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510k Database
Manufacturers
US
Hai Solutions
Medical Device Manufacturer
·
US , Carlsbad , CA
Hai Solutions - FDA 510(k) Cleared Devices
1 submissions
·
0 cleared
·
Since 2025
Official Website
1
Total
0
Cleared
1
Denied
FDA 510(k) Regulatory Record - Hai Solutions
General Hospital
✕
1
devices
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Not Cleared
Dec 23, 2025
QIKCAP System
DEN250004
·
SGX
General Hospital
·
327d
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