Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IsraelLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list EarlySense with 12 510(k) clearances. The most recent is a 510(k) clearance dated Jan 4, 2018: EarlySense Bed Sensing Unit.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jan 4, 2018 | EarlySense Bed Sensing UnitK171836 · BZQ | 510(k) clearances |
| May 6, 2016 | EarlySense Insight SytemK152911 · BZQ | 510(k) clearances |
| Aug 31, 2015 | EarlySense Central Display Station (CDS)K151006 · MSX | 510(k) clearances |
| Jun 13, 2014 | CHAIR SENSING UNIT FOR EARLYSENSE SYSTEMK133661 · BZQ | 510(k) clearances |
| Dec 18, 2013 | EARLYSENSEK131379 · BZQ | 510(k) clearances |
| Sep 10, 2012 | EARLYSENSE CENTRAL DISPLAY SYSTEMK121885 · MSX | 510(k) clearances |
| Jun 8, 2012 | EARLYSENSE (EVERON) SYSTEMK120465 · BZQ | 510(k) clearances |
| Apr 19, 2011 | EVERON CENTRAL DISPLAY STATION (CDS)K110521 · MSX | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
