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FDA 510(k) Applications Submitted by COOK BIOTECH INCORPORATED
FDA 510(k) Number
Submission Date
Device Name
Applicant
K132660
08/26/2013
NERVE CUFF
COOK BIOTECH INCORPORATED
K201000
04/16/2020
Biodesign Staple Line Reinforcement
Cook Biotech Incorporated
K130006
01/02/2013
BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS
COOK BIOTECH INCORPORATED
K170016
01/03/2017
Biodesign Fistula Plug
Cook Biotech Incorporated
K152033
07/22/2015
Cook ECM Powder
Cook Biotech Incorporated
K160136
01/20/2016
Flowable Wound Matrix
COOK BIOTECH INCORPORATED
K160869
03/30/2016
Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft
COOK BIOTECH INCORPORATED
K170945
03/30/2017
Biodesign Staple Line Reinforcement
Cook Biotech Incorporated
K161000
04/11/2016
Biodesign Otologic Repair Graft
COOK BIOTECH INCORPORATED
K161221
04/29/2016
Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug
Cook Biotech Incorporated
K171817
06/19/2017
Biodesign Diaphragmatic Hernia Graft
Cook Biotech Incorporated
K191696
06/25/2019
Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft
Cook Biotech Incorporated
K161762
06/27/2016
DynaMatrix/Dynamatrix Plus
COOK BIOTECH INCORPORATED
K162741
09/30/2016
AxoGuard Nerve Connector
COOK BIOTECH INCORPORATED
K162934
10/20/2016
Biodesign Parastomal Hernia Repair Graft
Cook Biotech Incorporated
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