Diagnostics 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 Exalenz Bioscience with 5 510(k) clearances. The most recent is a 510(k) clearance dated Feb 6, 2020: BreathID Smart System.
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.
| Date | Record | Source |
|---|---|---|
| Feb 6, 2020 | BreathID Smart SystemK193610 · MSQ | 510(k) clearances |
| Mar 8, 2018 | BreathID Hp SystemK173772 · MSQ | 510(k) clearances |
| Mar 8, 2018 | BreathID Hp Lab SystemK173777 · MSQ | 510(k) clearances |
| Oct 31, 2016 | BreathID Hp Lab SystemK162150 · MSQ | 510(k) clearances |
| May 22, 2013 | BREATHID HP SYSTEMK130524 · MSQ | 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
