510k
Database
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547
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1714
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380
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1356
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252
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2217
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2087
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126
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100
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8
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474
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441
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283
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3042
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52
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515
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2492
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155
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Polymer Patient Examination Glove
416
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System, Image Processing,...
401
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363
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359
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307
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System, Imaging, Pulsed Doppler,...
304
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Plate, Fixation, Bone
295
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Automated Radiological Image...
277
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Orthopedic Stereotaxic Instrument
236
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Intervertebral Fusion Device...
232
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Neuralynx, Inc.
Medical Device Manufacturer
·
US , Bozeman , MT
Neuralynx, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2011
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Neuralynx, Inc.
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 14, 2025
Atlas Stim Headbox (NK) (31-0601-0077)
K250094
·
GYC
Neurology
·
90d
Cleared
Jun 30, 2011
ENTERPRISE ELECTROPHYSIOLOGY SYSTEM
K110967
·
OMC
Neurology
·
85d
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Neurology
2