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 ×

    KDG Abutments

    FDA 510(k)
    FDA Class 2 ·Dental

    IQ FLEX M

    FDA Adverse Event
    Malfunction ·FIRST SOURCE INC.·Product code IZL·May 29, 2024

    MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VIEWFLEX XTRA ICE CATHETER

    FDA 510(k)
    FDA Class 2 ·Radiology

    AUTOPULSE® RESUSCITATION MODEL 100

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION·Product code DRM·November 3, 2014

    SMART CONTROL NITINOL STENT SYSTEM

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code FGE·August 24, 2011

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·July 1, 2013

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024