FDA applicant

Rastronics USA, Inc.

Indianapolis, IN5 decisions1985–19900 recalls

FDA records 5 decisions for Rastronics USA, Inc. (Indianapolis, IN) from 1985 to 1990: 5 510(k) clearances. Most are in product codes ETW (Calibrator, Hearing Aid / Earphone And…) and ETY (Tester, Auditory Impedance). 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 Rastronics USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rastronics USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Rastronics USA, Inc.

Which product codes does it file in?

What has FDA decided for it lately?