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

Hologic, Inc. is a medical device company headquartered in Waltham, Massachusetts. The company specializes in women's health, diagnostics, and medical imaging technologies.

Hologic has maintained a strong FDA 510(k) regulatory record since its founding in 1987. The company has received 114 FDA 510(k) clearances from 118 total submissions. Recent cleared devices span microbiology, radiology, and obstetrics & gynecology categories. The latest clearance in 2025 demonstrates continued active development and regulatory engagement.

Hologic's cleared device portfolio includes molecular diagnostic assays, advanced imaging systems, and fluid management platforms. The company operates in 36 countries and holds over 4,100 patents, reflecting significant scale and innovation capacity in women's health and diagnostic markets.

Explore the complete list of Hologic's FDA 510(k) cleared devices, including product codes and clearance dates, in the database.

Regulatory submissions have been managed by Regulatory Technology Services, LLC and Underwriters Laboratories, Inc..