FDA applicant
Terrats Medical SL
FDA records 23 decisions for Terrats Medical SL (Barberá Del Vallés, ES) from 2017 to 2026: 23 510(k) clearances. Most are in product codes NHA (Abutment, Implant, Dental, Endosseous) and DZE (Implant, Endosseous, Root-Form). Since 2016 its 510(k)s took a median of 110 days from receipt to decision, against 158 for FDA’s reviews in the same codes and years. Its devices cite 87 predicates, 49 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Terrats Medical SL’s devices, and how often a recall has named them.
FDA decisions per year
5in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Terrats Medical 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) Report