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

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    INDEX BPM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Kentrospine PSS Pedicle Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HERPESELECT 2 ELISA IGG, MODEL ELO920G

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TERUMO PERFUSION SYSTEM 8000

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·November 5, 2008

    LIGASURE IMPACT

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·August 17, 2011

    NAVILYST MEDICAL

    FDA Adverse Event
    Malfunction ·NAVILYST MEDICAL·Product code DQX·July 2, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012