BEUDAMED
    10 results · 28ms · Sources: EU EUDAMED, US FDA

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    GAMBRO CARTRIDGE BLOOD SETS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CARTRIDGE

    FDA Adverse Event
    Injury ·GAMBRO RENAL PRODUCTS S.A. DE C.V.·Product code FJK·July 8, 2015

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108696561·Fully Guided Sleeve Narrow, L25mm Drill (Purple)

    StrykeFlow

    FDA UDI
    STRYKER CORPORATION·07613327051827·Laser Fiber Guide, Flexible

    R & D DESIGNATION AP-035

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDISUL DISPOSABLE VAGINAL SPECULUM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CONTAK RENEWAL TR

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code DTB·April 22, 2013

    ACCU-CHEK FLEXLINK PLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code FRN·April 19, 2011

    ENDOVIVE STANDARD PEG KIT PULL METHOD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNT·July 3, 2008

    Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX¿ Complete Brain Probe Kit (comprised of IP1, CC1.P1) 2) LICOX¿ Complete Brain Probe Kit (comprised of IP2, CC1.P1) 3) LICOX¿ Complete Brain Tunnelling Probe Kit (comprised of VK5.2, CC1.P1 4) LICOX¿ Complete Brain Probe Kit (comprised of IM1, CC1.SB) Sterile Rx Only Manufacturer CMS -Gesse;schaft for medizinische Sondentechnik mbH Dorfstrasse 2 24247 <eilkendorf Germany Distributed by Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536, USA

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·December 24, 2014