HASEGAWA
K072065 08/14/2007 20.8-INCH (53CM) COLOR LCD MONITOR CDL2119A (CCL352I2) TOTOKU ELECTRIC CO., LTD MIKIO HASEGAWA
K071485 08/28/2007 TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888 TPC ADVANCED TECHNOLOGY, INC. SCOTT BECKLEY
K071936 08/23/2007 WOUNDSTAT, MODEL TC1001 TRAUMACURE INC. CAMPBELL HUTTON
K071822 08/20/2007 URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12 UROPLASTY, INC. LISA GALLATIN
K071992 08/15/2007 HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) VARIAN MEDICAL SYSTEMS VY TRAN
K071873 08/09/2007 MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM VARIAN MEDICAL SYSTEMS, INC. VY TRAN
K070938 08/06/2007 THROMBI-PASTE THROMBIN/GELATIN POWDER PASTE HEMOSTAT VASCULAR SOLUTIONS, INC. JAMES CHAPMAN
K071753 08/14/2007 MASTERSCREEN PNEUMO & MASTERSCOPE VIASYS HEALTHCARE GMBH YVETTE LLOYD
K071903 08/02/2007 ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE VISION-SCIENCES, INC. PAMELA PAPINEAU
K072088 08/29/2007 FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS VISION-SCIENCES, INC. PAMELA PAPINEAU
K072073 08/29/2007 VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR VISION-SCIENCES, INC. PAMELA PAPINEAU
K070661 08/29/2007 VITALCOR FEATHERWEIGHT VASCULAR CLAMPS VITALCOR, INC. DANIEL KAMM
K071660 08/31/2007 VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900 VOLCANO CORPORATION JENNIFER MOTTO
K072220 08/23/2007 PEDI CO2 EASY WESTMED, INC. DALE BICKLEY
K070754 08/31/2007 TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-155 ZIMMER TRABECULAR METAL TECHNOLOGY JENNIFER P HARAKAL


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