FDA applicant

Umi Intl.

Bedford, MA1 decision1997–19970 recalls

FDA records 1 decision for Umi Intl. (Bedford, MA) in 1997: 1 510(k) clearance. All are in product code IXA (Cassette, Radiographic Film). 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Umi Intl. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Umi Intl.

Which product codes does it file in?

What has FDA decided for it lately?