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

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    Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UGEO WS80A DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·November 6, 2014

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 2, 2011

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 18, 2013

    ARTICULEZE M HEAD 36MM +5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·November 5, 2013

    PINNACLE MTL INS NEUT36IDX54OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·November 5, 2013

    ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;

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

    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