BEUDAMED
    7 results · 35ms · Sources: EU EUDAMED, US FDA

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    MEDIBLEND (TM) CLINICAL BLOOD GAS MIXTURES

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SURETY COLUMN

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEVILBISS DV5M SMARTLINK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·October 26, 2010

    RESTORE ADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 20, 2012

    GALILEO ECHO

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·June 18, 2014

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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