OrbusNeich Medical (Shenzhen) Co., Ltd. FDA Approvals

0 new drug approvals and 8 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
JADE SCORE PTA Scoring Balloon Dilatation Catheter510(k)Sep 16, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 16, 2026
Teleport Glide Microcatheter510(k)Apr 10, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 10, 2026
COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)510(k)Jan 7, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 7, 2025
Sapphire NC ULTRA Coronary Dilatation Catheter510(k)Aug 16, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 16, 2024
Sapphire ULTRA Coronary Dilatation Catheter510(k)Aug 15, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 15, 2024
JADE PLUS PTA Balloon Dilatation Catheter510(k)Jun 11, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 11, 2024
Teleport XT Microcatheter510(k)Jan 7, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 7, 2024
Sapphire NC 24510(k)Oct 14, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 14, 2021