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97
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72
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240
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1548
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227
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191
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181
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166
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151
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Intervertebral Fusion Device...
136
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Thoracolumbosacral Pedicle Screw...
130
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Miracell Co., Ltd.
Medical Device Manufacturer
·
KR , Seoul
Miracell Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2026
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Miracell Co., Ltd.
Hematology
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 02, 2026
SMART M-CELL PRP Concentration System
K250516
·
QBV
Hematology
·
405d
Cleared
Apr 02, 2026
SMART M-CELL Bone Marrow Concentration System
K250518
·
QBV
Hematology
·
405d
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Hematology
2