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.

510(k) submissions have been managed by Arkra Y America, Inc. as regulatory consultant.

Arkray Factory, 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 - Arkray Factory, Inc.

6 devices

1-6 of 6

Data Source

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

Last updated: Jun 02, 2026