Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FinlandLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Optomed Oyj and its 1 subsidiaries with 8 510(k) clearances. The most recent is a 510(k) clearance dated Nov 20, 2020: Optomed Smartscope M5 with Optomed Smartscope FA.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Optomed Oyj and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Nov 20, 2020 | Optomed Smartscope M5 with Optomed Smartscope FAK201325 · HKI | 510(k) clearances |
| Apr 5, 2018 | Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior ModuleK180378 · HKI | 510(k) clearances |
| Apr 11, 2017 | HAAG-STREIT FUNDUS MODULE 300K163021 · HKI | 510(k) clearances |
| Dec 18, 2013 | OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2K132186 · HKI | 510(k) clearances |
| May 16, 2011 | OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1K110986 · HKI | 510(k) clearances |
| Oct 1, 2009 | OPTOMED SMARTSCOPE, MODEL M3-1 EY1K092056 · HKI | 510(k) clearances |
| Apr 14, 1999 | DERMACOOLK990417 · GEX | 510(k) clearances |
| Nov 12, 1993 | OPTOSCALPEL I LASER SYSTEMK923531 · HQB | 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
