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

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    HERPES VIRUS HOMINIS ANTIBODY TEST SYS.

    FDA 510(k)
    FDA Class 2 ·Microbiology

    16PW - PG&E - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588120850·16PW - PG&E - Poly White

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517077162·

    SOMNO STAR & SERIES SLEEP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    SYNTHES LCP PEDIATRIC PLATE SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 15, 2014

    EXTERNAL PULSE GENERATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·October 31, 2012

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 17, 2010

    Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

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