Medical Device Manufacturer · US , Mchenry , IL

W.L. Gore & Associates, Inc. - FDA 510(k) Cleared Devices

163 submissions · 148 cleared · Since 1980
163
Total
148
Cleared
0
Denied
163 devices
101-125 of 163
Cleared Feb 22, 1995
CVPRO CARDIOVASCULAR PATCH
K943736 · DXZ
Cardiovascular · 204d
Cleared Feb 13, 1995
GORE-TEX(R) CURVED SURGICALMEMBRANE
K945899 · FTL
General & Plastic Surgery · 73d
Cleared Sep 29, 1994
GORE-TEX SOFT TISSUE PATCH PLUS
K922452 · FTL
General & Plastic Surgery · 856d
Cleared Jul 28, 1994
GORE-TEX FACIAL IMPLANT
K933367 · FWP
General & Plastic Surgery · 384d
Cleared Jul 28, 1994
GORETEX SAM FACIAL IMPLANT
K942280 · FWP
General & Plastic Surgery · 79d
Not Cleared Jul 20, 1994
AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED
K941981 · DSY
Cardiovascular · 97d
Cleared Jun 10, 1994
GORE-TEX REGENERATIVE MATERIAL
K922627 · NPK
Dental · 737d
Cleared May 19, 1994
GORE SMOOTHER II AND GORE BPTB
K941269 · HRX
Orthopedic · 64d
Cleared May 18, 1994
GORE-TEX CARDIOVASCULAR PATCH
K940906 · DXZ
Cardiovascular · 83d
Cleared May 17, 1994
AOR-TEX VASCULAR GRAFT
K933987 · DSY
Cardiovascular · 273d
Cleared May 12, 1994
GORE LAPAROSCOPIC SUTURE PASSER
K935986 · GCJ
General & Plastic Surgery · 149d
Not Cleared May 04, 1994
DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III
K940824 · DYF
Cardiovascular · 118d
Not Cleared May 02, 1994
DIASTAT VASCULAR ACCESS GRAFT
K940062 · DSY
Cardiovascular · 116d
Cleared Mar 23, 1994
GORE SMOOTHER CRUCIAL TOOL
K936206 · HRX
Orthopedic · 84d
Cleared Feb 25, 1994
INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT...
K940327 · FMW
General Hospital · 32d
Cleared Feb 14, 1994
PROCEL(TM) DERMALINER GLOVE
K931094 · LYU
General Hospital · 348d
Cleared Jan 28, 1994
GORE-TEX SOFT TISSUE PATCH,SURGICAL MEMBRANE,MESH
K930822 · FTL
General & Plastic Surgery · 345d
Cleared Dec 08, 1993
FEP RINGED GORE-TEX STRETCH VASCUALR GRAFT WITH REMOVABLE RINGS
K933943 · DSY
Cardiovascular · 114d
Cleared Dec 08, 1993
FEP RINGED GORE-TEX VASCULAR GRAFT
K934726 · DYF
Cardiovascular · 68d
Cleared Nov 30, 1993
GORE-TEX PERIODONTAL MATERIAL - TITANIUM REINFORCED CONFIGURATIONS
K933541 · NPK
Dental · 132d
Cleared Nov 29, 1993
GORE-TEK(R) SOFT TISSUE PATCH
K926478 · FTL
General & Plastic Surgery · 335d
Cleared Oct 29, 1993
GORE-TEX MICRO MESH
K931150 · FTL
General & Plastic Surgery · 234d
Cleared Oct 22, 1993
GORE-TEX CARDIOVASCULAR PATCH & SURGICAL MEMBRANE
K930950 · DXZ
Cardiovascular · 241d
Cleared Sep 09, 1993
GORE-TEX(TM) DUAL MESH
K926565 · FTL
General & Plastic Surgery · 252d
Cleared Nov 24, 1992
FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT
K922905 · DSY
Cardiovascular · 161d

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