Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of GN Store NordLabelled by claude-sonnet-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 Madsen Electronics with 21 510(k) clearances. The most recent is a 510(k) clearance dated Aug 25, 2000: CAPELLA.
| Aug 25, 2000 | CAPELLAK002200 · EWO | 510(k) clearances |
| Jan 28, 1999 | CAPELLA COCHLEAR EMISSIONS ANALYZERK983851 · EWO | 510(k) clearances |
| Apr 11, 1995 | RH2000 REAL EAR MEASUREMENT SYSTEMK945199 · EWO | 510(k) clearances |
| Feb 2, 1995 | VOYAGER 522K945032 · EWO | 510(k) clearances |
| Jul 18, 1994 | HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENTK942749 · ESD | 510(k) clearances |
| Feb 18, 1994 | OTOACOUSTIC EMISSIONS UNIT CELESTA 503K931325 · EWO | 510(k) clearances |
| Nov 19, 1993 | ORBITER 922 CLINICAL AUDIOMETERK931324 · EWO | 510(k) clearances |
| Jun 19, 1991 | ZODIAC 901 MIDDLE-EAR ANALYZERK910247 · ETY | 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
