BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

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    CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756356763·FLIP PACK

    AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE

    FDA 510(k)
    FDA Class 2 ·Hematology

    GALAXY G3 MINI 1MM X 1CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·August 13, 2020

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 19, 2010

    ONYX, AVM

    FDA Adverse Event
    Malfunction ·EV3 NEUROVASCULAR·Product code MFE·July 2, 2014

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    FDA Adverse Event
    Malfunction ·MOOG MEDICAL DEVICES GROUP·Product code LZH·December 3, 2012

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021