Hologic, Inc.
FDA 510(k) & PMA Approved Devices — 54 products
Total Devices54
Categories29
Latest Approval2025-09-25
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 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) | DEN210035 | Genius Digital Diagnostics System with the Genius Cervical AI algorithm | QYV | 2024-01-31 | 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 |
| PMA | P210029 | Cytomegalovirus (cmv) dna quantitative assay | PAB | 2022-07-20 | 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 |
| 510(k) | K201019 | Genius AI Detection | QDQ | 2020-11-18 | View |
| 510(k) | K202294 | Affirm Contrast Biopsy | IZH | 2020-10-05 | View |
| 510(k) | K200866 | Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) | QEP | 2020-05-17 | View |
| 510(k) | K200436 | Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit | QEP | 2020-03-23 | View |
| 510(k) | K191281 | Omni Hysteroscope, Omni Lok cervical seal | HIH | 2019-08-29 | View |
| 510(k) | K190694 | Unifi Workspace v1.0.0 | LLZ | 2019-07-11 | View |
| 510(k) | K190515 | Aptima Combo 2 Assay (Panther System) | QEP | 2019-05-23 | View |
| 510(k) | K190452 | Aptima BV Assay | PQA | 2019-05-23 | View |
| 510(k) | K190472 | Aptima CV/TV Assay | PQA | 2019-05-16 | View |
| 510(k) | K182052 | Omni Instrument Tray | KCT | 2019-02-26 | View |
| 510(k) | DEN180047 | Aptima Mycoplasma genitalium Assay | QEP | 2019-01-23 | View |
| 510(k) | K182727 | Trident HD Specimen Radiography System | MWP | 2019-01-10 | View |
| PMA | P170025 | Hepatitis Viral B DNA Detection | MKT | 2018-12-28 | View |
| 510(k) | K182006 | Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths | HIH | 2018-12-06 | View |
| PMA | P080014 | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | MAQ | 2018-11-15 | View |
| PMA | P080015 | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | MAQ | 2018-11-15 | View |
| 510(k) | K181974 | MyoSure XL Tissue Removal Device for Fluent | HIH | 2018-08-23 | View |
| 510(k) | K180825 | Fluent Fluid Management System | HIG | 2018-08-03 | View |
| 510(k) | K180681 | Aptima Combo 2 Assay (Panther System) | LSL | 2018-06-13 | View |
| 510(k) | K173901 | MyoSure MANUAL Tissue Removal Device | HIH | 2018-05-08 | View |
| 510(k) | K180233 | Eviva Stereotactic Guided Breast Biopsy System | KNW | 2018-04-10 | View |
| 510(k) | K172629 | Panther Fusion AdV/hMPV/RV Assay | OCC | 2017-12-04 | View |
| 510(k) | K172282 | Panther Fusion Paraflu Assay | OOU | 2017-10-23 | View |
| 510(k) | K163623 | Quantra | LLZ | 2017-10-20 | View |
| 510(k) | K171963 | Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes | OCC | 2017-09-26 | View |
| 510(k) | K172566 | Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices | HIH | 2017-09-20 | View |
| PMA | P010013 | Device, thermal ablation, endometrial | MNB | 2017-07-18 | View |
| 510(k) | K162673 | Aptima Herpes Simplex Viruses 1 & 2 Assay | OQO | 2017-06-15 | View |
| 510(k) | K163052 | Brevera Biopsy System with Corlumina Imaging Technology | KNW | 2017-03-29 | View |
| PMA | P160023 | Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus | MZP | 2017-02-13 | View |
| PMA | P950039 | Processor, cervical cytology slide, automated | MKQ | 2016-10-26 | View |
| PMA | P080003 | Digital breast tomosynthesis | OTE | 2016-07-07 | View |
| PMA | P970058 | Analyzer, medical image | MYN | 2016-04-26 | View |
| 510(k) | K153486 | Affirm Prone Biopsy System | IZH | 2016-04-01 | View |
| PMA | P920048 | ENZYME IMMUNOASSAY, FETAL FIBRONECTIN | LKV | 2016-02-05 | View |
No matching devices.