BEUDAMED
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    IQon Spectral CT

    FDA 510(k)
    FDA Class 2 ·Radiology

    ORTHOPHOS XG 3D / CEPH

    FDA 510(k)
    FDA Class 2 ·Radiology

    TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA

    FDA 510(k)
    FDA Class 2 ·General Hospital

    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