BEUDAMED
    4 results · 12ms · Sources: EU EUDAMED, US FDA

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    SoftPath GUI version 4.2.3.4 2008-06-30 (Manuf Date). SoftPath GUI version 4.2.4.1 2008-09-30 (Manuf Date). SoftPath GUI version 4.3.0.3, 2008-07-23 (Manuf Date). SoftPath GUI version 4.3.0.4 2008-09-16 (Manuf Date). SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code LNX·January 26, 2009

    VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.

    FDA Enforcement
    Class II ·Terminated·Greiner Bio-One North America, Inc.·April 22, 2020

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    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