Panels › General, Plastic Surgery › Product code FTL · Class 2
Mesh, Surgical, Polymeric
Regulation 878.3300
2510(k)s in 12 months (337 all time)
0recalls in 12 months (73 all time)
58recalls that name a 510(k)
Top companies in FTL
| Company | 510(k)s | Recalls |
|---|---|---|
| W. L. Gore & Associates, Inc. | 37 | 1 |
| Sofradim Production | 36 | 1 |
| ETHICON, Inc. | 25 | 3 |
| C. R. Bard | 26 | 0 |
| Davol Inc., Sub. C. R. Bard, Inc. | 8 | 17 |
| Atrium Medical Corp. | 14 | 5 |
| Davol, Inc. | 4 | 4 |
| Tyrx, Inc. | 5 | 3 |
| American Medical Systems, Inc. | 3 | 4 |
| Covidien | 1 | 5 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 28, 2026 | K260474 | Liora Monofilament Scaffold TELA Bio, Inc. | FTL |
| May 21, 2026 | K253956 | ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) Sofradim Production, FR | FTL |
| Oct 24, 2025 | K253125 | Parietene Flat Sheet Mesh Medtronic - Sofradim Production, FR | FTL |
| Jul 24, 2025 | K251955 | Onflex Mesh Davol Inc., Subsidiary of C. R. Bard, Inc. | FTL |
| Jun 12, 2025 | K251557 | Bard® Mesh; Bard® Mesh Pre-Shaped Davol, Inc. | FTL |
| Apr 23, 2025 | K250869 | Parietene Macroporous Mesh (PPM5050 ) Sofradim Production, FR | FTL |
| Apr 9, 2025 | K250098 | Bard Soft Mesh; Bard Soft Mesh Pre-Shaped Davol, Inc. | FTL |
| Jan 17, 2025 | K243315 | ProGrip Self-Gripping Polypropylene Mesh Sofradim Production, FR | FTL |
| Jun 14, 2024 | K241250 | 3DMax Light Mesh Davol Inc., Subsidiary of C. R. Bard, Inc. | FTL |
| Jan 18, 2024 | K232373 | Progrip Self-Gripping Polypropylene Mesh Sofradim Production, FR | FTL |
| Nov 1, 2023 | K233402 | Bard 3DMax Mesh Davol Inc., Subsidiary of C. R. Bard, Inc. | FTL |
| Oct 18, 2023 | K232924 | T-Line® Hernia Mesh Deep Blue Medical Advances, Inc. | FTL |
| May 31, 2023 | K230671 | Pitch PaSoft Tissue Reinforcement Device Xiros, Ltd., GB | FTL |
| Feb 23, 2023 | K230227 | T-Line Hernia Mesh Deep Blue Medical Advances, Inc. | FTL |
| Dec 2, 2022 | K223218 | Parietene Macroporous Mesh Sofradim Production, FR | FTL |
| Nov 28, 2022 | K221556 | T-Line Hernia Mesh Deep Blue Medical Advances, Inc. | FTL |
| Sep 22, 2022 | K220540 | ProGrip Self-Gripping Polypropylene Mesh Covidien | FTL |
| Aug 26, 2022 | K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device Xiros, Ltd., GB | FTL |
| Jun 22, 2022 | K220586 | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Mono Sofradim Production, FR | FTL |
| Mar 18, 2022 | K211132 | ARISTE AB Mesh Ariste Medical, LLC | FTL |
| Aug 13, 2021 | K211563 | Pitch-Patchs Xiros, Ltd., GB | FTL |
| Jan 7, 2021 | K200918 | SurgiWrap FROST Mast Biosurgery | FTL |
| Aug 6, 2020 | K201143 | VICRYL Mesh ETHICON, Inc. | FTL |
| Jul 17, 2020 | K200818 | 3DMax MID Anatomical Mesh C.R. Bard, Inc. | FTL |
| Apr 8, 2020 | K192636 | TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large) Medtronic, Inc. | FTL |
| Mar 30, 2020 | K193144 | T-Line Hernia Mesh Deep Blue Medical Advances, Inc. | FTL |
| Mar 27, 2020 | K192389 | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) Medtronic, Inc. | FTL |
| Dec 6, 2019 | K192443 | Dextile Anatomical Mesh Sofradim Production, FR | FTL |
| Oct 22, 2019 | K191373 | VICRYL Mesh ETHICON, Inc. | FTL |
| Sep 27, 2019 | K192112 | FlexBand Plus International Life Sciences | FTL |
| Sep 26, 2019 | K191545 | Exogenesis Hernia Mesh Exogenesis Corporation | FTL |
| Dec 14, 2018 | K182008 | Phasix ST Mesh with Echo 2 Positioning System C.R. Bard, Inc. | FTL |
| Dec 4, 2018 | K181935 | Endoform Reconstructive Template - Non Absorbable Aroa Biosurgery , Ltd., NZ | FTL |
| Oct 31, 2018 | K182087 | DynaMesh-POSTERIOR Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft, DE | FTL |
| Aug 2, 2018 | K181094 | Polydioxanone Surgical Scaffold Lntegra Lifesciences | FTL |
| Jul 26, 2018 | K181268 | PROLENE (Polypropylene) 3D Patch ETHICON, Inc. | FTL |
| Jul 2, 2018 | K180910 | ULTRAPRO Mesh and ULTRAPRO ADVANCED ETHICON, Inc. | FTL |
| Jun 28, 2018 | K180829 | PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable ETHICON, Inc. | FTL |
| Jun 7, 2018 | K180122 | TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large) Medtronic, Inc. | FTL |
| Apr 30, 2018 | K172636 | VitaMESH Macroporous PP Surgical Mesh Proxy Biomedical , Ltd., IE | FTL |
| Apr 24, 2018 | K180030 | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) Medtronic, Inc. | FTL |
| Mar 9, 2018 | K173796 | Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PC Sofradim Production, FR | FTL |
| Feb 1, 2018 | K172395 | Duatene bilayer mesh Sofradim Production, FR | FTL |
| Oct 5, 2017 | K172089 | PROLENE Soft Polypropylene Mesh ETHICON, Inc. | FTL |
| Aug 9, 2017 | K170134 | Reperen Surgical Mesh Iconlab, Inc. | FTL |
| Jun 29, 2017 | K163212 | Parietene DS Composite Mesh Sofradim Production, FR | FTL |
| May 11, 2017 | K163576 | GORE SYNECOR Preperitoneal Biomaterial W. L. Gore & Associates, Inc. | FTL |
| May 1, 2017 | K170294 | VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning Syste C. R. Bard | FTL |
| Mar 11, 2017 | K163152 | PROLENE Soft Polypropylene Mesh ETHICON, Inc. | FTL |
| Dec 22, 2016 | K161550 | DynaMesh-VENTRAL Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft, DE | FTL |
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