FDA 510(k) Applications Received During December, 2007

FDA 510(k) Number Submission Date Device Name Applicant Contact
K073523 12/14/2007 INTERCEPTOR PLUS CORONARY FILTER SYSTEMS MEDTRONIC INC. COLLEEN MULLINS
K073395 12/05/2007 GILB-2, GLASS IONOMER PROTECTIVE COATING 3M ESPE DENTAL PRODUCTS KAREN O'MALLEY
K073645 12/26/2007 SIMPLER MINI DENTAL IMPLANT: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM, SM 3004 2.5 X 15MM 659543 BC LTD. HAROLD BERGMAN
K073530 12/19/2007 ACCIN ANTERIOR CERVICAL PLATE SYSTEM ACCELERATED INNOVATION, LLC MICHAEL KVITNITSKY
K073531 12/17/2007 ACCIN PEDICLE SCREW SYSTEM ACCELERATED INNOVATION, LLC MICHAEL KVITNITSKY
K073719 12/31/2007 ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE ADVANCED SURGICAL CONCEPTS MARY MCNAMARA-CULLINANE
K073471 12/11/2007 VANTAGECATH INTRAVASCULAR CATHETER ADVANTAGE MEDICAL DEVICE JAMES SMITH
K073573 12/20/2007 WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM AGAMATRIX CONNIE HERTEL
K073553 12/18/2007 CAMLOG IMPLANT SYSTEM ABUTMENTS ALTATEC GMBH LINDA K SCHULZ
K073716 12/31/2007 LIFE+CEL OR LIFECEL BATTERY AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. ALEX HENDERSON
K073505 12/13/2007 MODIFICATION TO VALEO VBR AMEDICA CORP. ADAM HERDER
K073430 12/06/2007 VALEO PEDICLE SCREW SPINAL SYSTEM AMEDICA CORP. JUSTIN EGGLETON
K073703 12/31/2007 AMS MINIARC SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC. BRAD ONSTAD
K073526 12/17/2007 AMICAS VISION SERIES PACS, MODEL 5.5 AMICAS, INC. PATRICE NEDELEC
K073547 12/18/2007 ANASEPT ANTIMICROBIAL SKIN AND WOUND CLEANSERS; ANASEPT ANTIMICROBIAL SKIN AND WOUND GEL ANACAPA TECHNOLOGIES, INC. ILA DOSHI
K073464 12/10/2007 ANGIODYNAMICS, INC., NEVERTOUCH II 400UM FIBER AND VENACURE PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K073672 12/27/2007 SKATER BILIARY CATHETER ANGIOTECH TRUDY ESTRIDGE
K073520 12/14/2007 ANGIOTECH CVC ANGIOTECH PHARMACEUTICALS, INC. TRUDY D ESTRIDGE
K073677 12/28/2007 SCANSCOPE XT SYSTEM APERIO TECHNOLOGIES JEFF RYBERG
K073648 12/26/2007 GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1 APEX BIOTECHNOLOGY CORP. THOMAS Y.S. SHEN
K073452 12/14/2007 MODIFICATION TO: ARAGON SURGICAL LAPCAP ARAGON SURGICAL INC. ALAN CURTIS
K073446 12/11/2007 GRIND GUARD ARCHTEK, INC. IAN P GORDON
K073632 12/26/2007 INTUITION, MODEL 0170 ARCOMA AB BENGT-HUGO JOHANSSON
K073416 12/03/2007 ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM ARKRAY FACTORY USA, INC. TOM SPEIKERS
K073451 12/11/2007 PRESSURE INJECTABLE PICC ARROW INTERNATIONAL, INC. KEVIN LENTZ
K073410 12/04/2007 SAVE RESUSCITATOR ARTIVENT CORPORATION GRACE HOLLAND
K073540 12/18/2007 ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT ATLANTIS COMPONENTS, INC. BETSY A BROWN
K073605 12/21/2007 ATRICURE COOLRAIL LINEAR PEN ATRICURE, INC. ALISON GRIMALDI
K073425 12/03/2007 MODIFICATION TO AURORA MRI SYSTEM AURORA IMAGING TECHNOLOGY, INC. MICHAEL A DOUGLAS
K073640 12/26/2007 ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS AXIS-SHIELD DIAGNOSTICS, LTD. CLAIRE DORA
K073396 12/03/2007 ANTIMICROBIAL ULTRASITE VALUE, ULTRASITE AG B. BRAUN MEDICAL, INC. REBECCA STOLARICK
K073538 12/17/2007 DUAL CHAMBER TPN CONTAINER B. BRAUN MEDICAL, INC. TRACY MADDOCK
K073184 12/20/2007 BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS BAUSCH & LOMB, INC. DEBRA KETCHUM
