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) |
|---|---|---|---|
| Nov 19, 2010 | Davol, Inc., Sub. C. R. Bard, Inc. BARD Ventrio Small Oval Hernia Patch 3.1" x 4.7"
Product Code: 0010211
Indicated for use in the reconstruction of soft tissue deficiencies such as for the repair of hernias. Terminated |
FTL | K081777 |
| Jun 8, 2010 | Ram Medical Inc Bard Mesh Monofilament Knitted Polypropylene Flat Mesh; size 6" x 6", 3 per box; Davol Inc., Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920.
Intended as reinforcement of Terminated |
FTL | None listed |
| Jun 8, 2010 | Ram Medical Inc Bard Mesh Monofilament Knitted Polypropylene; size 3" x 6", 3 units per box. Davol Inc. A Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920.
Intended as reinforcement of sof Terminated |
FTL | None listed |
| Jun 8, 2010 | Ram Medical Inc Bard Mesh Monofilament Knitted Polypropylene; size 10 x 14", 3 units per box; Davol Inc., A Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920.
Intended as reinforcement of s Terminated |
FTL | None listed |
| Jun 8, 2010 | Ram Medical Inc Bard Mesh Monofilament Knitted Polypropylene; Contents: size 2" x 4", 3 units per box, Davol Inc., A Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920.
Intended as reinforce Terminated |
FTL | None listed |
| May 4, 2010 | Davol, Inc., Sub. C. R. Bard, Inc. Bard Ventrio Small Oval Hernia Patch 8cm X 12cm (3.1" x 4.7"), Warwick, RI
Product Code: 0010211
The Ventrio Hernia Patch is a self-expanding non-absorbable, sterile prosthesis, containing two prima Terminated |
FTL | K081777 |
| Nov 16, 2009 | Generic Medical Devices GMD UNIVERSAL URINARY INCONTINENCE SLING, Rx ONLY Product Code 1020-18.
Intended for use in women as a suburethral sling for the treatment of stress urinary incontinence resulting from either urethra Terminated |
FTL | K083471 |
| Jan 28, 2009 | Davol, Inc., Sub. C. R. Bard, Inc. Bard 3D Max Mesh, Left large , Sterile
Pre-formed Knitted Polypropylene
Product Code: 0151531
Bard 3D Max Mesh is an anatomically shaped pre-formed polypropylene mesh indicated for use in the repair o Terminated |
FTL | K792281 |
| Jan 30, 2007 | Davol, Inc., Sub. C. R. Bard, Inc. Bard Composix Kugel Hernia Patch-
Large Circle 4.5'' with ePTFE
Product Code: 0010204 Completed |
FTL | K003323 |
| Jan 30, 2007 | Davol, Inc., Sub. C. R. Bard, Inc. Bard Composix Kugel Hernia Patch-
Large Oval with ePTFE , 5.4'' x 7.0''
Product Number: 0010202 Completed |
FTL | K003323 |
| May 23, 2006 | Kinetic Concepts, Inc Sterile packaged wound dressing with white and green inner pouch and outer carton labels, labeled in part:''***V.A.C.*** ABDOMINAL DRESSING WITH NON ADHERENT LAYER***Re-Order No. M6275080/5***Manufact Terminated |
FTL | K022011 |
| Feb 22, 2006 | Davol, Inc., Sub. C. R. Bard, Inc. Bard Composix Kugel Oval, 6.3'' x 12.3'' for hernia repairs
Product Code: 0010209 Completed |
FTL | None listed |
| Feb 22, 2006 | Davol, Inc., Sub. C. R. Bard, Inc. Bard Composix Kugel Large Circle, 4.5'' for hernia repairs
Product Code: 0010204 Completed |
FTL | None listed |
| Feb 22, 2006 | Davol, Inc., Sub. C. R. Bard, Inc. Bard Composix Kugel Large Oval, 5.4'' x 7'' for hernia repairs
Product Code: 0010202 Completed |
FTL | None listed |
| Feb 22, 2006 | Davol, Inc., Sub. C. R. Bard, Inc. Bard Composix Kugel Mesh X-Large Patch
Oval with ePTFE, 7.7'' x 9.7'' (19.6cm x 24.6cm)
Code: 0010208 Completed |
FTL | None listed |
| Feb 22, 2006 | Davol, Inc., Sub. C. R. Bard, Inc. Bard Composix Kugel Mesh X-Large Patch
Oval with ePTFE, 10.8'' x 13.7'' (25.4cm x 33cm)
Code: 0010207 Completed |
FTL | None listed |
| Feb 22, 2006 | Davol, Inc., Sub. C. R. Bard, Inc. Bard Composix Kugel Mesh X-Large Patch
Oval with ePTFE, 8.7'' x 10.7''
Code: 0010206 Completed |
FTL | K003323 |
| Jan 26, 2006 | Ethicon, Inc. PROCEED Surgical Mesh is a sterile, thin, flexible laminate mesh designed for the repair of hernias and other fascial deficiencies. The mesh product is comprised of an oxidized regenerated cellulose Terminated |
FTL | K031925 |
| Jul 20, 2004 | American Medical Systems Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1 Terminated |
FTL | K023516 |
| Jul 20, 2004 | McKesson General Medical Corporation PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3'x6', each mesh in a sealed pouch package, 6 packages per papercard carton Terminated |
FTL | None listed |
| Dec 18, 2003 | Owens & Minor Distribution, Inc. PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3''x6'', each mesh in a sealed pouch package, 6 packages per papercard carton. Cartons labeled in part ***ETHICON, INC., a Jo Terminated |
FTL | None listed |
| Dec 18, 2003 | Cardinal Health Prolene Polyproplyene Mesh, 3'' x 6'', Nonabsorbable Synthetic Surgical Mesh; six packages per box; sterile; product code PMII; Ethicon Inc., Somerville, NJ 08876 Terminated |
FTL | None listed |
| Dec 18, 2003 | Q-Med Corporation Product is a surgical device packaged in a box which is labeled as Sterile with the following identification: ''PMII PROLENE Mesh Polypropylene Nonabsorbable Synthetic surgical Mesh ETHICON'' Addition Terminated |
FTL | None listed |
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