W. L. Gore & Associates, Inc.
W. L. Gore & Associates, Inc. holds FDA 510(k) medical device clearances, first cleared 1980, most recent 2025, with 29 FDA device recalls on record.
Clearances by W. L. Gore & Associates, Inc. — page 2
101–163 of 163- K943736 — CVPRO CARDIOVASCULAR PATCH
- K945899 — GORE-TEX(R) CURVED SURGICALMEMBRANE
- K922452 — GORE-TEX SOFT TISSUE PATCH PLUS
- K933367 — GORE-TEX FACIAL IMPLANT
- K942280 — GORETEX SAM FACIAL IMPLANT
- K941981 — AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED
- K922627 — GORE-TEX REGENERATIVE MATERIAL
- K941269 — GORE SMOOTHER II AND GORE BPTB
- K940906 — GORE-TEX CARDIOVASCULAR PATCH
- K933987 — AOR-TEX VASCULAR GRAFT
- K935986 — GORE LAPAROSCOPIC SUTURE PASSER
- K940824 — DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III
- K940062 — DIASTAT VASCULAR ACCESS GRAFT
- K936206 — GORE SMOOTHER CRUCIAL TOOL
- K940327 — INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW
- K931094 — PROCEL(TM) DERMALINER GLOVE
- K930822 — GORE-TEX SOFT TISSUE PATCH,SURGICAL MEMBRANE,MESH
- K933943 — FEP RINGED GORE-TEX STRETCH VASCUALR GRAFT WITH REMOVABLE RINGS
- K934726 — FEP RINGED GORE-TEX VASCULAR GRAFT
- K933541 — GORE-TEX PERIODONTAL MATERIAL - TITANIUM REINFORCED CONFIGURATIONS
- K926478 — GORE-TEK(R) SOFT TISSUE PATCH
- K931150 — GORE-TEX MICRO MESH
- K930950 — GORE-TEX CARDIOVASCULAR PATCH & SURGICAL MEMBRANE
- K926565 — GORE-TEX(TM) DUAL MESH
- K922905 — FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT
- K920998 — GORE TUNNELER, MODIFICATION
- K915695 — PROCEL BURN COVER
- K914832 — SURGICAL APPAREL
- K915692 — CANNULATED DRILL BIT
- K914449 — GORE-TEX(R) SOFT TISSUE PATCH, PROCESS CHANGE
- K914447 — GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE
- K914448 — GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE
- K914450 — GORE-TEX(R) SURGICAL MEMBRANE, PROCESS CHANGE
- K912107 — GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM
- K910427 — MEMFIX SCREWS
- K910464 — GORE-TEX(R) EXPANDED PTFE SURGICAL MEMBRANE
- K904282 — BIFURCATED GORE TEX STRETCH VASCULAR GRAFT
- K903931 — GORE-TEX(R) STRETCH VASCULAR GRAFT
- K901641 — AXILLOBIFEMORAL GORE-TEX VASCULAR GRAFT
- K900195 — MODIFIED GORE-TEX SURGICAL TAPE
- K894580 — GORE-TEX SURGICAL TAPE
- K883694 — TENSIOMETER
- K880167 — GORE-TEX VASCULAR GRAFT
- K881732 — GORE-TEX VASCULAR GRAFT
- K862689 — 2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP
- K854299 — GORE-TEX PERIODONTAL MATERIAL
- K844142 — GORE-TEX TISSUE MATRIX
- K844584 — GORE-TEX TUNNELER
- K842144 — GORE-TEX VASCULAR GRAFT, FEP-RINGED
- K840864 — GORE-TEX CATHETER
- K833764 — STERILIZATION OF GORE-TEX SOFT TISSU
- K831516 — GORE-TEX SURGICAL MEMBRANE
- K830806 — VASCULAR GRAFT/BIFURCATED/FEP-RINGED
- K831873 — BONE SCREW
- K821717 — GORE-TES EXPANDED PTFE PATCH
- K822641 — GORE-TEX BARRIER SURG. DRAPES & GOWNS
- K821826 — FEP-RINGED GORE-TEX@ VASCULAR GRAFT
- K820909 — GORE-TEX PERITONEAL CATHETERR
- K821158 — FED RINGED-TEX VASCULAR GRAFT
- K820193 — GORE-TEX TISSUE REINFORCEMENT PATCH
- K811841 — GORE-TEX CARDIOVASCULAR PATCH
- K811510 — GORE-TEX VASULAR GRAFT
- K802095 — GORE-TEX VASCULAR GRAFT
Data sourced from openFDA. This site is unofficial and independent of the FDA.