510k
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419
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1266
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311
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963
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181
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752
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1629
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1023
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114
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80
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6
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405
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704
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314
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190
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2298
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43
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379
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1844
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138
Categories
GEX
Powered Laser Surgical Instrument
272
LLZ
System, Image Processing,...
256
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Automated Radiological Image...
241
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Electrosurgical, Cutting &...
227
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System, Imaging, Pulsed Doppler,...
227
HRS
Plate, Fixation, Bone
226
OLO
Orthopedic Stereotaxic Instrument
188
NHA
Abutment, Implant, Dental,...
175
NKB
Thoracolumbosacral Pedicle Screw...
155
LZA
Polymer Patient Examination Glove
154
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Insightec Txsonics, Inc.
Medical Device Manufacturer
·
US , Dallas , TX
Insightec Txsonics, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2006
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Insightec Txsonics, Inc.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 05, 2007
1.5T MRGFUS PELVIC COIL
K071966
·
MOS
Radiology
·
51d
Cleared
Jul 28, 2006
MRGFUS GENERAL PURPOSE AND BREAST COIL
K061715
·
MOS
Radiology
·
39d
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Radiology
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