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W. L. Gore & Associates, Inc.

163 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
GORE® Tri-Lobe Balloon Catheter (K250410)W. L. Gore & Associates, Inc.2025-06-02
GORE® PROPATEN® Vascular Graft (K240083)W. L. Gore & Associates, Inc.2024-03-01
GORE® PROPATEN® Vascular Graft (K232312)W. L. Gore & Associates, Inc.2024-01-09
GORE® ACUSEAL Vascular Graft (K233551)W. L. Gore & Associates, Inc.2023-12-19
GORE® ACUSEAL Vascular Graft (K231505)W. L. Gore & Associates, Inc.2023-06-23
GORE BIO-A Tissue Reinforcement (K191773)W. L. Gore & Associates, Inc.2019-07-31
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement (K181940)W. L. Gore & Associates, Inc.2018-08-17
GORE ENFORM Biomaterial (K173333)W. L. Gore & Associates, Inc.2018-04-05
GORE SYNECOR Preperitoneal Biomaterial (K163576)W. L. Gore & Associates, Inc.2017-05-11
GORE VIABIL Short Wire Biliary Endoprosthesis (K170740)W. L. Gore & Associates, Inc.2017-05-08
GORE BIO-A Tissue Reinforcement (K163217)W. L. Gore & Associates, Inc.2017-02-10
GORE DrySeal Flex Introducer Sheath (K160254)W. L. Gore & Associates, Inc.2016-05-12
GORE SYNECOR Biomaterial (K152609)W. L. Gore & Associates, Inc.2015-12-11
GORE SEAMGUARD Reinforcement (K150551)W. L. Gore & Associates, Inc.2015-03-30
GORE BIO-A WOUND MATRIX (K132397)W. L. Gore & Associates, Inc.2014-05-07
GORE SEAMGUARD REINFORCEMENT (K131658)W. L. Gore & Associates, Inc.2013-09-06
GORE ACUSEAL VASCULAR GRAFT (K130215)W. L. Gore & Associates, Inc.2013-04-09
GORE FLOW REVERSAL SYSTEM MODEL GFRS073 (K123156)W. L. Gore & Associates, Inc.2012-12-13
GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING (K121234)W. L. Gore & Associates, Inc.2012-11-20
GORE DRYSEAL SHEATH (K120428)W. L. Gore & Associates, Inc.2012-04-20
GORE EMBOLIC FILTER (K103500)W. L. Gore & Associates, Inc.2011-05-23
GORE DRYSEAL SHEATH (K093791)W. L. Gore & Associates, Inc.2010-03-22
GORE BIO-A FISTULA PLUG (K083266)W. L. Gore & Associates, Inc.2009-03-27
GORE FLOW REVERSAL SYSTEM (K083300)W. L. Gore & Associates, Inc.2009-02-04
GORE TRI-LOBE BALLOON CATHETER (K081799)W. L. Gore & Associates, Inc.2008-10-03
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE (K082356)W. L. Gore & Associates, Inc.2008-08-28
GORE INFINIT MESH (K081069)W. L. Gore & Associates, Inc.2008-05-30
GORE BALLOON SHEATH (K070770)W. L. Gore & Associates, Inc.2007-06-29
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS (K070644)W. L. Gore & Associates, Inc.2007-04-02
GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL (K063435)W. L. Gore & Associates, Inc.2006-11-28
GORE PROPATEN VASCULAR GRAFT (K062161)W. L. Gore & Associates, Inc.2006-11-09
GORE PRECLUDE VESSEL GUARD (K061727)W. L. Gore & Associates, Inc.2006-08-07
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL (K053200)W. L. Gore & Associates, Inc.2005-12-07
GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE (K051267)W. L. Gore & Associates, Inc.2005-06-15
GORE POLYPROPYLENE HERNIA MESH (K043081)W. L. Gore & Associates, Inc.2004-12-22
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL (K043056)W. L. Gore & Associates, Inc.2004-12-22
VIABIL BILIARY ENDOPROSTHESIS (K041423)W. L. Gore & Associates, Inc.2004-07-21
GORE TRI-LOBE BALLOON CATHETER (K033670)W. L. Gore & Associates, Inc.2004-05-05
GORE BIOABSORBABLE MESH (K033671)W. L. Gore & Associates, Inc.2003-12-31
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL (K032865)W. L. Gore & Associates, Inc.2003-11-28
GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL (K032168)W. L. Gore & Associates, Inc.2003-08-15
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE (K032073)W. L. Gore & Associates, Inc.2003-08-13
GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY (K031089)W. L. Gore & Associates, Inc.2003-05-08
SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL (K030782)W. L. Gore & Associates, Inc.2003-04-21
VIATORR ENDOPROSTHESIS (K024178)W. L. Gore & Associates, Inc.2003-03-07
VIABIL BILIARY ENDOPROSTHESIS (K014215)W. L. Gore & Associates, Inc.2002-12-19
MODIFICATION TO VIABAHN ENDOPROSTHESIS (K023811)W. L. Gore & Associates, Inc.2002-12-10
GORE 3.0T TORSO ARRAY (K023679)W. L. Gore & Associates, Inc.2002-11-18
PRECLUDE MVP DURA SUBSTITUTE (K021477)W. L. Gore & Associates, Inc.2002-11-08
DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL (K022782)W. L. Gore & Associates, Inc.2002-09-10
