510k
Database
Specialties
Anesthesiology
545
Cardiovascular
1708
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379
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1352
Ear, Nose, Throat
250
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981
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2215
General Hospital
2066
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126
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100
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8
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474
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980
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439
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282
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3008
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52
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515
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2476
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155
Categories
LZA
Polymer Patient Examination Glove
415
LLZ
System, Image Processing,...
398
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Powered Laser Surgical Instrument
363
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Mask, Surgical
358
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Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
289
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
228
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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) Regulatory Record - 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