510k
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Anesthesiology
207
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741
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187
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472
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92
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398
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782
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478
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77
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64
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1
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277
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309
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121
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81
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1482
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26
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155
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1101
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95
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IYN
System, Imaging, Pulsed Doppler,...
168
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Plate, Fixation, Bone
151
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Orthopedic Stereotaxic Instrument
131
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Powered Laser Surgical Instrument
127
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System, Image Processing,...
126
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Automated Radiological Image...
113
NHA
Abutment, Implant, Dental,...
105
GEI
Electrosurgical, Cutting &...
105
MAX
Intervertebral Fusion Device...
97
MBI
Fastener, Fixation,...
93
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Daehan Medical Systems Co., Ltd.
Medical Device Manufacturer
·
KR , Siheung-City
Daehan Medical Systems Co., Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2016
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Daehan Medical Systems Co., Ltd.
Neurology
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 03, 2019
DAEHAN Disposable CUP Electrodes
K180232
·
GXY
Neurology
·
429d
Cleared
Nov 01, 2018
DAEHAN Adhesive Surface Electrodes
K180247
·
GXY
Neurology
·
276d
Cleared
Dec 21, 2016
DMS Disposable Subdermal Needle Electrodes
K161566
·
GXZ
Neurology
·
198d
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3
Neurology
3