BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    The ETHICON™ Total Energy System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    3D Printed Interbody Systems

    FDA UDI
    Seaspine Orthopedics Corporation·10889981281441·Interbody, 14x13x6mm, 7 Degree, 3D

    WaveForm™ C

    FDA UDI
    Seaspine Orthopedics Corporation·10889981220006·Interbody, 14x13x6mm, 7 Degree, 3D

    Carnation Ambulatory Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400

    FDA 510(k)
    FDA Class 2 ·Immunology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 22, 2024

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·September 21, 2015

    UNKNOWN DEPUY LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWB·November 21, 2008

    DURATA STS OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011

    ENDOVIVE? STANDARD PEG KIT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KNT·July 23, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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