Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

118 results for "Hologic, Inc."
25–48 of 118
Search insights Median review: 87d Cleared: 98% Top manufacturer: Hologic, Inc. Lead specialty: Radiology
Cleared Mar 23, 2020
Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris)...
K200436 · QEP
Hologic, Inc.
Microbiology · 28d
Cleared Aug 29, 2019
Omni Hysteroscope, Omni Lok cervical seal
K191281 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 108d
Cleared Jul 11, 2019
Unifi Workspace v1.0.0
K190694 · LLZ
Hologic, Inc.
Radiology · 115d
Cleared May 23, 2019
Aptima Combo 2 Assay (Panther System)
K190515 · QEP
Hologic, Inc.
Microbiology · 83d
Cleared May 23, 2019
Aptima BV Assay
K190452 · PQA
Hologic, Inc.
Microbiology · 87d
Cleared May 16, 2019
Aptima CV/TV Assay
K190472 · PQA
Hologic, Inc.
Microbiology · 79d
Cleared Feb 26, 2019
Omni Instrument Tray
K182052 · KCT
Hologic, Inc.
General Hospital · 210d
Not Cleared Jan 23, 2019
Aptima Mycoplasma genitalium Assay
DEN180047 · QEP
Hologic, Inc.
Microbiology · 145d
Cleared Jan 10, 2019
Trident HD Specimen Radiography System
K182727 · MWP
Hologic, Inc.
Radiology · 104d
Cleared Dec 06, 2018
Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths
K182006 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 132d
Cleared Aug 23, 2018
MyoSure XL Tissue Removal Device for Fluent
K181974 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 30d
Cleared Aug 03, 2018
Fluent Fluid Management System
K180825 · HIG
Hologic, Inc.
Obstetrics & Gynecology · 126d
Cleared Jun 13, 2018
Aptima Combo 2 Assay (Panther System)
K180681 · LSL
Hologic, Inc.
Microbiology · 90d
Cleared May 08, 2018
MyoSure MANUAL Tissue Removal Device
K173901 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 137d
Cleared Apr 10, 2018
Eviva Stereotactic Guided Breast Biopsy System
K180233 · KNW
Hologic, Inc.
Gastroenterology & Urology · 71d
Cleared Dec 04, 2017
Panther Fusion AdV/hMPV/RV Assay
K172629 · OCC
Hologic, Inc.
Microbiology · 94d
Cleared Oct 23, 2017
Panther Fusion Paraflu Assay
K172282 · OOU
Hologic, Inc.
Microbiology · 87d
Cleared Oct 20, 2017
Quantra
K163623 · LLZ
Hologic, Inc.
Radiology · 302d
Cleared Sep 26, 2017
Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit,...
K171963 · OCC
Hologic, Inc.
Microbiology · 88d
Cleared Sep 20, 2017
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
K172566 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 26d
Cleared Jun 15, 2017
Aptima Herpes Simplex Viruses 1 & 2 Assay
K162673 · OQO
Hologic, Inc.
Microbiology · 262d
Cleared Mar 29, 2017
Brevera Biopsy System with Corlumina Imaging Technology
K163052 · KNW
Hologic, Inc.
Gastroenterology & Urology · 148d
Cleared Apr 01, 2016
Affirm Prone Biopsy System
K153486 · IZH
Hologic, Inc.
Radiology · 119d
Cleared Dec 09, 2015
ProParaFlu+ Assay
K153223 · OOU
Hologic, Inc.
Microbiology · 33d