Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in BelgiumLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 6 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Barco and its 3 subsidiaries with 104 510(k) clearances and 7 device recalls. The most recent is a 510(k) clearance dated Oct 2, 2026: Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Barco and its 3 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Oct 2, 2026 | Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630)K262412 · PGY | 510(k) clearances |
| Sep 30, 2026 | Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where “x” may be any numeric character).K261469 · DXJ | 510(k) clearances |
| Dec 13, 2024 | LCD Monitor (MDEC-2523)K243307 · GCJ | 510(k) clearances |
| Aug 2, 2024 | Coronis OneLookK242008 · PGY | 510(k) clearances |
| Dec 11, 2023 | Nio Color 8MP (MDNC-8132)K233693 · PGY | 510(k) clearances |
| Mar 21, 2023 | Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)K230520 · PGY | 510(k) clearances |
| Mar 11, 2022 | Demetra Dermatoscope BDEM-01K213957 · PSN | 510(k) clearances |
| Apr 15, 2021 | MDPC-8127K203364 · PSY | 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
