FTLFDA Class 2 · 21 CFR 878.3300 · implantable
Mesh, Surgical, Polymeric
Device family · General, Plastic Surgery
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
340
Manufacturers
39
Flagged signals
20
Adverse-event reports
158,901
Code matrix
| FDA product code | FTL |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| GMDN | — (crosswalk pending) |
| Implantable | Yes |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| 2016 | 4 | 2487.1 | 7,590 | |
| Other | 2013 | 15 | 475.2 | 6,638 |
| Other | 2016 | 3 | 11.6 | 19 |
| Other | 2015 | 9 | 11.1 | 73 |
| Other | 2010 | 7 | 8.4 | 39 |
| Other | 2017 | 11 | 6.7 | 48 |
| Other | 2016 | 10 | 6.1 | 38 |
| Other | 2010 | 5 | 6.0 | 16 |
| Other | 2013 | 3 | 5.0 | 6 |
| Other | 2011 | 4 | 4.8 | 9 |
| Other | 2015 | 7 | 4.3 | 14 |
| Injury | 2012 | 4 | 2.6 | 4 |
| Injury | 2017 | 5 | 2.6 | 6 |
| Injury | 2004 | 6 | 2.6 | 7 |
| Injury | 2022 | 44 | 2.4 | 59 |
| Injury | 2014 | 8 | 2.3 | 8 |
| Injury | 2013 | 3,580 | 2.3 | 4,326 |
| Injury | 2012 | 14 | 2.3 | 14 |
| Injury | 2013 | 14 | 2.2 | 12 |
| Injury | 2013 | 598 | 2.1 | 559 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 158,901 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| W. L. Gore & Associates, Inc. | 36 | 2017 | — |
| SOFRADIM PRODUCTION | 35 | 2025 | — |
| C.R. Bard, Inc. | 25 | 2020 | — |
| Ethicon, Inc. | 24 | 2020 | — |
| Atrium Medical Corp. | 11 | 2012 | — |
| Davol Inc., Sub. C. R. Bard, Inc. | 8 | 2010 | — |
| Genzyme Corp. | 6 | 2003 | — |
| United States Surgical, A Division of Tyco Healthc | 5 | 2001 | — |
| Deep Blue Medical Advances, Inc. | 4 | 2023 | — |
| ASPIDE MEDICAL | 4 | 2012 | — |
| Medtronic, Inc. | 4 | 2020 | — |
| Davol, Inc. | 4 | 2025 | — |
| Atrium Medical Corporation | 3 | 2015 | — |
| Caldera Medical, Inc. | 3 | 2010 | — |
| TORNIER, INC. | 3 | 2012 | — |
| AMERICAN MEDICAL SYSTEMS, INC. | 3 | 2009 | — |
| MAST Biosurgery USA, Inc. | 3 | 2007 | — |
| AESCULAP, INC. | 2 | 2006 | — |
| TEI Biosciences, Inc. | 2 | 2005 | — |
| Meadox Medicals, Div. Boston Scientific Corp. | 2 | 1994 | — |
| Cook Biotech, Inc. | 2 | 2012 | — |
| GENZYME CORPORATION | 2 | 2007 | — |
| Nuvasive, Inc. | 2 | 2009 | — |
| Smith & Nephew, Inc. | 2 | 2011 | — |
| SYNTHASOME, INC. | 2 | 2014 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
Parietene Flat Sheet Mesh · Medtronic - Sofradim Production510(k) · 2025-10-24
Onflex Mesh · Davol Inc., Subsidiary of C. R. Bard, Inc.510(k) · 2025-07-24
Bard® Mesh; Bard® Mesh Pre-Shaped · Davol, Inc.510(k) · 2025-06-12
Parietene Macroporous Mesh (PPM5050 ) · Sofradim Production510(k) · 2025-04-23
Bard Soft Mesh; Bard Soft Mesh Pre-Shaped · Davol, Inc.510(k) · 2025-04-09
ProGrip Self-Gripping Polypropylene Mesh · Sofradim Production510(k) · 2025-01-17
3DMax Light Mesh · Davol Inc., Subsidiary of C. R. Bard, Inc.510(k) · 2024-06-14
Progrip Self-Gripping Polypropylene Mesh · Sofradim Production510(k) · 2024-01-18
Bard 3DMax Mesh · Davol Inc., Subsidiary of C. R. Bard, Inc.510(k) · 2023-11-01
T-Line® Hernia Mesh · Deep Blue Medical Advances, Inc.510(k) · 2023-10-18
Pitch PaSoft Tissue Reinforcement Device · Xiros, Ltd.510(k) · 2023-05-31
T-Line Hernia Mesh · Deep Blue Medical Advances, Inc.510(k) · 2023-02-23
Parietene Macroporous Mesh · Sofradim Production510(k) · 2022-12-02
T-Line Hernia Mesh · Deep Blue Medical Advances, Inc.510(k) · 2022-11-28
ProGrip Self-Gripping Polypropylene Mesh · Covidien510(k) · 2022-09-22
Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device · Xiros, Ltd.510(k) · 2022-08-26
Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh · Sofradim Production510(k) · 2022-06-22
ARISTE AB Mesh · Ariste Medical, LLC510(k) · 2022-03-18
Pitch-Patchs · Xiros, Ltd.510(k) · 2021-08-13
SurgiWrap FROST · Mast Biosurgery510(k) · 2021-01-07
VICRYL Mesh · ETHICON, Inc.510(k) · 2020-08-06
3DMax MID Anatomical Mesh · C.R. Bard, Inc.510(k) · 2020-07-17
TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large) · Medtronic, Inc.510(k) · 2020-04-08
T-Line Hernia Mesh · Deep Blue Medical Advances, Inc.510(k) · 2020-03-30
TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) · Medtronic, Inc.510(k) · 2020-03-27
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.