Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of SonovaLabelled 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 15, 2026, FDA's public records list Bernafon-Maico with 9 510(k) clearances. The most recent is a 510(k) clearance dated Oct 28, 1998: MAICO MA42.
| Oct 28, 1998 | MAICO MA42K982723 · EWO | 510(k) clearances |
| Apr 22, 1998 | MAICO MA53K981142 · EWO | 510(k) clearances |
| Dec 15, 1997 | OPUS 2 - CANAL SERIES (ITC)K974069 · ESD | 510(k) clearances |
| Dec 15, 1997 | OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)K974152 · ESD | 510(k) clearances |
| Dec 15, 1997 | OPUS 2 - FULL CONCHA SERIES - ITEK974211 · ESD | 510(k) clearances |
| Oct 28, 1997 | DUALINE 100 BTEK973948 · ESD | 510(k) clearances |
| Jun 13, 1997 | DUALINE 400 CICK971158 · ESD | 510(k) clearances |
| Jun 6, 1997 | MAICO MA52K971080 · EWO | 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
