Mesh, Surgical, Polymeric
FDA product code FTL · 313 cleared devices
Class 2
General, Plastic Surgery
- Regulation
- 21 CFR 878.3300
- Review panel
- SU
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1979-11-27 – 2026-05-21
FTL
2004-04-01
FTL
2004-03-01
BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007
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FTL
2004-01-15
UGYTEX MESH
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FTL
2003-12-19
SHELHIGH NO-REACT BIOCUFF
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FTL
2003-11-28
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
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FTL
2003-10-02
IMMIX PLASTIFILM
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FTL
2003-09-29
TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004
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FTL
2003-09-22
MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET
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FTL
2003-09-17
PROCEED TRILAMINATE SURGICAL MESH
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FTL
2003-08-15
GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL
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FTL
2003-06-27
ORTHOMEND
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FTL
2003-05-19
ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH
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FTL
2003-03-14
IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP
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FTL
2003-02-26
V.A.C. ABDOMINAL DRESSING
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FTL
2003-02-20
SMALL BARD VENTRALEX PATCH
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FTL
2002-12-12
REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH
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FTL
2002-10-17
BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX
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FTL
2002-09-10
DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL
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FTL
2002-08-23
BARD CRURASOFT PATCH, MODELS 0116003 & 0116001
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FTL
2002-07-16
BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301
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FTL
2002-06-12
AFB (ABSORBABLE FOAM BUTTRESS)
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FTL
2001-12-03
MACROPORE SURGIWRAP (TS)
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FTL
2001-05-24
BIOSLING - BIOABSORBABLE POLYMER SLING & SURGICAL MESH
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FTL
2001-04-27
PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH
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FTL
2001-04-04
IVS TUNNELLER
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FTL
2001-02-21
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
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FTL
2001-02-15
PARIETEX COMPOSITE (PCO) MESH
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FTL
2001-01-26
MODIFICATION TO FLUOROTEX II SURGICAL MESH
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FTL
2001-01-26
MODIFICATION TO FLUROTEX SURGICAL MESH
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FTL
2001-01-24
SOFRADIM PARIETEX SURGICAL MESHES
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FTL
2001-01-22
COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
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FTL
2000-11-29
AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH
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FTL
2000-11-22
VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH
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FTL
2000-10-19
BIOMESH P1 AND BIOMESH PLUG AND PATCH
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FTL
2000-10-11
COMPOSIX E/X MESH
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FTL
2000-08-26
FLUOROTEX II SURGICAL MESH
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FTL
2000-07-24
ATRIUM LITE MESH
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FTL
2000-07-24
SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES
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FTL
2000-05-23
PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH
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FTL
2000-05-19
SOFTFORM FACIAL IMPLANT
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FTL
2000-03-02
SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX
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FTL
2000-02-17
PERMACOL
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FTL
2000-02-14
GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM)
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FTL
2000-01-27
ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT
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FTL
1999-11-18
STAR TEMPORARY WOUND COVER
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FTL
1999-07-29
GORE-TEX DUALMESH BIOMATERIAL
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FTL
1999-07-12
PARIETENE POLYPROPYLENE MESH
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FTL
1999-06-22
BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700
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FTL
1999-06-17
3D ANATOMICAL MESH
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FTL
1999-02-23
MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH
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FTL
1999-01-20
PARIETEX
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FTL
1999-01-07
FLUOROTEX SURGICAL MESH
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FTL
1998-11-06
MESH, SURGICAL, POLYMERIC
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FTL
1998-09-22
SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL
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FTL
1998-08-05
SHELHIGH NO-REACT PNEUMOPLEDGETS
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FTL
1998-05-20
SIS HERNIA REPAIR DEVICE
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FTL
1998-05-11
HERNIAMESH SURGICAL MESHES
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FTL
1998-04-30
MENTOR SUSPEND SLING
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FTL
1998-04-15
SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES
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FTL
1997-11-24
SOFTFORM FACIAL IMPLANT
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FTL
1997-11-04
VENTRAL WALL DEFECT REDUCTION SILO
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FTL
1997-09-10
PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH
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FTL
1997-08-06
BARD COMPOSITE PROSTHESIS
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FTL
1997-08-01
GRAFT PATCH
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FTL
1997-07-01
SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRA
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FTL
1997-02-18
RAPISEAL PATCH
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FTL
1997-02-06
GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE
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FTL
1997-01-27
S.A.M. FACIAL IMPLANT W/INTRODUCER
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FTL
1996-11-15
SURGICAL FABRICS
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FTL
1996-10-25
GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES
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FTL
1996-10-11
KUGEL HERNIA PATCH
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FTL
1996-09-16
POLYPROPYLENE MESH (VARIOUS SIZES)
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FTL
1996-09-03
SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.)
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FTL
1996-09-03
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
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FTL
1996-08-09
PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH
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FTL
1996-05-31
SURGICAL PATCH, SURGICAL MEMBRANE, SURGICAL MESH
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FTL
1996-04-01
SOFT TISSUE AUGMENTATION TUBE
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FTL
1996-03-15
PROLEX MESH
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FTL
1996-02-14
GLYCAR STAPLE STRIPS
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FTL
1996-01-24
GORE-TEX DUALMESH BIOMATERIAL WITH HOLES
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FTL
1995-11-14
GORE-TEX SAM FACIAL IMPLANT WITH INTRODUCER
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FTL
1995-10-07
GORE-TEX SOFT TISSUE PATCH
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FTL
1995-10-07
GORE-TEX DUALMESH BIOMATERIAL
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FTL
1995-10-07
GORE-TEX MYCROMESH BIOMATERIAL
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FTL
1995-09-26
BARD VISILEX MESH 3 X 6
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FTL
1995-04-24
GORE-TEX MYCROMESH PLUS BIOMATERIAL
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FTL
1995-04-24
GORE-TEX DUALMESH PLUS BIOMATERIAL
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FTL
1995-03-02
HERNIA MESH INTRODUCTION SYSTEM
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FTL
1995-02-13
GORE-TEX(R) CURVED SURGICALMEMBRANE
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FTL
1994-12-14
GLYCAR TISSUE REPAIR PATCH
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FTL
1994-12-08
TRELEX NATURAL(R) MESH
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FTL
1994-11-09
ACM PTFE SURGICAL MESH
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FTL
1994-09-29
GORE-TEX SOFT TISSUE PATCH PLUS
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FTL
1994-08-23
FLARED PATCH
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FTL
1994-07-08
PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT
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FTL
1994-06-30
BIOSIL MEDICAL GRADE SILICONE SHEETING FOR OBSTETRICAL & GYNOCOLOGY APPLICATIONS
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FTL
1994-01-28
GORE-TEX SOFT TISSUE PATCH,SURGICAL MEMBRANE,MESH
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FTL
1994-01-10
GIANTURCO-HELFRICH HERNIS MESH
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FTL
1993-12-16
ATRIUM POLYPROPYLENE MESH
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FTL
1993-11-29
GORE-TEK(R) SOFT TISSUE PATCH
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