FDA applicant
Haolang Medical USA Corporation
FDA records 3 decisions for Haolang Medical USA Corporation (Bellevue, WA) from 2021 to 2025: 3 510(k) clearances. Most are in product codes FOS (Catheter, Umbilical Artery) and MSD (Catheter, Hemodialysis, Implanted). Its devices cite 5 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 Haolang Medical USA Corporation’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 2021.
Planning a device like Haolang Medical USA Corporation’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