Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

115 results for "Hologic, Inc."
25–48 of 115
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
Cleared Nov 20, 2015
ProFlu+ Assay
K153219 · OCC
Hologic, Inc.
Microbiology · 15d
Cleared Nov 13, 2015
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
K152723 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 52d
Cleared Aug 14, 2015
Sertera Biopsy Device
K150169 · KNW
Hologic, Inc.
Gastroenterology & Urology · 200d