Arcuro Medical , 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
SuperBall-RC510(k)Feb 19, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 19, 2025
SuperBall Meniscal Repair System510(k)Aug 10, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Aug 10, 2023