510(k) Report

FDA applicant

Medal Intl. Sales Co., LLC

Fort Worth, TX1 decision1996–19960 recalls

FDA records 1 decision for Medal Intl. Sales Co., LLC (Fort Worth, TX) in 1996: 1 510(k) clearance. 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 Medal Intl. Sales Co., LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medal Intl. Sales Co., LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • KKXDrape, Surgical, Antimicrobial1decision

What has FDA decided for it lately?

  • K955872Volmed Operation DrapeMedal Intl. Sales Co., LLC · 1996

The one decision as Medal Intl. Sales Co., LLC →