FTL
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 335
Adverse events under product code FTL
product code FTL- Death
- 317
- Injury
- 66,072
- Malfunction
- 1,273
- Other
- 3
- Total
- 67,665
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FTL
1–100 of 335- K253125 — Parietene Flat Sheet Mesh
- K251955 — Onflex Mesh
- K251557 — Bard® Mesh; Bard® Mesh Pre-Shaped
- K250869 — Parietene Macroporous Mesh (PPM5050 )
- K250098 — Bard Soft Mesh; Bard Soft Mesh Pre-Shaped
- K243315 — ProGrip Self-Gripping Polypropylene Mesh
- K241250 — 3DMax Light Mesh
- K232373 — Progrip Self-Gripping Polypropylene Mesh
- K233402 — Bard 3DMax Mesh
- K232924 — T-Line® Hernia Mesh
- K230671 — Pitch PaSoft Tissue Reinforcement Device
- K230227 — T-Line Hernia Mesh
- K223218 — Parietene Macroporous Mesh
- K221556 — T-Line Hernia Mesh
- K220540 — ProGrip Self-Gripping Polypropylene Mesh
- K220091 — Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
- K220586 — Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh
- K211132 — ARISTE AB Mesh
- K211563 — Pitch-Patchs
- K200918 — SurgiWrap FROST
- K201143 — VICRYL Mesh
- K200818 — 3DMax MID Anatomical Mesh
- K192636 — TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large)
- K193144 — T-Line Hernia Mesh
- K192389 — TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
- K192443 — Dextile Anatomical Mesh
- K191373 — VICRYL Mesh
- K192112 — FlexBand Plus
- K191545 — Exogenesis Hernia Mesh
- K182008 — Phasix ST Mesh with Echo 2 Positioning System
- K181935 — Endoform Reconstructive Template - Non Absorbable
- K182087 — DynaMesh-POSTERIOR
- K181094 — Polydioxanone Surgical Scaffold
- K181268 — PROLENE (Polypropylene) 3D Patch
- K180910 — ULTRAPRO Mesh and ULTRAPRO ADVANCED
- K180829 — PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh
- K180122 — TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large)
- K172636 — VitaMESH Macroporous PP Surgical Mesh
- K180030 — TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
- K173796 — Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)
- K172395 — Duatene bilayer mesh
- K172089 — PROLENE Soft Polypropylene Mesh
- K170134 — Reperen Surgical Mesh
- K163212 — Parietene DS Composite Mesh
- K163576 — GORE SYNECOR Preperitoneal Biomaterial
- K170294 — VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4x 6) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6x8) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6x10) Oval
- K163152 — PROLENE Soft Polypropylene Mesh
- K161550 — DynaMesh-VENTRAL
- K153632 — Endoform Reconstructive Template
- K153236 — Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay
- K152609 — GORE SYNECOR Biomaterial
- K152678 — TYRX Neuro Antibacterial Envelope
- K151386 — C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic
- K143743 — ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH
- K151437 — ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug
- K150906 — ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh
- K150091 — Versatex Monofilament Mesh
- K142192 — Insightra Freedom Ventral Hernia Repair System
- K150291 — TYRX Neuro Absorbable Antibacterial Envelope
- K142706 — Modified ONFLEX Mesh
- K142711 — ONFLEX Mesh
- K143386 — Progrip Laparoscopic Self-Fixating Mesh
- K142611 — TYRX Neuro Absorbable Antibacterial Envelope
- K142908 — Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh
- K142900 — Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh
- K141560 — ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE
- K142091 — PARIETENE MACROPOROUS MESH
- K133889 — PREMIUM
- K141394 — X-REPAIR
- K141499 — X-REPAIRSL
- K140967 — FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK
- K133198 — ULTRAPRO COMFORT PLUG
- K140941 — PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH
- K132441 — BARD VENTRALEX HERNIA PATCH
- K132699 — AIGIS RX N (MEDIUM), AIGIS RX N (LARGE)
- K130428 — COVAMESH
- K131530 — DYNAMESH -CICAT
- K131969 — SYMBOTEX(TM) COMPOSITE MESH
- K131007 — AIGIS RX N MEDIUM; AIGIS RX N LARGE
- K130943 — AIGIS RX R PM/ AIGIS RX R ICD
- K130968 — VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
- K120844 — MEDLINX SURGICAL MESH
- K123479 — PROGRIP LAPAROSCOPIC SELF-FIXATING MESH
- K122436 — COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
- K113552 — FREEDOM INGUINAL HERNIA IMPLANT
- K113229 — VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING
- K113311 — TIO2MESH TM
- K120897 — PROGRIP LAPARSCOPIC SELF-FIXATING MESH
- K120025 — SURGIMESH XB - SKIRTED
- K120506 — PARIETEX COMPOSITE VENTRAL PATCH
- K121070 — C-QUR RPM MESH
- K111695 — HYBRID GRAFT
- K111337 — TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD
- K112499 — BIOMERIX COMPOSITE SURGICAL MESH
- K112567 — BIOMERIX ASSURE
- K112784 — RENASYS AB ABOMINAL DRESSING KIT
- K110663 — PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES)
- K100313 — HYDROFIX SURGICAL SHEET
- K111121 — VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH
- K102788 — TORNIER BIOFIBER SCAFFOLD
Data sourced from openFDA. This site is unofficial and independent of the FDA.