FDA 510(k) Applications for Medical Device Product Code: OOD (Surgical Film)

FDA 510(k) Applications for Medical Device Product Code "OOD"
(Surgical Film)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K142818	C.R. Bard	Phasix Mesh	03/31/2015
K161424	C.R. BARD INC.	Phasix Mesh	09/29/2016
K233999	Tepha, Inc.	GalaFLEX LITE Scaffold	04/09/2024
K140533	TEPHA, INC.	GALAFLEX MESH	05/21/2014
K162922	TEPHA, INC.	GalaFORM 3D	02/23/2017
K161092	Tepha, Inc.	GalaSHAPE 3D	08/23/2016
K202425	Tepha, Inc.	SurgiLattice scaffold	08/19/2021
K113721	TEPHA, INC.	TEPHAFLEX LIGHT MESH	02/15/2012
K130326	TEPHA, INC.	TEPHAFLEX MELTBLOWN CONSTRUCT	05/07/2013
K111946	TEPHA, INC.	TEPHAFLEX MESH	09/26/2011
K113723	TEPHA, INC.	TEPHAFLEX MESH	02/15/2012
K091633	TEPHA, INC.	TEPHAFLEX SURGICAL FILM	08/07/2009
K070894	TEPHA, INC.	TEPHAFLEX SURGICAL MESH	04/13/2007