Actis Medical Pty., Ltd. is one of 80 FDA 510(k) medical device manufacturers from Australia in the dataset, ranked by real submission volume.
Actis Medical Pty., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: SMART Osteotomy System
1
Total
1
Cleared
0
Denied
Actis Medical Pty., Ltd. has 1 FDA 510(k) cleared medical devices. Based in Torrensville, AU.
Latest FDA clearance: Apr 2026. Active since 2026. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Actis Medical Pty., Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Aztech Regulatory & Quality, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Actis Medical Pty., Ltd.
1 devices