GXQ

Death

11

Injury

446

Other

1

Total

458

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 →

• K251191 — Collagen Dura Regeneration Membrane - Repair Collagen Matrix, Inc. · 2025-11-18
• K250420 — Helios Dura Regeneration Matrix Helios Biomedical, Inc. · 2025-05-14
• K223445 — ArtiFascia Nurami Medical , Ltd. · 2023-08-10
• K212943 — SyntheCel Dura Repair Synthes (USA) Products, LLC · 2022-01-28
• K183513 — XenoSure Dura Biologic Patch LeMaitre Vascular, Inc. · 2019-06-13
• K172603 — Cerafix Dura Substitute Acera Surgical, Inc. · 2017-11-27
• K163456 — DuraGen Secure Dural Regeneration Matrix Integra LifeSciences Corporation · 2017-01-06
• K161370 — Durepair Dura Regeneration Matrix Medtronic Neurosurgery · 2016-11-02
• K161278 — Cerafix Dura Substitute Acera Surgical, Inc. · 2016-08-08
• K153613 — Cerafix Dura Substitute Acera Surgical, Inc. · 2016-03-16
• K150825 — Collagen Dural Regeneration Matrix Collagen Matrix, Inc. · 2015-11-20
• K152481 — DURAFORM Dural Graft Implant Codman & Shurtleff, Inc. · 2015-10-30
• K141608 — COLLAGEN DURA MEMBRANE Collagen Matrix, Inc. · 2015-01-16
• K132850 — BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM Rti Surgical, Inc. · 2014-03-31
• K131792 — SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY Synthes, Inc. · 2013-12-16
• K131015 — BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT Cook Biotech, Inc. · 2013-10-08
• K122791 — LYOPLANT ONLAY Aesculap, Inc. · 2013-06-04
• K120600 — DURAGEN SECURE DURAL REGNERATION MATRIX Integra Life Sciences · 2012-06-15
• K113071 — SYNTHECEL DURA REPLACEMENT DEVICES Synthes · 2012-01-09
• K092388 — DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO Integra LifeSciences Corporation · 2010-01-21
• K072207 — DURAGEN XS DURAL REGENERATION MATRIX Integra Lifesciences Corp. · 2007-08-23
• K061208 — LIFECELL DURAL SUBSTITUTE MATRIX Lifecell Corp. · 2007-01-03
• K063117 — MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX Medtronic Neurosurgery · 2006-11-03
• K061487 — DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE Collagen Matrix, Inc. · 2006-06-26
• K052211 — DUREPAIR DURA REGENERATION MATRIX Medtronic Neurosurgery · 2005-09-14
• K043427 — DURAGEN II DURAL REGENERATION MATRIX Integra Lifesciences Corp. · 2005-01-12
• K040888 — DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE Collagen Matrix, Inc. · 2004-12-01
• K041000 — DUREPAIR DURA REGENERATION MATRIX Medtronic Neurosurgery · 2004-07-27
• K041518 — CODMAN DURAFORM DURAL GRAFT IMPLANT Codman & Shurtleff, Inc. · 2004-06-22
• K032693 — DURAGEN PLUS DURAL GRAFT MATRIX Integra Lifesciences Corp. · 2003-09-30
• K031850 — DURASIS DURAL SUBSTITUTE Cook Biotech, Inc. · 2003-09-08
• K021477 — PRECLUDE MVP DURA SUBSTITUTE W. L. Gore & Associates, Inc. · 2002-11-08
• K982101 — SHELHIGH NO-REACT DURA SHIELD Shelhigh, Inc. · 2000-05-02
• K991413 — CODMAN ETHISORB DURA PATCH Johnson & Johnson Professionals, Inc. · 2000-03-13
• K982180 — DURAGEN DURAL GRAFT MATRIX Integra Lifesciences Corp. · 1999-07-06
• K984534 — PRECLUDE ACUSEAL DURA SUBSTITUTE W. L. Gore & Associates, Inc. · 1999-03-15
• K982282 — DURA-GUARD - DURAL REPAIR PATCH Bio-Vascular, Inc. · 1998-07-30
• K980548 — DURA-PATCH MODEL DP-XXX Bridger Biomed, Inc. · 1998-05-13
• K973706 — DURA-GUARD-DURAL REPAIR PATCH Bio-Vascular, Inc. · 1997-12-24
• K970851 — LYOPLANT DURA SUBSTITUTE(VARIOUS) Aesculap, Inc. · 1997-12-09
• K960470 — NEURO-PATCH Aesculap, Inc. · 1996-05-10
• K953969 — PRECLUDE DURA SUBSTITUTE W. L. Gore & Associates, Inc. · 1995-11-01
• K950956 — DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE Bio-Vascular, Inc. · 1995-06-02