Medical Device Manufacturer · US , West Lafayetta , IN

Cook Biotech Incorporated

16 submissions · 16 cleared · Since 2013
16
Total
16
Cleared
0
Denied

Cook Biotech Incorporated — FDA 510(k) Submissions

Cook Biotech Incorporated has submitted 16 FDA 510(k) premarket notifications since 2013, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Mesh, Surgical, Cuff, Nerve, Wound Dressing With Animal-derived Material(s), Polymer, Ent Synthetic-polyamide (mesh Or Foil Material), Barrier, Animal Source, Intraoral . Use the specialty filter in the sidebar to narrow results.

16 devices
1–16 of 16
Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)
K232646 · KHJ Polymer, Ent... · Ear, Nose, Throat
May 2024 268d
Biodesign Staple Line Reinforcement
K201000 · FTM Mesh, Surgical · General & Plastic Surgery
Jul 2020 88d
Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft
K191696 · OXN Mesh, Surgical, Collagen,... · General & Plastic Surgery
Dec 2019 185d
Biodesign Diaphragmatic Hernia Graft
K171817 · FTM Mesh, Surgical · General & Plastic Surgery
Mar 2018 267d
Biodesign Parastomal Hernia Repair Graft
K162934 · FTM Mesh, Surgical · General & Plastic Surgery
Jul 2017 263d
Biodesign Fistula Plug
K170016 · FTM Mesh, Surgical · General & Plastic Surgery
Jun 2017 169d
Biodesign Staple Line Reinforcement
K170945 · OXE Mesh, Surgical, Collagen,... · General & Plastic Surgery
Apr 2017 29d
DynaMatrix/Dynamatrix Plus
K161762 · NPL Barrier, Animal Source,... · Dental
Jan 2017 200d
AxoGuard Nerve Connector
K162741 · JXI Cuff, Nerve · Neurology
Oct 2016 31d
Flowable Wound Matrix
K160136 · KGN Wound Dressing With... · General & Plastic Surgery
Sep 2016 252d
Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug
K161221 · FTM Mesh, Surgical · General & Plastic Surgery
May 2016 27d
Biodesign Otologic Repair Graft
K161000 · KHJ Polymer, Ent... · Ear, Nose, Throat
May 2016 30d
Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft
K160869 · FTM Mesh, Surgical · General & Plastic Surgery
Apr 2016 30d
Cook ECM Powder
K152033 · KGN Wound Dressing With... · General & Plastic Surgery
Aug 2015 28d
NERVE CUFF
K132660 · JXI Cuff, Nerve · Neurology
Jan 2014 137d
BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS
K130006 · PAI Mesh, Surgical,... · Obstetrics & Gynecology
Apr 2013 93d
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