Hologic, Inc. - FDA 510(k) Cleared Devices
115
Total
111
Cleared
2
Denied
115 devices
Cleared
Jun 13, 2014
PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
Radiology
59d
Cleared
Oct 30, 2013
MULTIVIEW
Radiology
97d
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
May 31, 2013
SINGLE ENERGY (SE) FEMUR EXAMS
Radiology
116d
Cleared
Feb 08, 2013
MYOSURE INTRUMENT TRAY
General Hospital
284d
Cleared
Jan 29, 2013
CONTRAST ENHANCED DIGITAL MAMMOGRAPHY
Radiology
43d
Cleared
Dec 20, 2012
MAMMOGRAPHY PRIOR ENHANCEMENT (MPE)
Radiology
34d
Cleared
Oct 17, 2012
THS INSTRUMENT TRAY
General Hospital
202d
Cleared
Sep 19, 2012
MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL
Obstetrics & Gynecology
28d
Cleared
Sep 10, 2012
MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3...
Obstetrics & Gynecology
25d
Cleared
Jul 19, 2012
MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL...
Obstetrics & Gynecology
23d
Cleared
Jun 22, 2012
QUANTRA
Radiology
127d
Cleared
Apr 06, 2012
INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
Radiology
59d
Cleared
Mar 23, 2012
MYOSURE CONTROL UNIT
Obstetrics & Gynecology
24d
Cleared
Mar 06, 2012
HOLOGIC VISCERAL FAT SOFTWARE
Radiology
113d
Cleared
Aug 19, 2011
TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001
Radiology
79d
Cleared
Jun 02, 2011
INVADER FACTOR II
Pathology
422d
Cleared
Jun 01, 2011
INVADER FACTOR V
Pathology
419d
Cleared
May 13, 2011
INVADER MTHFR 677
Pathology
399d
Cleared
Apr 25, 2011
INVADER MTHFR 1298
Pathology
427d
Cleared
Mar 16, 2011
NHANES WHOLE BODY DXA REFERENCE DATABASE
Radiology
132d
Cleared
Feb 02, 2011
SECURVIEW DX DIAGNOSTIC WORKSTATION
Radiology
76d
Cleared
Jan 07, 2011
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
Radiology
38d
Cleared
Dec 02, 2010
SECRMARK BIOPSY SITE MARKING SYSTEM
General & Plastic Surgery
69d
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