BEUDAMED
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    FIBERBRONCHOSCOPE (PENTAX FB-17A)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Illuminated Mediastinal Access Port

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    CLEANSE S+ ULTRASONIC SCALER

    FDA 510(k)
    FDA Class 2 ·Dental

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 18, 2014

    SILVERHAWK

    FDA Adverse Event
    Malfunction ·FOXHOLLOW·Product code MCW·January 29, 2007

    MODULAR HANDLE

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·July 12, 2010

    Model Number U228, VISIONIST CRT-P EL MRI

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