BEUDAMED
    10 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 ×

    S-Wire

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ONE STEP FSH MENOPAUSAL TEST

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MICROFRANCE(R) WORMALD VASCULAR CLAMP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 13, 2025

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·June 3, 2019

    FOGARTY

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES PR·Product code MJN·March 24, 2025

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014

    MAXIMO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 7, 2013

    RECEPTAL 1 LITER/CE WITH VALVE (50/CAS)

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code GCX·June 24, 2011

    ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023