FDA applicant
Institut Georges Lopez
FDA records 3 decisions for Institut Georges Lopez (Lissieu, FR) from 2021 to 2022: 3 510(k) clearances. Most are in product codes KDL (Set, Perfusion, Kidney, Disposable) and KDN (System, Perfusion, Kidney). Its devices cite 4 predicates, 0 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 Institut Georges Lopez’s devices, and how often a recall has named them.
FDA decisions per year
2in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Institut Georges Lopez’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 “Institut”
FDA records each applicant name separately; these may or may not be the same firm.