BEUDAMED
    51 results · 28ms · Sources: EU EUDAMED, US FDA

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    OPTIMEDICA CATALYS PRECISION LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CATALYS LASER

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·January 24, 2024

    CATALYS LASER

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·July 28, 2023

    CATALYS SYSTEM

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·April 24, 2026

    CATALYS SYSTEM

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·October 30, 2023

    CATALYS SYSTEM

    FDA Adverse Event
    Injury ·AMO MANUFACTURING USA, LLC·Product code OOE·November 1, 2022

    CATALYS SYSTEM

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·January 26, 2026

    CATALYS SYSTEM

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·July 28, 2023

    CATALYS SYSTEM

    FDA Adverse Event
    Malfunction ·Product code OOE·October 12, 2021

    CATALYS SYSTEM

    FDA Adverse Event
    Injury ·AMO MANUFACTURING USA, LLC·Product code OOE·November 1, 2022

    CATALYS SYSTEM

    FDA Adverse Event
    Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·May 21, 2021

    CATALYS SYSTEM

    FDA Adverse Event
    Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·May 21, 2021

    OPHTHALMIC FEMTOSECOND LASER

    FDA Adverse Event
    Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·August 12, 2021

    CATALYS SYSTEM

    FDA Adverse Event
    Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·August 13, 2021

    CATALYS LASER

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·January 24, 2023

    CATALYS LASER

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·April 27, 2023

    CATALYS LASER

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·January 24, 2024

    CATALYS SYSTEM

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·January 15, 2025

    CATALYS SYSTEM

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·July 28, 2025

    CATALYS SYSTEM

    FDA Adverse Event
    Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·January 17, 2022