BEUDAMED
    5 results · 19ms · Sources: EU EUDAMED, US FDA

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    Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HD ErgoJust Video Extension, EuroJust ICU Cart Export For PTZ Video Ext. Video cart used for mobile medical record documentation.

    FDA Enforcement
    Class II ·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·August 15, 2018

    Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP) Product in use with Harmonie-E Long Term Monitoring System : ICTA-S & ICTA-D Seizure Detector, Slow wave Seizure Detector Harmonie-S Sleep System: Rapid Eye Movement Detector, Spindle Detector, Heart Rate Processor, Periodic Leg Movement Detector and Oximetry/Pulse rate Threshold Notification VITA/ICU Neurological Monitoring System: Burst Suppression Detector, Cerebral Function Monitor Trend, Visual and Auditory Notifications on all trends graphs in PolyTrends Harmonie {-s}{-E} Readers ,

    FDA Enforcement
    Class II ·Terminated·Stellate Systems·May 1, 2013

    ACU-RAY

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACU-TRAIN V (5)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ACU-RAY HF SERIES PORTABLE X-RAY UNIT

    FDA 510(k)
    FDA Class 2 ·Radiology