Misonix, Inc. - FDA 510(k) Cleared Devices

Misonix, Inc. specializes in ultrasonic surgical and wound care devices, with a manufacturing facility in Farmingdale, US. The company developed core technologies for minimally invasive surgical applications and therapeutic ultrasound systems.

Misonix received 17 FDA 510(k) clearances from 17 total submissions between 1998 and 2022. All cleared devices fall within the General & Plastic Surgery category. The company's regulatory record reflects sustained focus on ultrasonic surgical aspirators, lesion-generating systems, and ultrasonic wound care platforms.

The company is inactive and should be treated as a historical regulatory record. No FDA 510(k) clearances have been granted since 2022. Explore the complete device names, product codes, and clearance dates in the database.

510(k) submissions have been managed by Misonix as regulatory consultant.