Medical Device Manufacturer · US , Ridgefield , CT

Goodman Co., Ltd. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2001
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Goodman Co., Ltd. Cardiovascular ✕
2 devices
1-2 of 2
Cleared Apr 22, 2025
Aperta NSE PTA Balloon Dilatation Catheter
K243944 · PNO
Cardiovascular · 123d
Cleared Mar 28, 2024
Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040,...
K232013 · PNO
Cardiovascular · 266d
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All3 Cardiovascular 2 Radiology 1