BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    JOHNSON & JOHNSON MODULAR TOTAL KNEE PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Optima XR240amx

    FDA 510(k)
    FDA Class 2 ·Radiology

    BEDSIDE TINNITUS MASKER #1500

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    DEMIPULSE GENERATORS

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·June 18, 2014

    SIGMA 200 DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code DXY·October 26, 2010

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code HET·December 20, 2012

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020