BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    DUODERM HYDROACTIVE DRESSING AND CGF DRESSINGS

    FDA 510(k)
    FDA Unclassified ·Unknown

    REPROCESSED ARTHROSCOPIC SHAPERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    gel-e Flex+ gel OTC

    FDA 510(k)
    FDA Unclassified ·Unknown

    PORTEX® BIVONA® AIRE-CUF® ADULT TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD INC.·Product code JOH·September 1, 2016

    PORTEX® BIVONA® AIRE-CUF® ADULT TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD INC.·Product code JOH·September 1, 2016

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code MCM·January 14, 2013

    PUMP MMT-722LNAP PRDGM INS PL EN ML

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·November 24, 2010

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 3, 2014

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015