CryoLife, Inc.
FDA Regulatory Profile
CryoLife, Inc. appears in FDA public data with 14 recalls, 12 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0384-2022, Class II) was initiated on October 7, 2021. Its most recent 510(k) clearance was granted on February 14, 2019.
Summary
- Total Recalls
- 14
- 510(k) Clearances
- 12
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0384-2022 | Class II | BioGlue Surgical Adhesive, Model BG3510-5-G | October 7, 2021 |
| Z-0653-2021 | Class II | CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue culture medium c | November 10, 2020 |
| Z-0652-2021 | Class II | CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium con | November 10, 2020 |
| Z-1073-2019 | Class II | On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve | January 17, 2019 |
| Z-0121-2019 | Class II | CryoPatch SG Pulmonary Hemi-Artery, 1 graft | September 6, 2018 |
| Z-2556-2018 | Class II | BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for use as an | June 4, 2018 |
| Z-2272-2018 | Class II | Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020 | May 14, 2018 |
| Z-2271-2018 | Class II | Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO | May 14, 2018 |
| Z-2623-2017 | Class II | BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J | May 19, 2017 |
| Z-1219-2019 | Class II | CryoPatch SG Pulmonary Hemi-Artery Patch | November 21, 2016 |
| Z-2715-2017 | Class II | On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, o | June 12, 2015 |
| Z-1674-2014 | Class II | BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for | April 25, 2014 |
| Z-3108-2017 | Class II | On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replaceme | February 12, 2014 |
| Z-0809-2014 | Class II | Pulmonary Hemi-Artery SG Used in heart surgery | November 22, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K183635 | PhotoFix Decellularized Bovine Pericardium | February 14, 2019 |
| K172085 | PhotoFix Decellularized Bovine Pericardium | December 4, 2017 |
| K162506 | PhotoFix Decellularized Bovine Pericardium | March 9, 2017 |
| K132105 | PERCLOT TOPICAL | April 3, 2014 |
| K110581 | PROPATCH SOFT TISSUE REPAIR MATRIX | January 10, 2012 |
| K101587 | PROPATCH SOFT TISSUE REPAIR MATRIX | September 16, 2010 |
| K101866 | CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH | July 23, 2010 |
| K092021 | CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) | May 25, 2010 |
| K091626 | CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH | August 7, 2009 |
| K083106 | CRYOVALVE SG PULMONARY VALVE AND CONDUIT | February 6, 2009 |
| K033484 | HUMAN HEART VALVE, CRYOVALVE SG | February 7, 2008 |
| K061892 | PROPATCH SOFT TISSUE REPAIR MATRIX | November 22, 2006 |