FDA applicant
Norian Corp.
FDA records 3 decisions for Norian Corp. (Cupertino, CA) from 1988 to 1999: 3 510(k) clearances. Most are in product codes LYC (Bone Grafting Material, Synthetic) and GXP (Methyl Methacrylate For Cranioplasty). Its devices cite 5 predicates, 1 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 Norian Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Norian Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Norian Corp.’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