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

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    Filters Classification: Class Ii ×

    Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT

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

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025

    OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·July 4, 2012