Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in NetherlandsLabelled 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 14, 2026, FDA's public records list Enraf-Nonius with 5 510(k) clearances. The most recent is a 510(k) clearance dated Sep 12, 2025: Compact II.
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.
| Sep 12, 2025 | Compact IIK251083 · IPF | 510(k) clearances |
| Jun 25, 2025 | Curapuls 670K243112 · IMJ | 510(k) clearances |
| Oct 24, 2023 | Sonopuls 190K230472 · IMI | 510(k) clearances |
| Oct 16, 2015 | ELTRAC 471K151640 · ITH | 510(k) clearances |
| Apr 28, 2003 | FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130K030297 · GXY | 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
