Smartcardia SA is one of 92 FDA 510(k) medical device manufacturers from Switzerland in the dataset, ranked by real submission volume.
Smartcardia SA - FDA 510(k) Cleared Devices
Recent clearances: SmartCardia 7L Platform (MCT), SmartCardia 7L Platform
2
Total
2
Cleared
0
Denied
Smartcardia SA has 2 FDA 510(k) cleared medical devices. Based in Lausanne, CH.
Latest FDA clearance: Oct 2024. Active since 2023. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Smartcardia SA Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Steurer Consulting Group, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Smartcardia SA
2 devices