FDA Product Code
FDA Product Code FTL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3300
510(k) Clearances — 337 records · page 1 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260474 | Liora Monofilament Scaffold | TELA Bio, Inc. | 2026-09-28 | Traditional | PDF ↗ |
| K253956 | ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) | Sofradim Production | 2026-05-21 | Traditional | PDF ↗ |
| K253125 | Parietene Flat Sheet Mesh | Medtronic - Sofradim Production | 2025-10-24 | Special | PDF ↗ |
| K251955 | Onflex Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. | 2025-07-24 | Special | PDF ↗ |
| K251557 | Bard® Mesh; Bard® Mesh Pre-Shaped | Davol, Inc. | 2025-06-12 | Special | PDF ↗ |
| K250869 | Parietene Macroporous Mesh (PPM5050 ) | Sofradim Production | 2025-04-23 | Special | PDF ↗ |
| K250098 | Bard Soft Mesh; Bard Soft Mesh Pre-Shaped | Davol, Inc. | 2025-04-09 | Traditional | PDF ↗ |
| K243315 | ProGrip Self-Gripping Polypropylene Mesh | Sofradim Production | 2025-01-17 | Traditional | PDF ↗ |
| K241250 | 3DMax Light Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. | 2024-06-14 | Special | PDF ↗ |
| K232373 | Progrip Self-Gripping Polypropylene Mesh | Sofradim Production | 2024-01-18 | Traditional | PDF ↗ |
| K233402 | Bard 3DMax Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. | 2023-11-01 | Special | PDF ↗ |
| K232924 | T-Line® Hernia Mesh | Deep Blue Medical Advances, Inc. | 2023-10-18 | Special | PDF ↗ |
| K230671 | Pitch PaSoft Tissue Reinforcement Device | Xiros, Ltd. | 2023-05-31 | Traditional | PDF ↗ |
| K230227 | T-Line Hernia Mesh | Deep Blue Medical Advances, Inc. | 2023-02-23 | Special | PDF ↗ |
| K223218 | Parietene Macroporous Mesh | Sofradim Production | 2022-12-02 | Special | PDF ↗ |
| K221556 | T-Line Hernia Mesh | Deep Blue Medical Advances, Inc. | 2022-11-28 | Traditional | PDF ↗ |
| K220540 | ProGrip Self-Gripping Polypropylene Mesh | Covidien | 2022-09-22 | Special | PDF ↗ |
| K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022-08-26 | Traditional | PDF ↗ |
| K220586 | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh | Sofradim Production | 2022-06-22 | Special | PDF ↗ |
| K211132 | ARISTE AB Mesh | Ariste Medical, LLC | 2022-03-18 | Traditional | PDF ↗ |
| K211563 | Pitch-Patchs | Xiros, Ltd. | 2021-08-13 | Traditional | PDF ↗ |
| K200918 | SurgiWrap FROST | Mast Biosurgery | 2021-01-07 | Traditional | PDF ↗ |
| K201143 | VICRYL Mesh | ETHICON, Inc. | 2020-08-06 | Traditional | PDF ↗ |
| K200818 | 3DMax MID Anatomical Mesh | C.R. Bard, Inc. | 2020-07-17 | Traditional | PDF ↗ |
| K192636 | TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large) | Medtronic, Inc. | 2020-04-08 | Traditional | PDF ↗ |
| K193144 | T-Line Hernia Mesh | Deep Blue Medical Advances, Inc. | 2020-03-30 | Traditional | PDF ↗ |
| K192389 | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) | Medtronic, Inc. | 2020-03-27 | Traditional | PDF ↗ |
| K192443 | Dextile Anatomical Mesh | Sofradim Production | 2019-12-06 | Traditional | PDF ↗ |
| K191373 | VICRYL Mesh | ETHICON, Inc. | 2019-10-22 | Traditional | PDF ↗ |
| K192112 | FlexBand Plus | International Life Sciences | 2019-09-27 | Special | PDF ↗ |
| K191545 | Exogenesis Hernia Mesh | Exogenesis Corporation | 2019-09-26 | Traditional | PDF ↗ |
| K182008 | Phasix ST Mesh with Echo 2 Positioning System | C.R. Bard, Inc. | 2018-12-14 | Traditional | PDF ↗ |
| K181935 | Endoform Reconstructive Template - Non Absorbable | Aroa Biosurgery , Ltd. | 2018-12-04 | Traditional | PDF ↗ |
