3 results
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15ms
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Sources: EU EUDAMED, US FDA
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Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive
FDA Enforcement
Class II
·Completed·Withings Sas·August 22, 2018
The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures. During the planning phase, the desired instrument placement and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory levels and verify patient position prior to instrument advancement. During the assessment phase, the achieved instrument placement and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data.
FDA Enforcement
Class II
·Completed·QUANTUM SURGICAL SAS·October 16, 2024
Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive
FDA Recall
Completed
·Withings Sas 2 rue Maurice Hartmann Issy les Moulineaux France·Product code DXN·June 11, 2018