Singular Health Pty, Ltd. is one of 80 FDA 510(k) medical device manufacturers from Australia in the dataset, ranked by real submission volume.
Singular Health Pty, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: 3DICOM MD Cloud, 3Dicom MD
2
Total
2
Cleared
0
Denied
Singular Health Pty, Ltd. has 2 FDA 510(k) cleared medical devices. Based in Subiaco, AU.
Latest FDA clearance: Jan 2026. Active since 2022. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Singular Health Pty, Ltd. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Singular Health Pty, Ltd.
2 devices