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)
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Top companies in FTL

DateFirm and productCodeLinked 510(k)
Nov 19, 2010Davol, 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
FTLK081777
Jun 8, 2010Ram 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
FTLNone listed
Jun 8, 2010Ram 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
FTLNone listed
Jun 8, 2010Ram 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
FTLNone listed
Jun 8, 2010Ram 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
FTLNone listed
May 4, 2010Davol, 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
FTLK081777
Nov 16, 2009Generic 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
FTLK083471
Jan 28, 2009Davol, 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
FTLK792281
Jan 30, 2007Davol, Inc., Sub. C. R. Bard, Inc.
Bard Composix Kugel Hernia Patch- Large Circle 4.5'' with ePTFE Product Code: 0010204
Completed
FTLK003323
Jan 30, 2007Davol, Inc., Sub. C. R. Bard, Inc.
Bard Composix Kugel Hernia Patch- Large Oval with ePTFE , 5.4'' x 7.0'' Product Number: 0010202
Completed
FTLK003323
May 23, 2006Kinetic 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
FTLK022011
Feb 22, 2006Davol, Inc., Sub. C. R. Bard, Inc.
Bard Composix Kugel Oval, 6.3'' x 12.3'' for hernia repairs Product Code: 0010209
Completed
FTLNone listed
Feb 22, 2006Davol, Inc., Sub. C. R. Bard, Inc.
Bard Composix Kugel Large Circle, 4.5'' for hernia repairs Product Code: 0010204
Completed
FTLNone listed
Feb 22, 2006Davol, Inc., Sub. C. R. Bard, Inc.
Bard Composix Kugel Large Oval, 5.4'' x 7'' for hernia repairs Product Code: 0010202
Completed
FTLNone listed
Feb 22, 2006Davol, 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
FTLNone listed
Feb 22, 2006Davol, 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
FTLNone listed
Feb 22, 2006Davol, Inc., Sub. C. R. Bard, Inc.
Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 8.7'' x 10.7'' Code: 0010206
Completed
FTLK003323
Jan 26, 2006Ethicon, 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
FTLK031925
Jul 20, 2004American Medical Systems
Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1
Terminated
FTLK023516
Jul 20, 2004McKesson 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
FTLNone listed
Dec 18, 2003Owens & 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
FTLNone listed
Dec 18, 2003Cardinal 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
FTLNone listed
Dec 18, 2003Q-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
FTLNone listed

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