Medical Device Manufacturer · US , Waltham , MA

Hologic, Inc. - FDA 510(k) Cleared Devices

115 submissions · 111 cleared · Since 1987
115
Total
111
Cleared
2
Denied
115 devices
51-75 of 115
Cleared Jun 13, 2014
PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K140960 · LLZ
Radiology · 59d
Cleared Oct 30, 2013
MULTIVIEW
K132316 · LLZ
Radiology · 97d
Cleared Aug 22, 2013
MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)
K131581 · HIH
Obstetrics & Gynecology · 83d
Cleared Aug 22, 2013
MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK)
K131736 · HIH
Obstetrics & Gynecology · 70d
Cleared May 31, 2013
SINGLE ENERGY (SE) FEMUR EXAMS
K130277 · KGI
Radiology · 116d
Cleared Feb 08, 2013
MYOSURE INTRUMENT TRAY
K121280 · KCT
General Hospital · 284d
Cleared Jan 29, 2013
CONTRAST ENHANCED DIGITAL MAMMOGRAPHY
K123873 · MUE
Radiology · 43d
Cleared Dec 20, 2012
MAMMOGRAPHY PRIOR ENHANCEMENT (MPE)
K123530 · LLZ
Radiology · 34d
Cleared Oct 17, 2012
THS INSTRUMENT TRAY
K120947 · KCT
General Hospital · 202d
Cleared Sep 19, 2012
MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL
K122563 · HIH
Obstetrics & Gynecology · 28d
Cleared Sep 10, 2012
MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3...
K122498 · HIH
Obstetrics & Gynecology · 25d
Cleared Jul 19, 2012
MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL...
K121868 · HIH
Obstetrics & Gynecology · 23d
Cleared Jun 22, 2012
QUANTRA
K120472 · LLZ
Radiology · 127d
Cleared Apr 06, 2012
INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
K120388 · OXO
Radiology · 59d
Cleared Mar 23, 2012
MYOSURE CONTROL UNIT
K120593 · HIH
Obstetrics & Gynecology · 24d
Cleared Mar 06, 2012
HOLOGIC VISCERAL FAT SOFTWARE
K113356 · KGI
Radiology · 113d
Cleared Aug 19, 2011
TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001
K111508 · MWP
Radiology · 79d
Cleared Jun 02, 2011
INVADER FACTOR II
K100943 · NPR
Pathology · 422d
Cleared Jun 01, 2011
INVADER FACTOR V
K100980 · NPQ
Pathology · 419d
Cleared May 13, 2011
INVADER MTHFR 677
K100987 · OMM
Pathology · 399d
Cleared Apr 25, 2011
INVADER MTHFR 1298
K100496 · OMM
Pathology · 427d
Cleared Mar 16, 2011
NHANES WHOLE BODY DXA REFERENCE DATABASE
K103265 · KGI
Radiology · 132d
Cleared Feb 02, 2011
SECURVIEW DX DIAGNOSTIC WORKSTATION
K103385 · LLZ
Radiology · 76d
Cleared Jan 07, 2011
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
K103512 · IZH
Radiology · 38d
Cleared Dec 02, 2010
SECRMARK BIOPSY SITE MARKING SYSTEM
K102768 · NEU
General & Plastic Surgery · 69d

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