OOD

Phasix Mesh

Advisory panel: General, Plastic Surgery
Total cleared: 13

Adverse events under product code OOD

product code OOD

Death: 6
Injury: 1,005
Total: 1,011

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code OOD

K233999 — GalaFLEX LITE Scaffold Tepha, Inc. · 2024-04-09
K202425 — SurgiLattice scaffold Tepha, Inc. · 2021-08-19
K162922 — GalaFORM 3D Tepha, Inc. · 2017-02-23
K161424 — Phasix Mesh C.R. Bard, Inc. · 2016-09-29
K161092 — GalaSHAPE 3D Tepha, Inc. · 2016-08-23
K142818 — Phasix Mesh C. R. Bard · 2015-03-31
K140533 — GALAFLEX MESH Tepha, Inc. · 2014-05-21
K130326 — TEPHAFLEX MELTBLOWN CONSTRUCT Tepha, Inc. · 2013-05-07
K113721 — TEPHAFLEX LIGHT MESH Tepha, Inc. · 2012-02-15
K113723 — TEPHAFLEX MESH Tepha, Inc. · 2012-02-15
K111946 — TEPHAFLEX MESH Tepha, Inc. · 2011-09-26
K091633 — TEPHAFLEX SURGICAL FILM Tepha, Inc. · 2009-08-07
K070894 — TEPHAFLEX SURGICAL MESH Tepha, Inc. · 2007-04-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.