510(k) Report

FDA applicant

Y.M.K. International Co., Ltd.

Taipei, TW1 decision1994–19940 recalls

FDA records 1 decision for Y.M.K. International Co., Ltd. (Taipei, TW) in 1994: 1 510(k) clearance. All are in product code KDC (Instrument, Surgical, Disposable). 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 Y.M.K. International Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Y.M.K. International Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Y.M.K. International Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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