510k
Database
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304
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174
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1568
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112
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2212
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363
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1797
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GEX
Powered Laser Surgical Instrument
258
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System, Image Processing,...
248
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236
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System, Imaging, Pulsed Doppler,...
222
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Electrosurgical, Cutting &...
219
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Plate, Fixation, Bone
217
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Orthopedic Stereotaxic Instrument
182
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Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
151
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Intervertebral Fusion Device...
146
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Intrasense
Medical Device Manufacturer
·
FR , Toulose
Intrasense - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2007
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Intrasense
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 12, 2012
MYRIAN 1.11
K113620
·
LLZ
Radiology
·
218d
Cleared
Jun 29, 2009
MYRIAN 1.4
K091001
·
LLZ
Radiology
·
82d
Cleared
May 14, 2007
MYRIAN
K071000
·
LLZ
Radiology
·
35d
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3
Radiology
3