FDA 510(k) Decisions During March, 2009  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K083738 03/11/2009 HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05 ABBOTT VASCULAR NADINE SMITH
K090509 03/20/2009 FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS .035 PTA CATHETER ABBOTT VASCULAR-VASCULAR SOLUTIONS NADINE SMITH
K090372 03/30/2009 THE WAND MICROACCESS SAFETY INTRODUCER ACCESS SCIENTIFIC, INC. ALBERT MISAJON
K090281 03/04/2009 ACCUTECH FAMILY OF POWERFLEX LASER DELIVERY DEVICES ACCUTECH MEDICAL TECHNOLOGIES, INC. ANNE WORDEN
K083425 03/20/2009 FUSION ADVANTAGE CERVICAL CAGE, FUSION ADVANTAGE LUMBAR CAGE ADAPTIVE SPECIALTY, LLC J.D. WEBB
K090478 03/26/2009 AOS PROXIMAL HUMERAL NAIL ADVANCED ORTHOPAEDIC SOLUTIONS, INC. PAUL DONER
K090286 03/23/2009 PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE ADVANCED VASCULAR DYNAMICS HERBERT J SEMLER
K081433 03/26/2009 EK/P. AERUGINOSA PNA FISH ADVANDX, INC. HENRIK STENDER
K083311 03/04/2009 AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM AESCULAP IMPLANT SYSTEMS, INC. MATTHEW M HULL
K083625 03/11/2009 AERO DV TRACHEOBRONCHIAL STENT SYSTEM ALVEOLUS, INC TONY ALEXANDER
K083142 03/13/2009 PICASSO LASER SYSTEM AMD LASERS, LLC MAUREEN O'CONNELL
K090380 03/13/2009 MAGNUM M FIXATION DEVICE ARTHROCARE CORP. LAURA N KASPEROWICZ
K082074 03/02/2009 ATRICURE CRYO1 CRYO-ABLATION PROBE ATRICURE, INC. JAMES LUCKY
K083780 03/23/2009 SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2 AUDIO TECHNOLOGIES S.R.L. FRANCO BEONI
K083858 03/17/2009 BOND BONE AUGMA BIOMATERIALS, LTD. DAVID J COLLETTE
K090141 03/17/2009 PRONTOSAN ANTIMICROBIAL WOUND GEL B. BRAUN MEDICAL, INC. LISA GIAQUINTO
K082487 03/04/2009 M-50 SERIES SPO2 SENSOR BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. LEI CHEN
K090433 03/25/2009 I_OPEN 0.4T BEIJING WANDONG MEDICAL EQUIPMENT CO., LTD.
K090508 03/26/2009 THE BELMONT BUDDY LITE FLUID WARMER BELMONT INSTRUMENT CORP. URAIWAN P LABADINI
K083720 03/20/2009 OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K BIEN-AIR SURGERY SA HUGUES FROIDEVAUX
K082190 03/11/2009 BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298 BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K081835 03/19/2009 ACTICARE IC AND TSE BIOINDUCTION LIMITED KRISTA OAKES
K082346 03/16/2009 VITEK 2 GRAM NEGATIVE DORIPENEM BIOMERIEUX, INC. JOLYN TENLLADO
K090473 03/25/2009 DISCOVERY ELBOW - X-SMALL BIOMET MANUFACTURING CORP. PATRICIA S BERES
K083490 03/18/2009 BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685 BIOPRO, INC. DAVID MRAK
K090501 03/05/2009 BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1, 4005-03-15-S1 BIOPSY SCIENCES, LLC SHARON ROCKWELL
K090120 03/24/2009 REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106 BIOSENSE WEBSTER, INC. BALAKA DAS
K082345 03/13/2009 OXYGEN DEMAND VALVE BPR MEDICAL, LTD. BEN JOHNSON
K081168 03/23/2009 BRIT PACS SYSTEMS BRIT SYSTEMS, INC. ROBERT MURRY
K090095 03/13/2009 LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM BRONCUS TECHNOLOGIES, INC. MAHTAB FATEMI
K083869 03/27/2009 BT-TITE CV3, MINI IMPLANT, MINI SINGLE, SLOT IMPLANT, MODEL(S) DDDIII BTICV3, 1, AND DDDIIIBTISI BTLOCK SRL ESTHER BATTILANA
K082582 03/30/2009 SENTINEL, MODEL SP-001 C-RAD POSITIONING AB CRISTINA SVENSSON
