510k
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204
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734
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187
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461
Ear, Nose, Throat
91
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391
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767
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473
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77
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63
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274
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114
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76
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1474
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152
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1083
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93
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IYN
System, Imaging, Pulsed Doppler,...
167
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151
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Orthopedic Stereotaxic Instrument
130
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Powered Laser Surgical Instrument
125
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System, Image Processing,...
123
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Automated Radiological Image...
109
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Electrosurgical, Cutting &...
105
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Abutment, Implant, Dental,...
104
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Intervertebral Fusion Device...
96
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Thoracolumbosacral Pedicle Screw...
93
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Biosense Webster
Medical Device Manufacturer
·
US , Diamond Bar , CA
Biosense Webster - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2014
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Biosense Webster
Ear, Nose, Throat
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 30, 2020
TruDi Navigation System
K192397
·
PGW
Ear, Nose, Throat
·
149d
Cleared
Oct 24, 2016
CARTO ENT System
K161701
·
PGW
Ear, Nose, Throat
·
126d
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3
Ear, Nose, Throat
2
Cardiovascular
1