BEUDAMED
    9 results · 29ms · Sources: EU EUDAMED, US FDA

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    AMIGO-A288310 (SCOOTER, COMMUTER CART, 3-WHEELED)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Stryker 90-S Max SERFAS Energy Probe

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

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 29, 2014

    SPARC SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·December 5, 2012

    COLD PAK T-PAK 6X9

    FDA Adverse Event
    Injury ·CARDINAL HEALTH·Product code IMD·June 26, 2015

    Pipeline Flex Embolization Device

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

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

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025