510k
Database
Specialties
Anesthesiology
134
Cardiovascular
569
Chemistry
165
Dental
318
Ear, Nose, Throat
68
Gastroenterology & Urology
289
General & Plastic Surgery
524
General Hospital
375
Hematology
67
Immunology
57
Medical Genetics
0
Microbiology
234
Neurology
172
Obstetrics & Gynecology
62
Ophthalmic
51
Orthopedic
1295
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18
Physical Medicine
87
Radiology
871
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
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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Remedi Co., Ltd.
Medical Device Manufacturer
·
KR , Seoul
Remedi Co., Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2020
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Remedi Co., Ltd.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
May 13, 2024
REMEX-GR100
K240759
·
EHD
Radiology
·
54d
Cleared
Aug 03, 2021
Remex KA6
K212144
·
IZL
Radiology
·
25d
Cleared
Feb 28, 2020
R-Sensor, R-Sensor
K200284
·
MUH
Radiology
·
23d
Filters
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3
Radiology
3