BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    NOVA NA/K/CL/LI MODULE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ELLISON VITALLIUM FIXATION STAPLE SYS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COBAS 8000 COBAS C 701 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·April 15, 2026

    CONSULTA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code NIK·December 13, 2010

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·January 18, 2013

    SELF-RETAINING SCREWDRIVER FOR LOCKING SCREW

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code FSM·July 9, 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