Gemtier Medical (Shanghai), Inc. FDA Approvals

0 new drug approvals and 3 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
Sterile Syringe with Fixed Safety Needle for Single Use510(k)Mar 2, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Mar 2, 2022
Medical Face Mask510(k)Feb 4, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Feb 4, 2021
Medical Face Mask510(k)Feb 2, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Feb 2, 2021