BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    CITATION TMZF HA STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFIED PK300 AUTOMATIC EIA ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MAGNETIC RESONANCE DEVICE MRT 150A

    FDA 510(k)
    FDA Class 2 ·Radiology

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 7, 2013

    INTERSTIM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code EZW·January 13, 2011

    SPRINT

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·August 8, 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