FDA applicant

Rion Co. Ltd. Dba Rion Acoustic Device

Bristol, PA2 decisions1992–19930 recalls

FDA records 2 decisions for Rion Co. Ltd. Dba Rion Acoustic Device (Bristol, PA) from 1992 to 1993: 2 510(k) clearances. All are in product code ESD (Hearing Aid, Air-Conduction, Prescription). 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 Rion Co. Ltd. Dba Rion Acoustic Device’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rion Co. Ltd. Dba Rion Acoustic Device since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Rion Co. Ltd. Dba Rion Acoustic Device by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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See the 510(k) Report

Other applicant names beginning “Rion”

FDA records each applicant name separately; these may or may not be the same firm.

Rion Acoustic Instruments, Inc. 51

Rion Co. Ltd. Dba Rion Acoustic Device

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Rion”