FDA applicant
Adas3D Medical S.L.
FDA records 5 decisions for Adas3D Medical S.L. (Barcelona, ES) from 2021 to 2026: 5 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 61 days from receipt to decision, against 130 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 4 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 Adas3D Medical S.L.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Adas3D Medical S.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