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
26
devices
26-26 of 26
Filters
1
2
Cleared
Nov 20, 2015
ProFlu+ Assay
K153219
·
OCC
Microbiology
·
15d
1
2
Filters
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All
115
Radiology
62
Microbiology
26
Obstetrics & Gynecology
15
Pathology
5
Gastroenterology & Urology
3
General Hospital
3
General & Plastic Surgery
1