Medical Device Manufacturer · US , Cambridge , MA

Tepha, Inc. - FDA 510(k) Cleared Devices

18 submissions · 17 cleared · Since 2007
18
Total
17
Cleared
1
Denied

FDA 510(k) cleared devices by Tepha, Inc. General & Plastic Surgery ✕

18 devices
1-18 of 18
Cleared Apr 09, 2024
GalaFLEX LITE Scaffold
K233999 · OOD
General & Plastic Surgery · 113d
Cleared Aug 19, 2021
SurgiLattice scaffold
K202425 · OOD
General & Plastic Surgery · 359d
Cleared May 27, 2021
GalaSTITCH Absorbable Monofilament Suture
K211307 · NWJ
General & Plastic Surgery · 28d
Cleared Feb 23, 2017
GalaFORM 3D
K162922 · OOD
General & Plastic Surgery · 128d
Cleared Aug 23, 2016
GalaSHAPE 3D
K161092 · OOD
General & Plastic Surgery · 127d
Cleared May 21, 2014
GALAFLEX MESH
K140533 · OOD
General & Plastic Surgery · 78d
Cleared Sep 05, 2013
TEPHAFLEX BRAIDED SUTURE
K132348 · NWJ
General & Plastic Surgery · 38d
Cleared May 07, 2013
TEPHAFLEX MELTBLOWN CONSTRUCT
K130326 · OOD
General & Plastic Surgery · 88d
Cleared Feb 15, 2012
TEPHAFLEX LIGHT MESH
K113721 · OOD
General & Plastic Surgery · 58d
Cleared Feb 15, 2012
TEPHAFLEX MESH
K113723 · OOD
General & Plastic Surgery · 58d
Cleared Sep 26, 2011
TEPHAFLEX MESH
K111946 · OOD
General & Plastic Surgery · 80d
Cleared Aug 30, 2010
TEPHAFLEX COMPOSITE MESH
K101287 · OWT
General & Plastic Surgery · 115d
Cleared Aug 07, 2009
TEPHAFLEX SURGICAL FILM
K091633 · OOD
General & Plastic Surgery · 64d
Cleared Oct 30, 2008
TEPHAFLEX ABSORBABLE SUTURE
K082178 · NWJ
General & Plastic Surgery · 90d
Cleared Jul 15, 2008
TEPHAFLEX ABSORBABLE SUTURE
K081099 · NWJ
General & Plastic Surgery · 89d
Cleared Nov 29, 2007
TEPHAFLEX SURGICAL FILM
K072520 · FTL
General & Plastic Surgery · 83d
Cleared Apr 13, 2007
TEPHAFLEX SURGICAL MESH
K070894 · OOD
General & Plastic Surgery · 14d
Not Cleared Feb 08, 2007
TEPHAFLEX ABSORBABLE SUTURE
DEN060003 · NWJ
General & Plastic Surgery · 272d
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