510k
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532
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1643
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359
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1318
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242
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955
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2169
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2036
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126
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97
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8
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462
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952
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433
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274
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2828
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52
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515
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2403
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
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358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
299
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Hankil Tech Medical Co., Ltd.
Medical Device Manufacturer
·
KR , Hwaseong-Si
Hankil Tech Medical Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2024
Official Website
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hankil Tech Medical Co., Ltd.
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 27, 2026
HKT Anatomical Locking Trauma System
K254249
·
HRS
Orthopedic
·
60d
Cleared
Jan 19, 2024
HKT Anatomical Locking Trauma System
K231213
·
HRS
Orthopedic
·
266d
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Orthopedic
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