510k
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534
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1649
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359
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1323
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243
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956
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2174
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2038
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126
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97
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8
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462
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954
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433
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274
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2828
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52
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515
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2403
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155
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Polymer Patient Examination Glove
407
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System, Image Processing,...
381
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358
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351
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Electrosurgical, Cutting &...
301
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System, Imaging, Pulsed Doppler,...
284
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Automated Radiological Image...
275
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Plate, Fixation, Bone
269
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Orthopedic Stereotaxic Instrument
226
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Intervertebral Fusion Device...
209
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Shenzhen Borria Technology Co., Ltd.
Medical Device Manufacturer
·
CN , Shenzhen
Shenzhen Borria Technology Co., Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2021
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shenzhen Borria Technology Co., Ltd.
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 07, 2025
LED Therapy Mask (MN1, M226)
K242385
·
OHS
General & Plastic Surgery
·
238d
Cleared
Dec 15, 2023
IPL Hair Removal Device
K232939
·
OHT
General & Plastic Surgery
·
86d
Cleared
Dec 16, 2021
IPL hair removal machine
K213020
·
OHT
General & Plastic Surgery
·
87d
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3
General & Plastic Surgery
3