BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AGXO

    FDA UDI
    Oticon A/S·05707131261427·H110, BTE 13 WL 85 DBL AGXO

    AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE

    FDA 510(k)
    FDA Unclassified ·Unknown

    SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    INTELLAMAP ORION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 15, 2025

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 17, 2026

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 29, 2013

    TALENT THORACIC STENT GRAFT WITH XCELERANT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·June 15, 2011

    WALLFLEX ENTERAL DUODENAL STENT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MQR·August 22, 2008

    INTELLAMAP ORION?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·January 30, 2026

    INTELLAMAP ORION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·November 21, 2024

    INTELLAMAP ORION?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·February 26, 2026

    INTELLAMAP ORION

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·December 12, 2024

    Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026