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Tepha, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K233999GalaFLEX LITE ScaffoldApril 9, 2024
K202425SurgiLattice scaffoldAugust 19, 2021
K211307GalaSTITCH Absorbable Monofilament SutureMay 27, 2021
K162922GalaFORM 3DFebruary 23, 2017
K161092GalaSHAPE 3DAugust 23, 2016
K140533GALAFLEX MESHMay 21, 2014
K132348TEPHAFLEX BRAIDED SUTURESeptember 5, 2013
K130326TEPHAFLEX MELTBLOWN CONSTRUCTMay 7, 2013
K113721TEPHAFLEX LIGHT MESHFebruary 15, 2012
K113723TEPHAFLEX MESHFebruary 15, 2012
K111946TEPHAFLEX MESHSeptember 26, 2011
K101287TEPHAFLEX COMPOSITE MESHAugust 30, 2010
K091633TEPHAFLEX SURGICAL FILMAugust 7, 2009
K082178TEPHAFLEX ABSORBABLE SUTUREOctober 30, 2008
K081099TEPHAFLEX ABSORBABLE SUTUREJuly 15, 2008
K072520TEPHAFLEX SURGICAL FILMNovember 29, 2007
K070894TEPHAFLEX SURGICAL MESHApril 13, 2007
DEN060003TEPHAFLEX ABSORBABLE SUTUREFebruary 8, 2007