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541
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1672
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364
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245
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969
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2190
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2046
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126
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97
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466
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274
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2912
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52
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515
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155
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LZA
Polymer Patient Examination Glove
408
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System, Image Processing,...
386
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358
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Powered Laser Surgical Instrument
356
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302
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System, Imaging, Pulsed Doppler,...
296
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Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
219
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Zhuhai Yueja Medical Device Technology Co., Ltd.
Medical Device Manufacturer
·
CN , Zhuhai
Zhuhai Yueja Medical Device Technology Co., Ltd. - FDA 510(k) Cleared...
3 submissions
·
3 cleared
·
Since 2023
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Zhuhai Yueja Medical Device Technology Co., Ltd.
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 11, 2023
Wrist Blood Pressure Monitor
K232815
·
DXN
Cardiovascular
·
89d
Cleared
Dec 05, 2023
Electronic Blood Pressure Monitor
K232814
·
DXN
Cardiovascular
·
83d
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Cardiovascular
2
General Hospital
1