Headsafe Mfg Pty, Ltd. is one of 80 FDA 510(k) medical device manufacturers from Australia in the dataset, ranked by real submission volume.
Headsafe Mfg Pty, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Nurochek-Pro System, Nurochek-II System
2
Total
2
Cleared
0
Denied
Headsafe Mfg Pty, Ltd. has 2 FDA 510(k) cleared medical devices. Based in Surry Hills, AU.
Latest FDA clearance: Mar 2025. Active since 2023. Primary specialty: Neurology.
Browse the FDA 510(k) cleared devices submitted by Headsafe Mfg Pty, Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by RQM+ as regulatory consultant.
FDA 510(k) Regulatory Record - Headsafe Mfg Pty, Ltd.
2 devices