FDA applicant
Electro Medical Systems SA
FDA records 11 decisions for Electro Medical Systems SA (North Attleboro, MA) from 1995 to 2002: 11 510(k) clearances. Most are in product codes FFK (Lithotriptor, Electro-Hydraulic) and EFB (Handpiece, Air-Powered, Dental). Its devices cite 14 predicates, 6 of them its own earlier devices. 3 recalls are linked to its devices.
FDA’s records also spell it “Electro Medical Systems, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Electro Medical Systems SA’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Electro Medical Systems SA since 2007.
Recalls per year
1in 2009
Class I Class II/III not classified
Planning a device like Electro Medical Systems SA’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) ReportOther applicant names beginning “Electro”
FDA records each applicant name separately; these may or may not be the same firm.