K083675 03/19/2009 POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER C.R. BARD, INC. JESSICA AGNELLO
K090512 03/27/2009 POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER C.R. BARD, INC. ANGELA M BRADY
K090547 03/18/2009 ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U C.R. BARD, INC. CINDY MOSS
K083185 03/11/2009 CADI SMARTSENSE VITAL SIGNS AND WIRELESS TEMPERATURE MONITORI NG SYSTEM, MODEL S1 CADI SCIENTIFIC PTE.LTD STEPHEN H GORSKI
K083722 03/31/2009 ASCEND CALDERA MEDICAL, INC. MARA KORSUNSKY
K090623 03/24/2009 DIGITAL RADIOGRAPHY CXDI-40G COMPACT CANON U.S.A., INC. SHEILA DRISCOLL
K090466 03/23/2009 DIGITAL RETINAL CAMERA, CR-1 MARK II CANON, INC. SHEILA DRISCOLL
K090272 03/18/2009 SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES) CARDINAL HEALTH, INC. GINA RAJTEROWSKI
K090521 03/20/2009 DIAMONDBACK 360 DBX CARDIOVASCULAR SYSTEMS, INC. DAVID BROOKE
K090439 03/25/2009 FORUM CARL ZEISS MEDITEC, INC. KENT W JONES
K090634 03/23/2009 PHASEAL PROTECTOR P14, P21, P28 AND P50 CARMEL PHARMA AB. KJELL ANDREASSON
K083892 03/19/2009 FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030) CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K083612 03/04/2009 APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM CAYENNE MEDICAL, INC. KERESHMEH SHAHRIARI
K083607 03/04/2009 APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM CAYENNE MEDICAL, INC. KERESHMEH SHAHRIARI
K090229 03/13/2009 DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM 2-5MHZ CURVED LINEAR ARRAY, 5-10MHZ LINEAR ARRAY, 2-4MHZ PHASE ARRAY, 4-8MHZ TRANSV CHANG GUNG MEDICAL SUPPLIES & EQUIPMENT CORP. BOB LEIKER
K083433 03/18/2009 INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 CHATTANOOGA GROUP MICHAEL TREAS
K090100 03/11/2009 SOFTSEAL-STF CHITOGEN, INC. JANNA BEREUTER
K083596 03/02/2009 REEKROSS FAMILY OR OTW PTA CATHETERS CLEARSTREAM TECHNOLOGIES, LTD. FIONA N MHULLAIN
K090348 03/04/2009 CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET CODMAN & SHURTLEFF, INC. SHARON MCDERMOTT
K083024 03/27/2009 HYLATOPIC EMOLLIENT FOAM COLLEGIUM PHARMACEUTICAL INCORPORATED RONALD M GURGE
K083224 03/24/2009 CPI RAD VISION, MODEL VZW2944XX-YY COMMUNICATIONS & POWER INDUSTRIES CANADA, INC. NORM MORIKAWA
K083677 03/10/2009 PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 COMMWELL LTD. JONATHAN KAHAN
K083161 03/27/2009 ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100) CONMED LINVATEC SUE DAUTERMAN
K090128 03/19/2009 TAC-TITE (TM) CORE ESSENCE ORTHOPAEDICS, INC. SHAWN T HUXEL
K083776 03/05/2009 CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S CORPAK MEDSYSTEMS STEPHANIE WASIELEWSKI
K083791 03/04/2009 CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S CORPAK MEDSYSTEMS STEPHANIE WASIELEWSKI
K083325 03/09/2009 N-600X WITH SPD, OXIMAX N-600X COVIDIEN SCOTT D DICKERHOFF
K090419 03/09/2009 SILS STITCH ENDOSCOPIC SUTURING DEVICE COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES ROBERT ZOTT
K081424 03/19/2009 AFFIRM CO2 AND AFFIRM CO2 HP CYNOSURE, INC. GEORGE CHO
K090235 03/17/2009 ELITE MPX LASER SYSTEM WITH XPL HANDPIECE CYNOSURE, INC. GEORGE CHO
K090106 03/31/2009 PRELUDE ONE DANVILLE MATERIALS, INC. LINDSAY TILTON
K083182 03/04/2009 DATACOM DC PACS DATACOM TECHNOLOGY CORP. JEN KE-MIN
K090233 03/05/2009 GE DATEX-OHMEDA AISYS DATEX-OHMEDA, INC. JIM RASKOB
