BEUDAMED
    3,498 results · 39ms · Sources: EU EUDAMED, US FDA

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    TYPE PDU/CDU 9040 (SYSTEM ATHENA)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALLURA XPER FD

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·May 2, 2024

    AZURION

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·March 4, 2024

    AZURION

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·January 17, 2023

    AZURION

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·March 8, 2024

    AZURION

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·October 5, 2024

    AZURION

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·August 1, 2024

    AZURION

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·August 28, 2023

    AZURION

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·April 18, 2024

    AZURION

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·July 19, 2023

    AZURION

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·August 25, 2023

    AZURION

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·July 11, 2023

    LIGHTSPEED 16 SLICE

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS, LLC·Product code JAK·March 26, 2010

    AZURION

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·August 13, 2025

    AZURION

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·August 14, 2024

    AZURION

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·August 13, 2024

    AZURION

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·May 29, 2024

    AZURION

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·November 19, 2025

    AZURION

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·December 17, 2025

    PICOSURE

    FDA Adverse Event
    Malfunction ·CYNOSURE LLC·Product code GEX·May 3, 2024