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Manufacturers
KR
Dexcowin Co., Ltd.
Medical Device Manufacturer
·
KR , Seoul
Dexcowin Co., Ltd. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2009
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dexcowin Co., Ltd.
Radiology
✕
5
devices
1-5 of 5
Filters
Cleared
Oct 26, 2017
Cocoon Portable Handheld X-Ray System
K173046
·
MUH
Radiology
·
28d
Cleared
Oct 05, 2015
ADX6000 Portable X-Ray System
K143494
·
IZL
Radiology
·
300d
Cleared
May 09, 2014
ADX4000W
K134055
·
MUH
Radiology
·
129d
Cleared
Apr 24, 2014
DX3000-L
K133007
·
MUH
Radiology
·
211d
Cleared
Mar 10, 2009
ADX4000-L, DX3000-L
K083532
·
MUH
Radiology
·
102d
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Radiology
5