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    The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to non-invasive adjust valve pressure/performance level pre- and post-implantation by using magnetic adjustment tools without the need for radiographic confirmation. After surgical implantation, the Medtronic Neurosurgery StrataMR valves provide a non-invasive method to address changing patient needs in the management of hydrocephalus. The valve design enables the physician to adjust the valve pressure/performance level using the Medtronic StrataMR Adjustment Tools. The StrataMR valves are intended to maintain performance level setting under magnetic resonance imaging (MRI) exposure when scanned in accordance with the MRI conditions in the labeling. The StrataMR valves, small and regular, provide the full range of performance levels: 0.5, 1.0, 1.5, 2.0, and 2.5. The currently set performance level is discernible through use of the Indicator Tool or by x-ray (for corresponding settings, refer to figure 6). The dome is designed to allow needle puncture via a 25-gauge or smaller noncoring needle. The StrataMR valve can be flushed in either the distal or proximal direction by percutaneous finger pressure. Occluders are located proximally and distally to the central reservoir on the StrataMR valve regular and only distally on the small model to facilitate selective flushing.

    FDA Enforcement
    Class I ·Terminated·Medtronic Neurosurgery·April 19, 2017

    TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023

    TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023

    TruSignal Ear Sensor, REF TS-E-D; Oximeter

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023

    TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023

    TruSignal Wrap Sensor, REF TS-W-D; Oximeter

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023

    TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023

    TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023

    TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023

    TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023