BEUDAMED
    9 results · 27ms · 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 ×

    SCOUT BX Delivery System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Bernafon

    FDA UDI
    Bernafon AG·05711584114988·CZ7 MNR T R, 2.4G NFM SABE/MAC CORAL 7 GPL

    NMI HPICC III

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060

    FDA 510(k)
    FDA Class 2 ·Dental

    TENDRIL ST

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code NVN·January 13, 2014

    SERIES 50 XM FETAL/MATERNAL MONITOR

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code HGM·August 9, 2011

    MEDRAD INJECTION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDRAD - BAER·Product code DXT·July 2, 2013

    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026

    DRX Revolution Mobile X-Ray System

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