Hologic - FDA 510(k) Cleared Devices

Hologic, develops innovative medical technologies for women's health, diagnostics, and medical imaging. The company operates globally across 36 countries with approximately 7,000 employees and holds over 4,100 patents. Hologic maintains a manufacturing facility in Danbury, Connecticut.

The company has received 2 FDA 510(k) clearances from 2 total submissions since 2016. Recent cleared devices span microbiology and radiology specialties, including molecular diagnostics and imaging accessories. The latest clearance in 2025 confirms active regulatory engagement.

Hologic's product portfolio emphasizes breast health, gynecological health, lab diagnostics, and molecular testing technologies. The company recently completed an acquisition by Blackstone and TPG, strengthening its position in women's health innovation and diagnostic solutions.

Explore the complete list of device names, product codes, and clearance dates in the 510(k) database.