510k
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395
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1206
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298
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901
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170
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713
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1540
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925
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112
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79
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394
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668
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290
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178
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2201
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42
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360
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1771
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137
Categories
GEX
Powered Laser Surgical Instrument
253
LLZ
System, Image Processing,...
234
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Automated Radiological Image...
232
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System, Imaging, Pulsed Doppler,...
221
GEI
Electrosurgical, Cutting &...
218
HRS
Plate, Fixation, Bone
217
OLO
Orthopedic Stereotaxic Instrument
182
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
150
MAX
Intervertebral Fusion Device...
146
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Lexi Co., Ltd.
Medical Device Manufacturer
·
US , Cleveland , OH
Lexi Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2014
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Lexi Co., Ltd.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
May 27, 2021
ZedView
K200704
·
LLZ
Radiology
·
435d
Cleared
Mar 06, 2014
ZEDVIEW
K133022
·
LLZ
Radiology
·
161d
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2
Radiology
2