Biotech companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Cook MedicalLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Cook Biotech with 47 510(k) clearances and 15 device recalls. The most recent is a device recall dated Nov 22, 2024: Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Nov 22, 2024 | Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; andClass II · Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the prod | Device recalls |
| Nov 22, 2024 | Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.Class II · Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the prod | Device recalls |
| Nov 22, 2024 | Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, SterileClass II · Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the prod | Device recalls |
| Aug 7, 2024 | Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPClass II · Products expire prior to the expiration date printed on the product labeling | Device recalls |
| Aug 7, 2024 | Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order NumbeClass II · Products expire prior to the expiration date printed on the product labeling | Device recalls |
| Aug 7, 2024 | Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order NumbClass II · Products expire prior to the expiration date printed on the product labeling | Device recalls |
| Aug 7, 2024 | Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order NClass II · Products expire prior to the expiration date printed on the product labeling | Device recalls |
| Aug 7, 2024 | Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order NumbClass II · Products expire prior to the expiration date printed on the product labeling | Device recalls |
| May 24, 2024 | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)K232646 · KHJ | 510(k) clearances |
| Jul 13, 2020 | Biodesign Staple Line ReinforcementK201000 · FTM | 510(k) clearances |
| Dec 27, 2019 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue GraftK191696 · OXN | 510(k) clearances |
| Mar 13, 2018 | Biodesign Diaphragmatic Hernia GraftK171817 · FTM | 510(k) clearances |
| Jul 10, 2017 | Biodesign Parastomal Hernia Repair GraftK162934 · FTM | 510(k) clearances |
| Jun 21, 2017 | Biodesign Fistula PlugK170016 · FTM | 510(k) clearances |
| Apr 28, 2017 | Biodesign Staple Line ReinforcementK170945 · OXE | 510(k) clearances |
| Jan 13, 2017 | DynaMatrix/Dynamatrix PlusK161762 · NPL | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
