Hologic, Inc
41 FDA actions
CoolSeal Generator® (CSL-200-90)
Hologic, Inc.
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-60
Hologic, Inc
3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3D
Hologic, Inc
Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number:
Hologic, Inc
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima
Hologic, Inc.
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Hologic, Inc
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Hologic, Inc
Panther Fusion GI Expanded Bacterial Assay
Hologic, Inc.
Genius AI Detection 2.0
Hologic, Inc.
Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Versi
Hologic, Inc
Aptima SARS-CoV-2 Assay
Hologic, Inc.
The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 7173
Hologic, Inc.
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Hologic, Inc.
Aptima CMV Quant Assay
Hologic, Inc.
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Hologic, Inc.
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Nu
Hologic, Inc
BioZorb Marker. Radiographic soft tissue marker.
Hologic, Inc
Aptima BV Assay; Aptima CV/TV Assay
Hologic, Inc.
Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
Hologic, Inc.
Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 s
Hologic Inc
Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-
Hologic, Inc.
Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN,
Hologic Inc
Aptima HCV Quant Dx Assay
Hologic, Inc.
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
Hologic, Inc.
BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZ
Hologic, Inc
Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Re
Hologic, Inc.
PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully au
Hologic, Inc.
Genius Digital Diagnostics System with the Genius Cervical AI algorithm
Hologic, Inc.
Aptima Neisseria gonorrhoeae Assay
Hologic, Inc.
Aptima® Chlamydia trachomatis Assay
Hologic, Inc.
Aptima Trichomonas vaginalis Assay
Hologic, Inc.
Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the br
Hologic, Inc
Genius AI Detection 2.0 with CC-MLO Correlation
Hologic, Inc.
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
Hologic, Inc.
Panther Fusion AdV/hMPV/RV Assay
Hologic, Inc.
Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-
Hologic, Inc.
The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The Bi
Hologic, Inc
Genius AI Detection 2.0
Hologic, Inc.
Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis As
Hologic, Inc.
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptoco
Hologic, Inc
Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fu
Hologic, Inc