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 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list SyntheticMr AB with 8 510(k) clearances. The most recent is a 510(k) clearance dated Dec 6, 2024: SyMRI.
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.
| Dec 6, 2024 | SyMRIK242524 · LNH | 510(k) clearances |
| Mar 26, 2024 | SyMRIK233733 · LNH | 510(k) clearances |
| Nov 3, 2021 | SyMRIK203372 · LNH | 510(k) clearances |
| Jul 28, 2020 | SyMRIK201616 · LNH | 510(k) clearances |
| Jun 13, 2019 | SyMRIK191036 · LNH | 510(k) clearances |
| Jun 12, 2018 | SyMRIK181093 · LNH | 510(k) clearances |
| Jan 26, 2018 | SyMRIK173558 · LNH | 510(k) clearances |
| Aug 29, 2017 | SyMRIK162943 · LNH | 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