K073571 12/20/2007 TRICOS T RESORBABLE BONE SUBSTITUTE BAXTER HEALTHCARE CORPORATION BARBARA K BARBEAU
K073589 12/20/2007 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML) STEPTOCOCCUS ID/AST OR AST ONLY PHOENIX PANELS BECTON, DICKINSON & CO. MONICA GIGUERE
K073433 12/06/2007 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN (GN) -128 UG/ML BECTON, DICKINSON & CO. VICKI K WHITLEY
K073262 12/04/2007 BELLA BEEKLEY CORP. MARTINE M BOUTTE
K073438 12/07/2007 PROSTIM 1000/2000 BIO PROTECH, INC. E.J. SMITH
K073663 12/26/2007 GELSPRAY WOUND DRESSING BIOCURE, INC. JOHN GREENBAUM
K073406 12/04/2007 VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE BIOMERIEUX, INC. NANCY WEAVER
K073637 12/26/2007 PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS BIOMET MANUFACTURING CORP. ELIZABETH WRAY
K073434 12/06/2007 BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER BIPORE, INC. KEITH PALUCH
K073420 12/11/2007 BLACKSTONE ASCENT MULTIAXIAL SCREWS BLACKSTONE MEDICAL, INC. WHITNEY G TORNING
K073654 12/26/2007 BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR BLACKSTONE MEDICAL, INC. WHITNEY G TORNING
K073713 12/31/2007 BLUE SKY BIO DENTAL IMPLANT SYSTEM BLUE SKY BIO, LLC MICHELE VOVOLKA
K073623 12/26/2007 ATLANTIS 018 PERIPHERAL IMAGING CATHETER BOSTON SCIENTIFIC CORP. EMILLY TOJIMA
K073615 12/26/2007 BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED BRAINLAB AG PER PERSSON
K073458 12/28/2007 BT-TITE ONE(BTICV1), BT-TITE STANDARD(BTIVSM), BT-TITE CV2(BTICV2) BTLOCK SRL ESTER BATTILANA
K073598 12/21/2007 BARD DIGNICARE STOOL MANAGEMENT SYSTEM C.R. BARD, INC. MICHELLE GUDITH
K073423 12/05/2007 MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER C.R. BARD, INC. SUSAN D SCOTT
K073472 12/11/2007 VACCESS PTA BALLOON DILATATION CATHETER C.R. BARD, INC. JENNIFER LOGVIN
K073686 12/28/2007 C.T.M. POWER CHAIR, MODEL HS-1500 C.T.M. HOMECARE PRODUCT, INC. LINDA J BOVARD
K073534 12/17/2007 CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS CANDELA CORP. LISA LACROIX
K073539 12/17/2007 PROVISA CEM CAVEX HOLLAND B.V. RICHARD WOORTMAN
K073426 12/05/2007 APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MM CAYENNE MEDICAL, INC. KERESHMEH SHAHRIARI
K073417 12/04/2007 EMBOZENE MICROSPHERES CELONOVA BIOSCIENCES, INC. THOMAS A GORDY
K073669 12/26/2007 ORIA NATURA SPACER CHOICE SPINE, LP KAREN E WARDEN
K073459 12/10/2007 CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES CIBA VISION CORPORATION ALICIA M PLESNARSKI
K073481 12/11/2007 THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES CONMED LINVATEC JOY LOVETT
K073454 12/10/2007 FINGERTIP PULSE OXIMETER, MODEL CMS-50C CONTEC MEDICAL SYSTEM CO., LTD. DIANA HONG
K073475 12/18/2007 SYSTEM PLUS CONTINENTAL DENTAL LABORATORY KAREEN CHAMBERLAIN
K073391 12/04/2007 SURGISIS BIODESIGN TISSUE GRAFT COOK BIOTECH, INC. MARY A FADERAN
K073528 12/17/2007 VENA CAVA FILTER COOK INCORPORATED MOLLY BUSENBANK
K073496 12/12/2007 OPTILITE HOLMIUM LASER FIBERS COOK UROLOGICAL, INC. CINDY FOOTE
K073378 12/03/2007 ADVANCE 18LP PTA DILATATION CATHETER COOK, INC. NATHAN SIMON
K073627 12/26/2007 FLEXOR EVAC ASPIRATION CATHETER COOK, INC. KAREN BRADBURN
K073440 12/07/2007 FOUNDATION CAGE CORELINK LLC J.D. WEBB
K073557 12/19/2007 EEG NEUROAMP, MODEL CS10137 CORSCIENCE GMBH & CO. KG CHRISTINE BAUMANN
