FDA applicant
E.M.S Electro Medical Systems S.A
FDA records 28 decisions for E.M.S Electro Medical Systems S.A (Nyon, CH) from 2005 to 2026: 28 510(k) clearances. Most are in product codes ELC (Scaler, Ultrasonic) and EFB (Handpiece, Air-Powered, Dental). Since 2016 its 510(k)s took a median of 106 days from receipt to decision, against 112 for FDA’s reviews in the same codes and years. Its devices cite 43 predicates, 24 of them its own earlier devices. 3 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided E.M.S Electro Medical Systems S.A’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
3in 2024
Class I Class II/III not classified
Planning a device like E.M.S Electro Medical Systems S.A’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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