BEUDAMED
    10 results · 24ms · Sources: EU EUDAMED, US FDA

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    Persona Personalized Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AIM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861

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

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 30, 2019

    INSERTER INTERBODY / TRIAL

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MAX·September 4, 2025

    DST SERIES* EEA* ORVIL* 25MM DEVICE

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·November 3, 2014

    LIGASURE IMPACT THORACIC

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

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·July 3, 2013

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code KXT·August 9, 2012

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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