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508
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1581
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355
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1270
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233
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920
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2106
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1834
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126
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91
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8
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449
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923
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419
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2677
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49
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506
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2289
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154
Categories
LZA
Polymer Patient Examination Glove
377
LLZ
System, Image Processing,...
356
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Powered Laser Surgical Instrument
347
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Electrosurgical, Cutting &...
292
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Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
FXX
Mask, Surgical
258
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Xinxiang Kangbeier Medical Technology Co., Ltd.
Medical Device Manufacturer
·
CN , Changyuan
Xinxiang Kangbeier Medical Technology Co., Ltd. - FDA 510(k) Cleared ...
2 submissions
·
2 cleared
·
Since 2022
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Xinxiang Kangbeier Medical Technology Co., Ltd.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 21, 2023
Kangbeier Child Surgical Mask
K221753
·
OXZ
General Hospital
·
553d
Cleared
Jan 16, 2022
Kangbeier Surgical Mask (Model: KBR-1001)
K213920
·
FXX
General Hospital
·
32d
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2
General Hospital
2