510k
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540
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1660
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362
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244
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958
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2183
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2039
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126
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97
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466
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962
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433
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2868
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52
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515
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2428
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155
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Polymer Patient Examination Glove
407
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System, Image Processing,...
383
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358
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Powered Laser Surgical Instrument
351
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302
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System, Imaging, Pulsed Doppler,...
296
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Automated Radiological Image...
276
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Plate, Fixation, Bone
269
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Orthopedic Stereotaxic Instrument
226
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Intervertebral Fusion Device...
219
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Mivi Neuroscience, Inc.
Medical Device Manufacturer
·
US , Eden Prarie , MN
Mivi Neuroscience, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2015
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Mivi Neuroscience, Inc.
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 06, 2017
MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension...
K163233
·
DQY
Cardiovascular
·
140d
Cleared
Dec 09, 2015
MIVI Mi-AXUS Guide Catheter
K151396
·
DQY
Cardiovascular
·
197d
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5
Neurology
3
Cardiovascular
2