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

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    SpO2 Extension Cable

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SagiNova

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    RADIAL JAW 4 BIOPSY FORCEPS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code FCL·November 20, 2008

    RIATA ACTIVE FIXATION

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

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 23, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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