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

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    BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    OMRON WRIST DIGITAL BLOOD PRESSURE MONITOR HEM-601

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NEOLINE(TM)

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    SCREW

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·January 22, 2013

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·December 10, 2010

    THERMOPHORE HEATING PAD

    FDA Adverse Event
    BATTLE CREEK EQUIPMENT·Product code IRT·July 1, 2014

    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