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 GN Store NordLabelled 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 GN Danavox, Inc. with 10 510(k) clearances. The most recent is a 510(k) clearance dated Jun 17, 1997: AUDALLION III HEARING SYSTEM.
| Jun 17, 1997 | AUDALLION III HEARING SYSTEMK971031 · ESD | 510(k) clearances |
| Jun 17, 1997 | DANAVOX MODELS 163/162 BTEK971032 · ESD | 510(k) clearances |
| Nov 15, 1994 | DANAVOX MODEL CICK942331 · ESD | 510(k) clearances |
| Nov 3, 1992 | DFS GENIUS BTEK924185 · ESD | 510(k) clearances |
| Jan 28, 1991 | 133 SERIES BTEK905679 · ESD | 510(k) clearances |
| Jan 28, 1991 | 143 SERIES BTEK905692 · ESD | 510(k) clearances |
| Aug 9, 1990 | CAS (COMPUTERIZED ANALYZER SYSTEM)K896996 · ETW | 510(k) clearances |
| Apr 30, 1990 | DISCRETION, IN THE CANAL HEARING INSTRUMENTK896995 · ESD | 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
