FDA applicant

Seikagaku Corp.

Tokyo3 decisions2001–20110 recalls

FDA records 3 decisions for Seikagaku Corp. (Tokyo) from 2001 to 2011: 1 510(k) clearance and 2 original PMA approvals. Most are in product codes MOZ (Acid, Hyaluronic, Intraarticular) and LYA (Splint, Intranasal Septal). 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, orthopedic panel, where it files most

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

FDA decisions per year

1in 2011

2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Seikagaku Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Seikagaku Corp.

Which product codes does it file in?

What has FDA decided for it lately?