510k
Database
Specialties
Anesthesiology
117
Cardiovascular
507
Chemistry
156
Dental
276
Ear, Nose, Throat
59
Gastroenterology & Urology
258
General & Plastic Surgery
439
General Hospital
339
Hematology
63
Immunology
55
Medical Genetics
0
Microbiology
221
Neurology
133
Obstetrics & Gynecology
43
Ophthalmic
41
Orthopedic
1214
Pathology
18
Physical Medicine
58
Radiology
789
Toxicology
86
Categories
IYN
System, Imaging, Pulsed Doppler,...
145
HRS
Plate, Fixation, Bone
123
OLO
Orthopedic Stereotaxic Instrument
108
LLZ
System, Image Processing,...
93
MAX
Intervertebral Fusion Device...
80
NHA
Abutment, Implant, Dental,...
80
MBI
Fastener, Fixation,...
77
NKB
Thoracolumbosacral Pedicle Screw...
77
LNH
System, Nuclear Magnetic...
76
JAK
System, X-ray, Tomography, Computed
73
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About
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Hologic, Inc.
Medical Device Manufacturer
·
US , Waltham , MA
Hologic, Inc. - FDA 510(k) Cleared Devices
115 submissions
·
111 cleared
·
Since 1987
Official Website
115
Total
111
Cleared
2
Denied
FDA 510(k) cleared devices by Hologic, Inc.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 26, 2019
Omni Instrument Tray
K182052
·
KCT
General Hospital
·
210d
Cleared
Feb 08, 2013
MYOSURE INTRUMENT TRAY
K121280
·
KCT
General Hospital
·
284d
Cleared
Oct 17, 2012
THS INSTRUMENT TRAY
K120947
·
KCT
General Hospital
·
202d
Filters
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All
115
Radiology
62
Microbiology
26
Obstetrics & Gynecology
15
Pathology
5
General Hospital
3
Gastroenterology & Urology
3
General & Plastic Surgery
1