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242
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954
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2166
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2031
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97
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462
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433
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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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System, Image Processing,...
379
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357
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351
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Electrosurgical, Cutting &...
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
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
208
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Shanghai Sigma High-Tech Co., Ltd.
Medical Device Manufacturer
·
CN , Shanghai
Shanghai Sigma High-Tech Co., Ltd. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2024
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shanghai Sigma High-Tech Co., Ltd.
General & Plastic Surgery
✕
1
devices
1-1 of 1
Filters
Cleared
Dec 19, 2024
UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD,...
K242908
·
FTC
General & Plastic Surgery
·
86d
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General & Plastic Surgery
1