FDA applicant

Rotation Medical, Inc.

Plymouth, MN5 decisions2011–20142 recalls

FDA records 5 decisions for Rotation Medical, Inc. (Plymouth, MN) from 2011 to 2014: 5 510(k) clearances. Most are in product codes FTM (Mesh, Surgical) and GDW (Staple, Implantable). Its devices cite 6 predicates, 2 of them its own earlier devices. 2 recalls are 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 Rotation Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2011high 3 (2013) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

2in 2024

2011high 2 (2024) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Rotation Medical, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Rotation 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?

What has been recalled?