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Cook Biotech, Inc.

FDA Regulatory Profile

Summary

Total Recalls
15
510(k) Clearances
31
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0833-2025Class IICook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; andNovember 22, 2024
Z-0834-2025Class IICook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, SterileNovember 22, 2024
Z-0832-2025Class IICook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.November 22, 2024
Z-3257-2024Class IIBiodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vAugust 7, 2024
Z-3258-2024Class IIBiodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair August 7, 2024
Z-3256-2024Class IIBiodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vAugust 7, 2024
Z-3255-2024Class IIBiodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vAugust 7, 2024
Z-3260-2024Class IIBiodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair August 7, 2024
Z-3251-2024Class IIBiodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vagAugust 7, 2024
Z-3250-2024Class IIBiodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vagAugust 7, 2024
Z-3253-2024Class IIBiodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vagAugust 7, 2024
Z-3259-2024Class IIBiodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair August 7, 2024
Z-3254-2024Class IIBiodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vagAugust 7, 2024
Z-3252-2024Class IIBiodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vagAugust 7, 2024
Z-3261-2024Class IIBiodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repAugust 7, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K133306SIS HERNIA GRAFTJuly 23, 2014
K133011DIAPHRAGMATIC HERNIA GRAFTJune 20, 2014
K131015BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFTOctober 8, 2013
K111695HYBRID GRAFTApril 2, 2012
K110402BIODESIGN NIPPLE RECONSTRUCTION CYLINDERJune 20, 2011
K090688COOK UROLOGICAL GRAFTJuly 10, 2009
K082682SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUGFebruary 27, 2009
K082058DYNAMATRIXOctober 2, 2008
K073391SURGISIS BIODESIGN TISSUE GRAFTMarch 21, 2008
K070405MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENTOctober 17, 2007
K070738SIS FACIAL CYLINDER, SIS FACIAL IMPLANTApril 5, 2007
K062697SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFTOctober 13, 2006
K062696SURGISIS, SURGISIS ESOctober 13, 2006
K062729SURGISIS RVP RECTO-VAGINAL FISTULA PLUGOctober 10, 2006
K062320SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100October 2, 2006
K061711OASIS WOUND MATRIXJuly 19, 2006
K051048SURGISIS STAPLE LINE REINFORCEMENT IISeptember 23, 2005
K050246SIS DERMAL AUGMENTATION STRANDMay 19, 2005
K050337SIS FISTULA PLUGMarch 9, 2005
K034039SIS PLASTIC SURGERY MATRIXFebruary 18, 2004