Cook Biotech Incorporated is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Cook Biotech Incorporated - FDA 510(k) Cleared Devices
Recent clearances: Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6), Biodesign Staple Line Reinforcement, Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft
16
Total
16
Cleared
0
Denied
Cook Biotech Incorporated has 16 FDA 510(k) cleared medical devices. Based in West Lafayetta, US.
Latest FDA clearance: May 2024. Active since 2013. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by Cook Biotech Incorporated Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Cook Biotech Incorporated
16 devices
Cleared
May 24, 2024
Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6)
Ear, Nose, Throat
268d
Cleared
Jul 13, 2020
Biodesign Staple Line Reinforcement
General & Plastic Surgery
88d
Cleared
Dec 27, 2019
Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic...
General & Plastic Surgery
185d
Cleared
Mar 13, 2018
Biodesign Diaphragmatic Hernia Graft
General & Plastic Surgery
267d
Cleared
Jul 10, 2017
Biodesign Parastomal Hernia Repair Graft
General & Plastic Surgery
263d
Cleared
Jun 21, 2017
Biodesign Fistula Plug
General & Plastic Surgery
169d
Cleared
Apr 28, 2017
Biodesign Staple Line Reinforcement
General & Plastic Surgery
29d
Cleared
Jan 13, 2017
DynaMatrix/Dynamatrix Plus
Dental
200d
Cleared
Oct 31, 2016
AxoGuard Nerve Connector
Neurology
31d
Cleared
Sep 28, 2016
Flowable Wound Matrix
General & Plastic Surgery
252d
Cleared
May 26, 2016
Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug
General & Plastic Surgery
27d
Cleared
May 11, 2016
Biodesign Otologic Repair Graft
Ear, Nose, Throat
30d