Medical Device Manufacturer · AU , Adelaide, South Australia

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

13 submissions · 13 cleared · Since 1997

Recent clearances: Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo, Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo, Eye Prime

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ellex Medical Pty, Ltd. Radiology ✕

1 devices

1-1 of 1

Cleared Apr 11, 2019

Radiology · 15d

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: May 18, 2026