510k
Database
Specialties
Anesthesiology
508
Cardiovascular
1580
Chemistry
355
Dental
1268
Ear, Nose, Throat
233
Gastroenterology & Urology
919
General & Plastic Surgery
2104
General Hospital
1821
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
448
Neurology
921
Obstetrics & Gynecology
419
Ophthalmic
265
Orthopedic
2674
Pathology
49
Physical Medicine
505
Radiology
2287
Toxicology
154
Categories
LZA
Polymer Patient Examination Glove
372
LLZ
System, Image Processing,...
355
GEX
Powered Laser Surgical Instrument
347
GEI
Electrosurgical, Cutting &...
292
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
FXX
Mask, Surgical
252
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Yadu Medical (Henan) Co., Ltd.
Medical Device Manufacturer
·
CN , He Nan
Yadu Medical (Henan) Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2025
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Yadu Medical (Henan) Co., Ltd.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 04, 2026
Henan Yadu Level 4 Surgical Gowns (Reinforced)
K252301
·
FYA
General Hospital
·
195d
Cleared
Dec 03, 2025
Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)
K250564
·
FYA
General Hospital
·
280d
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2
General Hospital
2