FDA applicant

Amplivox, Ltd.

Eynsham, GB3 decisions2008–20170 recalls

FDA records 3 decisions for Amplivox, Ltd. (Eynsham, GB) from 2008 to 2017: 3 510(k) clearances. Most are in product codes NAS (Tympanometer) and ETY (Tester, Auditory Impedance). Its devices cite 3 predicates, 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, last Nov 3, 2026

FIG. A — Illustration, ear, nose and throat panel, where it files most

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

FDA decisions per year

1in 2017

2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Amplivox, Ltd. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Amplivox, Ltd.’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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Amplivox, Ltd.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?