FDA applicant

Amt Engineering Co., Ltd.

Gyeonggi Do, KR2 decisions2023–20240 recalls

FDA records 2 decisions for Amt Engineering Co., Ltd. (Gyeonggi Do, KR) from 2023 to 2024: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2024

2023high 1 (2023) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Amt Engineering Co., Ltd. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Amt Engineering Co., 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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Amt Engineering Co., Ltd.

Which product codes does it file in?

What has FDA decided for it lately?