510k
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Anesthesiology
199
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723
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186
Dental
455
Ear, Nose, Throat
86
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383
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752
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462
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75
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62
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1
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273
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289
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112
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75
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1467
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26
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148
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1073
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93
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IYN
System, Imaging, Pulsed Doppler,...
164
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Plate, Fixation, Bone
150
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Orthopedic Stereotaxic Instrument
129
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System, Image Processing,...
122
GEX
Powered Laser Surgical Instrument
122
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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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Enlighten Materials Co., Ltd.
Medical Device Manufacturer
·
TW , Taipei
Enlighten Materials Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2020
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Enlighten Materials Co., Ltd.
Dental
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 18, 2020
BB Base 3D printing resin for denture base
K191591
·
EBI
Dental
·
431d
Cleared
May 05, 2020
AA temp temporary restoration 3D printing photoreactive resin
K191590
·
EBG
Dental
·
326d
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Dental
2