FDA applicant

Grason-Stadler, Inc.

Littleton, MA17 decisions1979–20200 recalls

FDA records 17 decisions for Grason-Stadler, Inc. (Littleton, MA) from 1979 to 2020: 17 510(k) clearances. Most are in product codes EWO (Audiometer) and GWJ (Stimulator, Auditory, Evoked Response). Its devices cite 9 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Grason Stadler”.

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 Grason-Stadler, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2007high 1 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Grason-Stadler, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?