Braincool AB is one of 59 FDA 510(k) medical device manufacturers from Sweden in the dataset, ranked by real submission volume.
Braincool AB - FDA 510(k) Cleared Devices
Recent clearances: The IQoolTM System, The IQoolTM Warm System
4
Total
3
Cleared
1
Denied
Braincool AB has 3 FDA 510(k) cleared medical devices. Based in Medicon Village, SE.
Last cleared in 2023. Active since 2017. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Braincool AB Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Target Health, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Braincool AB
4 devices