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

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    TLS BULB DRAINAGE SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MODIFICATION TO AURORA DS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VISI MOBILE MONITIORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALARIS PUMP MODULE

    FDA Adverse Event
    Death ·CAREFUSION CORP·Product code FRN·May 16, 2014

    ITRAK 3500

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code LLZ·October 29, 2012

    UNKNOWN DEPUY FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HTG·September 7, 2010

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018