HOLOGIC, INC

FDA Filings

This page includes the latest FDA filings for HOLOGIC, INC. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Hologic, Inc.
Omni Hysteroscope, Omni Lok Cervical Seal2019-08-29
Hologic, Inc.
Unifi Workspace V1.0.02019-07-11
Hologic, Inc.
Aptima BV Assay2019-05-23
Hologic, Inc.
Aptima Combo 2 Assay (Panther System)2019-05-23
Hologic, Inc.
Aptima CV/TV Assay2019-05-16
Hologic, Inc
Omni Instrument Tray2019-02-26
Hologic, Inc.
Trident HD Specimen Radiography System2019-01-10
Hologic, Inc
Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths2018-12-06
Hologic, Inc
MyoSure XL Tissue Removal Device For Fluent2018-08-23
Hologic, Inc.
Fluent Fluid Management System2018-08-03
Hologic, Inc.
Aptima Combo 2 Assay (Panther System)2018-06-13
Hologic, Inc.
MyoSure MANUAL Tissue Removal Device2018-05-08
Hologic, Inc
Eviva Stereotactic Guided Breast Biopsy System2018-04-10
Hologic, Inc.
Panther Fusion AdV/hMPV/RV Assay2017-12-04
Hologic, Inc.
Panther Fusion Paraflu Assay2017-10-23
HOLOGIC, INC.
Quantra2017-10-20
Hologic, Inc.
Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes2017-09-26
Hologic, Inc.
Myosure Hysteroscopic Tissue Removal System And Myosure Tissue Removal Devices2017-09-20
HOLOGIC, INC.
Aptima Herpes Simplex Viruses 1 & 2 Assay2017-06-15
HOLOGIC, INC.
Brevera Biopsy System With Corlumina Imaging Technology2017-03-29
HOLOGIC
Affirm Lateral Arm Upright Biopsy Accessory2016-08-10
Hologic Inc
Affirm Prone Biopsy System2016-04-01
HOLOGIC, INC.
ProParaFlu+ Assay2015-12-09
HOLOGIC, INC.
ProFlu+ Assay2015-11-20
HOLOGIC, INC
Myosure Hysteroscopic Tissue Removal System And Myosure Tissue Removal Devices2015-11-13
Hologic, INC
Sertera Biopsy Device2015-08-14
HOLOGIC, INC.
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM2014-11-26
HOLOGIC, INC.
QUANTRA2014-10-10
HOLOGIC, INC.
Picture Archiving And Communications System2014-06-13
HOLOGIC, INC.
MULTIVIEW2013-10-30

Latest Premarket Applications

PMAManufacturerDevice NameDate
Hologic, Inc
Aptima HBV Quant Assay2020-02-14
HOLOGIC, INC.
Aptima HCV Quant Dx Assay2020-02-14
Hologic, Inc
Aptima HBV Quant Assay2020-01-21
HOLOGIC, INC.
Aptima HCV Quant Dx Assay2020-01-21
Hologic, Inc
Aptima HBV Quant Assay2019-12-16
HOLOGIC, INC.
Aptima HCV Quant Dx Assay2019-12-16
HOLOGIC, INC.
Selenia Dimensions 3D System High Resolution Tomosynthesis2019-10-24
HOLOGIC, INC.
Novasure Impedance Controlled Endometrial Ablation System2019-10-01
HOLOGIC, INC.
NovaSure Impedance Controlled Endometrial Ablation2019-09-26
HOLOGIC, INC.
ThinPrep 5000 Processor2019-09-03
HOLOGIC, INC.
Aptima HCV Quant Dx Assay2019-06-21
HOLOGIC, INC.
Aptima HCV Quant Dx Assay2019-05-21
Hologic, Inc
Aptima HBV Quant Assay2019-05-21
Hologic, Inc
Aptima HBV Quant Assay2019-04-28
HOLOGIC, INC.
APTIMA HCV Quant Dx Assay2019-04-28
HOLOGIC, INC.
APTIMA HCV Quant Dx Assay2019-04-26
Hologic, Inc
Aptima HBV Quant Assay2019-04-26
Hologic, Inc
Aptima HBV Quant Assay2019-03-21
HOLOGIC, INC.
Aptima HCV Quant Dx Assay2019-03-21
Hologic, Inc
Aptima HBV Quant Assay2019-03-08
HOLOGIC, INC.
NovaSure Impedance Controlled Endometrial Ablation System2019-03-01
Hologic, Inc
Aptima HBV Quant Assay2019-02-28
HOLOGIC, INC.
Aptima HCV Quant Dx Assay2019-02-28
HOLOGIC, INC.
NovaSure Impedance Controlled Endometrial Ablation System2019-01-09
Hologic, Inc
Aptima HBV Quant Assay2018-12-28
HOLOGIC, INC.
Aptima HCV Quant Dx Assay2018-12-28
HOLOGIC, INC.
ThinPrep Processor and ThinPrep Imaging System2018-12-20
HOLOGIC, INC.
Rapid fFN for the TLiIQ System2018-12-17
HOLOGIC, INC.
Cervista HPV 16/18 Assay2018-11-15
HOLOGIC, INC.
Cervista HPV HR Assay2018-11-15

