BEUDAMED
    2 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Iii ×

    Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6

    FDA Enforcement
    Class III ·Terminated·Stryker Instruments Div. of Stryker Corporation·July 27, 2022

    CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage: The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.

    FDA Enforcement
    Class III ·Terminated·Cardiovascular Systems, Inc.·March 5, 2014