FDA applicant

Mimedx Group, Inc.

Marietta, GA5 decisions2010–20110 recalls

FDA records 5 decisions for Mimedx Group, Inc. (Marietta, GA) from 2010 to 2011: 5 510(k) clearances. Most are in product codes OMR (Vessel Guard Or Cover) and FTL (Mesh, Surgical, Polymeric). Its devices cite 9 predicates, 1 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, cardiovascular panel, where it files most

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

FDA decisions per year

3in 2011

2010high 3 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Mimedx Group, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mimedx Group, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Mimedx Group, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?