BEUDAMED
    3 results · 10ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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