Onera B.V. is one of 68 FDA 510(k) medical device manufacturers from Netherlands in the dataset, ranked by real submission volume.
Onera B.V. - FDA 510(k) Cleared Devices
Recent clearances: Onera SleepMap (SLEEPMAP), Onera STS 2 (ONERA STS 2), Onera Sleep Test System (Onera STS)
4
Total
4
Cleared
0
Denied
Onera B.V. has 4 FDA 510(k) cleared medical devices. Based in Eindhoven, NL.
Latest FDA clearance: Mar 2026. Active since 2022. Primary specialty: Neurology.
Browse the FDA 510(k) cleared devices submitted by Onera B.V. Filter by specialty or product code using the sidebar.
2 devices have linked clinical trials registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Onera B.V.
4 devices