Candelis, Inc. is one of 5874 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Candelis, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ImageGrid StreamVue
4
Total
4
Cleared
0
Denied
Candelis, Inc. has 4 FDA 510(k) cleared medical devices. Based in Denton, US.
Latest FDA clearance: Jul 2026. Active since 2008. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Candelis, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Candelis, Inc.
4 devices