BEUDAMED
    12 results · 25ms · Sources: EU EUDAMED, US FDA

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    iRoot SP Plus

    FDA 510(k)
    FDA Class 2 ·Dental

    MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LASER-STIM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code PEA·June 14, 2024

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code PEA·July 22, 2024

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·January 10, 2025

    PRSVN FB INS RM/LL S2 9.5MM

    FDA Adverse Event
    Injury ·DEPUY IRELAND 9616671·Product code HRY·November 6, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 1, 2011

    PROLENE POLYPROPYLENE MESH

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·July 17, 2013

    TRUE METRIX

    FDA Adverse Event
    Injury ·TRIVIDIA HEALTH INC·Product code NBW·February 1, 2023

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025