BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    Bearing nsPVA Express™

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLXFIT INTERVERTEBRAL BODY FUSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE

    FDA 510(k)
    FDA Class 2 ·Neurology

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 6, 2014

    EX-PRESS MINI GLAUCOMA SHUNT

    FDA Adverse Event
    Injury ·OPTONOL, LTD·Product code KYF·July 16, 2013

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·November 18, 2015

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 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