BEUDAMED
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    Evoblock, Perléon

    FDA 510(k)
    FDA Class 2 ·Dental

    *

    FDA Adverse Event
    Injury ·Product code FJI·January 15, 1997

    DeepXray

    FDA 510(k)
    FDA Class 2 ·Radiology

    NeuroStar Advanced Therapy System (Version 3.8)

    FDA 510(k)
    FDA Class 2 ·Neurology

    2243621-1992-00096

    FDA Adverse Event
    Injury ·GAMBRO PLATE DIALYZER·Product code KDI·August 27, 1992

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 11, 2014

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·July 27, 2011

    ENDOPATH** ETS FLEX45

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 23, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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