FDA applicant

Miromatrix Medical, Inc.

Eden Prairie, MN6 decisions2014–20170 recalls

FDA records 6 decisions for Miromatrix Medical, Inc. (Eden Prairie, MN) from 2014 to 2017: 6 510(k) clearances. Most are in product codes FTM (Mesh, Surgical) and KGN (Wound Dressing With Animal-Derived Material (S)). Its devices cite 6 predicates, 3 of them its own earlier devices. 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 Miromatrix Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2014high 2 (2014) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Miromatrix Medical, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Miromatrix Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?