510k
Database
Specialties
Anesthesiology
136
Cardiovascular
573
Chemistry
165
Dental
321
Ear, Nose, Throat
68
Gastroenterology & Urology
292
General & Plastic Surgery
528
General Hospital
379
Hematology
67
Immunology
58
Medical Genetics
0
Microbiology
234
Neurology
173
Obstetrics & Gynecology
64
Ophthalmic
51
Orthopedic
1298
Pathology
18
Physical Medicine
88
Radiology
879
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
84
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Sewonmedix, Inc.
Medical Device Manufacturer
·
KR , Busan
Sewonmedix, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2016
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Sewonmedix, Inc.
Dental
✕
2
devices
1-2 of 2
Filters
Cleared
Jul 07, 2023
IH Implant System
K222707
·
DZE
Dental
·
303d
Cleared
Oct 14, 2016
IH Implant System
K153521
·
DZE
Dental
·
311d
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2
Dental
2