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United States·US-MF-000015763
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 1655, Roberts Boulevard NW, Kennesaw, United States
- Website
- www.artivion.com
- —
- —
- [email protected]
- Phone
- +1 770-419-3355
- PRRC Contact
- Drew Green
- EUDAMED SRN
- US-MF-000015763
- FDA FEI Number
- 3001451326
- DUNS Number
- 119253177
Catalogue (52)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PhotoFix Decellularized Bovine Pericardium | PFP1X10-G | EUDAMED | Class III | Active |
| PhotoFix Decellularized Bovine Pericardium | PFP1X14-G | EUDAMED | Class III | Active |
Related Companies
Authorised Representatives
- JOTEC GmbH DE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| May 28, 2024 | Z-2531-2024 | — | open, classified | Grafts were found to have been approved, released, shipped and implanted with an invalid test results. |
| May 28, 2024 | Z-2532-2024 | — | open, classified | Grafts were found to have been approved, released, shipped and implanted with an invalid test results. |
| Mar 6, 2024 | Z-1545-2024 | — | open, classified | The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus. |