Medical Device Manufacturer · US , Summerville , SC

Theradome, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2012

Total

Cleared

Denied

Theradome, Inc. has 5 FDA 510(k) cleared medical devices. Based in Summerville, US.

Historical record: 5 cleared submissions from 2012 to 2018. Primary specialty: General & Plastic Surgery.

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

510(k) submissions have been managed by Jacqueline A. Hauge as regulatory consultant.

Theradome, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Theradome, Inc.

5 devices

1-5 of 5

Data Source

Sourced from the FDA 510(k) public files . 175,730 total devices indexed.

Last updated: Jun 08, 2026