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 |
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 |
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