Hologic, Inc. - FDA 510(k) Cleared Devices
115
Total
111
Cleared
2
Denied
115 devices
Cleared
May 23, 2019
Aptima Combo 2 Assay (Panther System)
Microbiology
83d
Cleared
May 16, 2019
Aptima CV/TV Assay
Microbiology
79d
Cleared
Feb 26, 2019
Omni Instrument Tray
General Hospital
210d
Not Cleared
Jan 23, 2019
Aptima Mycoplasma genitalium Assay
Microbiology
145d
Cleared
Jan 10, 2019
Trident HD Specimen Radiography System
Radiology
104d
Cleared
Dec 06, 2018
Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths
Obstetrics & Gynecology
132d
Cleared
Aug 23, 2018
MyoSure XL Tissue Removal Device for Fluent
Obstetrics & Gynecology
30d
Cleared
Aug 03, 2018
Fluent Fluid Management System
Obstetrics & Gynecology
126d
Cleared
Jun 13, 2018
Aptima Combo 2 Assay (Panther System)
Microbiology
90d
Cleared
May 08, 2018
MyoSure MANUAL Tissue Removal Device
Obstetrics & Gynecology
137d
Cleared
Apr 10, 2018
Eviva Stereotactic Guided Breast Biopsy System
Gastroenterology & Urology
71d
Cleared
Dec 04, 2017
Panther Fusion AdV/hMPV/RV Assay
Microbiology
94d
Cleared
Oct 23, 2017
Panther Fusion Paraflu Assay
Microbiology
87d
Cleared
Oct 20, 2017
Quantra
Radiology
302d
Cleared
Sep 26, 2017
Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit,...
Microbiology
88d
Cleared
Sep 20, 2017
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
Obstetrics & Gynecology
26d
Cleared
Jun 15, 2017
Aptima Herpes Simplex Viruses 1 & 2 Assay
Microbiology
262d
Cleared
Mar 29, 2017
Brevera Biopsy System with Corlumina Imaging Technology
Gastroenterology & Urology
148d
Cleared
Apr 01, 2016
Affirm Prone Biopsy System
Radiology
119d
Cleared
Dec 09, 2015
ProParaFlu+ Assay
Microbiology
33d
Cleared
Nov 20, 2015
ProFlu+ Assay
Microbiology
15d
Cleared
Nov 13, 2015
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
Obstetrics & Gynecology
52d
Cleared
Aug 14, 2015
Sertera Biopsy Device
Gastroenterology & Urology
200d
Cleared
Nov 26, 2014
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
Obstetrics & Gynecology
124d
Cleared
Oct 10, 2014
QUANTRA
Radiology
74d
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