K073394 12/03/2007 SMARTLIPO LASER CYNOSURE, INC. GEORGE CHO
K073604 12/21/2007 DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD DADE BEHRING, INC. YUK-TING LEWIS
K073561 12/19/2007 DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR DADE BEHRING, INC. HELEN M LEE
K073701 12/31/2007 DANE TECHNOLOGIES WHEELCHAIR MOVER, MODEL WM 2000 DANE TECHNOLOGIES OLIVER PITTENGER
K073707 12/31/2007 GE DATEX-OHMEDA AISYS DATEX-OHMEDA, INC. DAN KOSEDNAR
K073582 12/20/2007 VRIICU SYSTEM DEEP BREEZE LTD. JEFF BAETZ
K073593 12/21/2007 I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016 DELTEX MEDICAL LIMITED NEIL R ARMSTRONG
K073486 12/18/2007 DENTIS DENTAL IMPLANT SYSTEM DENTIS CO. LTD. CHANG DAE KYU
K073412 12/04/2007 GRYPHON BR AND HEALIX BR ANCHORS DEPUY MITEK, A JOHNSON & JOHNSON COMPANY RUTH FORSTADT
K073529 12/26/2007 DEPUY SIGMA PS FEMORAL COMPONENTS DEPUY ORTHOPAEDICS, INC. NANCY FRIDDLE
K073570 12/20/2007 DEPUY TRI-LOCK BONE PRESERVATION STEM DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K073649 12/26/2007 BENGAL STACKABLE CAGE SYSTEM DEPUY SPINE, INC. SHARON SLAROWICZ
K073562 12/19/2007 MODIFICATION TO VIPER SPINE SYSTEM DEPUY SPINE, INC. CHRISTOPHER KLACZYK
K073565 12/19/2007 STANDARD WHEELCHAIR PLATFORM DESIGN SPECIFIC LTD DAWN EDWARDS
K073390 12/03/2007 DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS DIASORIN, INC. MARI MEYER
K073503 12/19/2007 VERSA LITE DIOMEDICS, INC. GARY MOCNIK
K073518 12/14/2007 FLASHLITE REBEL* DISCUS DENTAL, INC. VIVIAN LAI
K073427 12/07/2007 MEDILAS D FAMILY LASERS DORNIER MEDTECH AMERICA, INC. THERON GOBER
K073331 12/11/2007 DVO EXTENDED ARTICULATION HUMERAL HEADS DVO EXTREMITY SOLUTIONS, LLC JEFF ONDRLA
K073415 12/06/2007 NEMUS SYSTEM; NEMUS PC PERIPHERAL EB NEURO, S.P.A. ALLISON SCOTT
K073711 12/31/2007 MUCOGRAFT COLLAGEN MATRIX ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE PETER S REICHERTZ
K073221 12/05/2007 CADENCE II EDAN INSTRUMENTS, INC. WILLIAM STERN
K073559 12/19/2007 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II EDWARDS LIFESCIENCES RESEARCH MEDICAL JOHN W NICHOLSON
K073687 12/28/2007 HABIB LAPAROSCOPIC HEXABLATE EMCISION, LTD. NAGY HABIB
K073510 12/26/2007 ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM ENDIUS, INC. REGINA WAGNER
K073644 12/26/2007 ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES ENDOGASTRIC SOLUTIONS, INC. KEN PERINO
K073399 12/04/2007 TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE ENVISIONEERING, LLC. DAVID KENNEDY
K073709 12/31/2007 MODIFICATION TO VIEWMATE SYSTEM EP MEDSYSTEMS LARRY PICCIANO
K073507 12/14/2007 ANCHORAGE ACCESS KIT EPITEK, INC. WERNER HAMPL
K073484 12/11/2007 ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432 ETHICON ENDO-SURGERY, INC. RENEE L ROWE
K073688 12/28/2007 EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW EXACTECH, INC. GRAHAM CUTHBERT
K073579 12/20/2007 DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESEL NEIL R ARMSTRONG
K073706 12/31/2007 RESPIRATORY HUMIDIFIER, MODEL MR850 FISHER & PAYKEL HEALTHCARE, LTD. ADELE BINDON
K073382 12/03/2007 PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G FOCUS DIAGNOSTICS, INC. CONSTANCE BRIDGES
K073381 12/03/2007 PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M FOCUS DIAGNOSTICS, INC. CONSTANCE BRIDGES
