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540
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1660
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362
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244
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957
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2179
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2039
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126
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97
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960
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433
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274
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2846
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52
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515
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2417
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155
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Polymer Patient Examination Glove
407
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System, Image Processing,...
382
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358
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351
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301
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System, Imaging, Pulsed Doppler,...
288
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Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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Shandong Guyue Healthcare Appliance Co., Ltd.
Medical Device Manufacturer
·
CN , Binzhou
Shandong Guyue Healthcare Appliance Co., Ltd. - FDA 510(k) Cleared De...
1 submissions
·
1 cleared
·
Since 2025
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shandong Guyue Healthcare Appliance Co., Ltd.
Physical Medicine
✕
1
devices
1-1 of 1
Filters
Cleared
Sep 09, 2025
Electric Wheelchair (GY-E001)
K251891
·
ITI
Physical Medicine
·
81d
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1
Physical Medicine
1