BEUDAMED
    47 results · 23ms · Sources: EU EUDAMED, US FDA

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    CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526550131·GENUMEDI PT KNEE SUP SILVER L EW IV

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814213·GENUMEDI PT SILVER L IV

    Vilex Power Accessory

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731122247·KWire .054x9" (1.4x225mm)

    DMP SINGLE BONDING

    FDA 510(k)
    FDA Class 2 ·Dental

    PMP4 SELFCHECK ECG

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DIREXION? HI-FLO?

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