510k
Database
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134
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569
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165
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317
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68
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289
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522
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373
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67
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57
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0
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233
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171
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62
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50
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1295
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18
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87
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871
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88
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IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
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Orthopedic Stereotaxic Instrument
117
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System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Hologic
Medical Device Manufacturer
·
US , Danbury , CT
Hologic - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2016
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Hologic
Microbiology
✕
1
devices
1-1 of 1
Filters
Cleared
Sep 25, 2025
Panther Fusion GI Bacterial Assay
K251868
·
PCH
Microbiology
·
99d
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2
Radiology
1
Microbiology
1