510k
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733
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187
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459
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89
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766
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472
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77
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62
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274
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295
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114
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1472
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26
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152
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1080
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93
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IYN
System, Imaging, Pulsed Doppler,...
166
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Plate, Fixation, Bone
150
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Orthopedic Stereotaxic Instrument
129
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Powered Laser Surgical Instrument
125
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System, Image Processing,...
123
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Automated Radiological Image...
109
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Electrosurgical, Cutting &...
105
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Abutment, Implant, Dental,...
104
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Intervertebral Fusion Device...
96
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Fastener, Fixation,...
93
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Fmi Medical Systems, Inc.
Medical Device Manufacturer
·
US , Solon , OH
Fmi Medical Systems, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2018
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Fmi Medical Systems, Inc.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 05, 2020
CURA 778
K192590
·
JAK
Radiology
·
167d
Cleared
Oct 04, 2018
CURA 16
K173076
·
JAK
Radiology
·
370d
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Radiology
2