BEUDAMED
    44 results · 22ms · Sources: EU EUDAMED, US FDA

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    SOMA SAFE ENCLOSURE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TECO HOMOCYSTEINE ENZYMATIC ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Direxion and Direxion HI-FLO Torqueable Microcatheters

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DIREXION? HI-FLO?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·August 11, 2025

    DIREXION HI-FLO FATHOM-16 SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 13, 2025

    DIREXION?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·August 19, 2025

    DIREXION? TRANSEND?-14 SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·January 26, 2026

    DIREXION?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·May 2, 2025

    DIREXION?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·December 16, 2025

    DIREXION?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·April 21, 2025

    DIREXION? HI-FLO?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 24, 2026

    DIREXION? TRANSEND?-14 SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·December 10, 2025

    DIREXION? HI-FLO? FATHOM?-16 SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·April 23, 2025

    DIREXION TRANSEND-14 SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·March 31, 2025

    DIREXION? FATHOM?-16 SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·July 8, 2025

    DIREXION? HI-FLO? TRANSEND?-18 SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·May 14, 2026

    DIREXION? TRANSEND?-14 SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·March 4, 2026

    DIREXION? FATHOM?-16 SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 9, 2026

    DIREXION? TRANSEND?-14 SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 13, 2026

    DIREXION

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·June 5, 2025