FDA applicant
Talladium España, SL
FDA records 10 decisions for Talladium España, SL (Lleida, ES) from 2010 to 2026: 10 510(k) clearances. Most are in product codes NHA (Abutment, Implant, Dental, Endosseous) and KCT (Sterilization Wrap Containers, Trays…). Since 2016 its 510(k)s took a median of 178 days from receipt to decision, against 158 for FDA’s reviews in the same codes and years. Its devices cite 20 predicates, 6 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Talladium Espana, SL”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Talladium España, SL’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like Talladium España, SL’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 “Talladium”
FDA records each applicant name separately; these may or may not be the same firm.