Medical Device Manufacturer · US , Irvine , CA

Kentec Medical, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 1985

Total

Cleared

Denied

Kentec Medical, Inc. has 6 FDA 510(k) cleared medical devices. Based in Irvine, US.

Historical record: 6 cleared submissions from 1985 to 2012. Primary specialty: General Hospital.

Browse the FDA 510(k) cleared devices submitted by Kentec Medical, Inc. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.

Kentec Medical, Inc. is one of 14618 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Kentec Medical, Inc.

6 devices

1-6 of 6

Data Source

Sourced from the FDA 510(k) public files . 175,972 total devices indexed.

Last updated: Sep 06, 2026