FDA applicant

Bitco Intl.

Mclean, VA1 decision1995–19950 recalls

FDA records 1 decision for Bitco Intl. (Mclean, VA) in 1995: 1 510(k) clearance. All are in product code FPX (Strip, Adhesive, Closure, Skin). 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 Bitco Intl.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bitco Intl. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Bitco Intl.

Which product codes does it file in?

What has FDA decided for it lately?