Cook Biotech Incorporated
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 16
- Inspections
- 4
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K232646 | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-O | May 24, 2024 |
| K201000 | Biodesign Staple Line Reinforcement | July 13, 2020 |
| K191696 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tis | December 27, 2019 |
| K171817 | Biodesign Diaphragmatic Hernia Graft | March 13, 2018 |
| K162934 | Biodesign Parastomal Hernia Repair Graft | July 10, 2017 |
| K170016 | Biodesign Fistula Plug | June 21, 2017 |
| K170945 | Biodesign Staple Line Reinforcement | April 28, 2017 |
| K161762 | DynaMatrix/Dynamatrix Plus | January 13, 2017 |
| K162741 | AxoGuard Nerve Connector | October 31, 2016 |
| K160136 | Flowable Wound Matrix | September 28, 2016 |
| K161221 | Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug | May 26, 2016 |
| K161000 | Biodesign Otologic Repair Graft | May 11, 2016 |
| K160869 | Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft | April 29, 2016 |
| K152033 | Cook ECM Powder | August 19, 2015 |
| K132660 | NERVE CUFF | January 10, 2014 |
| K130006 | BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS | April 5, 2013 |