Carbon (Shenzhen) Medical Device Co., Ltd. FDA Approvals

0 new drug approvals and 2 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
Disposable Biopsy Needle510(k)Jul 11, 2025Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jul 11, 2025
Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System510(k)Apr 3, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 3, 2025