FDA applicant

MeVis Medical Solutions AG

Pewaukee, WI7 decisions2011–20260 recalls

FDA records 7 decisions for MeVis Medical Solutions AG (Pewaukee, WI) from 2011 to 2026: 7 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and LNH (System, Nuclear Magnetic Resonance Imaging). Its devices cite 11 predicates, 0 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, radiology panel, where it files most

How often FDA has decided MeVis Medical Solutions AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2011high 3 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

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

Planning a device like MeVis Medical Solutions AG’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

Other applicant names beginning “MeVis”

FDA records each applicant name separately; these may or may not be the same firm.

Mevis Technology GmbH & Co. KG 1

MeVis Medical Solutions AG

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?

Other applicant names beginning “MeVis”