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

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    CARESIDE DIRECT BILIRUBIN

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HP MODEL M1008B, NONINVASIVE BLOOD PRESSURE MODULE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AFX SYSTEM

    FDA Adverse Event
    Injury ·ENDOLOGIX, INC.·Product code MIH·March 7, 2013

    RESTORE PRIME ADVANCED

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·January 13, 2011

    XENFORM

    FDA Adverse Event
    Other ·TEI BIOSCIENCES INC.·Product code FTM·July 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