510k
Database
Specialties
Anesthesiology
534
Cardiovascular
1644
Chemistry
359
Dental
1323
Ear, Nose, Throat
243
Gastroenterology & Urology
956
General & Plastic Surgery
2174
General Hospital
2037
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126
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97
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8
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462
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952
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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
Toxicology
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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Jiangsu Huayuan Medical Technology Co., Ltd.
Medical Device Manufacturer
·
CN , Dongtai
Jiangsu Huayuan Medical Technology Co., Ltd. - FDA 510(k) Cleared Dev...
2 submissions
·
2 cleared
·
Since 2021
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Jiangsu Huayuan Medical Technology Co., Ltd.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 21, 2022
Nitrile Examination Gloves
K213044
·
LZA
General Hospital
·
121d
Cleared
Jun 23, 2021
Synthetic Vinyl Examination Gloves
K211045
·
LYZ
General Hospital
·
76d
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2
General Hospital
2