K090481 03/19/2009 DEMASQ IMAGING SPFTWARE DEVICE DEMASQ LIMITED STUART GALL
K083543 03/06/2009 DENOVISMED DENTAL IMPLANT SYSTEMS DENOVIS MEDICAL, LLC KEVIN A THOMAS
K090454 03/20/2009 ALLURE MB CERAMIC BRACKETS DENTSPLY INTERNTIONAL HELEN LEWIS
K090124 03/11/2009 GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCORD, MODEL 210813,210814 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY ZHENG LIU
K090492 03/31/2009 1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K083789 03/23/2009 ACE FISCHER EXTERNAL FIXATION SYSTEM DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K083642 03/06/2009 DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS DEPUY ORTHOPAEDICS, INC. DAWN SINCLAIR
K083843 03/20/2009 LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K090374 03/11/2009 STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K090230 03/06/2009 EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. FRANK JURCZAK
K090664 03/23/2009 DEVON ACCUBP CUFF DEVON MEDICAL INC. RUTH WU
K083532 03/10/2009 ADX4000-L, DX3000-L DEXCOWIN CO., LTD CLAUDE YANG
K090073 03/06/2009 D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT DIAGNOSTIC HYBRIDS, INC. GAIL R GOODRUM
K083649 03/09/2009 CARDIUS 3 X-ACT DIGIRAD CORP. JOEL TUCKEY
K083320 03/06/2009 DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE DUKAL CORP. JIM VILARDI
K082899 03/10/2009 DYNAMIPEAK PEAK FLOW METER DYNAMITECH MEDICAL, INC KEITH LOWREY
K082465 03/25/2009 EVERON EARLYSENSE LTD. DALIA ARGAMAN
K082039 03/20/2009 SYNCHRO HP PLATFORM EL.EN. ELECTRONIC ENGINEERING SPA ANDREA TOZZI
K083478 03/17/2009 SMOOTHLIPO ELEME MEDICAL, INC. MICHAIL PANKRATOV, MD
K083651 03/13/2009 REVELATION STEM, MODEL 427-21/42-080/180 ENCORE MEDICAL, L.P. TEFFANY HUTTO
K083788 03/03/2009 ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR ENDO OPTIKS, INC. DONALD R WATSON
K090310 03/24/2009 EQUIVABONE ETEX CORP. CHRISTOPHER KLACZYK
K083615 03/16/2009 EUROIMMUN ANTI BP 180-4X ELISA (IGG) EUROIMMUN US INC KATHRYN KOHL
K083342 03/12/2009 ORBITAL RECONSTRUCTIVE IMPLANT II EVERA MEDICAL, INC. RANDY KESTEN
K083825 03/19/2009 EOI SPINAL SYSTEM EXPANDING ORTHOPEDICS, INC. JANICE M HOGAN
K083122 03/04/2009 HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041 FISHER & PAYKEL HEALTHCARE, LTD. STEPHANIE COSTE
K083832 03/16/2009 ZEST NASAL MASK FISHER & PAYKEL HEALTHCARE, LTD. TINA MASON
K083697 03/19/2009 FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M FUKUDA DENSHI USA, INC. DOUG BLAKELY
K083750 03/23/2009 CAPNOSTAT / CAPNOFLEX CO2 SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES ROBERT L CASARSA
K083471 03/03/2009 GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020 GENERIC MEDICAL DEVICE, INC. MONICA MONTANEZ
K083389 03/26/2009 COALITION SPACER GLOBUS MEDICAL INC. KELLY J BAKER
K090026 03/31/2009 CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266 HEMCON MEDICAL TECHNOLOGIES, INC. KEVIN HAWKINS
K090495 03/27/2009 TRUEBALANCE BLOOD GLUCOSE SYSTEM HOME DIAGNOSTICS, INC. KAREN DEVINCENT
K090610 03/13/2009 HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM HOSPIRA, INC. YULIYA MATLIN
K090108 03/19/2009 HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR HOVEROUND CORP. TONY DIGIOVANNI
