FDA applicant
Genoss Co., Ltd.
FDA records 23 decisions for Genoss Co., Ltd. (Suwon-Si, KR) from 2007 to 2025: 23 510(k) clearances. Most are in product codes EIH (Powder, Porcelain) and LYC (Bone Grafting Material, Synthetic). Since 2016 its 510(k)s took a median of 273 days from receipt to decision, against 187 for FDA’s reviews in the same codes and years. Its devices cite 25 predicates, 8 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Genoss”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Genoss Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Genoss 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