510k
Database
Specialties
Anesthesiology
538
Cardiovascular
1656
Chemistry
360
Dental
1323
Ear, Nose, Throat
244
Gastroenterology & Urology
957
General & Plastic Surgery
2176
General Hospital
2039
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
959
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2844
Pathology
52
Physical Medicine
515
Radiology
2413
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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Our United Corporation
Medical Device Manufacturer
·
CN , Xi'An
Our United Corporation - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2020
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Our United Corporation
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 02, 2021
TaiChiB
K210921
·
IYE
Radiology
·
218d
Cleared
Mar 12, 2021
TaiChiC
K203250
·
IWB
Radiology
·
128d
Cleared
Aug 07, 2020
TaiChiA
K193207
·
IYE
Radiology
·
261d
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3
Radiology
3