BEUDAMED
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    Sonosite PX Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    WU'S 4-WHEELED NEO SCOOTER, WT-L4

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE

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

    BIPOL LEAD MODEL 300

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·October 22, 2008

    UNICEL® DXC 800 SYNCHRON® CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·August 17, 2011

    PELVISOFT ACELLULAR COLLAGEN BIOMESH

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABS.·Product code FTM·July 3, 2013

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019