FDA applicant

Mercan AB

Austin, TX2 decisions2001–20010 recalls

FDA records 2 decisions for Mercan AB (Austin, TX) in 2001: 2 510(k) clearances. Most are in product codes KKX (Drape, Surgical, Antimicrobial) and FYA (Gown, Surgical). 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 Mercan AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mercan AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Mercan AB

Which product codes does it file in?

What has FDA decided for it lately?