VIABAHN ENDOPROSTHESIS (K013648)W. L. Gore & Associates, Inc.2002-01-08
GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE (K013346)W. L. Gore & Associates, Inc.2001-12-19
GORE INTRODUCER SHEATH (K013282)W. L. Gore & Associates, Inc.2001-12-14
CARDIOVASCULAR ARRAY (K013810)W. L. Gore & Associates, Inc.2001-11-27
GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT (K013250)W. L. Gore & Associates, Inc.2001-10-26
PRECLUDE PERICARDIAL MEMBRANE (K012098)W. L. Gore & Associates, Inc.2001-09-20
MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL (K010936)W. L. Gore & Associates, Inc.2001-05-21
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES (K010228)W. L. Gore & Associates, Inc.2001-02-21
SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL (K001789)W. L. Gore & Associates, Inc.2000-07-06
GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM) (K000185)W. L. Gore & Associates, Inc.2000-02-14
PTFE RINGED GORE-TEX VASCULAR GRAFT (K991683)W. L. Gore & Associates, Inc.1999-09-08
GORE-TEX DUALMESH BIOMATERIAL (K992189)W. L. Gore & Associates, Inc.1999-07-29
EPTFE RINGED GORE-TEX VASCULAR GRAFT (K991602)W. L. Gore & Associates, Inc.1999-07-09
ACUSEAL CARDIOVASCULAR PATCH (K984526)W. L. Gore & Associates, Inc.1999-04-08
PRECLUDE ACUSEAL DURA SUBSTITUTE (K984534)W. L. Gore & Associates, Inc.1999-03-15
GORE REVOX THYROPLASTY IMPLANT (K983525)W. L. Gore & Associates, Inc.1998-12-10
SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES (K981051)W. L. Gore & Associates, Inc.1998-04-15
GORE RESOLUT XT REGENERATIVE MATERIAL (K973594)W. L. Gore & Associates, Inc.1997-12-17
GORE IRRIGATION SET (K964067)W. L. Gore & Associates, Inc.1997-06-05
RESOLUT REGENERATIVE MATERIAL (K970884)W. L. Gore & Associates, Inc.1997-05-08
GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD) (K964061)W. L. Gore & Associates, Inc.1997-02-20
GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE (K965038)W. L. Gore & Associates, Inc.1997-02-06
S.A.M. FACIAL IMPLANT W/INTRODUCER (K964761)W. L. Gore & Associates, Inc.1997-01-27
GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES (K963619)W. L. Gore & Associates, Inc.1996-10-25
RESOLUT REGENERATIVE MATERIAL (K962624)W. L. Gore & Associates, Inc.1996-10-03
MINI FLEX COIL (K961628)W. L. Gore & Associates, Inc.1996-09-05
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES (K962401)W. L. Gore & Associates, Inc.1996-09-03
GORE SPHEREX IMPLANT (K962241)W. L. Gore & Associates, Inc.1996-08-22
GORE BURR HOLE COVER (K960656)W. L. Gore & Associates, Inc.1996-08-14
PRECLUDE SYNBLOC MEMBRANE (K961802)W. L. Gore & Associates, Inc.1996-07-31
SAM FACIAL IMPLANT (K961210)W. L. Gore & Associates, Inc.1996-06-19
PRECLUDE IMA SLEEVE (K960532)W. L. Gore & Associates, Inc.1996-05-23
DIASTAT VASCULAR ACCESS GRAFT (K955533)W. L. Gore & Associates, Inc.1996-05-15
GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS (K960292)W. L. Gore & Associates, Inc.1996-04-15
DIASTAT VASCULAR ACCESS GRAFT (K955532)W. L. Gore & Associates, Inc.1996-03-11
SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL (K955364)W. L. Gore & Associates, Inc.1996-02-01
GORE-TEX DUALMESH BIOMATERIAL WITH HOLES (K955494)W. L. Gore & Associates, Inc.1996-01-24
GORE-TEX SAM FACIAL IMPLANT WITH INTRODUCER (K952898)W. L. Gore & Associates, Inc.1995-11-14
PRECLUDE DURA SUBSTITUTE (K953969)W. L. Gore & Associates, Inc.1995-11-01
GORE-TEX SOFT TISSUE PATCH (K951700)W. L. Gore & Associates, Inc.1995-10-07
GORE-TEX DUALMESH BIOMATERIAL (K951676)W. L. Gore & Associates, Inc.1995-10-07
GORE-TEX MYCROMESH BIOMATERIAL (K951675)W. L. Gore & Associates, Inc.1995-10-07
DIASTAT VASCULAR ACCESS GRAFT (K953287)W. L. Gore & Associates, Inc.1995-10-06
DIASTAT VASCULAR ACCESS GRAFT (K953288)W. L. Gore & Associates, Inc.1995-10-06
GORE SMOOTHER GUIDED RASP (K951163)W. L. Gore & Associates, Inc.1995-06-01
GORE-TEX DUALMESH PLUS BIOMATERIAL (K946106)W. L. Gore & Associates, Inc.1995-04-24
GORE-TEX MYCROMESH PLUS BIOMATERIAL (K946107)W. L. Gore & Associates, Inc.1995-04-24
RESOLUT REGENERATIVE MATERIAL (K932866)W. L. Gore & Associates, Inc.1995-03-28
GORE-TEX SAM FACIAL IMPLANT (K946267)W. L. Gore & Associates, Inc.1995-03-22
GORE LAPAROSCOPIC SUTURE PASSER (NON-STERILE) (K945953)W. L. Gore & Associates, Inc.1995-03-03
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