510k
Database
Specialties
Anesthesiology
136
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570
Chemistry
165
Dental
319
Ear, Nose, Throat
68
Gastroenterology & Urology
291
General & Plastic Surgery
526
General Hospital
378
Hematology
67
Immunology
57
Medical Genetics
0
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234
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173
Obstetrics & Gynecology
62
Ophthalmic
51
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1296
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18
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88
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875
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
151
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...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Sk, Inc.
Medical Device Manufacturer
·
KR , Seongnam-Si
Sk, Inc. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2024
1
Total
1
Cleared
0
Denied
FDA 510(k) cleared devices by Sk, Inc.
Radiology
✕
1
devices
1-1 of 1
Filters
Cleared
Jul 01, 2024
Hyper Insight - ICH
K240353
·
QAS
Radiology
·
147d
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1
Radiology
1