Medical Device Manufacturer · US , Salt Lake City , UT

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

2 submissions · 2 cleared · Since 1994

Total

Cleared

Denied

Orbtek, Inc. has 2 FDA 510(k) cleared medical devices. Based in Salt Lake City, US.

Historical record: 2 cleared submissions from 1994 to 1997. Primary specialty: Ophthalmic.

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

Orbtek, 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 - Orbtek, Inc.

2 devices

1-2 of 2

Data Source

Sourced from the FDA 510(k) public files . 175,218 total devices indexed.

Last updated: Apr 28, 2026