BEUDAMED
    8 results · 20ms · 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 ×

    EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Eko Murmur Analysis Software (EMAS)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 9, 2023

    ONE TOUCH ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·November 24, 2008

    DUROM ACETABULAR COMPONENT 54/48 CODE N

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWA·August 30, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 23, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025