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

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    H.R. JAKOBI SURG. INSTRUMENTS #11 27/37

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

    CUSTOM IV SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GAUZE SPONGE-NON-STERILE SPONGE

    FDA 510(k)
    FDA Unclassified ·Unknown

    CADD ADMINISTRATION SETS

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FPA·September 25, 2019

    CADD ADMINISTRATION SETS

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FPA·September 25, 2019

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 27, 2014

    MUSTANG¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LIT·November 15, 2012

    COBAS 6000 E601 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·September 14, 2010

    CADD ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FPA·September 23, 2019

    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