Medical Device Manufacturer · AU , Malaga

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

3 submissions · 3 cleared · Since 2016

Recent clearances: ADAPT Tissue, CardioCel 3D, VascuCel

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Admedus Regen Pty, Ltd. Cardiovascular ✕

3 devices

1-3 of 3

Cleared Apr 03, 2020

Cardiovascular · 30d

Cleared Apr 28, 2017

Cardiovascular · 28d

Cleared Oct 14, 2016

Cardiovascular · 29d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: May 29, 2026