| 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-2271-2018 | Class II | Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO | May 14, 2018 |
| Z-2272-2018 | Class II | Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020 | 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 |