K073614 12/26/2007 WG-SURGICAL SUTURES WITH NEEDLE FOOSIN MEDICAL SUPPLIES INC. DIANA HONG
K073650 12/26/2007 FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371 FUJIFILM MEDICAL SYSTEMS USA, INC. DANIEL KAMM
K073675 12/28/2007 T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP GAYMAR INDUSTRIES, INC. BETHANY J GILBERT
K073588 12/26/2007 GC MODELS OPA-100 AND JC-50 GC AMERICA, INC. MARK HEISS
K073625 12/26/2007 MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM GE HEALTHCARE SYSTEMS INFORMATION TECHNOLOGIES MARGARET MUCHA
K073462 12/10/2007 MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES JOEL KENT
K073408 12/04/2007 GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA NICOLE LANDREVILLE
K073543 12/17/2007 OEC 9900 ELITE GE OEC MEDICAL SYSTEMS MARIA C FRAME
K073439 12/07/2007 TRANSITION STABILIZATION SYSTEM GLOBUS MEDICAL INC. KELLY J BAKER
K073517 12/14/2007 H-LINK INTEGRATED ROD GLOBUS MEDICAL, INC. KELLY J BAKER
K073636 12/26/2007 TINNITUS SOUND GENERATOR MODULE GN RESOUND A/S LARS HAGANDER
K073576 12/19/2007 NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES HAROD ENTERPRISES, INC. NORRIS R HAROD
K073554 12/18/2007 NEUN HERAEUS KULZER GMBH CHERYL V ZIMMERMAN
K043617 12/21/2007 IMAGECHECKER CT CAD SOFTWARE SYSTEM HOLOGIC, INC. ARTHUR FRIEDMAN
K073527 12/17/2007 VARIAX ELBOW SYSTEM HOWMEDICA OSTEONICS CORP FRANCISCO HARO
K073656 12/26/2007 OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM HYPERMED, INC. CHAS BURR
K073664 12/26/2007 FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER INJECTIMED, INC. RICHARD G HUNTER
K073545 12/19/2007 AUDICOR, HEMO AMBULATORY MONITOR INOVISE MEDICAL, INC. KENDRA RATHKEY
K073377 12/03/2007 ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K073384 12/03/2007 SMART COUPLER, MODEL M015401 INTELLIGENT HEARING SYSTEMS EDWARD MISKIEL
K073690 12/28/2007 INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM INTERLACE MEDICAL, INC. RON ADAMS
K073689 12/28/2007 LEP2000 THERAPY SYSTEM INTERNATIONAL MEDICAL INSTRUMENTS, INC. M. JOYCE HEINRICH
K073710 12/31/2007 INTOUCH REMOTE PRESENCE ROBOTIC SYSTEM, MODEL RP-7 INTOUCH TECHNOLOGIES BILL STOUT
K073404 12/04/2007 IFS LASER SYSTEM INTRALASE CORP. MAUREEN WEINER
K073704 12/31/2007 I-DIXEL J. MORITA USA, INC. KEITH A BARRITT
K073696 12/31/2007 VERAVIEWEPOCS J. MORITA USA, INC. KEITH A BARRITT
K073485 12/12/2007 VISTAKON (NARAFILCON) A SOFT CONTACT LENS JOHNSON & JOHNSON VISION CARE, INC. ROSALIND B WILLIAMS
K073519 12/14/2007 QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 KENSEY NASH CORP. CINDY VARUGHESE
K073590 12/20/2007 KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. HEATHER VIELE
K073516 12/14/2007 DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR KYPHON, INC. PAMELA SEGALE
K073552 12/20/2007 LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY LABORIE MEDICAL TECHNOLOGIES, CORP BARBARA MORNET
K073655 12/26/2007 PEGASUS STEERABLE (PTCA) GUIDEWIRE LAKE REGION MFG., INC. KAREN MORTENSEN
K073702 12/31/2007 PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR LAZARUS MEDICAL LLC CYNTHIA J.M NOLTE
K073479 12/11/2007 KINETIC-SL ANTERIOR CERVICAL PLATE SYSTEM LIFE SPINE REBECCA M BROOKS
K073480 12/11/2007 LIFE SPINE CROSS CONNECTOR LIFE SPINE REBECCA M BROOKS
