FDA applicant

Balfour, Inc.

Mchenry, IL3 decisions1983–19840 recalls

FDA records 3 decisions for Balfour, Inc. (Mchenry, IL) from 1983 to 1984: 3 510(k) clearances. All are in product code KKX (Drape, Surgical, Antimicrobial). 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 and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Balfour, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Balfour, Inc.

Which product codes does it file in?

What has FDA decided for it lately?