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Cook Biotech, Inc.

16 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Ste recall (Z-0832-2025)Cook Biotech, Inc.2025-01-10
Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and recall (Z-0833-2025)Cook Biotech, Inc.2025-01-10
Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile recall (Z-0834-2025)Cook Biotech, Inc.2025-01-10
Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recall (Z-3250-2024)Cook Biotech, Inc.2024-09-25
Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recall (Z-3251-2024)Cook Biotech, Inc.2024-09-25
Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recall (Z-3252-2024)Cook Biotech, Inc.2024-09-25
Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recall (Z-3253-2024)Cook Biotech, Inc.2024-09-25
Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recall (Z-3254-2024)Cook Biotech, Inc.2024-09-25
Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair recall (Z-3255-2024)Cook Biotech, Inc.2024-09-25
Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair recall (Z-3256-2024)Cook Biotech, Inc.2024-09-25
Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair recall (Z-3257-2024)Cook Biotech, Inc.2024-09-25
Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue f recall (Z-3258-2024)Cook Biotech, Inc.2024-09-25
Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue f recall (Z-3259-2024)Cook Biotech, Inc.2024-09-25
Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue f recall (Z-3260-2024)Cook Biotech, Inc.2024-09-25
Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal fl recall (Z-3261-2024)Cook Biotech, Inc.2024-09-25
Surgisis peripheral vascular patch; catalog number C-VSLH-4S-1x10. recall (Z-0577-03)Cook Biotech, Inc.2003-02-26

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Every clearance here is in the API, with alerts when new ones post.