Medical device makerLabelled 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 Osko with 6 510(k) clearances. The most recent is a 510(k) clearance dated Jun 29, 2020: Edge Air(1417) Digital Flat Panel X-ray Detector.
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 |
|---|---|---|
| Jun 29, 2020 | Edge Air(1417) Digital Flat Panel X-ray DetectorK201503 · MQB | 510(k) clearances |
| Oct 6, 2017 | Edge Air Digital Flat Panel X-ray DetectorK172681 · MQB | 510(k) clearances |
| Oct 6, 2017 | Edge Digital Flat Panel X-ray DetectorK172682 · MQB | 510(k) clearances |
| Jul 28, 2017 | Smart Stitching Software System, Image Processing, RadiologicalK163048 · LLZ | 510(k) clearances |
| May 7, 2015 | Diagnostic X-ray SystemK150663 · KPR | 510(k) clearances |
| Apr 8, 2015 | ELIAN Digital Diagnostic X-ray SystemK150506 · KPR | 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
