510(k) Report

FDA applicant

Teikoku Pharma USA, Inc.

San Jose, CA1 decision2008–20080 recalls

FDA records 1 decision for Teikoku Pharma USA, Inc. (San Jose, CA) in 2008: 1 510(k) clearance. All are in product code NAD (Dressing, Wound, Occlusive). 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 Teikoku Pharma USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Teikoku Pharma USA, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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