Ceevra, Inc. is one of 16094 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Ceevra, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Ceevra Reveal 4, Ceevra Reveal 3+, Ceevra Reveal 3+
6
Total
6
Cleared
0
Denied
Ceevra, Inc. has 6 FDA 510(k) cleared medical devices. Based in Lafayette, US.
Latest FDA clearance: Aug 2026. Active since 2017. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Ceevra, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Rac Medical, 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 - Ceevra, Inc.
6 devices
Cleared
Aug 25, 2026
Ceevra Reveal 4
Radiology
103d
Cleared
Mar 04, 2025
Ceevra Reveal 3+
Radiology
74d
Cleared
Dec 05, 2023
Ceevra Reveal 3+
Radiology
29d
Cleared
Apr 25, 2023
Ceevra Reveal 3
Radiology
231d
Cleared
Jul 10, 2018
Ceevra Reveal 2.0
Radiology
271d
Cleared
Aug 03, 2017
Clarity Reveal
Radiology
86d