510k
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204
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735
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187
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464
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91
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391
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767
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473
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77
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63
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1
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275
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296
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114
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77
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1475
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26
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152
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1083
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93
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IYN
System, Imaging, Pulsed Doppler,...
167
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Plate, Fixation, Bone
151
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Orthopedic Stereotaxic Instrument
130
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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
NHA
Abutment, Implant, Dental,...
105
GEI
Electrosurgical, Cutting &...
105
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Eiken Chemical Co., Ltd.
Medical Device Manufacturer
·
JP , Taito-Ku
Eiken Chemical Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2015
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Eiken Chemical Co., Ltd.
Hematology
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 02, 2020
OC-Auto SENSOR io iFOB Test
K191147
·
OOX
Hematology
·
247d
Cleared
Aug 20, 2015
OC-Light S FIT
K143325
·
KHE
Hematology
·
273d
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2
Hematology
2