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205
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741
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187
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472
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92
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398
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778
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477
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77
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64
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1
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277
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308
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121
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81
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1481
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26
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155
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1099
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94
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IYN
System, Imaging, Pulsed Doppler,...
168
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Plate, Fixation, Bone
151
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Orthopedic Stereotaxic Instrument
131
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127
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System, Image Processing,...
125
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Automated Radiological Image...
113
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Electrosurgical, Cutting &...
105
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Abutment, Implant, Dental,...
105
MAX
Intervertebral Fusion Device...
96
NKB
Thoracolumbosacral Pedicle Screw...
93
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Coapt, LLC
Medical Device Manufacturer
·
US , Chicago , IL
Coapt, LLC - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2017
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Coapt, LLC
Neurology
✕
3
devices
1-3 of 3
Filters
Cleared
May 24, 2019
COMPLETE CONTROL System Gen2
K191083
·
GXY
Neurology
·
30d
Cleared
Apr 04, 2019
Dome Electrode
K190416
·
GXY
Neurology
·
42d
Cleared
Apr 14, 2017
Complete Control System
K162891
·
GXY
Neurology
·
179d
Filters
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3
Neurology
3