510k
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142
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581
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167
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324
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68
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296
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537
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384
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67
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58
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0
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234
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173
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69
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52
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1304
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18
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88
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888
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88
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IYN
System, Imaging, Pulsed Doppler,...
152
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Plate, Fixation, Bone
136
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Orthopedic Stereotaxic Instrument
118
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System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
87
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
84
NKB
Thoracolumbosacral Pedicle Screw...
83
LNH
System, Nuclear Magnetic...
83
JAK
System, X-ray, Tomography, Computed
79
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Epitel
Medical Device Manufacturer
·
US , Salt Lake City , UT
Epitel - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2025
1
Total
1
Cleared
0
Denied
FDA 510(k) cleared devices by Epitel
Neurology
✕
1
devices
1-1 of 1
Filters
Cleared
Mar 21, 2025
REMI Remote EEG Monitoring System
K243185
·
OMC
Neurology
·
172d
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Neurology
1