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Anesthesiology
542
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1680
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365
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1338
Ear, Nose, Throat
249
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975
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2196
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2048
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126
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99
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8
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469
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965
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434
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279
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2940
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52
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515
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2444
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155
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LZA
Polymer Patient Examination Glove
409
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System, Image Processing,...
388
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Mask, Surgical
358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
306
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System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
278
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Ningbo Xinwell Medical Technology Co., Ltd.
Medical Device Manufacturer
·
CN , Ningbo Cixi
Ningbo Xinwell Medical Technology Co., Ltd. - FDA 510(k) Cleared Devi...
2 submissions
·
2 cleared
·
Since 2024
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ningbo Xinwell Medical Technology Co., Ltd.
Gastroenterology & Urology
✕
2
devices
1-2 of 2
Filters
Cleared
Jun 07, 2024
Disposable Hemostatic Clips
K232969
·
PKL
Gastroenterology & Urology
·
260d
Cleared
Apr 12, 2024
Disposable Injection Needles
K232200
·
FBK
Gastroenterology & Urology
·
262d
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Gastroenterology & Urology
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