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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 17, 2025 | Chamberlain Technologies LLC SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog Number: T1415 Completed |
FTL | K061445 |
| Jun 17, 2025 | Chamberlain Technologies LLC SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030 Completed |
FTL | K072974 |
| Jun 17, 2025 | Chamberlain Technologies LLC SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415 Completed |
FTL | K072974 |
| Jun 17, 2025 | Chamberlain Technologies LLC SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet, Model/Catalog Number: T3030 Completed |
FTL | K061445 |
| Aug 6, 2024 | W.L. Gore & Associates, Inc. GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25; Open, Classified |
FTL | K053200 |
| Jul 27, 2023 | Davol, Inc. Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficienci Open, Classified |
FTL | K130968 |
| Jul 27, 2023 | Davol, Inc. Ventralight ST w Echo PS 4.5" Circle
A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencie Open, Classified |
FTL | K130968 |
| Jul 27, 2023 | Davol, Inc. Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficien Open, Classified |
FTL | K130968 |
| Jul 27, 2023 | Davol, Inc. Ventralight ST 4" x 6" Ellipse with Echo PS
Catalog Number: 5955460 Open, Classified |
FTL | K130968 |
| Feb 27, 2023 | Covidien, LP Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe-
Shaped, 9 x 8 cm (3.6" x 3.1"). Intended for the reinforcement of tissues during surgical repair
Model Number: PCO2H3 Open, Classified |
FTL | K173796 |
| Jan 13, 2021 | Covidien Llc Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of inguinal hernias via laparoscopic or posterior open procedures Item Code: TECT151 Terminated |
FTL | K173796 |
| Oct 23, 2020 | Ethicon, Inc. PROCEED Surgical Mesh
Hernia Mesh Oval, 15 cm x 20 cm Terminated |
FTL | K060713 |
| Oct 5, 2018 | Covidien LLC Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20)
Product Usage:
The PCOPM15 and PCOPM20 reorder codes are circular in shape, made from a three-dimensional monofilament polyester Terminated |
FTL | K081126 K142908 |
| Apr 26, 2018 | Sofradim Production Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M
The device is made out of a macroporous three-dimensional monofilament polyester textile. Its intended use is for the repair of abdominal wa Terminated |
FTL | K150091 |
| Mar 15, 2018 | Covidien LLC LigaSure" Exact Dissector Nano Coated 20.6mm-21cm
Product Usage:
A bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundl Terminated |
FTL | K150091 |
| Feb 23, 2018 | Atrium Medical Corporation ProLite Mesh - mesh, surgical, polymeric
ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures re Terminated |
FTL | K151437 |
| Aug 19, 2016 | Novus Scientific Ab TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030 Terminated |
FTL | K092224 |
| Jun 29, 2016 | TYRX Inc. TRYX Neuro Absorbable Antibacterial Envelope
Product Usage:
Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD) Terminated |
FTL | K063091 |
| Jun 29, 2016 | TYRX Inc. TRYX Absorbable Antibacterial Envelope
Product Usage:
Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD) Terminated |
FTL | K063091 |
| Jun 29, 2016 | TYRX Inc. TRYX Antibacterial Envelope Rx Only
Product Usage:
Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD) Terminated |
FTL | K063091 |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange PhysioMesh Flexible Composite Mesh 15 x 15cm;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number PHY1515Q;
EXP (repackager), Ethicon (OEM)
Mesh, surgical, polym Terminated |
FTL | None listed |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange PhysioMesh Flexible Composite Mesh 10cm x 15cm;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number PHY1015V;
EXP (repackager), Ethicon (OEM)
Mesh, surgical, pol Terminated |
FTL | None listed |
| Feb 11, 2015 | Stryker Craniomaxillofacial Division MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right
Product Usage:
MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications Terminated |
FTL | K040364 |
| Feb 10, 2015 | MAST Biosurgery USA, Inc The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm
(01) 18964050255027
(17) 170731(10)52804
LOT 52804 2017-08 REF25502-01
Product is wrapped in a foil pouch that is then se Terminated |
FTL | K061473 |
| Nov 7, 2014 | Davol, Inc., Subs. C. R. Bard, Inc. Bard PerFix Light Plug
The Bard PerFix Light Plug is indicated for reinforcement if soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects. Terminated |
FTL | K092032 |
| Jan 23, 2014 | Davol, Inc., Subs. C. R. Bard, Inc. Composix L/P with Echo PS 6" X 8" Product Code 0144680
The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable posi Terminated |
FTL | K102766 |
| Jan 23, 2014 | Davol, Inc., Subs. C. R. Bard, Inc. Composix L/P with Echo PS 10" X 13" Product Code 0144113
The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable po Terminated |
FTL | K102766 |
| Aug 9, 2013 | Atrium Medical Corporation C-QUR TacShield Mesh (All sizes and shapes).
Intended for use in soft tissue deficiencies. Terminated |
FTL | K100076 |
| Aug 9, 2013 | Atrium Medical Corporation C-QUR V-Patch Mesh (All sizes and shapes).
Intended for use in soft tissue deficiencies. Terminated |
FTL | K090909 |
| Aug 9, 2013 | Atrium Medical Corporation C-QUR Edge Mesh (All sizes and shapes).
Intended for use in soft tissue deficiencies. Terminated |
FTL | K050311 |
| Aug 9, 2013 | Atrium Medical Corporation C-QUR Mesh (All Sizes, shapes).
Intended for use in soft tissue deficiencies. Terminated |
FTL | K050311 |
| Feb 7, 2013 | Allergen Medical SeriScaffold Surgical Scaffold
Product Number: SCF10X25AGEN.
