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

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    MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STERILIZATION TRAY LINER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 8, 2013

    RESTORE PRIME ADVANCED

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

    CRYSTALLINE PASSIVE FIXATION

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·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