7 results
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34ms
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Sources: EU EUDAMED, US FDA
Tepha, Incorporated
FDA registration
Tepha, Incorporated·1 product·🇺🇸 United States
GALAFLEX
FDA Adverse Event
Injury
·TEPHA, INCORPORATED·Product code OOD·April 12, 2024
TEPHAFLEX MESH
FDA Adverse Event
Injury
·TEPHA INCORPORATED·Product code OOD·October 17, 2012
GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. GalaSHAPE" 3D is also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
FDA Recall
Terminated
·Tepha Incorporated·Product code OOD·November 21, 2016
GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. GalaSHAPE" 3D is also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
FDA Enforcement
Class II
·Terminated·Tepha Incorporated·January 11, 2017
GALAFLEX SCAFFOLD P4HB
FDA Adverse Event
Injury
·BECTON DICKINSON AND COMPANY / TEPHA, INCORPORATED·Product code OOD·September 7, 2022
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices