Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

118 results for "Hologic, Inc."
1–24 of 118
Search insights Median review: 87d Cleared: 98% Top manufacturer: Hologic, Inc. Lead specialty: Radiology
Cleared Sep 02, 2026
I-View®
K254090 · MUE
Hologic, Inc.
Radiology · 257d
Cleared Aug 12, 2026
Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)
K262792 · KNW
Hologic, Inc.
General & Plastic Surgery · 6d
Cleared Jun 17, 2026
CoolSeal Generator® (CSL-200-90)
K253634 · GEI
Hologic, Inc.
General & Plastic Surgery · 210d
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