510k
Database
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Anesthesiology
545
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1709
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380
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1355
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252
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982
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2215
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2079
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126
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100
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474
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980
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441
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282
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3023
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52
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515
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2486
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155
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LZA
Polymer Patient Examination Glove
416
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System, Image Processing,...
399
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Powered Laser Surgical Instrument
363
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358
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Electrosurgical, Cutting &...
307
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System, Imaging, Pulsed Doppler,...
304
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Plate, Fixation, Bone
290
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Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
231
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Brain Sentinel, Inc.
Medical Device Manufacturer
·
US , San Antonio , TX
Brain Sentinel, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2019
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Brain Sentinel, Inc.
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
CT
Feb 06, 2021
SPEAC System
K200276
·
POS
Neurology
·
368d
Cleared
May 11, 2019
SPEAC System
K182180
·
POS
Neurology
·
271d
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Neurology
2