BEUDAMED
    35 results · 24ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FATHOM 16

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQX·April 7, 2025

    FATHOM? -16

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQX·June 23, 2025

    FATHOM -16

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQX·March 19, 2025

    FATHOM? -16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DQX·November 6, 2025

    FATHOM -16

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQX·December 6, 2024

    FATHOM -16

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQX·December 3, 2024

    FATHOM -16

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQX·December 3, 2024

    FATHOM? -16

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQX·May 14, 2025

    MUSTANG?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·March 12, 2026

    FATHOM? -16

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQX·June 16, 2025

    FATHOM? -16

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQX·May 12, 2025

    FATHOM -16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DQX·March 17, 2025

    FATHOM? -16

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQX·April 22, 2025

    FATHOM? -16

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQX·December 15, 2025

    FATHOM? -16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DQX·April 22, 2025

    FATHOM? -16

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQX·December 9, 2025

    FATHOM? -16

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQX·August 15, 2025

    FATHOM? -16

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQX·January 12, 2026

    FATHOM? -16

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQX·January 15, 2026