FDA applicant

Sigmedics, Inc.

Fairborn1 decision1994–19940 recalls

FDA records 1 decision for Sigmedics, Inc. (Fairborn) in 1994: 1 original PMA approval. All are in product code MKD (Stimulator, Functional Walking Neuromuscular…). 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, neurology panel, where it files most

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

FDA decisions per year

No FDA decision for Sigmedics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Sigmedics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?