Latest De Novo Filings

De NovoManufacturerDevice NameDate
Hologic, Inc.
Aptima Mycoplasma Genitalium Assay2019-01-23

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
DEFINITY CERVICAL DILATOR, 9MM
Hologic, Inc.2020-02-13
DEFINITY CERVICAL DILATOR, 7MM
Hologic, Inc.2020-02-13
DEFINITY CERVICAL DILATOR, 5MM
Hologic, Inc.2020-02-13
Flourocsan InSight
Hologic, Inc.2020-02-13
I -View™ Contrast Enhanced Digital Mammography
Hologic, Inc.2019-12-25
6mm Operative Sheath
Hologic, Inc.2019-12-18
3.7mm Diagnostic Sheath
Hologic, Inc.2019-12-18
Omni Hysteroscope
Hologic, Inc.2019-12-18
HOLOGIC
Hologic, Inc.2019-12-16
HOLOGIC
Hologic, Inc.2019-12-16
HOLOGIC
Hologic, Inc.2019-12-16
HOLOGIC
Hologic, Inc.2019-12-16
HOLOGIC
Hologic, Inc.2019-12-16
HOLOGIC
Hologic, Inc.2019-12-16
HOLOGIC
Hologic, Inc.2019-12-16
HOLOGIC
Hologic, Inc.2019-12-16
ThinPrep Imaging System
Hologic, Inc.2019-12-11
ThinPrep Imaging System
Hologic, Inc.2019-12-11
PANTHER FUSION
Hologic, Inc.2019-12-09
Selenia Dimensions
Hologic, Inc.2019-11-26
Selenia Dimensions
Hologic, Inc.2019-11-26
Selenia Dimensions
Hologic, Inc.2019-11-26
Selenia Dimensions
Hologic, Inc.2019-11-26
ThinPrep
Hologic, Inc.2019-11-21
ThinPrep
Hologic, Inc.2019-11-21
3Dimensions
Hologic, Inc.2019-11-13
3Dimensions
Hologic, Inc.2019-11-13
MYOSURE XL HYSTEROSCOPY SET
Hologic, Inc.2019-11-08
MYOSURE HYSTEROSCOPY SET
Hologic, Inc.2019-11-08
Omni Hysteroscopy Standard Set
Hologic, Inc.2019-11-08
Omni Hysteroscopy Light Set
Hologic, Inc.2019-11-08
MYOSURE XL HYSTEROSCOPY SET
Hologic, Inc.2019-11-08
MYOSURE HYSTEROSCOPY SET
Hologic, Inc.2019-11-08
Omni Instrument Tray
Hologic, Inc.2019-11-08
5.5mm Operative Sheath
Hologic, Inc.2019-11-08

Related Finance Registrations

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