510(k) Report

FDA applicant

Visiomed Group SA

Paris, FR2 decisions2011–20180 recalls

FDA records 2 decisions for Visiomed Group SA (Paris, FR) from 2011 to 2018: 2 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and FLL (Continuous Measurement Thermometer). Its devices cite 2 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2018

2011: 12018: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

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

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Other applicant names beginning “Visiomed”

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