K081346 03/23/2009 HOYA IS INJECTOR SYSTEM HOYA SURGICAL OPTICS, INC. STEVEN L ZIEMBA
K090223 03/31/2009 ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024 ICAD, INC. JOHN A DELUCIA
K083192 03/04/2009 INCLUSIVE TITANIUM ABUTMENT BLANKS INCLUSIVE DENTAL SOLUTIONS KEITH D ALLRED
K083511 03/03/2009 ENVIRO SHARP SOLUTIONS 3 INDUSTRIAL WATER SOLUTIONS, INC THOMAS P STEWART
K081740 03/12/2009 HEMOBAND, MODELS HB-NS AND HB-NSXL INNOVATIONS FOR ACCESS, INC. HAL J OIEN
K083908 03/06/2009 BLACK NITRILE EXAMINATION GLOVES INNOVATIVE GLOVES CO; LTD RAJEEV K SOOD
K082853 03/23/2009 CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR INSPIRED TECHNOLOGIES, INC. PAUL DRYDEN
K083518 03/13/2009 ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K083414 03/02/2009 RADIONICS XKNIFE HDRT SYSTEM INTEGRA RADIONICS, INC. KEVIN O'CONNELL
K082147 03/20/2009 BODYMETRIX BX2000 INTELAMETRIX, INC HEIDI STARK
K083081 03/04/2009 MODIFICATION TO SECURACATH, MODEL: SPK01 INTERRAD MEDICAL, INC. SEW-WAH TAY
K083919 03/13/2009 AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. STEVE CAMP
K080611 03/04/2009 MESA SPINAL SYSTEM K2M, INC. RICHARD W WOODS
K080852 03/30/2009 KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1 KARL STORZ ENDOSCOPY-AMERICA, INC. CRYSTAL DIZOL
K083357 03/04/2009 OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510 KCI USA, INC. CHRISTY H OVIATT
K083609 03/06/2009 KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE KFX MEDICAL GAYLE HIROTA
K090067 03/24/2009 BACTRACK SELECT BREATHALYZER, MODEL S80 KHN SOLUTIONS, LLC DANIEL KAMM
K083801 03/19/2009 BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70 KHN SOLUTIONS, LLC DANIEL KAMM
K083234 03/25/2009 KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100 KIMBERLY-CLARK CORP. LISA PEACOCK
K082177 03/27/2009 KIMGUARD ONE-STEP STERILIZATION WRAP KIMBERLY-CLARK CORP. LISA PEACOCK
K083432 03/31/2009 DRILL FREE MMF SCREW KLS MARTIN L.P. TOM FAUCET
K082614 03/06/2009 EVOX ELECTRO DIAGNOSTIC DEVICE LABORIE MEDICAL TECHNOLOGIES, INC. BARBARA MORNET
K090252 03/04/2009 MODIFICATION TO: LANX SPINAL FIXATION SYSTEM LANX, INC. ANDREW LAMBORNE
K083206 03/10/2009 LOUSEBUSTER LARADA SCIENCES PHIL TRIOLO
K083909 03/18/2009 SPINAL INJECTION SYSTEM LAURIMED LLC SEVRINA CIUCCI
K083891 03/23/2009 VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901 MAINE STANDARDS CO. HOLLY CRESSMAN
K081269 03/20/2009 AVIE A1C TEST SYSTEM MEC DYNAMICS CORP EMMANUEL MPOCK
K083558 03/06/2009 MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C MEDACTA INTERNATIONAL, SA NATALIE J KENNEL
K081775 03/25/2009 THE MEDCOMP .010" VASCULAR GUIDEWIRES MEDCOMP LISA WEIKERT
K083802 03/20/2009 SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025 MEDI-GLOBE CORPORATION SCOTT KARLER
K080404 03/13/2009 EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR MEDICA CORP. PHOTIOS MAKRIS
K082967 03/26/2009 MORTARA STRESS ECHO BED MEDICAL POSITIONING, INC. CAROL WHITE
K083792 03/25/2009 WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055 MEDSHAPE SOLUTIONS JACK GRIFFIS
K090659 03/26/2009 ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHETERS FOR LEFT HEART DELIVERY MEDTRONIC INC. BRUCE BACKLUND
K090112 03/26/2009 MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700 MEDTRONIC POWERED SURGICAL SOLUTIONS JEFFERY HENDERSON
