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540
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1660
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362
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1323
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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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8
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464
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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
Categories
LZA
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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Electrosurgical, Cutting &...
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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Wenzhou Xikang Medical Instruments Co., Ltd.
Medical Device Manufacturer
·
CN , Wenzhou
Wenzhou Xikang Medical Instruments Co., Ltd. - FDA 510(k) Cleared Dev...
2 submissions
·
2 cleared
·
Since 2022
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Wenzhou Xikang Medical Instruments Co., Ltd.
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 21, 2022
Disposable Blood Pressure Cuff
K222420
·
DXQ
Cardiovascular
·
102d
Cleared
May 18, 2022
WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood...
K212416
·
DXQ
Cardiovascular
·
288d
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Cardiovascular
2