W. L. Gore & Associates, Inc.
FDA 510(k) medical device clearances.
Top product codes for W. L. Gore & Associates, Inc.
Recent clearances by W. L. Gore & Associates, Inc.
1–100 of 163- K250410 — GORE® Tri-Lobe Balloon Catheter
- K240083 — GORE® PROPATEN® Vascular Graft
- K232312 — GORE® PROPATEN® Vascular Graft
- K233551 — GORE® ACUSEAL Vascular Graft
- K231505 — GORE® ACUSEAL Vascular Graft
- K191773 — GORE BIO-A Tissue Reinforcement
- K181940 — GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement
- K173333 — GORE ENFORM Biomaterial
- K163576 — GORE SYNECOR Preperitoneal Biomaterial
- K170740 — GORE VIABIL Short Wire Biliary Endoprosthesis
- K163217 — GORE BIO-A Tissue Reinforcement
- K160254 — GORE DrySeal Flex Introducer Sheath
- K152609 — GORE SYNECOR Biomaterial
- K150551 — GORE SEAMGUARD Reinforcement
- K132397 — GORE BIO-A WOUND MATRIX
- K131658 — GORE SEAMGUARD REINFORCEMENT
- K130215 — GORE ACUSEAL VASCULAR GRAFT
- K123156 — GORE FLOW REVERSAL SYSTEM MODEL GFRS073
- K121234 — GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING
- K120428 — GORE DRYSEAL SHEATH
- K103500 — GORE EMBOLIC FILTER
- K093791 — GORE DRYSEAL SHEATH
- K083266 — GORE BIO-A FISTULA PLUG
- K083300 — GORE FLOW REVERSAL SYSTEM
- K081799 — GORE TRI-LOBE BALLOON CATHETER
- K082356 — GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
- K081069 — GORE INFINIT MESH
- K070770 — GORE BALLOON SHEATH
- K070644 — GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS
- K063435 — GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL
- K062161 — GORE PROPATEN VASCULAR GRAFT
- K061727 — GORE PRECLUDE VESSEL GUARD
- K053200 — GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
- K051267 — GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE
- K043056 — GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
- K043081 — GORE POLYPROPYLENE HERNIA MESH
- K041423 — VIABIL BILIARY ENDOPROSTHESIS
- K033670 — GORE TRI-LOBE BALLOON CATHETER
- K033671 — GORE BIOABSORBABLE MESH
- K032865 — GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
- K032168 — GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL
- K032073 — GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
- K031089 — GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY
- K030782 — SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
- K024178 — VIATORR ENDOPROSTHESIS
- K014215 — VIABIL BILIARY ENDOPROSTHESIS
- K023811 — MODIFICATION TO VIABAHN ENDOPROSTHESIS
- K023679 — GORE 3.0T TORSO ARRAY
- K021477 — PRECLUDE MVP DURA SUBSTITUTE
- K022782 — DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL
- K013648 — VIABAHN ENDOPROSTHESIS
- K013346 — GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE
- K013282 — GORE INTRODUCER SHEATH
- K013810 — CARDIOVASCULAR ARRAY
- K013250 — GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT
- K012098 — PRECLUDE PERICARDIAL MEMBRANE
- K010936 — MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
- K010228 — GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
- K001789 — SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
- K000185 — GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM)
- K991683 — PTFE RINGED GORE-TEX VASCULAR GRAFT
- K992189 — GORE-TEX DUALMESH BIOMATERIAL
- K991602 — EPTFE RINGED GORE-TEX VASCULAR GRAFT
- K984526 — ACUSEAL CARDIOVASCULAR PATCH
- K984534 — PRECLUDE ACUSEAL DURA SUBSTITUTE
- K983525 — GORE REVOX THYROPLASTY IMPLANT
- K981051 — SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES
- K973594 — GORE RESOLUT XT REGENERATIVE MATERIAL
- K964067 — GORE IRRIGATION SET
- K970884 — RESOLUT REGENERATIVE MATERIAL
- K964061 — GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)
- K965038 — GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE
- K964761 — S.A.M. FACIAL IMPLANT W/INTRODUCER
- K963619 — GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES
- K962624 — RESOLUT REGENERATIVE MATERIAL
- K961628 — MINI FLEX COIL
- K962401 — GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
- K962241 — GORE SPHEREX IMPLANT
- K960656 — GORE BURR HOLE COVER
- K961802 — PRECLUDE SYNBLOC MEMBRANE
- K961210 — SAM FACIAL IMPLANT
- K960532 — PRECLUDE IMA SLEEVE
- K955533 — DIASTAT VASCULAR ACCESS GRAFT
- K960292 — GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS
- K955532 — DIASTAT VASCULAR ACCESS GRAFT
- K955364 — SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
- K955494 — GORE-TEX DUALMESH BIOMATERIAL WITH HOLES
- K952898 — GORE-TEX SAM FACIAL IMPLANT WITH INTRODUCER
- K953969 — PRECLUDE DURA SUBSTITUTE
- K951675 — GORE-TEX MYCROMESH BIOMATERIAL
- K951676 — GORE-TEX DUALMESH BIOMATERIAL
- K951700 — GORE-TEX SOFT TISSUE PATCH
- K953287 — DIASTAT VASCULAR ACCESS GRAFT
- K953288 — DIASTAT VASCULAR ACCESS GRAFT
- K951163 — GORE SMOOTHER GUIDED RASP
- K946106 — GORE-TEX DUALMESH PLUS BIOMATERIAL
- K946107 — GORE-TEX MYCROMESH PLUS BIOMATERIAL
- K932866 — RESOLUT REGENERATIVE MATERIAL
- K946267 — GORE-TEX SAM FACIAL IMPLANT
- K945953 — GORE LAPAROSCOPIC SUTURE PASSER (NON-STERILE)
Data sourced from openFDA. This site is unofficial and independent of the FDA.