510(k) Report

FDA applicant

Auralogic

Norwalk, CT1 decision1986–19860 recalls

FDA records 1 decision for Auralogic (Norwalk, CT) in 1986: 1 510(k) clearance. No recall is linked to its devices.

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

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

FDA decisions per year

No FDA decision for Auralogic since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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