OrbusNeich Medical (Shenzhen) Co., Ltd. is one of 2114 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
OrbusNeich Medical (Shenzhen) Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: JADE SCORE PTA Scoring Balloon Dilatation Catheter, Teleport Glide Microcatheter, COREPASS Modular Microcatheter (FLEX)
10
Total
10
Cleared
0
Denied
OrbusNeich Medical (Shenzhen) Co., Ltd. has 10 FDA 510(k) cleared cardiovascular devices. Based in Shenzhen, CN.
Latest FDA clearance: Sep 2026. Active since 2020.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - OrbusNeich Medical (Shenzhen) Co., Ltd.
10 devices
Cleared
Sep 16, 2026
JADE SCORE PTA Scoring Balloon Dilatation Catheter
Cardiovascular
110d
Cleared
Apr 10, 2026
Teleport Glide Microcatheter
Cardiovascular
192d
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