Medical Device Manufacturer · AU , Rydalmere

Imaxeon Pty, Ltd. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2024
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
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