Device type
Apparatus, Nitric Oxide Delivery
Product code MRN · Class II · 21 CFR 868.5165 · Anesthesiology
Recent 510(k)s
Oct 30, 2026
K253095
ULSPIRA TS™ Nitric Oxide Therapy System
Airgas Therapeutics, LLC
- MRN
- Class II
Recent recalls
Oct 7, 2026
Z-3306-2026
NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.
NOXBOX LTD
- MRN
- Class II
- Ongoing
Sep 23, 2026
Z-3165-2026
NOxBOXi Nitric Oxide Delivery System.
NOXBOX LTD
- MRN
- Class II
- Ongoing