Medical Device Manufacturer · US , Bend , OR

Challenge Mfg., Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1988

Total

Cleared

Denied

Challenge Mfg., Inc. has 4 FDA 510(k) cleared medical devices. Based in Bend, US.

Historical record: 4 cleared submissions from 1988 to 1991. Primary specialty: Obstetrics & Gynecology.

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

Challenge Mfg., 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 - Challenge Mfg., Inc.

4 devices

1-4 of 4

Data Source

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

Last updated: Apr 27, 2026