Artivion, Inc.
Artivion, Inc. holds FDA 510(k) medical device clearance, cleared in 2025, with 3 FDA device recalls on record.
Top product codes for Artivion, Inc.
FDA recalls by Artivion, Inc.
- Z-2532-2024 — (1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoPatch SG Pulmonary Human Cardiac Branch Patch, SGP020, Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology.
- Z-2531-2024 — CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
- Z-1545-2024 — CryoValve SG Cryopreserved Pulmonary Human Heart Valve
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Artivion, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.