Hologic, Inc.
FDA 510(k) & PMA Approved Devices — 109 products
Total Devices109
Categories0
Latest FDA decision
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K254090 | I-View® | MUE | 2026-09-02 | View |
| 510(k) | K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) | KNW | 2026-08-12 | View |
| 510(k) | K253634 | CoolSeal Generator® (CSL-200-90) | GEI | 2026-06-17 | View |
| 510(k) | K251993 | Panther Fusion GI Expanded Bacterial Assay | PCH | 2025-09-25 | View |
| 510(k) | K243341 | Genius AI Detection 2.0 | QDQ | 2025-07-31 | View |
| 510(k) | K243396 | Aptima SARS-CoV-2 Assay | QQX | 2025-02-13 | View |
| 510(k) | K243935 | Aptima CMV Quant Assay | PAB | 2025-01-17 | View |
| 510(k) | K243345 | Aptima BV Assay; Aptima CV/TV Assay | PQA | 2024-11-25 | View |
| 510(k) | K242465 | Panther Fusion SARS-CoV-2/Flu A/B/RSV assay | QOF | 2024-11-15 | View |
| 510(k) | K240886 | Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205) | HIG | 2024-07-25 | View |
| 510(k) | K233352 | Aptima HCV Quant Dx Assay | MZP | 2024-07-24 | View |
| 510(k) | K241240 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | QOF | 2024-07-18 | View |
| 510(k) | K231329 | Aptima Neisseria gonorrhoeae Assay | LSL | 2024-01-26 | View |
| 510(k) | K230451 | Aptima® Chlamydia trachomatis Assay | MKZ | 2023-11-16 | View |
| 510(k) | K231316 | Aptima Trichomonas vaginalis Assay | OUY | 2023-11-06 | View |
| 510(k) | K230096 | Genius AI Detection 2.0 with CC-MLO Correlation | QDQ | 2023-05-23 | View |
| 510(k) | K222736 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | QOF | 2023-05-16 | View |
| 510(k) | K231017 | Panther Fusion AdV/hMPV/RV Assay | OCC | 2023-05-05 | View |
| 510(k) | K221449 | Genius AI Detection 2.0 | QDQ | 2022-10-06 | View |
| 510(k) | K220321 | Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris | QEP | 2022-06-03 | View |
No matching devices.