Bain Medical Equipment (Guangzhou) Co., Ltd. FDA Approvals

0 new drug approvals and 5 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
NovaLine Tubing Set for Hemodialysis (BL 124)510(k)May 15, 2026Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	May 15, 2026
NovaLine SP-C35 Transducer Protector (956007)510(k)Jun 28, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jun 28, 2024
DORA Disposable A.V. Fistula Needle Sets510(k)Apr 8, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Apr 8, 2022
NovaLine Tubing Sets for Hemodialysis510(k)Mar 10, 2021Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Mar 10, 2021
Surgical Masks510(k)Feb 25, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Feb 25, 2021