FDA applicant

Sodemsystems

Geneva, CH8 decisions1994–20030 recalls

FDA records 8 decisions for Sodemsystems (Geneva, CH) from 1994 to 2003: 8 510(k) clearances. Most are in product codes HBB (Motor, Drill, Pneumatic) and ERL (Drill, Surgical, Ent (Electric Or Pneumatic)…). Its devices cite 13 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, neurology panel, where it files most

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

FDA decisions per year

No FDA decision for Sodemsystems since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sodemsystems by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Sodemsystems

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?