510k
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525
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1612
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356
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1304
Ear, Nose, Throat
235
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928
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2135
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1991
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126
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91
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8
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449
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942
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429
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272
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2704
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52
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515
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2334
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155
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LZA
Polymer Patient Examination Glove
403
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System, Image Processing,...
370
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Mask, Surgical
357
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
266
HRS
Plate, Fixation, Bone
262
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Shenzhen Sanping Image Technology Co., Ltd.
Medical Device Manufacturer
·
CN , Shenzhen
Shenzhen Sanping Image Technology Co., Ltd. - FDA 510(k) Cleared Devi...
2 submissions
·
2 cleared
·
Since 2025
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shenzhen Sanping Image Technology Co., Ltd.
Gastroenterology & Urology
✕
1
devices
1-1 of 1
Filters
Cleared
Oct 31, 2025
Flexible Ureterorenoscope system (Electronic Endoscope Image Processor,...
K250917
·
FGB
Gastroenterology & Urology
·
218d
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2
Gastroenterology & Urology
1
Ear, Nose, Throat
1