510k
Database
Specialties
Anesthesiology
130
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566
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162
Dental
309
Ear, Nose, Throat
68
Gastroenterology & Urology
286
General & Plastic Surgery
512
General Hospital
369
Hematology
67
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56
Medical Genetics
0
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232
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163
Obstetrics & Gynecology
60
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49
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1287
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18
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85
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866
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
133
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
99
MBI
Fastener, Fixation,...
84
NHA
Abutment, Implant, Dental,...
83
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
80
JAK
System, X-ray, Tomography, Computed
79
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Poskom Co., Ltd.
Medical Device Manufacturer
·
KR , Gyeonggi-Do
Poskom Co., Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2022
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Poskom Co., Ltd.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 23, 2026
AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)
K253244
·
IZL
Radiology
·
147d
Cleared
Dec 19, 2025
Airbile-100
K250976
·
IZL
Radiology
·
263d
Cleared
Dec 20, 2022
AirRay
K222896
·
IZL
Radiology
·
88d
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3
Radiology
3