Medical Device Manufacturer · US , Edina , MN

Arkray Factory, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2014

Total

Cleared

Denied

Arkray Factory, Inc. has 6 FDA 510(k) cleared medical devices. Based in Edina, US.

Historical record: 6 cleared submissions from 2014 to 2019. Primary specialty: Chemistry.

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

Regulatory submissions have been managed by Arkra Y America, Inc. and Arkray Factory USA, Inc..

Arkray Factory, Inc. is one of 13015 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Arkray Factory, Inc.

6 devices

1-6 of 6

Data Source

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

Last updated: Jun 02, 2026