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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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97
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462
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951
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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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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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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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Wuxi Hisky Medical Technologies Co., Ltd.
Medical Device Manufacturer
·
CN , Wuxi
Wuxi Hisky Medical Technologies Co., Ltd. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2018
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Wuxi Hisky Medical Technologies Co., Ltd.
General & Plastic Surgery
✕
1
devices
1-1 of 1
Filters
Cleared
Jul 24, 2025
Confocal Microprobe Imaging System (BrightP980)
K243711
·
OWN
General & Plastic Surgery
·
234d
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5
Radiology
4
General & Plastic Surgery
1