Miracell Co., Ltd. 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
SMART M-CELL PRP Concentration System510(k)Apr 2, 2026Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Apr 2, 2026
SMART M-CELL Bone Marrow Concentration System510(k)Apr 2, 2026Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Apr 2, 2026