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)
Top companies in FTM
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2024 | TEI Biosciences, Inc. TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm. Open, Classified |
FTM | K060989 |
| Sep 30, 2024 | TEI Biosciences, Inc. Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm. Open, Classified |
FTM | K171357 |
| Sep 30, 2024 | TEI Biosciences, Inc. Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm. Open, Classified |
FTM | K071807 |
| Sep 30, 2024 | TEI Biosciences, Inc. SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm Open, Classified |
FTM | None listed |
| Sep 30, 2024 | TEI Biosciences, Inc. SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm, 20x0.5 cm, and 10x25 cm Fenestrated. Open, Classified |
FTM | K083898 |
| Sep 30, 2024 | TEI Biosciences, Inc. SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25 cm, 1x5 cm, 10x25 cm 4x7cm Fenestrated, Open, Classified |
FTM | K083898 |
| Sep 30, 2024 | TEI Biosciences, Inc. SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x25 cm, 20x30 cm, and 25x40 cm. Open, Classified |
FTM | K162965 |
| Sep 30, 2024 | TEI Biosciences, Inc. SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25cm, 10x15cm Semi-Oval, Open, Classified |
FTM | K083898 |
| Sep 30, 2024 | TEI Biosciences, Inc. SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin. Open, Classified |
FTM | K071807 |
| Sep 30, 2024 | TEI Biosciences, Inc. SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 10x20 cm Fenestrated, 8x16 cm Semi-Oval, 15x15 cm Semi-Oval, 8x20 cm Fenestrated, Open, Classified |
FTM | K071807 K171357 |
| Sep 30, 2024 | TEI Biosciences, Inc. SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x15 cm, 1.0 10x20 cm, 1.0 16x20 cm, 1.0 13x25 cm, 1.0 4x16 cm, 1.0 3x3 cm, 1.0 4x Open, Classified |
FTM | K071807 |
| Sep 25, 2024 | Cook Biotech, Inc. Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias.
Order Number (GPN): G46603 Open, Classified |
FTM | K062729 |
| Sep 25, 2024 | Cook Biotech, Inc. Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas.
Order Number (GPN): G46603 Open, Classified |
FTM | K062729 |
| Sep 25, 2024 | Cook Biotech, Inc. Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas.
Order Number (GPN): G46602 Open, Classified |
FTM | K062729 |
| Sep 25, 2024 | Cook Biotech, Inc. Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas.
Order Number (GPN): G46601 Open, Classified |
FTM | K062729 |
| Sep 25, 2024 | Cook Biotech, Inc. Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.
Order Number (GPN): G46373 Open, Classified |
FTM | K062729 |
| Sep 25, 2024 | Cook Biotech, Inc. Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.
Order Number (GPN): G46372 Open, Classified |
FTM | K062729 |
| Sep 25, 2024 | Cook Biotech, Inc. Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.
Order Number (GPN): G46374 Open, Classified |
FTM | K062729 |
| Sep 25, 2024 | Cook Biotech, Inc. Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.
Order Number (GPN): G54614 Open, Classified |
FTM | K062729 |
| Sep 25, 2024 | Cook Biotech, Inc. Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.
Order Number (GPN): G54613 Open, Classified |
FTM | K062729 |
| Sep 25, 2024 | Cook Biotech, Inc. Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.
Order Number (GPN): G54612 Open, Classified |
FTM | K062729 |
| Sep 25, 2024 | Cook Biotech, Inc. Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.
Order Number (GPN): G24668 Open, Classified |
FTM | K062729 |
| Sep 25, 2024 | Cook Biotech, Inc. Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.
Order Number (GPN): G24667 Open, Classified |
FTM | K062729 |
| Mar 26, 2024 | Baxter Healthcare Corporation Baxter Supple Peri-Guard Repair Patch (new product codes):
a) SPG0404,
b) SPG0406,
c) SPG0608,
d) SPG0814,
e) SPG1016 Open, Classified |
FTM | K223052 |
| Mar 26, 2024 | Baxter Healthcare Corporation Baxter Peri-Guard Repair Patch (new product codes):
a) PG0404,
b) PG0608,
c) PG0814,
d) PG1016,
e) PG1225 Open, Classified |
FTM | K223052 |
| Mar 26, 2024 | Baxter Healthcare Corporation Baxter Supple Peri-Guard Repair Patch (legacy product codes):
a) PC0404SNBIO,
b) PC0608NSBIO,
c) PC0814SNBIO,
d) PC1016SNBIO Open, Classified |
FTM | K983162 |
| Mar 26, 2024 | Baxter Healthcare Corporation Baxter Peri-Guard Repair Patch (legacy product codes):
a) PC0404NBIO,
b) PC0608NBIO,
c) PC0814NBIO,
d) PC1016NBIO Open, Classified |
FTM | K983162 |
| Jan 5, 2024 | Baxter Healthcare Corporation Peri-Guard Repair Patch, Product Codes:
a) PC1016NBIO: 10X16CMUS,
b) PC1225NBIO: 12X25CMUS,
c) PC0404NBIO: 4X4CMUS,
d) PC0608NBIO: 6X8CMUS,
e) PC0814NBIO: 8X14CMUS Open, Classified |
FTM | K223052 |
| Dec 29, 2021 | Stryker Leibinger GmbH & Co. KG MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032 Terminated |
FTM | K040364 |
| Dec 11, 2020 | Baxter Healthcare Corporation VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor excluding transvaginal pelvic organ prolapse and for use in the repair of rectal prolapse excluding rect Terminated |
FTM | K062915 |
| Aug 21, 2019 | AZIYO BIOLOGICS CanGaroo Envelopes labeled as the following:
1. CanGaroo Envelope (Large) (single pack);
2. CanGaroo Envelope (Medium) (single pack);
3. CanGaroo Envelope (Extra Large) (single pack);
4. C Terminated |
FTM | K140306 K173242 +1 |
| Aug 21, 2019 | AZIYO BIOLOGICS BioEnvelope, surgical mesh envelope. Labeled as the following:
1. BioEnvelope (Medium) (single pack);
2. BioEnvelope (Large) (single pack);
3. BioEnvelope (Extra Large) (single pack);
4. Terminated |
FTM | K140306 |
| Feb 14, 2019 | ACell, Inc Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists Terminated |
FTM | K170763 |
| Feb 14, 2019 | ACell, Inc Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists Terminated |
FTM | K170763 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex Reinforced BioScaffold 18x22cm, Part Number F10254-1822G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 2S Reinforced BioScaffold 20x20cm, Part Number F10258-2020G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 1S Reinforced BioScaffold 18x22cm, Part Number F10256-1822G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G Terminated |
FTM | K153633 |
| Apr 6, 2018 | AROA Biosurgery, LTD. OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G Terminated |
FTM | K153633 |
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