Kaneka Medical America, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Kaneka Medical America, LLC - FDA 510(k) Cleared Devices
Recent clearances: Thrombuster II Aspiration Catheter, i-ED COIL System
2
Total
2
Cleared
0
Denied
Kaneka Medical America, LLC has 2 FDA 510(k) cleared medical devices. Based in New York, US.
Last cleared in 2021. Active since 2021. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Kaneka Medical America, LLC Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by KANEKA Corporation as regulatory consultant.
FDA 510(k) Regulatory Record - Kaneka Medical America, LLC
2 devices