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1642
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359
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242
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954
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2166
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126
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97
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462
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433
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274
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2819
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52
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515
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2400
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155
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LZA
Polymer Patient Examination Glove
407
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379
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357
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351
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299
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System, Imaging, Pulsed Doppler,...
283
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Automated Radiological Image...
275
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Plate, Fixation, Bone
269
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Orthopedic Stereotaxic Instrument
226
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Intervertebral Fusion Device...
208
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Dk Medical Systems Co., Ltd.
Medical Device Manufacturer
·
KR , Pyeongtaek-Si
Dk Medical Systems Co., Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2025
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dk Medical Systems Co., Ltd.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 10, 2026
AeroDR TX c02
K253446
·
KPR
Radiology
·
190d
Cleared
Aug 01, 2025
INNOVISION-DXII
K250790
·
KPR
Radiology
·
140d
Cleared
Jul 18, 2025
INNOVISION-P5
K250750
·
IZL
Radiology
·
128d
Filters
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3
Radiology
3