Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

115 results for "Hologic, Inc."
1–24 of 115
Cleared Sep 25, 2025
Panther Fusion GI Expanded Bacterial Assay
K251993 · PCH
Hologic, Inc.
Microbiology · 90d
Cleared Jul 31, 2025
Genius AI Detection 2.0
K243341 · QDQ
Hologic, Inc.
Radiology · 279d
Cleared Feb 13, 2025
Aptima SARS-CoV-2 Assay
K243396 · QQX
Hologic, Inc.
Microbiology · 105d
Cleared Jan 17, 2025
Aptima CMV Quant Assay
K243935 · PAB
Hologic, Inc.
Microbiology · 28d
Cleared Nov 25, 2024
Aptima BV Assay
K243345 · PQA
Hologic, Inc.
Microbiology · 28d
Cleared Nov 15, 2024
Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
K242465 · QOF
Hologic, Inc.
Microbiology · 87d
Cleared Jul 25, 2024
Fluent Pro Fluid Management System (FLT-200)
K240886 · HIG
Hologic, Inc.
Obstetrics & Gynecology · 115d
Cleared Jul 24, 2024
Aptima HCV Quant Dx Assay
K233352 · MZP
Hologic, Inc.
Microbiology · 299d
Cleared Jul 18, 2024
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
K241240 · QOF
Hologic, Inc.
Microbiology · 76d
Not Cleared Jan 31, 2024
“Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”
DEN210035 · QYV
Hologic, Inc.
Pathology · 887d
Cleared Jan 26, 2024
Aptima Neisseria gonorrhoeae Assay
K231329 · LSL
Hologic, Inc.
Microbiology · 263d
Cleared Nov 16, 2023
Aptima® Chlamydia trachomatis Assay
K230451 · MKZ
Hologic, Inc.
Microbiology · 268d
Cleared Nov 06, 2023
Aptima Trichomonas vaginalis Assay
K231316 · OUY
Hologic, Inc.
Microbiology · 182d
Cleared May 23, 2023
Genius AI Detection 2.0 with CC-MLO Correlation
K230096 · QDQ
Hologic, Inc.
Radiology · 130d
Cleared May 16, 2023
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
K222736 · QOF
Hologic, Inc.
Microbiology · 249d
Cleared May 05, 2023
Panther Fusion AdV/hMPV/RV Assay
K231017 · OCC
Hologic, Inc.
Microbiology · 25d
Cleared Oct 06, 2022
Genius AI Detection 2.0
K221449 · QDQ
Hologic, Inc.
Radiology · 141d
Cleared Jun 03, 2022
Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test...
K220321 · QEP
Hologic, Inc.
Microbiology · 120d
Cleared Nov 18, 2020
Genius AI Detection
K201019 · QDQ
Hologic, Inc.
Radiology · 215d
Cleared Oct 05, 2020
Affirm Contrast Biopsy
K202294 · IZH
Hologic, Inc.
Radiology · 53d
Cleared May 17, 2020
Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)
K200866 · QEP
Hologic, Inc.
Microbiology · 46d
Cleared Mar 23, 2020
Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris)...
K200436 · QEP
Hologic, Inc.
Microbiology · 28d
Cleared Aug 29, 2019
Omni Hysteroscope, Omni Lok cervical seal
K191281 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 108d
Cleared Jul 11, 2019
Unifi Workspace v1.0.0
K190694 · LLZ
Hologic, Inc.
Radiology · 115d