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510k Database
Manufacturers
DK
Sp Medical A/S
Medical Device Manufacturer
·
DK , Karise
Sp Medical A/S - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2026
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sp Medical A/S
Cardiovascular
✕
1
devices
1-1 of 1
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Cleared
Jul 14, 2026
Accoat Guide Wire
K253667
·
DQX
Cardiovascular
·
235d
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Cardiovascular
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