Polarean, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Polarean, Inc. - FDA 510(k) Cleared Devices
Recent clearances: XENOVIEW 3.0T Chest Coil, XENOVIEW 3.0T Chest Coil, XENOVIEW 3.0T Chest Coil
4
Total
4
Cleared
0
Denied
Polarean, Inc. has 4 FDA 510(k) cleared medical devices. Based in Research Triangle Park, US.
Latest FDA clearance: Nov 2024. Active since 2022. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Polarean, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by MethodSense, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Polarean, Inc.
4 devices