BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    BURKE CONGENITAL THORACOSCOPY INSTRUMENTS

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    MEDCOMP C.A.V.H. CATHETER

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

    EkoSonic Endovascular System with Control Unit 4.0

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MENTOR SMOOTH ROUND HIGH PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·October 17, 2019

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 13, 2014

    RIATA PASSIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 14, 2013

    CINCH ANCHOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION DIV.·Product code LGW·January 13, 2011

    Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; 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