Medical Device Manufacturer · US , Dallas , TX

Neo-Sigma, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1989

Total

Cleared

Denied

Neo-Sigma, Inc. has 4 FDA 510(k) cleared medical devices. Based in Dallas, US.

Historical record: 4 cleared submissions from 1989 to 1989. Primary specialty: General Hospital.

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

Neo-Sigma, 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 - Neo-Sigma, Inc.

4 devices

1-4 of 4

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: Apr 27, 2026