FDA applicant

Fibre Formations, Inc.

Mchenry, IL5 decisions1978–19790 recalls

FDA records 5 decisions for Fibre Formations, Inc. (Mchenry, IL) from 1978 to 1979: 5 510(k) clearances. Most are in product codes EYQ (Garment, Protective, For Incontinence) and FMP (Protector, Skin Pressure). 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 Fibre Formations, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fibre Formations, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Fibre Formations, Inc.

Which product codes does it file in?

What has FDA decided for it lately?