FDA applicant
Pou YU Biotechnology Co., Ltd.
FDA records 6 decisions for Pou YU Biotechnology Co., Ltd. (Fusing Township, Changhua Cty, TW) from 2008 to 2011: 6 510(k) clearances. All are in product code NHA (Abutment, Implant, Dental, Endosseous). Its devices cite 6 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 Pou YU Biotechnology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2011
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like Pou YU Biotechnology 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