BEUDAMED
    8 results · 21ms · 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.
    Filters Regulation: Us FDA ×

    SilentZPro 2.0

    FDA 510(k)
    FDA Class 2 ·Dental

    HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    hyperion X5, NewTom GO, X-RADiUS COMPACT

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 30, 2024

    ARCHITECT C8000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JGS·August 23, 2011

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 3, 2014

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 3, 2013

    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