BEUDAMED
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    TENS and EMS Unit

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    NA

    FDA UDI
    DEPUY MITEK, LLC·10886705012275·RETRACTOR ARM 12mm x 35mm

    IQ BODY FLUIDS CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    Specular Microscope CEM- 530

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DIAMOND CARPAL FUSION PLATE SCREW

    FDA Adverse Event
    Injury ·SMALL BONE INNOVATIONS, INC.·Product code HWC·December 3, 2008

    ALARIS EXTENSION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP.·Product code FPA·August 31, 2011

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 29, 2013

    VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extensions Azurion 7 series (722136), Allura Xper R9 (722303). The product is software, used during an endovascular intervention procedure.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·February 19, 2020