K081266 03/05/2009 MERCURY MEDICAL PEEP VALVE MERCURY ENTERPRIZES DBA MERCURY MEDICAL BRIAN L MORRISON
K083702 03/05/2009 TRACH-ASSIST MERGENET MEDICAL PAUL DRYDEN
K090084 03/06/2009 ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE MERIT MEDICAL SYSTEMS, INC. SUSAN SCOTT
K090168 03/12/2009 AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415 MICROVENTION, INC. FLORIN TRUUVERT
K090001 03/05/2009 V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503 MICROVENTION, INC. NAOMI GONG
K090274 03/03/2009 MICRUS ONE 2 ONE GUIDEWIRE AND SOFT GUIDEWIRE MICRUS ENDOVASCULAR CORPORATION PATRICK LEE
K090267 03/16/2009 SV DBS BRAIN ARRAY, MODEL 1500SV-SMS64 MIDWEST R.F. LLC. DAVID M PETERSON
K083796 03/09/2009 MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT MILTEX, INC. JENNIFER J BOSLEY
K082819 03/20/2009 DERMATOLOGIC TREATMENT SYSTEM (DTS) G2 MIRAMAR LABS, INC. KATHY O'SHAUGHNESSY
K083412 03/09/2009 PATHFAST HSCRP MITSUBISHI KAGAKU IATRON HELEN LANDICHO
K090080 03/23/2009 CIRRUS OPEN MRI-TECH SP. ZO.O. ANITA CHAN
K083662 03/26/2009 CRITICOOL MTRE ADVANCED TECHNOLOGY LTD. IFAT OREN
K083493 03/20/2009 MYOSCIENCE CRYO-TOUCH MYOSCIENCE INC TRACEY HENRY
K062187 03/24/2009 BETACHEK GLUCOSE TEST NATIONAL DIAGNOSTIC PRODUCTS BRANDON BRANSGROVE
K090553 03/31/2009 NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER NAVISCAN, INC. HEATHER JALISI
K081851 03/02/2009 NEOSS ACCESS ABUTMENTS NEOSS, LTD. FREDRIK ENGMAN
K090552 03/16/2009 UROCARE NEUSOFT MEDICAL SYSTEMS CO., LTD. TIAN YANFANG
K090410 03/27/2009 COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY NEW STAR LASERS, INC. NATALIE R VOLLRATH
K083456 03/02/2009 NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P NIHON KOHDEN AMERICA, INC. JACK COGGAN
K082719 03/30/2009 NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P NIKKISO CO. LTD. FUMIAKI KANAI
K081970 03/11/2009 BIOCLEAN CHEMO SHIELD NITRITEX (M) SDN. BHD. DEREK WATTS
K082528 03/06/2009 SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM NOBLE ANESTHESIA-AIR, INC. ALEXANDER B HENDERSON
K083341 03/20/2009 NUVASIVE HELIX-T ACP SYSTEM NUVASIVE, INC. HAN FAN
K081330 03/06/2009 CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) O-TWO MEDICAL TECHNOLOGIES, INC. PAUL DRYDEN
K090259 03/31/2009 OKAMOTO ULTRA THIN OKAMOTO U.S.A., INC. JEFFERY N GIBBS
K081615 03/18/2009 OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN OLYMPUS AMERICA, INC. STEPHANIE G DONNELLY
K081709 03/16/2009 OLYMPUS AFP - ALPHA-FETOPROTEIN OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) STEPHANIE G DONNELLY
K090349 03/09/2009 CLEARVUE PRONE BREAST TREATMENT TABLE ORBITAL THERAPY, LLC CHAS BURR
K083726 03/11/2009 PEDINAIL INTRAMEDULLARY NAILING SYSTEM ORTHOPEDIATRICS, CORP. GARY BARNETT
K083830 03/20/2009 OSCAR BONE RESECTOR ORTHOSONICS, LTD. MICHAEL J YOUNG
K090408 03/20/2009 MODIFICATION TO: DSS STABILIZATION SYSTEM PARADIGM SPINE, LLC ADAM HERDER
K083619 03/06/2009 PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-10020 PARCUS MEDICAL, LLC BARTON BRACY
K090075 03/06/2009 PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257, 10258 PARCUS MEDICAL, LLC BARTON BRACY
K090597 03/16/2009 FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH PASCAL CO., INC. VINCENT M TENTARELLI
