Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SwedenLabelled 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 Osstell with 5 510(k) clearances. The most recent is a 510(k) clearance dated Sep 8, 2026: Reusable SmartPeg.
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 |
|---|---|---|
| Sep 8, 2026 | Reusable SmartPegK261987 · EKX | 510(k) clearances |
| Aug 22, 2019 | Osstell BeaconK181888 · EKX | 510(k) clearances |
| Feb 19, 2015 | Osstell IDxK142358 · EKX | 510(k) clearances |
| Apr 9, 2014 | MEGA ISQK132401 · EKX | 510(k) clearances |
| Sep 26, 2008 | OSSTELL ISQ IMPLANT STABILITY METERK082523 · EKX | 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
