OrbusNeich Medical (Shenzhen) Co., Ltd. is one of 1554 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: Teleport Glide Microcatheter, COREPASS Modular Microcatheter (FLEX), Sapphire NC ULTRA Coronary Dilatation Catheter
9
Total
9
Cleared
0
Denied
OrbusNeich Medical (Shenzhen) Co., Ltd. has 9 FDA 510(k) cleared medical devices. Based in Shenzhen, CN.
Latest FDA clearance: Apr 2026. Active since 2020. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by OrbusNeich Medical (Shenzhen) Co., Ltd. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - OrbusNeich Medical (Shenzhen) Co., Ltd.
9 devices
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