FDA applicant
Te ME NA S.A.R.L.
FDA records 7 decisions for Te ME NA S.A.R.L. (Oldsmar, FL) from 1999 to 2008: 7 510(k) clearances. Most are in product codes BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)) and BXN (Stimulator, Nerve, Battery-Powered). Its devices cite 3 predicates, 2 of them its own earlier devices. 22 recalls are linked to its devices.
FDA’s records also spell it “Te ME NA Sas”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Te ME NA S.A.R.L.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2008
2026 so far, outlined.
Recalls per year
2in 2014
Class I Class II/III not classified
Planning a device like Te ME NA S.A.R.L.’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) Report