FDA applicant
Nibec Co., Ltd.
FDA records 4 decisions for Nibec Co., Ltd. (Los Angeles, CA) from 2013 to 2015: 4 510(k) clearances. Most are in product codes NPM (Bone Grafting Material, Animal Source) and NPL (Barrier, Animal Source, Intraoral). Its devices cite 8 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Nibec Company, Limited”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Nibec Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2015
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2013.
Planning a device like Nibec Co., Ltd.’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