Ocuject, LLC FDA Approvals

0 new drug approvals and 7 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
LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle510(k)Oct 25, 2024General Hospital	General Hospital	510(k)Substantially Equivalent (Special)	Oct 25, 2024
SteriCap Safety Needle; VitreJect Safety Needle510(k)Nov 27, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Abbreviated)	Nov 27, 2023
VitreJect® Needle; OcuSafe® Needle510(k)Sep 14, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Sep 14, 2023
VitreJect Syringe510(k)Sep 8, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Sep 8, 2023
MiniLoad Syringe510(k)Oct 13, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Special)	Oct 13, 2021
SteriCap Mini Needle and Standard Needles510(k)Sep 30, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Special)	Sep 30, 2021
MiniLoad Syringe510(k)Feb 19, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Feb 19, 2021