510k
Database
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Anesthesiology
545
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1694
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370
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1351
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250
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979
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2213
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2057
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126
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100
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8
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474
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980
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438
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280
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2986
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52
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515
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2466
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155
Categories
LZA
Polymer Patient Examination Glove
413
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System, Image Processing,...
398
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Powered Laser Surgical Instrument
363
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Mask, Surgical
358
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Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
284
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
224
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Brightonix Imaging
Medical Device Manufacturer
·
KR , Seoul
Brightonix Imaging - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2025
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Brightonix Imaging
Radiology
✕
1
devices
1-1 of 1
Filters
Cleared
Aug 15, 2025
PHAROS
K250170
·
KPS
Radiology
·
206d
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