Imaxeon Pty, Ltd. is one of 80 FDA 510(k) medical device manufacturers from Australia in the dataset, ranked by real submission volume.
Imaxeon Pty, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: MEDRAD Centargo CT Injection System, MEDRAD Centargo CT Injection System
2
Total
2
Cleared
0
Denied
Imaxeon Pty, Ltd. has 2 FDA 510(k) cleared medical devices. Based in Rydalmere, AU.
Latest FDA clearance: Sep 2025. Active since 2024. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Imaxeon Pty, Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Bayer Medical Care, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Imaxeon Pty, Ltd.
2 devices