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Hologic, Inc.

FDA 510(k) & PMA Approved Devices — 54 products

Total Devices54
Categories29
Latest FDA decision2026-08-12
TypeNumberDevice NameCodeDateActions
510(k) K262792 Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)KNW2026-08-12 View
510(k) K253634 CoolSeal Generator® (CSL-200-90)GEI2026-06-17 View
PMA P920048 ENZYME IMMUNOASSAY, FETAL FIBRONECTINLKV2026-03-05 View
PMA P010013 Device, thermal ablation, endometrialMNB2025-12-17 View
PMA P080003 Digital breast tomosynthesisOTE2025-11-24 View
PMA P170025 Hepatitis Viral B DNA DetectionMKT2025-10-07 View
510(k) K251993 Panther Fusion GI Expanded Bacterial AssayPCH2025-09-25 View
PMA P950039 Processor, cervical cytology slide, automatedMKQ2025-08-27 View
510(k) K243341 Genius AI Detection 2.0QDQ2025-07-31 View
510(k) K243396 Aptima SARS-CoV-2 AssayQQX2025-02-13 View
510(k) K243935 Aptima CMV Quant AssayPAB2025-01-17 View
510(k) K243345 Aptima BV Assay; Aptima CV/TV AssayPQA2024-11-25 View
510(k) K242465 Panther Fusion SARS-CoV-2/Flu A/B/RSV assayQOF2024-11-15 View
PMA P210029 Cytomegalovirus (cmv) dna quantitative assayPAB2024-10-23 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)HIG2024-07-25 View
510(k) K233352 Aptima HCV Quant Dx AssayMZP2024-07-24 View
510(k) K241240 Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayQOF2024-07-18 View
510(k) K231329 Aptima Neisseria gonorrhoeae AssayLSL2024-01-26 View
510(k) K230451 Aptima® Chlamydia trachomatis AssayMKZ2023-11-16 View
510(k) K231316 Aptima Trichomonas vaginalis AssayOUY2023-11-06 View

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Related Clinical Trials

NCT05199701Prospective Case Collection Study for New Mammography TechnologiesACTIVE_NOT_RECRUITINGNCT06636539Prospective Case Collection Study of Contrast-Enhanced Mammography Imaging Acquired on a New Investigational DeviceACTIVE_NOT_RECRUITINGNCT03621306DXA Study of Precision and ReliabilityRECRUITING
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