OrbusNeich Medical (Shenzhen) Co., Ltd. - FDA 510(k) Cleared Devices
8
Total
8
Cleared
0
Denied
FDA 510(k) cleared devices by OrbusNeich Medical (Shenzhen) Co., Ltd. Cardiovascular ✕
8 devices
Cleared
Jan 07, 2025
COREPASS Modular Microcatheter (FLEX)
Cardiovascular
130d
Cleared
Aug 16, 2024
Sapphire NC ULTRA Coronary Dilatation Catheter
Cardiovascular
290d
Cleared
Aug 15, 2024
Sapphire ULTRA Coronary Dilatation Catheter
Cardiovascular
289d
Cleared
Jun 11, 2024
JADE PLUS PTA Balloon Dilatation Catheter
Cardiovascular
57d
Cleared
Jan 07, 2024
Teleport XT Microcatheter
Cardiovascular
219d
Cleared
Oct 14, 2021
Sapphire NC 24
Cardiovascular
125d
Cleared
Dec 10, 2020
JADE
Cardiovascular
125d
Cleared
Jul 28, 2020
Jade
Cardiovascular
28d