Manamed, LLC - FDA 510(k) Cleared Devices

Manamed, LLC designs and manufactures recovery and mobility solutions, including vascular therapy, lymphedema therapy, and cold therapy devices. The company operates with a manufacturing facility in Denton, Texas, and serves over 1,500 customers globally with a focus on post-operative rehabilitation and injury prevention.

Manamed has received 1 FDA 510(k) clearance from 1 total submission. The company specializes in Cardiovascular devices, with its first and latest clearance both occurring in 2025. The cleared device, PlasmaFlow X Compression Sleeve Device, reflects the company's core expertise in compression and vascular therapies.

The company remains active in the medical device market, with recent FDA clearance demonstrating ongoing innovation in compression and circulation-support technologies. Explore the device names, product codes, and clearance dates in the database to learn more about Manamed's regulatory submissions.