FDA applicant

Keisei Medical Industrial Co., Ltd.

Bethel, CT4 decisions1986–19860 recalls

FDA records 4 decisions for Keisei Medical Industrial Co., Ltd. (Bethel, CT) in 1986: 4 510(k) clearances. Most are in product codes GES (Blade, Scalpel) and GDX (Scalpel, One-Piece). 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 Keisei Medical Industrial Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Keisei Medical Industrial Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Keisei Medical Industrial Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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See the 510(k) Report

Other applicant names beginning “Keisei”

FDA records each applicant name separately; these may or may not be the same firm.

Keisei (Usa) Co., Ltd. 2

Keisei Medical Industrial Co., Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Keisei”