K073411 12/04/2007 LITEDUO LIGHT INSTRUMENTS YORAM LEVY
K073506 12/13/2007 LUMINEX LX 100/200 INSTRUMENT LUMINEX CORP. NANCY KRUNIC
DEN070013 12/04/2007 ID-TAG RESPIRATORY VIRAL PANEL LUMINEX MOLECULAR DIAGNOSTICS, INC. GLORIA LEE
K073436 12/06/2007 SPECTRA VRMII 1-SWITCHED ND:YAG LASER SYSTEM LUTRONIC CORPORATION MAUREEN O'CONNELL
K073461 12/10/2007 ORTHO ANCHOR SCREWS M.I.S. IMPLANTS TECHNOLOGIES LTD. IMAN KHORSHID
K073592 12/20/2007 OPTISTAR ELITE INJECTION SYSTEM MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS DALE MOORE
K073468 12/27/2007 MIMICS MATERIALISE N.V. MIEKE JANSSEN
K073449 12/10/2007 SURGICASE MATERIALISE N.V. MIEKE JANSSEN
K073467 12/10/2007 SPINEASSIST SYSTEM MAZOR SURGICAL TECHNOLOGIES LTD. AHAVA STEIN
K073497 12/13/2007 HDL CHOLESTEROL REAGENT, MODEL 10211 MEDICA CORP. PHOTIOS MAKRIS
K073476 12/10/2007 COMPACT AUTO-SAFETY INJECTOR (CASI) MEDICAL HOUSE (ASI) LIMITED ROSE Y GUANG
K073555 12/20/2007 INSULIN PROTECTOR MEDICOOL, INC. EUGENE CHANG
K072942 12/06/2007 MEDLINE DISPOSABLE VAGINAL SPECULUM MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K073718 12/31/2007 MEDLINE GASTROSTOMY TUBE MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K073356 12/03/2007 PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715 MEDTRONIC MINIMED MARK J FAILLACE
K073139 12/12/2007 SMALL LUMEN PERITONEAL CATHETER MEDTRONIC NEUROSURGERY JEFFREY HENDERSON
K073456 12/10/2007 T-QUEST SYSTEM MEDX, INC. MICHAEL HANUSHEWSKY
K073556 12/19/2007 MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS MEDXPERT GMBH FRANZ MENEAN
K073513 12/14/2007 MERITS E700 PORCE LIFT MERITS HEALTH PRODUCTS CO., LTD. STEVE CHAO
K073397 12/03/2007 MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-H (BP A50) MICROLIFE CORP. SUSAN D GOLDSTEIN-FALK
K073398 12/03/2007 MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3MK1-3 (BP W100) MICROLIFE CORP. SUSAN D GOLDSTEIN-FALK
K073401 12/04/2007 EARPOPPER, MODEL EP-2000, EP-2100, EP-3000 MICROMEDICS, INC. TOM LOPAC
K073442 12/07/2007 MICRUS MICROCOIL SYSTEMS MICRUS ENDOVASCULAR CORPORATION JULIA GROSS
K073647 12/26/2007 MINITAPE EXTRA URETHRAL SLING MPATHY MEDICAL DEVICES, LTD. LOUIS J MAZZARESE
K073646 12/26/2007 MINITAPE URETHRAL SLING MPATHY MEDICAL DEVICES, LTD. LOUIS J MAZZARESE
K073521 12/17/2007 MUSMATE WALKING AID MUSMATE LTD ANDREW JAMES WYND
K073699 12/31/2007 MCT-DIABETES MYCARE TEAM, INC. DIANE MANDELL HORWITZ
K073652 12/26/2007 ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE NAKAMURA MAGNIFIER CO., LTD. CHARLIE ITO
K073665 12/26/2007 ALGO 5 NEWBORN HEARING SCREENER NATUS MEDICAL, INC. TOM BOLES
K073671 12/27/2007 PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE NDO SURGICAL, INC. JOHN J VOZELLA
K073448 12/10/2007 MEDICAL DISPLAY, MD205MG NEC DISPLAY SOLUTIONS, LTD. SHUICHI KINO
K073596 12/21/2007 NEOMED SINGLE LUMEN UMBILICAL CATHETER NEOMED, INC. PENNY NORTHCUTT
K073651 12/26/2007 NEOTRACT ANCHOR SYSTEM NEOTRACT, INC. SUZAN MOSER
K073455 12/14/2007 E-VAC NEW LEAF MEDICAL, INC. RICHARD T NOCK
K073375 12/03/2007 NEWDEAL TIBIAXYS SYSTEM NEWDEAL SAS JUDITH O'GRADY
K073491 12/12/2007 EEG-1100A SWITCH BOX NIHON KOHDEN AMERICA, INC. JACK COGGAN
K073550 12/19/2007 PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION NIHON KOHDEN AMERICA, INC. JACK COGGAN
