FDA applicant

Eisai U.S.A., Inc.

Torrance, CA1 decision1987–19870 recalls

FDA records 1 decision for Eisai U.S.A., Inc. (Torrance, CA) in 1987: 1 510(k) clearance. All are in product code FCD (Barium Enema Kit). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Eisai U.S.A., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Eisai U.S.A., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Eisai U.S.A., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Eisai U.S.A., Inc.’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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Eisai U.S.A., Inc.

Which product codes does it file in?

What has FDA decided for it lately?