Audax D.O.O. is one of 8 FDA 510(k) medical device manufacturers from Slovenia in the dataset, ranked by real submission volume.
Audax D.O.O. - FDA 510(k) Cleared Devices
Recent clearances: AudaxCeph Cephalogram Analysis Software
1
Total
1
Cleared
0
Denied
Audax D.O.O. has 1 FDA 510(k) cleared medical devices. Based in Ljubljana, SI.
Latest FDA clearance: May 2025. Active since 2025. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Audax D.O.O. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Trellis Enterprises, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Audax D.O.O.
1 devices