BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    MEDICOR QUALITY CONTROL BUFFER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners

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

    VS-SENSE TEST

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 5, 2014

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·October 15, 2012

    THERAPY ABLATION CATHETER

    FDA Adverse Event
    Malfunction ·IRVINE BIOMEDICAL, A ST JUDE MEDICAL COMPANY·Product code OAD·August 6, 2010

    PROPONENT DR SL (Model L201)

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