BEUDAMED
    8 results · 19ms · 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 ×

    Sunrise

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PCA Syringe Sets

    FDA 510(k)
    FDA Class 2 ·General Hospital

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 3, 2014

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    POPULAR PLASTICS·Product code IKX·July 12, 2013

    Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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