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

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    Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL1455

    FDA Enforcement
    Class I ·Terminated·Focus Diagnostics Inc·April 13, 2016

    Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2650, MOL1451, MOL1452, MOL1455

    FDA Enforcement
    Class II ·Terminated·Focus Diagnostics Inc·April 13, 2016

    Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2850, MOL1451, MOL1452, MOL1455

    FDA Enforcement
    Class I ·Terminated·Focus Diagnostics Inc·April 13, 2016

    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