FDA applicant
Foshan Nanhai Plus Medical Co, Ltd.
FDA records 8 decisions for Foshan Nanhai Plus Medical Co, Ltd. (Foshan, CN) from 2015 to 2022: 8 510(k) clearances. Most are in product codes FYA (Gown, Surgical) and FXX (Mask, Surgical). Since 2016 its 510(k)s took a median of 187 days from receipt to decision, against 177 for FDA’s reviews in the same codes and years. Its devices cite 1 predicate, 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 Foshan Nanhai Plus Medical Co, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
5in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2015.
Planning a device like Foshan Nanhai Plus Medical 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