ClearanceBrief
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)
Get daily alerts for FTLSample briefCSV

Top companies in FTL

DateFirm and productCodeLinked 510(k)
Jun 17, 2025Chamberlain Technologies LLC
SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog Number: T1415
Completed
FTLK061445
Jun 17, 2025Chamberlain Technologies LLC
SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030
Completed
FTLK072974
Jun 17, 2025Chamberlain Technologies LLC
SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415
Completed
FTLK072974
Jun 17, 2025Chamberlain Technologies LLC
SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet, Model/Catalog Number: T3030
Completed
FTLK061445
Aug 6, 2024W.L. Gore & Associates, Inc.
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
Open, Classified
FTLK053200
Jul 27, 2023Davol, 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
FTLK130968
Jul 27, 2023Davol, 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
FTLK130968
Jul 27, 2023Davol, 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
FTLK130968
Jul 27, 2023Davol, Inc.
Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460
Open, Classified
FTLK130968
Feb 27, 2023Covidien, 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
FTLK173796
Jan 13, 2021Covidien 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
FTLK173796
Oct 23, 2020Ethicon, Inc.
PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm
Terminated
FTLK060713
Oct 5, 2018Covidien 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
FTLK081126
K142908
Apr 26, 2018Sofradim 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
FTLK150091
Mar 15, 2018Covidien 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
FTLK150091
Feb 23, 2018Atrium 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
FTLK151437
Aug 19, 2016Novus Scientific Ab
TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030
Terminated
FTLK092224
Jun 29, 2016TYRX Inc.
TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Terminated
FTLK063091
Jun 29, 2016TYRX Inc.
TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Terminated
FTLK063091
Jun 29, 2016TYRX Inc.
TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Terminated
FTLK063091
Jul 24, 2015EXP 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
FTLNone listed
Jul 24, 2015EXP 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
FTLNone listed
Feb 11, 2015Stryker 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
FTLK040364
Feb 10, 2015MAST 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
FTLK061473
Nov 7, 2014Davol, 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
FTLK092032
Jan 23, 2014Davol, 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
FTLK102766
Jan 23, 2014Davol, 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
FTLK102766
Aug 9, 2013Atrium Medical Corporation
C-QUR TacShield Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
Terminated
FTLK100076
Aug 9, 2013Atrium Medical Corporation
C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
Terminated
FTLK090909
Aug 9, 2013Atrium Medical Corporation
C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
Terminated
FTLK050311
Aug 9, 2013Atrium Medical Corporation
C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.
Terminated
FTLK050311
Feb 7, 2013Allergen Medical
SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
Terminated
FTLK080442
Nov 7, 2012American 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
FTLK053371
Sep 20, 2012Davol, 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
FTLK101851
Sep 20, 2012Davol, 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
FTLK101851
May 2, 2012Coloplast 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
FTLK041632
K053361 +1
Jan 27, 2012Novomedicus 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
FTLK093166
Jan 27, 2012Novomedicus 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
FTLK093166
Nov 1, 2011Davol, 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
FTLK101928
Aug 3, 2011Boston 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
FTLK071957
Jul 7, 2011American 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
FTLK082677
May 23, 2011Davol, 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
FTLK033814
May 2, 2011Davol, 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
FTLK021736
Feb 22, 2011Generic 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
FTLK083471
Feb 1, 2011Covidien 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
FTLK915526
Jan 14, 2011Ethicon, 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
FTLK060713
Dec 27, 2010American 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
FTLK053371
Nov 23, 2010Davol, 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
FTLK052155
Nov 19, 2010Davol, 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
FTLK081777
Nov 19, 2010Davol, 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
FTLK081777

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.