Lina Medical Aps FDA Approvals

0 new drug approvals and 3 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
LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeVu (SCP-100-1)510(k)Aug 22, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Aug 22, 2024
SafeAir combi (SFR-combi-US)510(k)Apr 26, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Apr 26, 2023
LiNA OperaScope Needle510(k)Sep 2, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Sep 2, 2022