ClearanceBrief
Panels › Neurology › Product code GXQ · Class 2

Dura Substitute

Regulation 882.5910

1510(k)s in 12 months (43 all time)
0recalls in 12 months (23 all time)
20recalls that name a 510(k)
Get daily alerts for GXQSample briefCSV

Top companies in GXQ

DateFirm and productCodeLinked 510(k)
Jan 10, 2025Cook Biotech, Inc.
Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile
Open, Classified
GXQK160869
Oct 30, 2024Integra LifeSciences Corp.
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Open, Classified
GXQK152481
Jul 20, 2023Medtronic Neurosurgery
Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR
Open, Classified
GXQK161370
Feb 24, 2022Collagen Matrix, Inc.
RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125
Terminated
GXQK061487
Feb 24, 2022Collagen Matrix, Inc.
DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
Terminated
GXQK061487
Dec 8, 2015Synthes (USA) Products LLC
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement f
Terminated
GXQK113071
K131792
Dec 8, 2015Synthes (USA) Products LLC
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement f
Terminated
GXQK113071
K131792
Dec 8, 2015Synthes (USA) Products LLC
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement f
Terminated
GXQK113071
K131792
Dec 8, 2015Synthes (USA) Products LLC
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement f
Terminated
GXQK113071
K131792
Dec 8, 2015Synthes (USA) Products LLC
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement f
Terminated
GXQK113071
K131792
Nov 18, 2013Synovis Surgical Innovations, Inc.
Dura Guard, Dural Repair Patch with Apex Processing. For use as a dura substitute for the closure of dura mater during neurosurgery. Product Code: DG0209SN DG0209SN DG0209SN DG0209SN DG02
Terminated
GXQK982282
May 10, 2013Integra LifeSciences Corporation
Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for the reduction of peridural fibrosis.
Terminated
GXQNone listed
May 10, 2013Integra LifeSciences Corporation
DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects. DuraGen XS is an easy to handle, soft, white, pliable, non-friable, por
Terminated
GXQK072207
May 10, 2013Integra LifeSciences Corporation
DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridu
Terminated
GXQK032693
May 10, 2013Integra LifeSciences Corporation
Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is an absorbable implant for repair of dural defects. Suturable DuraGen is an easy to handle, soft, white, plia
Terminated
GXQK043427
May 10, 2013Integra LifeSciences Corporation
Dural Graft Matrix DuraGen Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. Dur
Terminated
GXQK982180
Nov 24, 2010Integra LifeSciences Corp.
DuraGen XS Dural Regeneration Matrix: 1 inch x 3 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA DuraGen XS is indicated as a dural substitute for repair of d
Terminated
GXQNone listed
Nov 24, 2010Integra LifeSciences Corp.
DuraGen XS Dural Regeneration Matrix: 5 inches x 7 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA DuraGen XS is indicated as a dural substitute for repair of
Terminated
GXQK072207
Nov 24, 2010Integra LifeSciences Corp.
DuraGen XS Dural Regeneration Matrix: 4 inches x 5 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA DuraGen XS is indicated as a dural substitute for repair of
Terminated
GXQK072207
Nov 24, 2010Integra LifeSciences Corp.
DuraGen XS Dural Regeneration Matrix: 3 inches x 3 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA DuraGen XS is indicated as a dural substitute for repair of
Terminated
GXQK072207
Nov 24, 2010Integra LifeSciences Corp.
DuraGen XS Dural Regeneration Matrix: 2 inches x 2 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA DuraGen XS is indicated as a dural substitute for repair of
Terminated
GXQK072207
Mar 11, 2010Integra LifeSciences Corp
Suturable DuraGen Dural Regeneration Matrix; Non-Pyrogenic; Sterility guaranteed unless package is damaged or opened. Rx only. Manufacturer: Integra LifeSciences Corporation, Plainsboro, NJ 08536 Sut
Terminated
GXQK043427
Jul 20, 2004Shelhigh Inc
EnDura No-React Dural Substitute. Product comes in different sizes (2x10, 4x4, 5x6, 6x10, 10x12, and 12 cm diameters), sterile, stored in 2% benzyl alcohol, and distributed by Integra NeuroSciences,
Terminated
GXQNone listed

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.