| K182087 | DynaMesh-POSTERIOR | Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft | 2018-10-31 | Traditional | PDF ↗ |
| K181094 | Polydioxanone Surgical Scaffold | Lntegra Lifesciences | 2018-08-02 | Traditional | PDF ↗ |
| K181268 | PROLENE (Polypropylene) 3D Patch | ETHICON, Inc. | 2018-07-26 | Traditional | PDF ↗ |
| K180910 | ULTRAPRO Mesh and ULTRAPRO ADVANCED | ETHICON, Inc. | 2018-07-02 | Traditional | PDF ↗ |
| K180829 | PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh | ETHICON, Inc. | 2018-06-28 | Traditional | PDF ↗ |
| K180122 | TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large) | Medtronic, Inc. | 2018-06-07 | Traditional | PDF ↗ |
| K172636 | VitaMESH Macroporous PP Surgical Mesh | Proxy Biomedical , Ltd. | 2018-04-30 | Traditional | PDF ↗ |
| K180030 | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) | Medtronic, Inc. | 2018-04-24 | Traditional | PDF ↗ |
| 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) | Sofradim Production | 2018-03-09 | Traditional | PDF ↗ |
| K172395 | Duatene bilayer mesh | Sofradim Production | 2018-02-01 | Traditional | PDF ↗ |
| K172089 | PROLENE Soft Polypropylene Mesh | ETHICON, Inc. | 2017-10-05 | Traditional | PDF ↗ |
| K170134 | Reperen Surgical Mesh | Iconlab, Inc. | 2017-08-09 | Traditional | PDF ↗ |
| K163212 | Parietene DS Composite Mesh | Sofradim Production | 2017-06-29 | Traditional | PDF ↗ |
| K163576 | GORE SYNECOR Preperitoneal Biomaterial | W. L. Gore & Associates, Inc. | 2017-05-11 | Traditional | PDF ↗ |
| 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 | C. R. Bard | 2017-05-01 | Traditional | PDF ↗ |
| K163152 | PROLENE Soft Polypropylene Mesh | ETHICON, Inc. | 2017-03-11 | Traditional | PDF ↗ |
| K161550 | DynaMesh-VENTRAL | Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft | 2016-12-22 | Traditional | PDF ↗ |
| K153632 | Endoform Reconstructive Template | Aroa Biosurgery Limited (Formerly Mesynthes Limited) | 2016-06-16 | Traditional | PDF ↗ |
| 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 | C.R. Bard, Inc. | 2016-05-13 | Traditional | PDF ↗ |
| K152609 | GORE SYNECOR Biomaterial | W. L. Gore & Associates, Inc. | 2015-12-11 | Traditional | PDF ↗ |
| K152678 | TYRX Neuro Antibacterial Envelope | Tyrx, Inc. | 2015-11-17 | Traditional | PDF ↗ |
| K151386 | C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic | Atrium Medical Corporation | 2015-10-22 | Traditional | PDF ↗ |
| K143743 | ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH | C.R. Bard, Inc. | 2015-09-18 | Traditional | PDF ↗ |
| K151437 | ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug | Atrium Medical Corporation | 2015-08-27 | Traditional | PDF ↗ |
| K150906 | ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh | Ehicon, Inc. | 2015-07-24 | Traditional | PDF ↗ |
| K150091 | Versatex Monofilament Mesh | Sofradim Production | 2015-05-26 | Traditional | PDF ↗ |
| K142192 | Insightra Freedom Ventral Hernia Repair System | Insightra Medical | 2015-05-07 | Traditional | PDF ↗ |
| K150291 | TYRX Neuro Absorbable Antibacterial Envelope | Medtronic Tyrx, Inc. | 2015-03-27 | Traditional | PDF ↗ |
| K142706 | Modified ONFLEX Mesh | C.R. Bard, Inc. | 2015-03-25 | Traditional | PDF ↗ |
| K142711 | ONFLEX Mesh | C.R. Bard, Inc. | 2015-03-20 | Traditional | PDF ↗ |
| K143386 | Progrip Laparoscopic Self-Fixating Mesh | Sofradim Production | 2015-03-13 | Special | PDF ↗ |
| K142611 | TYRX Neuro Absorbable Antibacterial Envelope | Medtronic Tyrx, Inc. | 2014-12-31 | Traditional | PDF ↗ |
