# Cryolife, Inc.

- Location (FDA's records): Kennesaw, GA
- FDA decisions: 14 (1999–2019): 12 510(k) clearances and 2 original PMA approvals
- Product codes: OHA (3), FTM (3), DXZ (3), PSQ (2), QSY (1), MNO (1), MUQ (1)
- Predicates its devices cite: 14 (8 its own); citations of its devices by later devices: 12 (8 its own)
- Recalls linked to its devices: 20 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- DePuy Orthopaedics, Inc.: 2 (https://510kreport.com/company/depuy-orthopaedics)
- Sulzer Carbomedics, Inc.: 1 (https://510kreport.com/company/sulzer-carbomedics)
- Pegasus Biologics, Inc.: 1 (https://510kreport.com/company/pegasus-biologics)
- Depuy, Inc.: 1 (https://510kreport.com/company/depuy)
- Hemostasis, LLC: 1 (https://510kreport.com/company/hemostasis)

## Firms that cite its devices most
- Synovis Orthopedic & Woundcare: 2 (https://510kreport.com/company/synovis-orthopedic-woundcare)
- Artivion, Inc.: 1 (https://510kreport.com/company/artivion)
- DePuy Orthopaedics, Inc.: 1 (https://510kreport.com/company/depuy-orthopaedics)

## Its most-cited devices
- K061892: Propatch Soft Tissue Repair Matrix (2006), cited by 3
- K101587: Propatch Soft Tissue Repair Matrix (2010), cited by 2
- K083106: Cryovalve SG Pulmonary Valve and Conduit (2009), cited by 2
- K092021: Cryovalve SG Pulmonary Human Heart Valve (and Conduit) (2010), cited by 2
- K033484: Human Heart Valve, Cryovalve SG (2008), cited by 1
- K172085: PhotoFix Decellularized Bovine Pericardium (2017), cited by 1

## Recent decisions
- K183635: PhotoFix Decellularized Bovine Pericardium (Feb 14, 2019)
- K172085: PhotoFix Decellularized Bovine Pericardium (Dec 4, 2017)
- K162506: PhotoFix Decellularized Bovine Pericardium (Mar 9, 2017)
- K132105: Perclot Topical (Apr 3, 2014)
- K110581: Propatch Soft Tissue Repair Matrix (Jan 10, 2012)
- K101587: Propatch Soft Tissue Repair Matrix (Sep 16, 2010)
- K101866: Cryopatch SG Pulmonary Human Cardiac Patch (Jul 23, 2010)
- K092021: Cryovalve SG Pulmonary Human Heart Valve (and Conduit) (May 25, 2010)

Source page: https://510kreport.com/company/cryolife