Medical Device Manufacturer · US , Louisville , CO

Bolder Surgical, LLC - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2020

Total

Cleared

Denied

Bolder Surgical, LLC has 5 FDA 510(k) cleared medical devices. Based in Louisville, US.

Last cleared in 2023. Active since 2020. Primary specialty: General & Plastic Surgery.

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

510(k) submissions have been managed by Third Party Review Group, LLC as regulatory consultant.

Bolder Surgical, LLC 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 - Bolder Surgical, LLC

5 devices

1-5 of 5

Data Source

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

Last updated: May 15, 2026