BEUDAMED
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    Elecsys CA-125 II assay

    FDA 510(k)
    FDA Class 2 ·Immunology

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707012306·CALIBRA 1ST MOL BANDS W/G8025-03 n.UL 34

    GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO OUTBACK CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    11CM ANGLE ATTACHMENT

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 6, 2014

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 3, 2013

    ADVANTA BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·June 2, 2011

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020