510k
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Specialties
Anesthesiology
538
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1654
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360
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1323
Ear, Nose, Throat
243
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957
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2175
General Hospital
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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958
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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
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Anhui Xinyisheng Medical Technology Co.,Ltd
Medical Device Manufacturer
·
CN , Suzhou
Anhui Xinyisheng Medical Technology Co.,Ltd - FDA 510(k) Cleared Devi...
2 submissions
·
2 cleared
·
Since 2021
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Anhui Xinyisheng Medical Technology Co.,Ltd
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 28, 2022
Disposable Medical Nitrile Examination Gloves- Tested for Use With...
K213325
·
LZC
General Hospital
·
115d
Cleared
Dec 09, 2021
Disposable Medical Nitrile Examination Gloves (Model:XYS-001)
K213371
·
LZA
General Hospital
·
58d
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2
General Hospital
2