510k
Database
Specialties
Anesthesiology
538
Cardiovascular
1654
Chemistry
360
Dental
1323
Ear, Nose, Throat
243
Gastroenterology & Urology
957
General & Plastic Surgery
2175
General Hospital
2038
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
958
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2828
Pathology
52
Physical Medicine
515
Radiology
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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Heuron Co., Ltd.
Medical Device Manufacturer
·
KR , Incheon
Heuron Co., Ltd. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2021
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Heuron Co., Ltd.
Radiology
✕
5
devices
1-5 of 5
Filters
Cleared
May 15, 2024
Heuron ICH
K233247
·
QAS
Radiology
·
230d
Cleared
Oct 13, 2023
Veuron-Brain-pAb3
K231642
·
LLZ
Radiology
·
130d
Cleared
Jul 12, 2022
Veuron-Brain-mN1
K203279
·
LNH
Radiology
·
613d
Cleared
Feb 04, 2022
Veuron-Brain-pAb2
K213801
·
LLZ
Radiology
·
60d
Cleared
Jan 15, 2021
Veuron-Brain-pAb
K203142
·
LLZ
Radiology
·
87d
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Radiology
5