BEUDAMED
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    Neodent Implant System – Custom Abutments

    FDA 510(k)
    FDA Class 2 ·Dental

    T-TECH DIGITAL, MODEL WL-22XXA SERIES

    FDA 510(k)
    FDA Class 2 ·Neurology

    BRELLA-SPEC(TM) VAGINAL SPECULUM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    AGILE ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·December 26, 2024

    AGILE ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·December 26, 2024

    AGILE ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 20, 2025

    AGILE ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 14, 2025

    AGILE ESOPHAGEAL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 30, 2025

    FLEXI-SEAL FMS

    FDA Adverse Event
    Injury ·CONVATEC·Product code KNT·November 13, 2008

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·September 4, 2011

    GYNECARE PROLIFT ANTERIOR PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·July 18, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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