BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    INTRA AORTIC BALLOON

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756333016·VAGINAL DELIVERY TRAY

    Alta Multipurpose Device

    FDA 510(k)
    FDA Class 2 ·Radiology

    COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·June 25, 2014

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·January 2, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·November 1, 2010

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

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