FDA.report

W. L. GORE & ASSOCIATES, INC.

Matched from indexed company URL: W. L. Gore & Associates, Inc.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30039102123003910212W. L. GORE & ASSOCIATES, INC.1N2026-01-01301 AIRPORT RD. ELKTON MD US 21921
30072843133007284313W. L. GORE & ASSOCIATES, INC.1N2026-01-0132360 N. North Valley Parkway Phoenix AZ US 85085
30131641763013164176W. L. Gore & Associates, Inc.1N2026-01-012890 De La Cruz Blvd Santa Clara CA US 95050

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
279191507419857P8200831969-12-31
951181797209625P2500171969-12-31
951181253488152P200030Gore Excluder Conformable AAA Endoprosthesis (CEXC)MIH 2020-12-22
951181937396450P040027GORE VIATORR TIPSMIR2004-12-06
2012471901820704P020004EXCLUDER BIFURCATED ENDOPROSTHESISMIH2002-11-06
951181901820704P020004EXCLUDER BIFURCATED ENDOPROSTHESISMIH2002-11-06
279191716122038K992189GORE-TEX DUALMESH BIOMATERIALFTL1999-07-29
951181388323003K984534PRECLUDE ACUSEAL DURA SUBSTITUTEGXQ1999-03-15
951181751801878K984526ACUSEAL CARDIOVASCULAR PATCHDXZ1999-04-08
279192002551956K963619GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLESFTL1996-10-25
951181114465519K953969PRECLUDE DURA SUBSTITUTEGXQ1995-11-01
951181114465519K953969PRECLUDE DURA SUBSTITUTEGXQ1995-11-01
951182068591385K912107GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MMDXZ1991-10-11
951181798914526K250410GORE® Tri-Lobe Balloon CatheterDQY2025-06-02
279191861707444K222919GORE® ENFORM BiomaterialOXF2022-12-19
279191749852894K191773GORE BIO-A Tissue ReinforcementOWT2019-07-31
279191797051041K181940GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementOXC2018-08-17
279191232765069K180919GORE Tri-Lumen CatheterDQY2018-10-05
951181232765069K180919GORE Tri-Lumen CatheterDQY2018-10-05
279191365574258K173333GORE ENFORM BiomaterialOXF2018-04-05
951181049840280K172567GORE Molding and Occlusion Balloon CatheterMJN2018-01-31
279191254747058K170740GORE VIABIL Short Wire Biliary EndoprosthesisFGE2017-05-08
279191294755320K163576GORE SYNECOR Preperitoneal BiomaterialFTL2017-05-11
951181476135407K160254GORE DrySeal Flex Introducer SheathDYB2016-05-12
951181177831617K152913GORE TIPS Set, GORE TIPS Sheath, GORE TIPS NeedleDYB2016-07-21
279191371899710K152609GORE SYNECOR BiomaterialFTL2015-12-11
951181375279239K121234GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATINGDYB2012-11-20
951181958154855K120428GORE DRYSEAL SHEATHDYB2012-04-20
279191226112304K083266GORE BIO-A FISTULA PLUGFTL2009-03-27
951181874821506K081799GORE TRI-LOBE BALLOON CATHETERDQY2008-10-03
279191668542258K081184GORE VIABIL BILILARY ENDOPROSTHESISFGE2008-07-22
279191898767852K070644GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERSFTL2007-04-02
279191722741417K063435GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIALFTL2006-11-28
279191480572899K053200GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIALFTL2005-12-07
279191883623076K043056GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIALFTL2004-12-22
279191086973719K041423VIABIL BILIARY ENDOPROSTHESISFGE2004-07-21
279191764693654K033671GORE BIOABSORBABLE MESHOWT2003-12-31
951181427722453K021477PRECLUDE MVP DURA SUBSTITUTEGXQ2002-11-08
951181907175205K012098PRECLUDE PERICARDIAL MEMBRANEDXZ2001-09-20

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
FTL92017-05-11
DQY42025-06-02
DYB42016-07-21
GXQ42002-11-08
FGE32017-05-08
DXZ32001-09-20
OXF22022-12-19
OWT22019-07-31
MIH22002-11-06
MIH 12020-12-22
OXC12018-08-17
MJN12018-01-31
MIR12004-12-06

PMA

GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

2022-12-21

W. L. Gore & Associates, Inc.3250 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP160021 Supplement NumberS036 Date Received12/15/2022 Decision Date12/21/2022 Product Code PRL  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason ...

GORE® TAG® Thoracic Branch Endoprosthesis

2022-12-21

W. L. Gore & Associates, Inc.3450 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP210032 Supplement NumberS005 Date Received12/15/2022 Decision Date12/21/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason ...

GORE® TAG® Thoracic Branch Endoprosthesis (TBE)

2022-10-05

W. L. Gore & Associates, Inc.3450 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP210032 Supplement NumberS004 Date Received09/06/2022 Decision Date10/05/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason ...

GORE® TAG® Thoracic Branch Endoprosthesis

2022-08-05

W. L. Gore & Associates, Inc.3450 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP210032 Supplement NumberS003 Date Received07/26/2022 Decision Date08/05/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason ...

GORE® TAG® Thoracic Branch Endoprosthesis

2022-07-21

W. L. Gore & Associates, Inc.3450 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP210032 Supplement NumberS002 Date Received06/22/2022 Decision Date07/21/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason ...

GORE® TAG® Thoracic Branch Endoprosthesis

2022-07-08

W. L. Gore & Associates, Inc.3450 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP210032 Supplement NumberS001 Date Received06/09/2022 Decision Date07/08/2022 Product Code MIH  Advisory Committee Cardiovascular Clinical TrialsNCT02777593 Supplement Typenorma...

GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

2022-07-05

W. L. Gore & Associates, Inc.3250 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP160021 Supplement NumberS035 Date Received06/08/2022 Decision Date07/05/2022 Product Code PRL  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason ...

GORE TAG Thoracic Branch Endoprosthesis (TBE )

2022-05-13

W. L. Gore & Associates, Inc.3450 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP210032 Date Received08/24/2021 Decision Date05/13/2022 Product Code MIH  Advisory Committee Cardiovascular Clinical TrialsNCT02777593 Expedited Review Granted? No

GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

2022-03-18

W. L. Gore & Associates, Inc.3250 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP160021 Supplement NumberS034 Date Received02/11/2022 Decision Date03/18/2022 Product Code PRL  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason ...

GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

2022-02-22

W. L. Gore & Associates, Inc.3250 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP160021 Supplement NumberS033 Date Received01/20/2022 Decision Date02/22/2022 Product Code PRL  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason ...

GORE® VIATORR® TIPS Endoprosthesis

2022-02-22

W. L. GORE & ASSOCIATES, INC.32360 N North Valley Parkwayphoenix, AZ 85085 PMA NumberP040027 Supplement NumberS090 Date Received01/20/2022 Decision Date02/22/2022 Product Code MIR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Re...

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