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."
49–72 of 118
Search insights Median review: 87d Cleared: 98% Top manufacturer: Hologic, Inc. Lead specialty: Radiology
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
Cleared Nov 26, 2014
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
K142029 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 124d
Cleared Oct 10, 2014
QUANTRA
K142037 · LLZ
Hologic, Inc.
Radiology · 74d
Cleared Jun 13, 2014
PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K140960 · LLZ
Hologic, Inc.
Radiology · 59d
Cleared Oct 30, 2013
MULTIVIEW
K132316 · LLZ
Hologic, Inc.
Radiology · 97d
Cleared Aug 22, 2013
MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK)
K131736 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 70d
Cleared Aug 22, 2013
MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)
K131581 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 83d
Cleared May 31, 2013
SINGLE ENERGY (SE) FEMUR EXAMS
K130277 · KGI
Hologic, Inc.
Radiology · 116d
Cleared Feb 08, 2013
MYOSURE INTRUMENT TRAY
K121280 · KCT
Hologic, Inc.
General Hospital · 284d
Cleared Jan 29, 2013
CONTRAST ENHANCED DIGITAL MAMMOGRAPHY
K123873 · MUE
Hologic, Inc.
Radiology · 43d
Cleared Dec 20, 2012
MAMMOGRAPHY PRIOR ENHANCEMENT (MPE)
K123530 · LLZ
Hologic, Inc.
Radiology · 34d
Cleared Oct 17, 2012
THS INSTRUMENT TRAY
K120947 · KCT
Hologic, Inc.
General Hospital · 202d
Cleared Sep 19, 2012
MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL
K122563 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 28d
Cleared Sep 10, 2012
MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3...
K122498 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 25d
Cleared Jul 19, 2012
MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL...
K121868 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 23d
Cleared Jun 22, 2012
QUANTRA
K120472 · LLZ
Hologic, Inc.
Radiology · 127d
Cleared Apr 06, 2012
INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
K120388 · OXO
Hologic, Inc.
Radiology · 59d
Cleared Mar 23, 2012
MYOSURE CONTROL UNIT
K120593 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 24d
Cleared Mar 06, 2012
HOLOGIC VISCERAL FAT SOFTWARE
K113356 · KGI
Hologic, Inc.
Radiology · 113d
Cleared Aug 19, 2011
TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001
K111508 · MWP
Hologic, Inc.
Radiology · 79d
Cleared Jun 02, 2011
INVADER FACTOR II
K100943 · NPR
Hologic, Inc.
Pathology · 422d
Cleared Jun 01, 2011
INVADER FACTOR V
K100980 · NPQ
Hologic, Inc.
Pathology · 419d