Medical Device Manufacturer · US , West Lafayetta , IN

Cook Biotech Incorporated - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2013
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
1-16 of 16
Cleared May 24, 2024
Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6)
K232646 · KHJ
Ear, Nose, Throat · 268d
Cleared Jul 13, 2020
Biodesign Staple Line Reinforcement
K201000 · FTM
General & Plastic Surgery · 88d
Cleared Dec 27, 2019
Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic...
K191696 · OXN
General & Plastic Surgery · 185d
Cleared Mar 13, 2018
Biodesign Diaphragmatic Hernia Graft
K171817 · FTM
General & Plastic Surgery · 267d
Cleared Jul 10, 2017
Biodesign Parastomal Hernia Repair Graft
K162934 · FTM
General & Plastic Surgery · 263d
Cleared Jun 21, 2017
Biodesign Fistula Plug
K170016 · FTM
General & Plastic Surgery · 169d
Cleared Apr 28, 2017
Biodesign Staple Line Reinforcement
K170945 · OXE
General & Plastic Surgery · 29d
Cleared Jan 13, 2017
DynaMatrix/Dynamatrix Plus
K161762 · NPL
Dental · 200d
Cleared Oct 31, 2016
AxoGuard Nerve Connector
K162741 · JXI
Neurology · 31d
Cleared Sep 28, 2016
Flowable Wound Matrix
K160136 · KGN
General & Plastic Surgery · 252d
Cleared May 26, 2016
Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug
K161221 · FTM
General & Plastic Surgery · 27d
Cleared May 11, 2016
Biodesign Otologic Repair Graft
K161000 · KHJ
Ear, Nose, Throat · 30d
Cleared Apr 29, 2016
Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair...
K160869 · FTM
General & Plastic Surgery · 30d
Cleared Aug 19, 2015
Cook ECM Powder
K152033 · KGN
General & Plastic Surgery · 28d
Cleared Jan 10, 2014
NERVE CUFF
K132660 · JXI
Neurology · 137d
Cleared Apr 05, 2013
BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS
K130006 · PAI
Obstetrics & Gynecology · 93d
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