BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    BILE DISK

    FDA 510(k)
    FDA Class 1 ·Microbiology

    LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES

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

    ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

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

    CONCERTO CRT-D DR AT

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code NIK·October 31, 2012

    9600

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

    OT VERIO TEST STRIP

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE GMBH·Product code CGA·May 30, 2022

    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