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

Smart Alfa Teknoloji San. Ve Tic. A.S. has 2 FDA 510(k) cleared medical devices. Based in Ankara, TR.

Latest FDA clearance: May 2026. Active since 2025. Primary specialty: Anesthesiology.

Browse the FDA 510(k) cleared devices submitted by Smart Alfa Teknoloji San. Ve Tic. A.S. Filter by specialty or product code using the sidebar.

1 device has linked clinical trial registered on ClinicalTrials.gov. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.

FDA 510(k) Regulatory Record - Smart Alfa Teknoloji San. Ve Tic. A.S.

2 devices
1-2 of 2
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