510k
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553
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1736
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387
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1407
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258
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997
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2244
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2105
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127
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105
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8
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477
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988
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452
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286
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3087
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52
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517
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2517
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156
Categories
LZA
Polymer Patient Examination Glove
423
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System, Image Processing,...
402
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Powered Laser Surgical Instrument
366
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361
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Electrosurgical, Cutting &...
313
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System, Imaging, Pulsed Doppler,...
306
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Plate, Fixation, Bone
300
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Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
238
MAX
Intervertebral Fusion Device...
235
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Medexel Co.,Ltd
Medical Device Manufacturer
·
KR , Anseong-Si
Medexel Co.,Ltd - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2016
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medexel Co.,Ltd
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 15, 2024
TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))
K231856
·
QNQ
General Hospital
·
266d
Cleared
Jul 24, 2018
Autokeeper
K172095
·
FMI
General Hospital
·
378d
Cleared
Feb 02, 2016
Top Fine Pen Needle
K152410
·
FMI
General Hospital
·
160d
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3
General Hospital
3