FDA applicant

Sopro - Acteon Group

La Ciotat, FR4 decisions2014–20160 recalls

FDA records 4 decisions for Sopro - Acteon Group (La Ciotat, FR) from 2014 to 2016: 4 510(k) clearances. Most are in product codes MUH (System, X-Ray, Extraoral Source, Digital) and HIF (Insufflator, Laparoscopic). 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, dental panel, where it files most

How often FDA has decided Sopro - Acteon Group’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2014high 2 (2015) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Sopro - Acteon Group by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sopro - Acteon Group’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 “Sopro”

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

Sopro 25 Sopro-Comeg GmbH 1

Sopro - Acteon Group

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Sopro”