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531
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1642
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359
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1314
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242
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953
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2165
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2031
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126
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97
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8
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462
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951
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433
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274
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2817
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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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System, Image Processing,...
379
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357
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
298
IYN
System, Imaging, Pulsed Doppler,...
283
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
208
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Astrasono Technology Co., Ltd.
Medical Device Manufacturer
·
CN , Shenzhen
Astrasono Technology Co., Ltd. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2025
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Astrasono Technology Co., Ltd.
Radiology
✕
1
devices
1-1 of 1
Filters
Cleared
Sep 30, 2025
Astrasono A3Pro Bladder Scanner (A3Pro)
K250331
·
IYO
Radiology
·
237d
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Radiology
1