Medical Device Manufacturer · CN , Shenzhen

OrbusNeich Medical (Shenzhen) Co., Ltd. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2020
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
1-9 of 9
Cleared Apr 10, 2026
Teleport Glide Microcatheter
K253361 · DQY
Cardiovascular · 192d
Cleared Jan 07, 2025
COREPASS Modular Microcatheter (FLEX)
K242588 · DQY
Cardiovascular · 130d
Cleared Aug 16, 2024
Sapphire NC ULTRA Coronary Dilatation Catheter
K233499 · LOX
Cardiovascular · 290d
Cleared Aug 15, 2024
Sapphire ULTRA Coronary Dilatation Catheter
K233505 · LOX
Cardiovascular · 289d
Cleared Jun 11, 2024
JADE PLUS PTA Balloon Dilatation Catheter
K241025 · LIT
Cardiovascular · 57d
Cleared Jan 07, 2024
Teleport XT Microcatheter
K231608 · DQY
Cardiovascular · 219d
Cleared Oct 14, 2021
Sapphire NC 24
K211807 · LOX
Cardiovascular · 125d
Cleared Dec 10, 2020
JADE
K202231 · LIT
Cardiovascular · 125d
Cleared Jul 28, 2020
Jade
K201794 · LIT
Cardiovascular · 28d
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