BEUDAMED
    7 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 ×

    EVIS Exera III Gastrointestinal Videoscope GIF-1TH190

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Surgical Mask

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

    MODIFICATION TO: HORIZON 9000WS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·July 20, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 18, 2013

    ACCOLADE DR SL MRI (Model L311)

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