Micropace Pty, Ltd. is one of 140 FDA 510(k) medical device manufacturers from Australia in the dataset, ranked by real submission volume.
Micropace Pty, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: OneStim-DUO Cardiac Stimulator (MP5003-4CO), STIMLAB, EPS320 CARDIAC STIMULATOR
3
Total
3
Cleared
0
Denied
Micropace Pty, Ltd. has 3 FDA 510(k) cleared medical devices. Based in Campsie, N.S.W., AU.
Latest FDA clearance: Jun 2026. Active since 2002. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Micropace Pty, Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Acorn N Oakes, LLC as regulatory consultant. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.
FDA 510(k) Regulatory Record - Micropace Pty, Ltd.
3 devices