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

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    EzDent-i/ E2/ Prora View/ Smart M Viewer

    FDA 510(k)
    FDA Class 2 ·Radiology

    WORLAND UNICONDYLAR TIBIAL BEARING

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT

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

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 29, 2014

    ASR UNI FEMORAL IMPL SIZE 43

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 10, 2011

    PWRD ECH FLEX 60MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 8, 2013

    Model Number L211 PROPONENT DR SL MRI Pacemaker

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

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

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