510k
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Specialties
Anesthesiology
202
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731
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187
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459
Ear, Nose, Throat
87
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388
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760
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468
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77
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62
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1
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274
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293
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113
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76
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1468
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26
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150
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1078
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93
Categories
IYN
System, Imaging, Pulsed Doppler,...
164
HRS
Plate, Fixation, Bone
150
OLO
Orthopedic Stereotaxic Instrument
129
LLZ
System, Image Processing,...
123
GEX
Powered Laser Surgical Instrument
122
QIH
Automated Radiological Image...
109
NHA
Abutment, Implant, Dental,...
104
GEI
Electrosurgical, Cutting &...
104
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Kaneka Pharma America, LLC
Medical Device Manufacturer
·
US , Hudson , NH
Kaneka Pharma America, LLC - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2010
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Kaneka Pharma America, LLC
Ophthalmic
✕
1
devices
1-1 of 1
Filters
Cleared
Apr 18, 2017
Lacriflow CL
K170247
·
OKS
Ophthalmic
·
81d
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4
Cardiovascular
2
Ophthalmic
1
Neurology
1