FDA applicant

Marlen Mfg. & Development Co.

Bedford, OH1 decision1988–19880 recalls

FDA records 1 decision for Marlen Mfg. & Development Co. (Bedford, OH) in 1988: 1 510(k) clearance. All are in product code EZQ (Pouch, Colostomy). 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 Marlen Mfg. & Development Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Marlen Mfg. & Development Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Marlen Mfg. & Development Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Marlen Mfg. & Development Co.

Which product codes does it file in?

What has FDA decided for it lately?