K090325 03/11/2009 JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE) PATHWAY MEDICAL TECHNOLOGIES, INC. BRIT BAIRD
K083873 03/19/2009 PICC (CT RATED AND NON-RATED) PFM MEDICAL, INC SALVADORE PALOMARES
K081830 03/16/2009 IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1 PHADIA AB MARTIN MANN
K083188 03/13/2009 VARELISA RECOMBI ANA SCREEN, MODEL 12 596 PHADIA US INC. MARTIN R MANN
K090483 03/20/2009 SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS PHILIPS MEDICAL SYSTEMS LARRY MILANA
K090590 03/16/2009 VERADIUS, MODEL 718-130 PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. LYNN HARMER
K090625 03/24/2009 WIRELESS PORTABLE DETECTOR FD-W17 PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. LYNN HARMER
K090403 03/31/2009 AUTOSPECT PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. ROBERT Z PHILLIPS
K082937 03/11/2009 LIFEPAK 15 MONITOR/DEFIBRILLATOR PHYSIO-CONTROL, INC. TERESA DAVIDSON
K090524 03/19/2009 GO GO ELITE TRAVELER V THREE WHEEL SCOOTER, MODEL SC40EV PRIDE MOBILITY PRODUCTS CORP. THOMAS J SCHAPPERT
K082964 03/09/2009 PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5) PRISM CLINICAL IMAGING, INC. JAMES L REUSS
K083233 03/02/2009 THE PFT FILTER PULMONARY FILTRATION TECHNOLOGIES LLC PAUL DRYDEN
K083688 03/18/2009 PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR PULMONETIC SYSTEMS, INC. ROBERT C SAMEC
K083749 03/10/2009 CARDIOVIEW32 REVIEW MODULE QRS DIAGNOSTIC, LLC. MARY KAY JENSEN
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K090248 03/04/2009 BIPAP AUTOSV RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP ZITA A YURKO
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K083694 03/06/2009 SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES SYNTHES (USA) SHERI L MUSGUNG
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K090020 03/13/2009 BEL-CYPHER, MODEL Y977 TAKARA-BELMONT CO., LTD. KUNIHIKO SOBUE
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K083073 03/13/2009 THEKEN ATOLL CERVICO-THORACIC SYSTEM THEKEN SPINE LLC DALE DAVISON
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K081984 03/04/2009 LABORPRO SYSTEM TRIG MEDICAL LTD KEREN SHTIEGMAN
K081813 03/12/2009 UNIVERSAL COMPRESSION FRACTURE REPAIR SYSTEM U.S. IMPLANT SOLUTIONS, LLC SCOTT GARRETT
K090502 03/10/2009 NOVA SAFE SCALP VEIN BLOOD COLLECTION SET U.S. SAFETY SYRINGES CO., INC. CHRISTINA SMITH
K090083 03/23/2009 CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090 UNICARE BIOMEDICAL, INC. STAN YANG
K083784 03/30/2009 PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER, VASCULAR SOLUTIONS, INC. CHARMAINE SUTTON
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K090295 03/04/2009 BODYVIZ, MODEL 100 VISUAL MEDICAL SOLUTIONS, LLC J. HARVEY KNAUSS
K090644 03/31/2009 VITABLOCS, MODEL VX55-**** VITA ZAHNFABRIK H. RAUTER GMBH & CO. ELIZABETH WOLFSEN
K083266 03/27/2009 GORE BIO-A FISTULA PLUG W.L. GORE & ASSOCIATES,INC BARBARA L SMITH
K081748 03/27/2009 ONEPLANT DENTAL IMPLANT SYSTEM WARANTEC CO., LTD. DANIEL KAMM
K082478 03/09/2009 WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62 WELCH ALLYN, INC. JOHN SAWYER
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K083446 03/31/2009 CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING ZIOSOFT, INC. RICHARD BALL
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