K073489 12/12/2007 OLYMPUS IGA REAGENT OLYMPUS AMERICA INC. STEPHANIE G DONNELLY
K073490 12/12/2007 OLYMPUS IGG REAGENT OLYMPUS AMERICA INC. STEPHANIE G DONNELLY
K073487 12/12/2007 OLYMPUS IGM REAGENT OLYMPUS AMERICA INC. STEPHANIE G DONNELLY
K073409 12/04/2007 OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM OMNIGUIDE, INC. DOUGLAS W WOODRUFF
K073602 12/26/2007 MODIFICATION TO: APEX KNEE SYSTEM OMNLIFE SCIENCE WILLIAM MCCALLUM
K073407 12/04/2007 PACIFICA OR-NIM MEDICAL LTD. CAMPBELL HUTTON
K073670 12/27/2007 KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260 OREX COMPUTED RADIOGRAPHY LTD DAN LAOR
K073714 12/31/2007 TRAUMACAD VERSION 2.0 ORTHOCRAT, LTD. GEORGE J HATTUB
K073624 12/26/2007 MODULAR FOOT SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. DEREK LEWIS
K073720 12/31/2007 ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT OSMETECH MOLECULAR DIAGNOSTICS ROBERT DICHECK
K073685 12/28/2007 OTA COLLAGEN BIOMATERIAL OSSEOUS TECHNOLOGIES OF AMERICA DAVID J COLLETTE
K073465 12/14/2007 US/GS ULTRA WIDE SYSTEM OSSTEM IMPLANT CO.,LTD MIN JOO KIM
K073405 12/04/2007 PLEXUR M OSTEOTECH, INC. CHRISTOPHER TALBOT
K073617 12/28/2007 PHARAON LIPO OSYRIS JAOUAD ZEMMOURI
K073512 12/18/2007 START JUNIOR OTTO BOCK HEALTH CARE, LP BERT HERMAN
K073568 12/20/2007 PSL BIOZIR BLOCK P.S.L. INTERNATIONAL INC. CATHERINE FENG
K073386 12/03/2007 JOINT STIM, MODEL 1000 PAIN MANAGEMENT TECHNOLOGIES JOSHUA LEFKOVITZ
K073363 12/11/2007 THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300 PALADIN BIOMEDICAL CORPORATION ROBERT BICKFORD
K073583 12/20/2007 MODIFICATION TO PALOMAR LUX1540 HANDPIECE PALOMAR MEDICAL PRODUCTS, INC. SHARON TIMBERLAKE
K073698 12/31/2007 SECURE PARKELL, INC. DANIEL R SCHECHTER
K073376 12/03/2007 PHILIPS ECG ALGORITHM PHILIPS MEDICAL SYSTEMS PAUL SCHRADER
K073477 12/17/2007 PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS PHOTONOVA OFSWEDEN AB CONNIE HOY
K073662 12/26/2007 PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS PLAYTEX PRODUCTS, INC. KEITH EDGETT
K073441 12/07/2007 ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 POSSIS MEDICAL, INC. MIKE BURNSIDE
K073708 12/31/2007 FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM PRECISION SURGERY LTD. KAREN E WARDEN
K073693 12/31/2007 COSTORSOL PRESERVATION SOLUTIONS, INC. NEIL BURRIS
K073542 12/18/2007 CYCLETRAC CT-5000 PT PRODUCTS, LLC MICHELE CONWAY
K073630 12/26/2007 MODIFICATION TO: BPCARD, MODEL Z-7000-0700 QRS DIAGNOSTIC, LLC. MARY KAY JENSEN
K073549 12/18/2007 Q-PLUS T QUANTA SYSTEM, S.P.A. ISABELLA CARRER
K073349 12/31/2007 RELIANCE BUTTRESS WASHER SYSTEM RELIANCE MEDICAL SYSTEMS, LLC BRET M BERRY
K073638 12/26/2007 SWIFT LT RESMED LTD. DAVID D'CRUZ
K073600 12/21/2007 COMFORTGEL FULL FACE MASK RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP ZITA T YURKOS
K073419 12/05/2007 PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA EMBOLIZATION PARTICLES RJ MEDICAL, INC. JIM INNES
K073544 12/18/2007 PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA FOAM EMBOLIZATION PARTICLES RJ MEDICAL, INC. JIM INNES
K073501 12/13/2007 ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG ROCHE DIAGNOSTICS CORP. THERESA A BUSH
K073498 12/19/2007 LAPAROSCOPIC AND ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES, LAPAROSCOPY RUDOLF SYSTEM RUDOLF MEDICAL GMBH + CO. KG FRANZ MENEAN
