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Cook Biotech Incorporated

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories7
Latest FDA decision2024-05-24
TypeNumberDevice NameCodeDateActions
510(k) K232646 Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)KHJ2024-05-24 View
510(k) K201000 Biodesign Staple Line ReinforcementFTM2020-07-13 View
510(k) K191696 Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue GraftOXN2019-12-27 View
510(k) K171817 Biodesign Diaphragmatic Hernia GraftFTM2018-03-13 View
510(k) K162934 Biodesign Parastomal Hernia Repair GraftFTM2017-07-10 View
510(k) K170016 Biodesign Fistula PlugFTM2017-06-21 View
510(k) K170945 Biodesign Staple Line ReinforcementOXE2017-04-28 View
510(k) K161762 DynaMatrix/Dynamatrix PlusNPL2017-01-13 View
510(k) K162741 AxoGuard Nerve ConnectorJXI2016-10-31 View
510(k) K160136 Flowable Wound MatrixKGN2016-09-28 View
510(k) K161221 Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugFTM2016-05-26 View
510(k) K161000 Biodesign Otologic Repair GraftKHJ2016-05-11 View
510(k) K160869 Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftFTM2016-04-29 View
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