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Earlysense, Ltd.

FDA Regulatory Profile

Earlysense, Ltd. has 0 FDA recalls, 0 inspections, 12 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Jan 4, 2018

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances12Oct 4, 2026Not statedCurrent
Inspections0Oct 27, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K171836EarlySense Bed Sensing UnitJan 4, 2018
K152911EarlySense Insight SytemMay 6, 2016
K151006EarlySense Central Display Station (CDS)Aug 31, 2015
K133661CHAIR SENSING UNIT FOR EARLYSENSE SYSTEMJun 13, 2014
K131379EARLYSENSEDec 18, 2013
K121885EARLYSENSE CENTRAL DISPLAY SYSTEMSep 10, 2012
K120465EARLYSENSE (EVERON) SYSTEMJun 8, 2012
K110521EVERON CENTRAL DISPLAY STATION (CDS)Apr 19, 2011
K100376EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0Aug 6, 2010
K092062EVERON 1.0May 24, 2010
K082465EVERONMar 25, 2009
K070375EARLYSENSE ES-16 SYSTEMNov 15, 2007

FDA data resources