SenTec AG

FDA Regulatory Profile

Summary

Total Recalls
14
510(k) Clearances
7
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2592-2023Class IIMembrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, July 25, 2023
Z-1980-2023Class IIV-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).May 2, 2023
Z-0148-2023Class IIsentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuoAugust 22, 2022
Z-1134-2021Class IISenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuouDecember 10, 2020
Z-2155-2019Class IISenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indicated for continuous, May 2, 2019
Z-2153-2019Class IISenTec Standard Starter Set with and without Service Gas (2 changers each) - Product Usage: Is indicMay 2, 2019
Z-2154-2019Class IISenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - Product Usage: is indicMay 2, 2019
Z-2152-2019Class IISenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasMay 2, 2019
Z-2156-2019Class IISenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monMay 2, 2019
Z-0088-2017Class IISDMS (SenTec Digital Monitoring System)September 15, 2016
Z-1501-2015Class IISentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, TherMarch 25, 2015
Z-0433-2013Class IISenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane Changer is indicated fNovember 5, 2012
Z-0434-2013Class IISenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane Changer InsertNovember 5, 2012
Z-2199-2012Class IISenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and July 9, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K243765LuMon(TM) SystemAugust 7, 2025
K232516Sentec Digital Monitoring System (SDMS) tCOM+May 17, 2024
K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software inDecember 17, 2015
K101690SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLEDecember 3, 2010
K071672SENTEC DIGITAL MONITORING SYSTEMSeptember 12, 2007
K041548SENTEC DIGITAL MONITOR MODEL #SDMAugust 9, 2004
K862340SENTEC LASER GUIDE LINE, MODEL SGL-05July 11, 1986