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Hologic

FDA 510(k) & PMA Approved Devices — 2 products

Total Devices2
Categories2
Latest FDA decision2025-09-25
TypeNumberDevice NameCodeDateActions
510(k) K251868 Panther Fusion GI Bacterial AssayPCH2025-09-25 View
510(k) K161575 Affirm Lateral Arm Upright Biopsy AccessoryIZH2016-08-10 View

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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