510k
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288
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876
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161
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1480
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108
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77
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1718
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135
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GEX
Powered Laser Surgical Instrument
250
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Automated Radiological Image...
226
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System, Imaging, Pulsed Doppler,...
221
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System, Image Processing,...
221
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Plate, Fixation, Bone
216
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Electrosurgical, Cutting &...
207
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Orthopedic Stereotaxic Instrument
180
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Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
147
MAX
Intervertebral Fusion Device...
146
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Medisono, LLC
Medical Device Manufacturer
·
US , Wilmington , DE
Medisono, LLC - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2017
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medisono, LLC
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
May 17, 2017
Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT...
K170078
·
IYN
Radiology
·
128d
Cleared
Feb 23, 2017
Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10
K163688
·
IYN
Radiology
·
57d
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Radiology
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