510k
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Anesthesiology
339
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1083
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276
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831
Ear, Nose, Throat
149
Gastroenterology & Urology
643
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1345
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782
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100
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72
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1
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370
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592
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250
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160
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2074
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40
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315
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1613
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132
Categories
GEX
Powered Laser Surgical Instrument
232
IYN
System, Imaging, Pulsed Doppler,...
212
HRS
Plate, Fixation, Bone
211
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Automated Radiological Image...
208
LLZ
System, Image Processing,...
200
GEI
Electrosurgical, Cutting &...
186
OLO
Orthopedic Stereotaxic Instrument
171
NHA
Abutment, Implant, Dental,...
162
NKB
Thoracolumbosacral Pedicle Screw...
139
MAX
Intervertebral Fusion Device...
138
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Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.
Medical Device Manufacturer
·
CN , Zhenjiang
Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. - FDA 510(k) Cleare...
14 submissions
·
14 cleared
·
Since 2009
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
May 22, 2025
YUWELL® Infrared Ear Thermometer (YHT100)
K250878
·
FLL
General Hospital
·
59d
Cleared
May 20, 2021
YUWELL infrared ear thermometer: YHT101, YHT200
K203583
·
FLL
General Hospital
·
163d
Cleared
Dec 07, 2020
YUWELL Infrared Thermometer
K201864
·
FLL
General Hospital
·
154d
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14
Cardiovascular
5
Anesthesiology
5
General Hospital
3
Physical Medicine
1