FDA applicant
Geistlich Pharma AG
FDA records 43 decisions for Geistlich Pharma AG (Washington, DC) from 1983 to 2026: 43 510(k) clearances. Most are in product codes LYC (Bone Grafting Material, Synthetic) and NPM (Bone Grafting Material, Animal Source). Since 2016 its 510(k)s took a median of 130 days from receipt to decision, against 132 for FDA’s reviews in the same codes and years. Its devices cite 68 predicates, 45 of them its own earlier devices. 6 recalls are linked to its devices.
FDA’s records also spell it “Geistlich-Pharma”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Geistlich Pharma AG’s devices, and how often a recall has named them.
FDA decisions per year
7in 2025
2026 so far, outlined.
Recalls per year
3in 2020
Class I Class II/III not classified
Planning a device like Geistlich Pharma AG’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