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510k Database
Manufacturers
TR
Smart Alfa Teknoloji San. Ve Tic. A.S.
Medical Device Manufacturer
·
TR , Ankara
Smart Alfa Teknoloji San. Ve Tic. A.S. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2025
Recent clearances:
MSK Go
,
Nerveblox
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Smart Alfa Teknoloji San. Ve Tic. A.S.
Anesthesiology
✕
1
devices
1-1 of 1
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Cleared
Aug 15, 2025
Nerveblox
K250818
·
QRG
Anesthesiology
·
150d
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2
Anesthesiology
1
Radiology
1