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409
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1235
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308
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930
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179
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726
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1585
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113
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79
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400
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689
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297
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183
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2239
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43
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370
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1811
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138
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GEX
Powered Laser Surgical Instrument
260
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System, Image Processing,...
255
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Automated Radiological Image...
236
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System, Imaging, Pulsed Doppler,...
224
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Electrosurgical, Cutting &...
221
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Plate, Fixation, Bone
219
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Orthopedic Stereotaxic Instrument
183
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Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
151
MAX
Intervertebral Fusion Device...
148
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Fukuda Denshi Co., Ltd.
Medical Device Manufacturer
·
US , Redmond , WA
Fukuda Denshi Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2008
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Fukuda Denshi Co., Ltd.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 08, 2011
UF-760AG
K110920
·
ITX
Radiology
·
7d
Cleared
Sep 09, 2008
UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM
K081919
·
ITX
Radiology
·
64d
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2
Radiology
2