K073522 12/14/2007 VITRIFICATION KIT & VITRIFICATION WARMING KIT SAGE IN-VITRO FERTILIZATION INC. GRACE HOLLAND
K073500 12/13/2007 ACTIVE ANTERIOR CERVICAL PLATE SYSTEM SANACOR MIKE ENSIGN
K073533 12/17/2007 SANARUS V2 TREATMENT SYSTEM SANARUS MEDICAL, INC. LISA HENRY
K073634 12/26/2007 MULTIGENT CREATININE (ENZYMATIC) ASSAY SENTINEL CH. SPA FABIO ROTA
K073705 12/31/2007 MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE SHANDONG QIAOPAI GROUP CO., LTD MARK JOB
K073577 12/20/2007 SHARPS TRANSPORT TUBE, MODEL 50035 SHARPS COMPLIANCE, INC. DAVID OLMSTEAD
K073684 12/28/2007 SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL SHEFFIELD INDUSTRIES, DIV. OF FARIA LTD. KATHLEEN HACKU
K073418 12/05/2007 SYNGO IMAGING CCF VA10A SIEMENS AG, MEDICAL SOLUTIONS SABINE SCHROEDEL
K073373 12/03/2007 SYNGO VOLUME PERFUSION-CT BODY SIEMENS AG, MEDICAL SOLUTIONS RALF HOFMANN
K073537 12/17/2007 NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS NOOR MALKI
K073674 12/28/2007 BONE FIXATION WIRE (KIRSCHNER WIRE) SIGNAL MEDICAL CORP. LOUIS A SERAFIN
K073635 12/26/2007 SBI SR MTP TOE IMPLANT SMALL BONE INNOVATIONS INC. JEFFREY ZIGLER
K073551 12/18/2007 SMITH & NEPHEW INSTRUMENT TRAYS SMITH & NEPHEW INC., ENDOSCOPY DIV. JULIE ACKER
K073466 12/10/2007 SMITH & NEPHEW INTRADISCAL CATHETER SYSTEM SMITH & NEPHEW, INC. MASON W ROBBINS
K073509 12/13/2007 TWINFIX PK FP SUTURE ANCHOR SMITH & NEPHEW, INC. DEANA BOUSHELL
K073380 12/03/2007 SYNTHESIS PH.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARETERIAL FILTER AND HARDSHELL VENOUS/CARIOTOMY RESERVOI SORIN GROUP ITALIA S.R.L. BARRY SALL
K073563 12/19/2007 MODIFICATION TO PROXIS SYSTEM ST. JUDE MEDICAL LINH PHAM
K073700 12/31/2007 6F PROXIS SYSTEM ST. JUDE MEDICAL, INC. LINH PHAM
K073586 12/26/2007 MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM STAAR SURGICAL CO. DIANA SMITH
K073591 12/26/2007 MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM STAAR SURGICAL CO. DIANA SMITH
K073613 12/21/2007 REPROCESSED SCISSOR TIPS STERILMED, INC. JOSHUA CLARIN
K073683 12/28/2007 VERIFY CHALLENGE PACKS - VERSION 2 STERIS CORPORATION JOHN SCOVILLE
K073618 12/26/2007 VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK STERIS CORPORATION JOHN R SCOVILLE
K073628 12/26/2007 SYNOCTA ABUTMENTS STRAUMANN USA ELAINE ALAN
K073633 12/26/2007 STRYKER ESSX MICRODEBRIDER SYSTEM STRYKER IRELAND LTD., INSTRUMENTS DIVISION COLETTE O'CONNOR
K073470 12/10/2007 AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX STRYKER SPINE SIMONA VOIC
K073437 12/06/2007 THOR ANTERIOR PLATING SYSTEM STRYKER SPINE CURTIS TRUESDALE
K073450 12/10/2007 SUTTER ELECTROSURGICAL CABLES SUTTER MEDIZINTECHNIK GMBH THOMAS A BOONE
K073478 12/11/2007 SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K073715 12/31/2007 ELIPO SYNERON MEDICAL LTD. YONI IGER
K073572 12/19/2007 MATRIX RF APPLICATOR SYNERON MEDICAL LTD. YONI IGER
K073460 12/10/2007 SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES SYNTHES (USA) SHERI L MUSGNUNG
K073402 12/04/2007 SYNTHES OLECRANON OSTEOTOMY NAILING SYSTEM SYNTHES (USA) KARL J NITTINGER
K073372 12/03/2007 ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI) SYSTEMSONE THOMAS ARTHUR
K073622 12/26/2007 EASY GRIP DENTAL IMPLANT SYSTEM T.F.I. SYSTEM S.R.L DOTT. CLAUDIO MECHELLI
