BEUDAMED
    147 results · 40ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Catalog Number: PSO-VT

    FDA Enforcement
    Class II ·Ongoing·Sophysa S.A.·May 22, 2024

    The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Catalog Number: PSO-VTT

    FDA Enforcement
    Class II ·Ongoing·Sophysa S.A.·May 22, 2024

    POLARIS ADJUSTABLE VALVE/ANTECHAMBER 10-140

    FDA Adverse Event
    Malfunction ·SOPHYSA SA·Product code JXG·May 20, 2014

    POLARIS

    FDA Adverse Event
    Malfunction ·SOPHYSA SA·Product code JXG·November 30, 2017

    PARENCHYMAL PRESSIO CATHETER

    FDA Adverse Event
    Malfunction ·SOPHYSA SA·Product code GWM·November 14, 2017

    PARENCHYMAL PRESSIO CATHETER

    FDA Adverse Event
    Malfunction ·SOPHYSA SA·Product code GWM·December 19, 2017

    PARENCHYMAL PRESSIO CATHETER

    FDA Adverse Event
    Malfunction ·SOPHYSA SA·Product code GWM·October 6, 2017

    SOPHY ADJUSTABLE PRESSURE VALVE SHUNT

    FDA Adverse Event
    Other ·SOPHYSA SA·Product code JXG·October 14, 2003

    SOPHY(R) ADJUSTABLE PRESSURE VALVE SHUNT

    FDA Adverse Event
    Other ·SOPHYSA SA·Product code JXG·October 24, 2003

    SOPHY ADJUSTABLE PRESSURE VALVE SHUNT

    FDA Adverse Event
    Other ·SOPHYSA SA·Product code JXG·December 3, 2003

    SOPHY ADJUSTABLE PRESSURE VALVE SHUNT

    FDA Adverse Event
    Other ·SOPHYSA SA·Product code JQG·December 9, 2003

    POLARIS SPV ADJUSTABLE VALVE

    FDA Adverse Event
    Injury ·SOPHYSA SA·Product code JXG·October 27, 2014

    POLARIS ADJUSTABLE PRESSURE VALVE

    FDA Adverse Event
    Other ·SOPHYSA SA·Product code JXG·April 23, 2007

    POLARIS ADJUSTABLE VALVE

    FDA Adverse Event
    Other ·SOPHYSA SA·Product code JXG·April 30, 2007

    SOPHY

    FDA Adverse Event
    Malfunction ·SOPHYSA SA·Product code JXG·November 24, 2017

    POLARIS SPV KIT PREATTACHED/BO19-10

    FDA Adverse Event
    Malfunction ·SOPHYSA SA·Product code JXG·February 13, 2013

    POLARIS SPVB KIT PREATTACHED/BO19-10

    FDA Adverse Event
    Malfunction ·SOPHYSA SA·Product code JXG·February 13, 2013

    POLARIS SPV ADJUSTABLE VALVE/BURR HOLE

    FDA Adverse Event
    Malfunction ·SOPHYSA SA·Product code JXG·February 13, 2013

    POLARIS SPV ADJUSTABLE VALVE/BURR HOLE

    FDA Adverse Event
    Malfunction ·SOPHYSA SA·Product code JXG·February 13, 2013

    POLARIS VALVE

    FDA Adverse Event
    Malfunction ·SOPHYSA SA·Product code JXG·October 17, 2018