| CoolSeal Generator® (CSL-200-90) (K253634) | Hologic, Inc. | 2026-06-17 |
| Panther Fusion GI Expanded Bacterial Assay (K251993) | Hologic, Inc. | 2025-09-25 |
| Genius AI Detection 2.0 (K243341) | Hologic, Inc. | 2025-07-31 |
| Aptima SARS-CoV-2 Assay (K243396) | Hologic, Inc. | 2025-02-13 |
| Aptima CMV Quant Assay (K243935) | Hologic, Inc. | 2025-01-17 |
| Aptima BV Assay; Aptima CV/TV Assay (K243345) | Hologic, Inc. | 2024-11-25 |
| Panther Fusion SARS-CoV-2/Flu A/B/RSV assay (K242465) | Hologic, Inc. | 2024-11-15 |
| 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) (K240886) | Hologic, Inc. | 2024-07-25 |
| Aptima HCV Quant Dx Assay (K233352) | Hologic, Inc. | 2024-07-24 |
| Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay (K241240) | Hologic, Inc. | 2024-07-18 |
| “Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm” (DEN210035) | Hologic, Inc. | 2024-01-31 |
| Aptima Neisseria gonorrhoeae Assay (K231329) | Hologic, Inc. | 2024-01-26 |
| Aptima® Chlamydia trachomatis Assay (K230451) | Hologic, Inc. | 2023-11-16 |
| Aptima Trichomonas vaginalis Assay (K231316) | Hologic, Inc. | 2023-11-06 |
| Genius AI Detection 2.0 with CC-MLO Correlation (K230096) | Hologic, Inc. | 2023-05-23 |
| Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay (K222736) | Hologic, Inc. | 2023-05-16 |
| Panther Fusion AdV/hMPV/RV Assay (K231017) | Hologic, Inc. | 2023-05-05 |
| Genius AI Detection 2.0 (K221449) | Hologic, Inc. | 2022-10-06 |
| 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 (K220321) | Hologic, Inc. | 2022-06-03 |
| Genius AI Detection (K201019) | Hologic, Inc. | 2020-11-18 |
| Affirm Contrast Biopsy (K202294) | Hologic, Inc. | 2020-10-05 |
| Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) (K200866) | Hologic, Inc. | 2020-05-17 |
| 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 (K200436) | Hologic, Inc. | 2020-03-23 |
| Omni Hysteroscope, Omni Lok cervical seal (K191281) | Hologic, Inc. | 2019-08-29 |
| Unifi Workspace v1.0.0 (K190694) | Hologic, Inc. | 2019-07-11 |
| Aptima BV Assay (K190452) | Hologic, Inc. | 2019-05-23 |
| Aptima Combo 2 Assay (Panther System) (K190515) | Hologic, Inc. | 2019-05-23 |
| Aptima CV/TV Assay (K190472) | Hologic, Inc. | 2019-05-16 |
| Omni Instrument Tray (K182052) | Hologic, Inc. | 2019-02-26 |
| Aptima Mycoplasma genitalium Assay (DEN180047) | Hologic, Inc. | 2019-01-23 |
| Trident HD Specimen Radiography System (K182727) | Hologic, Inc. | 2019-01-10 |
| Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths (K182006) | Hologic, Inc. | 2018-12-06 |
| MyoSure XL Tissue Removal Device for Fluent (K181974) | Hologic, Inc. | 2018-08-23 |
| Fluent Fluid Management System (K180825) | Hologic, Inc. | 2018-08-03 |
| Aptima Combo 2 Assay (Panther System) (K180681) | Hologic, Inc. | 2018-06-13 |
| MyoSure MANUAL Tissue Removal Device (K173901) | Hologic, Inc. | 2018-05-08 |
| Eviva Stereotactic Guided Breast Biopsy System (K180233) | Hologic, Inc. | 2018-04-10 |
| Panther Fusion AdV/hMPV/RV Assay (K172629) | Hologic, Inc. | 2017-12-04 |
| Panther Fusion Paraflu Assay (K172282) | Hologic, Inc. | 2017-10-23 |
| Quantra (K163623) | Hologic, Inc. | 2017-10-20 |
| Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes (K171963) | Hologic, Inc. | 2017-09-26 |
| Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices (K172566) | Hologic, Inc. | 2017-09-20 |
| Aptima Herpes Simplex Viruses 1 & 2 Assay (K162673) | Hologic, Inc. | 2017-06-15 |
| Brevera Biopsy System with Corlumina Imaging Technology (K163052) | Hologic, Inc. | 2017-03-29 |
| Affirm Prone Biopsy System (K153486) | Hologic, Inc. | 2016-04-01 |
| ProParaFlu+ Assay (K153223) | Hologic, Inc. | 2015-12-09 |
| ProFlu+ Assay (K153219) | Hologic, Inc. | 2015-11-20 |
| Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices (K152723) | Hologic, Inc. | 2015-11-13 |
| Sertera Biopsy Device (K150169) | Hologic, Inc. | 2015-08-14 |
| MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM (K142029) | Hologic, Inc. | 2014-11-26 |
| QUANTRA (K142037) | Hologic, Inc. | 2014-10-10 |
| PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM (K140960) | Hologic, Inc. | 2014-06-13 |
| MULTIVIEW (K132316) | Hologic, Inc. | 2013-10-30 |
| MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK) (K131581) | Hologic, Inc. | 2013-08-22 |
| MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK) (K131736) | Hologic, Inc. | 2013-08-22 |
| SINGLE ENERGY (SE) FEMUR EXAMS (K130277) | Hologic, Inc. | 2013-05-31 |
| MYOSURE INTRUMENT TRAY (K121280) | Hologic, Inc. | 2013-02-08 |
| CONTRAST ENHANCED DIGITAL MAMMOGRAPHY (K123873) | Hologic, Inc. | 2013-01-29 |
| MAMMOGRAPHY PRIOR ENHANCEMENT (MPE) (K123530) | Hologic, Inc. | 2012-12-20 |
| THS INSTRUMENT TRAY (K120947) | Hologic, Inc. | 2012-10-17 |
| MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL (K122563) | Hologic, Inc. | 2012-09-19 |
| MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK) (K122498) | Hologic, Inc. | 2012-09-10 |
| MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK) (K121868) | Hologic, Inc. | 2012-07-19 |
| QUANTRA (K120472) | Hologic, Inc. | 2012-06-22 |
| INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM (K120388) | Hologic, Inc. | 2012-04-06 |
| MYOSURE CONTROL UNIT (K120593) | Hologic, Inc. | 2012-03-23 |
| HOLOGIC VISCERAL FAT SOFTWARE (K113356) | Hologic, Inc. | 2012-03-06 |
| TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001 (K111508) | Hologic, Inc. | 2011-08-19 |
| INVADER FACTOR II (K100943) | Hologic, Inc. | 2011-06-02 |
| INVADER FACTOR V (K100980) | Hologic, Inc. | 2011-06-01 |
| INVADER MTHFR 677 (K100987) | Hologic, Inc. | 2011-05-13 |
| INVADER MTHFR 1298 (K100496) | Hologic, Inc. | 2011-04-25 |
| NHANES WHOLE BODY DXA REFERENCE DATABASE (K103265) | Hologic, Inc. | 2011-03-16 |
| SECURVIEW DX DIAGNOSTIC WORKSTATION (K103385) | Hologic, Inc. | 2011-02-02 |
| AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (K103512) | Hologic, Inc. | 2011-01-07 |
| SECRMARK BIOPSY SITE MARKING SYSTEM (K102768) | Hologic, Inc. | 2010-12-02 |
| DIGITAL SPOT MAMMOGRAPHY SYSTEM (K100692) | Hologic, Inc. | 2010-04-06 |
| MAMMOSITE MULTI LUMEN (K092405) | Hologic, Inc. | 2009-08-27 |
| MAMMOSITE II RADIATION THERAPY SYSTEM (K091378) | Hologic, Inc. | 2009-07-02 |
| R2 DIGITALNOW HD(DIGITALNOW HD) (K091368) | Hologic, Inc. | 2009-06-04 |
| QUANTRA (K082483) | Hologic, Inc. | 2008-09-12 |
| 1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION (K080711) | Hologic, Inc. | 2008-09-02 |
| MAMMOSITE CAVITY EVALUATION DEVICE (K081179) | Hologic, Inc. | 2008-05-09 |
| APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS (K072847) | Hologic, Inc. | 2008-03-28 |
| IMAGECHECKER CT CAD SOFTWARE SYSTEM (K043617) | Hologic, Inc. | 2007-12-21 |
| SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003 (K062107) | Hologic, Inc. | 2006-08-18 |
| HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS (K061561) | Hologic, Inc. | 2006-07-28 |
| IVA (MXA II SOFTWARE OPTION) (K060111) | Hologic, Inc. | 2006-04-24 |
| FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM (K051025) | Hologic, Inc. | 2005-05-13 |
| INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS (K042480) | Hologic, Inc. | 2004-10-29 |
| PEDIATRIC REFERENCE DATABASE (K041266) | Hologic, Inc. | 2004-08-11 |
| SECURVIEW DX SOFTCOPY WORKSTATION (K041555) | Hologic, Inc. | 2004-08-09 |
| LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM (K040884) | Hologic, Inc. | 2004-04-23 |
| HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER (K033224) | Hologic, Inc. | 2003-11-05 |
| HOLOGIC DR IMAGEPRO (K032546) | Hologic, Inc. | 2003-10-16 |
| HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY (K023398) | Hologic, Inc. | 2002-11-08 |
| HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER (K002711) | Hologic, Inc. | 2000-09-28 |
| OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W (K992775) | Hologic, Inc. | 1999-10-01 |
| EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W (K992677) | Hologic, Inc. | 1999-09-03 |
| FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W (K983028) | Hologic, Inc. | 1998-11-13 |