510k
Database
Specialties
Anesthesiology
134
Cardiovascular
569
Chemistry
164
Dental
314
Ear, Nose, Throat
68
Gastroenterology & Urology
289
General & Plastic Surgery
521
General Hospital
373
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
233
Neurology
168
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1294
Pathology
18
Physical Medicine
86
Radiology
870
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
MBI
Fastener, Fixation,...
85
NHA
Abutment, Implant, Dental,...
84
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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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) cleared devices by 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