Medicrea International FDA Approvals

0 new drug approvals and 2 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
Infinity OCT System and PASS OCT Spinal System510(k)Apr 19, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Apr 19, 2022
CD Horizon Spinal System and PASS LP Spinal System510(k)Apr 8, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Apr 8, 2022