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Cook Biotech, Inc.

FDA 510(k) & PMA Approved Devices — 29 products

Total Devices29
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K131015 BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFTGXQ2013-10-08 View
510(k) K111695 HYBRID GRAFTFTL2012-04-02 View
510(k) K110402 BIODESIGN NIPPLE RECONSTRUCTION CYLINDERFTM2011-06-20 View
510(k) K090688 COOK UROLOGICAL GRAFTPAG2009-07-10 View
510(k) K082682 SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUGFTM2009-02-27 View
510(k) K082058 DYNAMATRIXNPL2008-10-02 View
510(k) K073391 SURGISIS BIODESIGN TISSUE GRAFTFTM2008-03-21 View
510(k) K070405 MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENTFTM2007-10-17 View
510(k) K070738 SIS FACIAL CYLINDER, SIS FACIAL IMPLANTFTM2007-04-05 View
510(k) K062697 SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFTFTL2006-10-13 View
510(k) K062696 SURGISIS, SURGISIS ESFTM2006-10-13 View
510(k) K062729 SURGISIS RVP RECTO-VAGINAL FISTULA PLUGFTM2006-10-10 View
510(k) K062320 SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100FTM2006-10-02 View
510(k) K061711 OASIS WOUND MATRIXKGN2006-07-19 View
510(k) K051048 SURGISIS STAPLE LINE REINFORCEMENT IIFTM2005-09-23 View
510(k) K050246 SIS DERMAL AUGMENTATION STRANDFTM2005-05-19 View
510(k) K050337 SIS FISTULA PLUGFTM2005-03-09 View
510(k) K034039 SIS PLASTIC SURGERY MATRIXFTM2004-02-18 View
510(k) K031850 DURASIS DURAL SUBSTITUTEGXQ2003-09-08 View
510(k) K031069 SURGISIS NERVE CUFFJXI2003-05-15 View
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