FDA applicant

Aztec Medical, Inc.

Arlington, TX1 decision1990–19900 recalls

FDA records 1 decision for Aztec Medical, Inc. (Arlington, TX) in 1990: 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 Aztec Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Aztec Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Aztec”

FDA records each applicant name separately; these may or may not be the same firm.

Aztec Medical Products, Inc. 5

Aztec Medical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Aztec”