Surgical mesh for use in open or laparoscopic procedures. Terminated |
FTL | K080442 |
| Nov 7, 2012 | American Medical Systems, Inc. AMS AdVance" Male Sling System
720088-01 AMS AdVance" Male Sling System (US)
720088-02 AMS AdVance" Male Sling System (Intl)
72404224 AMS Male TO Sling System (Intl).
The AMS AdVance Male Sling Syste Terminated |
FTL | K053371 |
| Sep 20, 2012 | Davol, Inc., Subs. C. R. Bard, Inc. Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm)
Product Code 5954790.
The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device Terminated |
FTL | K101851 |
| Sep 20, 2012 | Davol, Inc., Subs. C. R. Bard, Inc. Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm)
Product Code 5954810.
The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device Terminated |
FTL | K101851 |
| May 2, 2012 | Coloplast Manufacturing US, LLC Coloplast, Restorelle DirectFix, Posterior Polypropylene Mesh, Catalogue Number 501460, Rx Only, Manufacturer, Coloplast A/S 3050 Denmark
Restorelle is a ploypropylene mesh that may be used for the Terminated |
FTL | K041632 K053361 +1 |
| Jan 27, 2012 | Novomedicus Llc The Artificial Bur HypoPack is a Temporary Fascial Prothesis with Hypobaric Wound Dressing. For Single Patient Use only.
Contents: 1. Large Bur Patch (Sterile: EO), 20cm x 40cm Loop Sheet, 20cm x 40cm Terminated |
FTL | K093166 |
| Jan 27, 2012 | Novomedicus Llc The Artificial Bur Patch is a Temporary Fascial Prothesis. For Single Patient Use only. Use with Negative Pressure Wound Dressing.
Contents: Large Bur Patch (Sterile: EO), 20cm x 40cm Loop Sheet, 20cm Terminated |
FTL | K093166 |
| Nov 1, 2011 | Davol, Inc., Sub. C. R. Bard, Inc. Bard Ventralex" ST Medium Circle with Strap Hernia Patch Diameter 6.4cm /2.5", Catalog Number: 5950008.
Intended for use in the reconstruction of soft tissue, where weakness exists, in procedures inv Terminated |
FTL | K101928 |
| Aug 3, 2011 | Boston Scientific Corporation Pinnacle Pelvic Floor Repair Kit--Anterior/Apical STERILE, and Pinnacle Pelvic Floor Repair Kit--Posterior STERILE.
Boston Scientific, Corp.
Indicated for tissue reinforcement and stabilization of fa Terminated |
FTL | K071957 |
| Jul 7, 2011 | American Medical Systems, Inc. Elevate System with IntePro Lite", Anterior and Apical Prolapse Repair System, REF720093-01, Sterile EO, Manufactured by:American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA
Terminated |
FTL | K082677 |
| May 23, 2011 | Davol, Inc., Sub. C. R. Bard, Inc. Bard Soft Mesh 4"x6" (10cm x 15cm) Flat, Product Code: 0117010.
The Bard Soft Mesh patch is a non-absorbable, sterile prosthesis. It has a large pore design and is constructed of knitted polypropy Terminated |
FTL | K033814 |
| May 2, 2011 | Davol, Inc., Sub. C. R. Bard, Inc. BardVentralex" Hernia Patch Medium Circle with Strap Diameter 6.4cm /2.5",\
Catalog #0010302,
lot number HUTL1283.
The BardVentralex" Hernia Patch is a self-expanding, non-absorbable, sterile prosth Terminated |
FTL | K021736 |
| Feb 22, 2011 | Generic Medical Devices The GMD UNIVERSAL URINARY INCONTINENCE SLING (Code 1010) is supplied sterile and is intended for single patient use only.
The GMD Universal Sling is a sterile, single use device for the treatment of Terminated |
FTL | K083471 |
| Feb 1, 2011 | Covidien LP AutoSuture SURGIPRO Polyproylene Mesh Clear 3" x 5" Sterile
REF SPM 35
Surgipro Flat Sheet mesh is a non-absorbable, polypropylene surgical mesh exhibiting high burst strength and tensile strength Terminated |
FTL | K915526 |
| Jan 14, 2011 | Ethicon, Inc. PROCEED Surgical Mesh; Product Code PCDG1; :Lot BMG618; Ethicon, Inc. a Johnson & Johnson Company.
Used for the repair of hernias and other fascial deficiencies that require the addition of a reinfor Open, Classified |
FTL | K060713 |
| Dec 27, 2010 | American Medical Systems, Inc. Model # 720088-01: AMS AdVance Male Sling System, US; Model # 720088-02: AMS AdVance Male Sling System, INTL; Model # 72404224: Male TO Sling System, INTL.
Sterilization Method ETO, American Medical Terminated |
FTL | K053371 |
| Nov 23, 2010 | Davol, Inc., Sub. C. R. Bard, Inc. BARD Mesh Pre-shaped (1.8" x 4.0"/4.5cm x 10cm)
Product code: 0112700
Intended use: Bard Pre-shaped mesh is a pre-shaped mesh constructed of knitted polypropylene monofilaments. It is indicated for Terminated |
FTL | K052155 |
| Nov 19, 2010 | Davol, Inc., Sub. C. R. Bard, Inc. BARD Ventrio Small Circle Hernia Patch 3.0"
Product Code: 0010213
Indicated for use in the reconstruction of soft tissue deficiencies such as for the repair of hernias. Terminated |
FTL | K081777 |
| Nov 19, 2010 | Davol, Inc., Sub. C. R. Bard, Inc. BARD Ventrio Large Oval Hernia Patch 5.4" x 7.0"
Product Code: 0010212
Indicated for use in the reconstruction of soft tissue deficiencies such as for the repair of hernias. Terminated |
FTL | K081777 |
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