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Manufacturers
KR
Edgecare, Inc.
Medical Device Manufacturer
·
KR , Seoul
Edgecare, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2024
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Edgecare, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 24, 2026
EdgeFlow Gel Pad
K252337
·
MUI
Radiology
·
270d
Cleared
Apr 17, 2026
EdgeFlow UW20
K252237
·
IYO
Radiology
·
274d
Cleared
Mar 06, 2024
EdgeFlow UH10
K231677
·
IYO
Radiology
·
271d
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3
Radiology
3