Medical Device Manufacturer · KR , Yongin-Si

H&abyz Co., Ltd. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2021

4

Total

4

Cleared

0

Denied

FDA 510(k) cleared devices by H&abyz Co., Ltd. Radiology ✕

4 devices

1-4 of 4

Cleared Aug 04, 2025

Radiology · 105d

Cleared Mar 06, 2023

A1417MCW/A1717MCW/F1417MCW

Radiology · 66d

Cleared Nov 15, 2021

ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)

Radiology · 14d

Cleared Mar 12, 2021

Radiology · 136d