| K253634 | CoolSeal Generator® (CSL-200-90) | Hologic, Inc. | 2026-06-17 | 210 | 0 |
| K251993 | Panther Fusion GI Expanded Bacterial Assay | Hologic, Inc. | 2025-09-25 | 90 | 0 |
| K243341 | Genius AI Detection 2.0 | Hologic, Inc. | 2025-07-31 | 279 | 0 |
| K243396 | Aptima SARS-CoV-2 Assay | Hologic, Inc. | 2025-02-13 | 105 | 0 |
| K243935 | Aptima CMV Quant Assay | Hologic, Inc. | 2025-01-17 | 28 | 0 |
| K243345 | Aptima BV Assay; Aptima CV/TV Assay | Hologic, Inc. | 2024-11-25 | 28 | 0 |
| K242465 | Panther Fusion SARS-CoV-2/Flu A/B/RSV assay | Hologic, Inc. | 2024-11-15 | 87 | 0 |
| K240886 | Fluent Pro Fluid Management System (FLT-200); Fluent Pro Flu | Hologic, Inc. | 2024-07-25 | 115 | 0 |
| K233352 | Aptima HCV Quant Dx Assay | Hologic, Inc. | 2024-07-24 | 299 | 0 |
| K241240 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | Hologic, Inc. | 2024-07-18 | 76 | 0 |
| DEN210035 | “Genius™ Digital Diagnostics System with the Genius™ Cervica | Hologic, Inc. | 2024-01-31 | 887 | 0 |
| K231329 | Aptima Neisseria gonorrhoeae Assay | Hologic, Inc. | 2024-01-26 | 263 | 0 |
| K230451 | Aptima® Chlamydia trachomatis Assay | Hologic, Inc. | 2023-11-16 | 268 | 0 |
| K231316 | Aptima Trichomonas vaginalis Assay | Hologic, Inc. | 2023-11-06 | 182 | 0 |
| K230096 | Genius AI Detection 2.0 with CC-MLO Correlation | Hologic, Inc. | 2023-05-23 | 130 | 0 |
| K222736 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | Hologic, Inc. | 2023-05-16 | 249 | 1 |
| K231017 | Panther Fusion AdV/hMPV/RV Assay | Hologic, Inc. | 2023-05-05 | 25 | 0 |
| K221449 | Genius AI Detection 2.0 | Hologic, Inc. | 2022-10-06 | 141 | 0 |
| K220321 | Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 | Hologic, Inc. | 2022-06-03 | 120 | 0 |
| K201019 | Genius AI Detection | Hologic, Inc. | 2020-11-18 | 215 | 0 |
| K202294 | Affirm Contrast Biopsy | Hologic, Inc. | 2020-10-05 | 53 | 0 |
| K200866 | Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay | Hologic, Inc. | 2020-05-17 | 46 | 0 |
| K200436 | Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo | Hologic, Inc. | 2020-03-23 | 28 | 0 |
| K191281 | Omni Hysteroscope, Omni Lok cervical seal | Hologic, Inc. | 2019-08-29 | 108 | 0 |
| K190694 | Unifi Workspace v1.0.0 | Hologic, Inc. | 2019-07-11 | 115 | 0 |
| K190452 | Aptima BV Assay | Hologic, Inc. | 2019-05-23 | 87 | 0 |
| K190515 | Aptima Combo 2 Assay (Panther System) | Hologic, Inc. | 2019-05-23 | 83 | 0 |
| K190472 | Aptima CV/TV Assay | Hologic, Inc. | 2019-05-16 | 79 | 0 |
| K182052 | Omni Instrument Tray | Hologic, Inc. | 2019-02-26 | 210 | 0 |
| DEN180047 | Aptima Mycoplasma genitalium Assay | Hologic, Inc. | 2019-01-23 | 145 | 0 |
| K182727 | Trident HD Specimen Radiography System | Hologic, Inc. | 2019-01-10 | 104 | 0 |
| K182006 | Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths | Hologic, Inc. | 2018-12-06 | 132 | 0 |
| K181974 | MyoSure XL Tissue Removal Device for Fluent | Hologic, Inc. | 2018-08-23 | 30 | 0 |
| K180825 | Fluent Fluid Management System | Hologic, Inc. | 2018-08-03 | 126 | 0 |
| K180681 | Aptima Combo 2 Assay (Panther System) | Hologic, Inc. | 2018-06-13 | 90 | 0 |
| K173901 | MyoSure MANUAL Tissue Removal Device | Hologic, Inc. | 2018-05-08 | 137 | 0 |
| K180233 | Eviva Stereotactic Guided Breast Biopsy System | Hologic, Inc. | 2018-04-10 | 71 | 0 |
| K172629 | Panther Fusion AdV/hMPV/RV Assay | Hologic, Inc. | 2017-12-04 | 94 | 0 |
| K172282 | Panther Fusion Paraflu Assay | Hologic, Inc. | 2017-10-23 | 87 | 0 |
| K163623 | Quantra | Hologic, Inc. | 2017-10-20 | 302 | 0 |
| K171963 | Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal F | Hologic, Inc. | 2017-09-26 | 88 | 0 |
| K172566 | Myosure Hysteroscopic Tissue Removal System and Myosure Tiss | Hologic, Inc. | 2017-09-20 | 26 | 0 |
| K162673 | Aptima Herpes Simplex Viruses 1 & 2 Assay | Hologic, Inc. | 2017-06-15 | 262 | 0 |
| K163052 | Brevera Biopsy System with Corlumina Imaging Technology | Hologic, Inc. | 2017-03-29 | 148 | 1 |
| K153486 | Affirm Prone Biopsy System | Hologic, Inc. | 2016-04-01 | 119 | 0 |
| K153223 | ProParaFlu+ Assay | Hologic, Inc. | 2015-12-09 | 33 | 0 |
| K153219 | ProFlu+ Assay | Hologic, Inc. | 2015-11-20 | 15 | 0 |
| K152723 | Myosure Hysteroscopic Tissue Removal System and Myosure Tiss | Hologic, Inc. | 2015-11-13 | 52 | 0 |
| K150169 | Sertera Biopsy Device | Hologic, Inc. | 2015-08-14 | 200 | 3 |
| K142029 | MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM | Hologic, Inc. | 2014-11-26 | 124 | 0 |