FDA applicant

Ams

Gyeonggi-Do, KR3 decisions2010–20170 recalls

FDA records 3 decisions for Ams (Gyeonggi-Do, KR) from 2010 to 2017: 3 510(k) clearances. Most are in product codes EIH (Powder, Porcelain) and CFR (Hexokinase, Glucose). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Ams Co., Ltd.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

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

FDA decisions per year

1in 2017

2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Ams by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Ams

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?