BEUDAMED
    8 results · 23ms · Sources: EU EUDAMED, US FDA

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    Double Balloon Endoscope EN-840T, Over-tube TS-1214C

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

    ALAMO C

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SELECTIVA SB GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIPOL LEAD MODEL 300

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·November 6, 2014

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·September 2, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

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

    VANGUARD COMPLETE KNEE FEMUR RIGHT 60MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·February 27, 2025

    Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; 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