Simplivia Healthcare , 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
Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor510(k)Oct 21, 2025General Hospital	General Hospital	510(k)Substantially Equivalent (Special)	Oct 21, 2025
Chemfort Female Luer Lock Adaptor510(k)Aug 5, 2025General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Aug 5, 2025
Chemfort® Catheter Adaptor510(k)Aug 2, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Aug 2, 2023
OnGuard2 Chemfort Closed Administration (CADM)510(k)Sep 23, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Sep 23, 2021
TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set510(k)Feb 25, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Feb 25, 2021