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

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    Filters Classification: Class Ii ×

    Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB

    FDA Enforcement
    Class II ·Ongoing·Covidien, LP·April 10, 2024

    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