FDA applicant
Etymonic Design, Inc.
FDA records 2 decisions for Etymonic Design, Inc. (Dorchester, Ontario, CA) from 1989 to 2001: 2 510(k) clearances. All are in product code ETW (Calibrator, Hearing Aid / Earphone And…). Its devices cite 1 predicate, 1 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
How often FDA has decided Etymonic Design, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Etymonic Design, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Etymonic Design, Inc.’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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