BEUDAMED
    4 results · 30ms · 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.
    Filters Status: Open, Classified ×

    sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring.

    FDA Recall
    Open, Classified ·SenTec AG Ringstrasse 39 Therwil Switzerland·Product code LKD·August 22, 2022

    SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxide partial pressure (PCo2), oxygen partial pressure (POs), functional oxygen saturation (PsO2), and pulse rate (PR), using either a single digital sensor (V-Sign Sensor 2 or OxiVenT sensor).

    FDA Recall
    Open, Classified ·SenTec AG Ringstrasse 39 Therwil Switzerland·Product code LKD·December 10, 2020

    V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).

    FDA Recall
    Open, Classified ·SenTec AG Ringstrasse 39 Therwil Switzerland·Product code LKD·May 2, 2023

    Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).

    FDA Recall
    Open, Classified ·SenTec AG Ringstrasse 39 Therwil Switzerland·Product code LKD·July 25, 2023