BEUDAMED
    7 results · 28ms · Sources: EU EUDAMED, US FDA

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    Suture-TOOL System

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

    Auryon Atherectomy System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Iliad Pedicle Screw System and Zenius Pedicle Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014

    RIATA ST ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011

    NATURALYTE

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 19, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025