BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    VASPAR SEALENT

    FDA 510(k)
    FDA Class 1 ·Pathology

    TERATECH MODEL 2000 HANDHELD ULTRASOUND SYSTEM WITH DOPPLER AND HARMONIC IMAGING MODES

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEALEX BIOSPONGE WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 9, 2014

    EXTERNAL PULSE GENERATOR

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

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·August 18, 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