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133
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568
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163
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313
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68
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287
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514
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371
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67
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56
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232
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61
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49
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1291
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18
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85
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868
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88
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IYN
System, Imaging, Pulsed Doppler,...
150
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Plate, Fixation, Bone
134
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Orthopedic Stereotaxic Instrument
117
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System, Image Processing,...
100
MBI
Fastener, Fixation,...
85
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Abutment, Implant, Dental,...
84
MAX
Intervertebral Fusion Device...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Neuraxis
Medical Device Manufacturer
·
US , Carmel , IN
Neuraxis - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2024
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Neuraxis
Gastroenterology & Urology
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 16, 2025
NeurAxis IB-Stim (01-1020)
K252024
·
QHH
Gastroenterology & Urology
·
108d
Cleared
May 15, 2025
NeurAxis IB-Stim (01-1020)
K250451
·
QHH
Gastroenterology & Urology
·
86d
Cleared
Oct 30, 2024
NeurAxis IB-Stim (01-1020)
K241533
·
QHH
Gastroenterology & Urology
·
153d
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3
Gastroenterology & Urology
3