BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    AFFINITY Proximal Tibia System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ADVIA Centaur CA 125II

    FDA 510(k)
    FDA Class 2 ·Immunology

    GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY

    FDA 510(k)
    FDA Class 2 ·Hematology

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 3, 2014

    ASR UNI FEMORAL IMPL SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTL LTD·Product code KWA·August 15, 2011

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013

    TRUE METRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·August 28, 2024

    Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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