510(k) Report

FDA applicant

Mid America Medical, Inc.

Covington, KY1 decision1994–19940 recalls

FDA records 1 decision for Mid America Medical, Inc. (Covington, KY) in 1994: 1 510(k) clearance. All are in product code FXX (Mask, 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 Mid America Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mid America Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mid America Medical, Inc. 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?

  • FXXMask, Surgical1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K934974Fluid Resistant Mask with Wrap Around Eye ShieldMid America Medical, Inc. · 19941cites it

What has FDA decided for it lately?

  • K934974Fluid Resistant Mask with Wrap Around Eye ShieldMid America Medical, Inc. · 1994

The one decision as Mid America Medical, Inc. →