Cook Biotech, Inc.
Cook Biotech, Inc. holds FDA 510(k) medical device clearances, first cleared 1998, most recent 2014, with 15 FDA device recalls on record.
Top product codes for Cook Biotech, Inc.
FDA recalls by Cook Biotech, Inc.
10 most recent of 15- Z-0832-2025 — Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
- Z-0833-2025 — Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
- Z-0834-2025 — Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile
- Z-3252-2024 — 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
- Z-3260-2024 — Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46603
- Z-3261-2024 — Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPN): G46603
- Z-3257-2024 — 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
- Z-3251-2024 — 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
- Z-3258-2024 — Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46601
- Z-3256-2024 — 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
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Cook Biotech, Inc.
- K133306 — SIS HERNIA GRAFT
- K133011 — DIAPHRAGMATIC HERNIA GRAFT
- K131015 — BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT
- K111695 — HYBRID GRAFT
- K110402 — BIODESIGN NIPPLE RECONSTRUCTION CYLINDER
- K090688 — COOK UROLOGICAL GRAFT
- K082682 — SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG
- K082058 — DYNAMATRIX
- K073391 — SURGISIS BIODESIGN TISSUE GRAFT
- K070405 — MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT
- K070738 — SIS FACIAL CYLINDER, SIS FACIAL IMPLANT
- K062696 — SURGISIS, SURGISIS ES
- K062697 — SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT
- K062729 — SURGISIS RVP RECTO-VAGINAL FISTULA PLUG
- K062320 — SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100
- K061711 — OASIS WOUND MATRIX
- K051048 — SURGISIS STAPLE LINE REINFORCEMENT II
- K050246 — SIS DERMAL AUGMENTATION STRAND
- K050337 — SIS FISTULA PLUG
- K034039 — SIS PLASTIC SURGERY MATRIX
- K031850 — DURASIS DURAL SUBSTITUTE
- K031069 — SURGISIS NERVE CUFF
- K022044 — SURGISIS STAPLE LINE REINFORCEMENT
- K010952 — SURGISIS GUIDED TISSUE REGENERATION MATRIX
- K020732 — SS MATRIX
- K020654 — STRATASIS SLING KIT
- K001785 — SURGISIS PERIPHERAL VASCULAR PATCH
- K993948 — SIS WOUND DRESSING II
- K992159 — SURGISIS SLING
- K980431 — SURGISIS
- K973170 — SIS WOUND DRESSING
Data sourced from openFDA. This site is unofficial and independent of the FDA.