Shinva Ande Healthcare Apparatus Co., Ltd. FDA Approvals

0 new drug approvals and 4 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
Closed System Transfer Device510(k)Nov 23, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Nov 23, 2022
Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization510(k)Oct 7, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Oct 7, 2022
Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles510(k)Mar 1, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Mar 1, 2022
Disposable IV catheter510(k)Jul 23, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jul 23, 2021