Teleflex Medical Sdn. Bhd. FDA Approvals

0 new drug approvals and 3 device clearances on file. Matched by name to TFX.

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
Rusch Latex Gold Foley Catheter510(k)Aug 5, 2026Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Aug 5, 2026
Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled510(k)May 15, 2026Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	May 15, 2026
Rusch SoftSimplastic Foley Catheters510(k)Jan 20, 2026Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jan 20, 2026