BEUDAMED
    9 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 ×

    Low Ejection Fraction AI-ECG Algorithm

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    E-Cath STIM acc. Tsui

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AIGIS RX N (MEDIUM), AIGIS RX N (LARGE)

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

    IMP,TM 3.7MM MTX,10MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·July 8, 2022

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·September 12, 2014

    BASIC CONFIGURATION MODEL 6100 BASE

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code ---·July 19, 2011

    INCEPTA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 18, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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