NOXBOX LTD

FDA Regulatory Profile

Summary

Total Recalls
4 (3 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0028-2026Class INOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-ISeptember 9, 2025
Z-0029-2026Class INOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-ISeptember 9, 2025
Z-2544-2025Class IINOxBOXi Nitric Oxide Delivery SystemJuly 19, 2023
Z-1667-2023Class INOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery DeviceMay 3, 2023