FDA applicant

Monagan Ent., Inc.

Albion, NY1 decision1999–19990 recalls

FDA records 1 decision for Monagan Ent., Inc. (Albion, NY) in 1999: 1 510(k) clearance. All are in product code FRA (Purifier, Air, Ultraviolet, Medical). 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 hospital panel, where it files most

How often FDA has decided Monagan Ent., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Monagan Ent., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Monagan Ent., Inc.

Which product codes does it file in?

What has FDA decided for it lately?