ClearanceBrief
Panels › General, Plastic Surgery › Product code FTM · Class 2

Mesh, Surgical

Regulation 878.3300

1510(k)s in 12 months (164 all time)
0recalls in 12 months (76 all time)
72recalls that name a 510(k)
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Top companies in FTM

DateFirm and productCodeLinked 510(k)
Apr 6, 2018AROA Biosurgery, LTD.
OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620G
Terminated
FTMK153633
Apr 6, 2018AROA Biosurgery, LTD.
OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G
Terminated
FTMK153633
Apr 6, 2018AROA Biosurgery, LTD.
OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G
Terminated
FTMK153633
Apr 6, 2018AROA Biosurgery, LTD.
OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G
Terminated
FTMK153633
Apr 6, 2018AROA Biosurgery, LTD.
OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G
Terminated
FTMK153633
Apr 3, 2014Ethicon, Inc.
Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and other fascial deficiencies that require the addition
Open, Classified
FTMK060713
Jan 27, 2012Howmedica Osteonics Corp dba Stryker Craniomaxillofacial
MEDPOR TITAN Cranial Temporal with Template - Right, Catalog Number 81038. MEDPOR Biomaterial with embedded Titanium Mesh Implants are intended for non-weight bearing applications of craniofacial rec
Terminated
FTMK040364
Nov 23, 2011Synovis Surgical Inovation Div. of
Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSDV), sterile EO, Rx Only, Synovis Surgical Innovations, A Division of Synovis Life Technologies, Inc, 2575 University Ave W.,
Terminated
FTMK041669
Nov 9, 2011LifeCell Corporation
LifeCell Strattice Reconstructive Tissue Matrix for Stoma Reinforcement Catalog #0606008 (6 x 6 cm), 0808008 (8 cm x 8 cm), (0610008 ( 6 cm x 10 cm). Intended for use as a soft tissue patch to reinfo
Terminated
FTMK070560
Jul 21, 2011ACell, Inc
MatriStem Plastic Surgery Matrix XS Intended for implantation to reinforce tissue where weakness exists in urological, gynecological, and gastrointestinal anatomy, including, but not limited to the
Terminated
FTMNone listed
Mar 2, 2011Davol, Inc., Sub. C. R. Bard, Inc.
XenMatrix Surgical Graft ,Sterile, Porcine Dermal Matrix 19 x 35 cm Rectangle Catalog #: 1161935
Terminated
FTMK081272
Mar 2, 2011Davol, Inc., Sub. C. R. Bard, Inc.
XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 19 x 28 cm Rectangle Catalog #: 1161928
Terminated
FTMK081272
Mar 2, 2011Davol, Inc., Sub. C. R. Bard, Inc.
XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 15 x 20 cm Rectangle Catalog #: 1161520
Terminated
FTMK081272
Mar 2, 2011Davol, Inc., Sub. C. R. Bard, Inc.
XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 10 x 15 cm Rectangle Catalog #: 1161015
Terminated
FTMK081272
Sep 29, 2010LifeCell Corporation
Strattice Reconstructive Tissue Matrix for Stoma Reinforcement. 8 cm x 8 cm Packaged in an inner foil pouch inside outer foil pouch tertiary carton. LifeCell Corporation, One Millennium Way, Branchbur
Terminated
FTMK070560
Jan 27, 2009American Medical Systems
AMS InteXen LP Collagen Dermal Matrix, REF 72404066. Product Size: 8 x 12 cm. AMS InteXen LP is a sterile non-perforated processed porcine collagen dermal matrix. Sterile EO. American Medical
Terminated
FTMK050445
Jun 15, 2007Synovis Surgical Inovation Div. of
Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, (PSD 28-U-V), 28mm, US Surgical Staplers. Each package contains the following components: Cartridge and anvi
Terminated
FTMK041669
Jun 15, 2007Synovis Surgical Inovation Div. of
Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, ( PSD 25-U-V), 25 mm, US Surgical Staplers. Each package contains the following components: Cartridge and anv
Terminated
FTMK041669
Jun 15, 2007Synovis Surgical Inovation Div. of
Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, ( PSD 21-U-V), 21mm, US Surgical Staplers. Each package contains the following components: Cartridge and anvi
Terminated
FTMK041669
Jun 15, 2007Synovis Surgical Inovation Div. of
Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, ( PSD 29-E-V), 29 mm, Ethicon Circular stapler. Each package contains the following components: Cartridge and
Terminated
FTMK041669
Jun 15, 2007Synovis Surgical Inovation Div. of
Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, (PSD 25-E-V), 25mm, Ethicon Circular stapler. Each package contains the following components: Cartridge and
Terminated
FTMK041669
Jun 15, 2007Synovis Surgical Inovation Div. of
Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement,( PSD 21-E-V), 21mm, Ethicon Circular stapler. Each package contains the following components: Cartridge and an
Terminated
FTMK041669
May 10, 2007Ethicon, Inc.
Gynecare PROLIFT Total Pelvic Repair System PFRT01 Ethicon Deutschland
Terminated
FTMK013718
Apr 13, 2006Synovis Surgical Inovation Div. of
Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement. Do not reuse. Ethylene Oxide Sterilized. Made in the U.S.A. Synovis Surgical Innovations A division of Synovis Life
Terminated
FTMK041669
Jun 14, 2005Synovis Surgical Inovation Div. of
Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V), 4506 E-V. PSD-V is an implantable surgical mesh comprised of non-crosslinked bovine pericardium in a dehydrated form.
Terminated
FTMNone listed
Jun 14, 2005Synovis Surgical Inovation Div. of
Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V), 4506 ETS-V. PSD-V is an implantable surgical mesh comprised of non-crosslinked bovine pericardium in a dehydrated form
Terminated
FTMNone listed

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