510(k) Report

FDA applicant

Electro Medical Systems (Ems Sa)

Nyon, CH3 decisions1990–20070 recalls

FDA records 3 decisions for Electro Medical Systems (Ems Sa) (Nyon, CH) from 1990 to 2007: 2 510(k) clearances and 1 original PMA approval. Most are in product codes ELC (Scaler, Ultrasonic) and NBN (Generator, Shock-Wave, For Pain Relief). 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 Electro Medical Systems (Ems Sa)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Electro Medical Systems (Ems Sa) by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Electro”

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