Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Embla Systems, Inc. with 9 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Sep 27, 2019: Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable B….
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.
| Sep 27, 2019 | Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor InfantK180001 · MNR | 510(k) clearances |
| Mar 1, 2019 | XactTrace Single Use Respiratory Effort Belt SystemK173793 · MNR | 510(k) clearances |
| Nov 13, 2017 | Disposable Snap ElectrodeK172703 · GXY | 510(k) clearances |
| Apr 11, 2017 | REMbrandtK163617 · OLZ | 510(k) clearances |
| Dec 1, 2016 | RemLogicK162140 · OLZ | 510(k) clearances |
| Jun 23, 2016 | SANDMAN ELITEK153353 · OLZ | 510(k) clearances |
| Apr 24, 2013 | embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder). The Embletta Gold is a battery operated Class II · Calibration error for Embla Embletta Gold units calibrated through service center between June 15, 2012 to February 27, | Device recalls |
| Feb 21, 2013 | EMBLETTA MPRK122516 · MNR | 510(k) clearances |
| Aug 31, 2011 | MDRIVEK111742 · MNR | 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
