FDA applicant
Medicrea International S.A.S. (Medtronic)
FDA records 4 decisions for Medicrea International S.A.S. (Medtronic) (Rillieux-La-Pape, FR) from 2024 to 2026: 4 510(k) clearances. Most are in product codes QIH (Automated Radiological Image Processing Software) and MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 52 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 2 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Medicrea International S.A.S. (Medtronic)’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
2in 2025
Class I Class II/III not classified
Planning a device like Medicrea International S.A.S.…’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 “Medicrea”
FDA records each applicant name separately; these may or may not be the same firm.