Hologic, Inc. - FDA 510(k) Cleared Devices
115
Total
111
Cleared
2
Denied
Hologic, Inc. has 111 FDA 510(k) cleared medical devices. Based in Waltham, US.
Latest FDA clearance: Sep 2025. Active since 1987. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Hologic, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Hologic, Inc.
115 devices
Cleared
Sep 25, 2025
Panther Fusion GI Expanded Bacterial Assay
Microbiology
90d
Cleared
Jul 31, 2025
Genius AI Detection 2.0
Radiology
279d
Cleared
Feb 13, 2025
Aptima SARS-CoV-2 Assay
Microbiology
105d
Cleared
Jan 17, 2025
Aptima CMV Quant Assay
Microbiology
28d
Cleared
Nov 25, 2024
Aptima BV Assay
Microbiology
28d
Cleared
Nov 15, 2024
Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
Microbiology
87d
Cleared
Jul 25, 2024
Fluent Pro Fluid Management System (FLT-200)
Obstetrics & Gynecology
115d
Cleared
Jul 24, 2024
Aptima HCV Quant Dx Assay
Microbiology
299d
Cleared
Jul 18, 2024
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
Microbiology
76d
Not Cleared
Jan 31, 2024
“Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”
Pathology
887d
Cleared
Jan 26, 2024
Aptima Neisseria gonorrhoeae Assay
Microbiology
263d
Cleared
Nov 16, 2023
Aptima® Chlamydia trachomatis Assay
Microbiology
268d
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