Biomendex OY is one of 32 FDA 510(k) medical device manufacturers from Finland in the dataset, ranked by real submission volume.
Biomendex OY - FDA 510(k) Cleared Devices
Recent clearances: Adaptos®Fuse Bone Graft
1
Total
1
Cleared
0
Denied
Biomendex OY has 1 FDA 510(k) cleared medical devices. Based in Tampere, FI.
Latest FDA clearance: Feb 2026. Active since 2026. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Biomendex OY Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Bruder Consulting & Venture Group as regulatory consultant.
FDA 510(k) Regulatory Record - Biomendex OY
1 devices