Hologic, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Panther Fusion GI Expanded Bacterial Assay, Genius AI Detection 2.0, Aptima SARS-CoV-2 Assay
115
Total
111
Cleared
2
Denied
FDA 510(k) Regulatory Record - Hologic, Inc. Obstetrics & Gynecology ✕
15 devices
Cleared
Jul 25, 2024
Fluent Pro Fluid Management System (FLT-200)
Obstetrics & Gynecology
115d
Cleared
Aug 29, 2019
Omni Hysteroscope, Omni Lok cervical seal
Obstetrics & Gynecology
108d
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
May 08, 2018
MyoSure MANUAL Tissue Removal Device
Obstetrics & Gynecology
137d
Cleared
Sep 20, 2017
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
Obstetrics & Gynecology
26d
Cleared
Nov 13, 2015
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
Obstetrics & Gynecology
52d
Cleared
Nov 26, 2014
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
Obstetrics & Gynecology
124d
Cleared
Aug 22, 2013
MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)
Obstetrics & Gynecology
83d
Cleared
Aug 22, 2013
MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK)
Obstetrics & Gynecology
70d
Cleared
Sep 19, 2012
MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL
Obstetrics & Gynecology
28d