Disa Medinotec is one of 8 FDA 510(k) medical device manufacturers from South Africa in the dataset, ranked by real submission volume.
Disa Medinotec - FDA 510(k) Cleared Devices
Recent clearances: OutFlo Aortic Valve Dilatation Balloon Catheter, Trachealator
2
Total
2
Cleared
0
Denied
Disa Medinotec has 2 FDA 510(k) cleared medical devices. Based in Johannesburg, ZA.
Latest FDA clearance: Mar 2025. Active since 2021. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Disa Medinotec Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Biologics Consulting Group and Biologics Consulting Group, Inc..
FDA 510(k) Regulatory Record - Disa Medinotec
2 devices