Healthium Medtech Limited FDA Approvals

0 new drug approvals and 5 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
CEPTRE® Knotted UHMWPE Suture PEEK Anchor510(k)Jan 4, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 4, 2024
SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant510(k)Dec 28, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 28, 2023
INFILOOP® Fixed Loop UHMWPE Suture Titanium Button510(k)Nov 8, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 8, 2023
T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button510(k)Aug 4, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 4, 2023
Stativ® Knotted UHMWPE Suture Anchor510(k)Mar 22, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 22, 2023