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

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    SleepImage System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Oticon

    FDA UDI
    Oticon A/S·05707131331410·OPN 2, KIT 13 NFM R C001

    SimpliCore

    FDA UDI
    Kerr Corporation·00195062153471·Kerr SimpliCore Obturator for ZenFlex ONE Size ...

    ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

    6000CMS

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·June 11, 2013

    TRAPEZOID RX

    FDA Adverse Event
    BOSTON SCIENTIFIC·Product code LQC·July 15, 2011

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018