510k
Database
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Anesthesiology
330
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1055
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268
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793
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148
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619
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1307
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746
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97
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72
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1
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364
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566
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240
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154
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2032
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38
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309
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1570
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130
Categories
GEX
Powered Laser Surgical Instrument
227
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Plate, Fixation, Bone
208
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System, Imaging, Pulsed Doppler,...
207
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Automated Radiological Image...
204
LLZ
System, Image Processing,...
197
GEI
Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
168
NHA
Abutment, Implant, Dental,...
153
MAX
Intervertebral Fusion Device...
137
NKB
Thoracolumbosacral Pedicle Screw...
133
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Sonacare Medical, LLC
Medical Device Manufacturer
·
US , Charlotte , NC
Sonacare Medical, LLC - FDA 510(k) Cleared Devices
2 submissions
·
1 cleared
·
Since 2015
2
Total
1
Cleared
1
Denied
FDA 510(k) Regulatory Record - Sonacare Medical, LLC
Gastroenterology & Urology
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 21, 2016
Sonablate
K160942
·
PLP
Gastroenterology & Urology
·
260d
Not Cleared
Oct 09, 2015
Sonablate 450
DEN150011
·
PLP
Gastroenterology & Urology
·
200d
Filters
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2
Gastroenterology & Urology
2