K073667 12/26/2007 NITI-S BILIARY STENT TAEWOONG MEDICAL CO., LTD CATHRYN N CAMBRIA
K073494 12/19/2007 CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING TAIDOC TECHNOLOGY CORPORATION YUHUA CHEN
K073445 12/07/2007 CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-3026 TAIDOC TECHNOLOGY CORPORATION ERICA LI
K073532 12/17/2007 DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES TECHNOMED EUROPE MAURICE ROOST
K073370 12/13/2007 TC MATRIX CLINICAL CHEMISTRY ANALYZER TECO DIAGNOSTICS JIM VAECHHES
K073474 12/11/2007 CAPIOX CIRCUIT CONNECTORS TERUMO CORP. GARRY COURTNEY
K073581 12/20/2007 ICI P AND S SERIES IR CAMERAS TEXAS INFRARED IAN P GORDON
K073612 12/21/2007 URIC ACID (AOX), SCAL, NORTROL, ABTROL THERMO FISHER SCIENTIFIC OY PAIVI SORMUNEN
K073431 12/14/2007 FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T TIANJIN NEW BAY BIORESEARCH CO., LTD. ARMANDO TORRESCANO
K073495 12/12/2007 TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT TISSUELINK MEDICAL, INC. SOM KOVVURI
K073514 12/14/2007 TRANS1 AXIAL FIXATON SYSTEM TRANS1 INCORPORATED WILLIAM JACKSON
K073643 12/26/2007 TRANS1 AXIALIF 2-LEVEL OR II SYSTEM TRANS1 INCORPORATED ROBERT SHERIDAN
K073515 12/14/2007 TRANS1 FACET SCREW TRANS1 INCORPORATED WILLIAM JACKSON
K073432 12/06/2007 TRAUSON BONE PLATE TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD. DIANA HONG
K073653 12/26/2007 SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K073424 12/05/2007 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K073558 12/19/2007 SENSITITRE 18-24 SUSCEPTIBILITY PLATE TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K073444 12/11/2007 TRITON MEIDCAL TMED IV-SET TRITON MEDICAL, LLC IAN P GORDON
K073435 12/06/2007 KODAK 9000, KODAK 9000 3D TROPHY MARIE-PIERRE LABAT-CAMY
K073492 12/12/2007 DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM TYSON BIORESEARCH, INC. WEN-HAI TSAI
K073585 12/20/2007 INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 7905 VASCULAR SOLUTIONS, INC. ALYSSA MALINSKI
K073400 12/04/2007 VARICATH PERIPHERAL INFUSION CATHETER VEINRX INC. GREGORY MATHISON
K073694 12/31/2007 IVENT 2001 MRI CONDITIONAL VERSAMED MEDICAL SYSTEMS, INC. PAUL DRYDEN
K073502 12/13/2007 VERTEBRON VBR SYSTEM VERTEBRON, INC. LUIS NESPRIDO
K073473 12/14/2007 EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 85700 VOLCANO CORPORATION ARLENE BLADES
K073673 12/27/2007 SOYALA FULL FACE MASK GEL VENTED WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG RALF EGENOLF
K073383 12/04/2007 WELL LEAD REINFORCED ENDOTRACHEAL TUBE WELL LEAD MEDICAL INSTRUMENTS ARTHUR J WARD
K073374 12/03/2007 COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET WILLIAM COOK EUROPE APS MOLLY BUSENBARK
K073535 12/17/2007 BIOFOAM BONE WEDGE WRIGHT MEDICAL TECHNOLOGY, INC. BRAD SHEALS
K073482 12/14/2007 ALLOMAP MOLECULAR EXPRESSION TESTING XDX ROSE ROMEO
K073457 12/10/2007 MSTAR MPD4500 XINAOMDT TECHNOLOGY CO., LTD. DIANE HONG
K073620 12/26/2007 GUARDIAN HEMOSTASIS VALVE ZERUSA LIMITED GER BRETT
K073567 12/20/2007 BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES ZIMMER GMBH PATRICIA JENKS
K073499 12/13/2007 VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES ZIMMER, INC. ERIC S PITTMAN


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