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
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.
Aptima Herpes Simplex Viruses 1 & 2 Assay2017-06-15
HOLOGIC, INC.
Brevera Biopsy System With Corlumina Imaging Technology2017-03-29
Hologic Inc
Affirm Prone Biopsy System2016-04-01
HOLOGIC / GEN-PROBE INCORPORATED
APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)2013-10-17
HOLOGIC, INC.
MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL2012-09-19
HOLOGIC, INC.
INVADER FACTOR II2011-06-02
HOLOGIC, INC.
INVADER FACTOR V2011-06-01
HOLOGIC, INC.
INVADER MTHFR 6772011-05-13
HOLOGIC, INC.
INVADER MTHFR 12982011-04-25
HOLOGIC, INC.
R2 DIGITALNOW HD(DIGITALNOW HD)2009-06-04
HOLOGIC, INC.
IMAGECHECKER CT CAD SOFTWARE SYSTEM2007-12-21
HOLOGIC, INC.
HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY2002-11-08
HOLOGIC, INC.
MODIFIED QDR-1000 X-RAY BONE DENSITOMETER1989-12-21

Latest Premarket Applications

PMAManufacturerDevice NameDate
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 HCV Quant Dx Assay2019-04-28
Hologic, Inc
Aptima HBV Quant Assay2019-04-28
Hologic, Inc
Aptima HBV Quant Assay2019-04-26
HOLOGIC, INC.
APTIMA HCV Quant Dx 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 HCV Quant Dx Assay2019-02-28
Hologic, Inc
Aptima HBV Quant Assay2019-02-28
HOLOGIC, INC.
NovaSure Impedance Controlled Endometrial Ablation System2019-01-09
HOLOGIC, INC.
Aptima HCV Quant Dx Assay2018-12-28
Hologic, Inc
Aptima HBV Quant 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
HOLOGIC, INC.
Aptima HCV Quant DX Assay2018-10-31
Hologic, Inc
Aptima HBV Quant Assay2018-10-31
HOLOGIC, INC.
Aptima HCV Quant Dx Assay2018-10-16
Hologic, Inc
Aptima HBV Quant Assay2018-10-16
HOLOGIC, INC.
Cervista® HPV HR Assay2018-10-09
HOLOGIC, INC.
Cervista HPV 16/18 Assay2018-10-09

Latest De Novo Filings

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

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
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
MyoSure XL Rod Lens Hysteroscope Outflow Channel
Hologic, Inc.2019-11-08
MyoSure XL Rod Lens Hysteroscope
Hologic, Inc.2019-11-08
MyoSure Rod Lens Hysteroscope Outflow Channel
Hologic, Inc.2019-11-08
MyoSure Rod Lens Hysteroscope
Hologic, Inc.2019-11-08
ThinPrep
Hologic, Inc.2019-10-23
ThinPrep
Hologic, Inc.2019-10-23
ImageChecker CAD 10.0
Hologic, Inc.2019-10-07
Quantra
Hologic, Inc.2019-10-07
DigitalNow HD
Hologic, Inc.2019-10-07
Quantra
Hologic, Inc.2019-10-07
DICOM 6000
Hologic, Inc.2019-10-07
Cenova
Hologic, Inc.2019-10-07
Aptima
Hologic, Inc.2019-10-04
Aptima
Hologic, Inc.2019-10-04
Horizon Wi
Hologic, Inc.2019-10-02
Horizon W
Hologic, Inc.2019-10-01
Horizon Ci
Hologic, Inc.2019-10-01
Horizon A
Hologic, Inc.2019-10-01
Affirm Prone Biopsy System
Hologic, Inc.2019-09-27

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