510(k) Report

FDA applicant

Resound Corp.

Redwood City, CA41 decisions1989–19990 recalls

FDA records 41 decisions for Resound Corp. (Redwood City, CA) from 1989 to 1999: 41 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and EWO (Audiometer). Its devices cite 13 predicates, 11 of them its own earlier devices. 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 Resound Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Resound Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Resound Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Resound Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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