| 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 | Sofradim Production | 2014-11-14 | Special | PDF ↗ |
| 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 | Sofradim Production | 2014-10-28 | Special | PDF ↗ |
| K141560 | ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE | ETHICON, Inc. | 2014-10-23 | Traditional | PDF ↗ |
| K142091 | PARIETENE MACROPOROUS MESH | Sofradim Production | 2014-10-17 | Traditional | PDF ↗ |
| K133889 | PREMIUM | Cousin Biotech Sas | 2014-09-04 | Traditional | PDF ↗ |
| K141394 | X-REPAIR | Synthasome | 2014-08-06 | Special | PDF ↗ |
| K141499 | X-REPAIRSL | Synthasome, Inc. | 2014-07-02 | Special | PDF ↗ |
| K140967 | FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK | Insightra Medical | 2014-06-10 | Special | PDF ↗ |
| K133198 | ULTRAPRO COMFORT PLUG | ETHICON, Inc. | 2014-05-30 | Traditional | PDF ↗ |
| K140941 | PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH | Sofradim Production | 2014-05-07 | Special | PDF ↗ |
| K132441 | BARD VENTRALEX HERNIA PATCH | C.R. Bard, Inc. | 2013-12-13 | Special | PDF ↗ |
| K132699 | AIGIS RX N (MEDIUM), AIGIS RX N (LARGE) | Tyrx, Inc. | 2013-11-26 | Traditional | PDF ↗ |
| K130428 | COVAMESH | Biomup S.A. | 2013-10-25 | Traditional | PDF ↗ |
| K131530 | DYNAMESH -CICAT | Feg Textiltechnik Forschungs-Und Entwicklungsgesel | 2013-10-23 | Traditional | PDF ↗ |
| K131969 | SYMBOTEX(TM) COMPOSITE MESH | Sofradim Production | 2013-08-22 | Traditional | PDF ↗ |
| K131007 | AIGIS RX N MEDIUM; AIGIS RX N LARGE | Tyrx, Inc. | 2013-07-10 | Traditional | PDF ↗ |
| K130943 | AIGIS RX R PM/ AIGIS RX R ICD | Tyrx, Inc. | 2013-05-20 | Traditional | PDF ↗ |
| K130968 | VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM | C.R. Bard, Inc. | 2013-05-01 | Special | PDF ↗ |
| K120844 | MEDLINX SURGICAL MESH | Medlinx Acala Pte, Ltd. | 2012-12-13 | Traditional | PDF ↗ |
| K123479 | PROGRIP LAPAROSCOPIC SELF-FIXATING MESH | Sofradim Production | 2012-12-11 | Special | PDF ↗ |
| K122436 | COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM | C.R. Bard, Inc. | 2012-11-02 | Special | PDF ↗ |
| K113552 | FREEDOM INGUINAL HERNIA IMPLANT | Insightra Medical | 2012-08-23 | Traditional | PDF ↗ |
| K113229 | VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING | C.R. Bard, Inc. | 2012-07-20 | Traditional | PDF ↗ |
| K113311 | TIO2MESH TM | Biocer Entwicklungs GmbH | 2012-07-17 | Traditional | PDF ↗ |
| K120897 | PROGRIP LAPARSCOPIC SELF-FIXATING MESH | Sofradim Production | 2012-06-29 | Traditional | PDF ↗ |
| K120025 | SURGIMESH XB - SKIRTED | Aspide Medical | 2012-06-26 | Special | PDF ↗ |
| K120506 | PARIETEX COMPOSITE VENTRAL PATCH | Sofradim Production | 2012-06-13 | Traditional | PDF ↗ |
| K121070 | C-QUR RPM MESH | Atrium Medical Corp. | 2012-04-26 | Special | PDF ↗ |
| K111695 | HYBRID GRAFT | Cook Biotech, Inc. | 2012-04-02 | Traditional | PDF ↗ |
| K111337 | TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD | Tornier, Inc. | 2012-01-25 | Traditional | PDF ↗ |
| K112567 | BIOMERIX ASSURE | Biomerix Corporation | 2011-12-23 | Traditional | PDF ↗ |
| K112499 | BIOMERIX COMPOSITE SURGICAL MESH | Biomerix Corporation | 2011-12-23 | Traditional | PDF ↗ |
| K112784 | RENASYS AB ABOMINAL DRESSING KIT | Smith & Nephew, Inc. | 2011-11-22 | Special | PDF ↗ |
| K110663 | PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES) | Sofradim Production | 2011-08-11 | Traditional | PDF ↗ |
| K100313 | HYDROFIX SURGICAL SHEET | Mimedx Group, Inc. | 2011-06-14 | Traditional | PDF ↗ |
Product code FTL · Class II · General, Plastic Surgery. Data: openFDA.