FDA applicant

Audigence, Inc.

Melbourne, FL1 decision2010–20100 recalls

FDA records 1 decision for Audigence, Inc. (Melbourne, FL) in 2010: 1 510(k) clearance. All are in product code EWO (Audiometer). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ear, nose and throat panel, where it files most

How often FDA has decided Audigence, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Audigence, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Audigence, Inc.

Which product codes does it file in?

What has FDA decided for it lately?