Data / Medical devices / Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant
Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant (SGY): 3 FDA-registered makers in 2 countries
3 establishments in 2 countries are registered with the FDA to make Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant (product code SGY, Class 2, 21 CFR 876.5881). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on January 15, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- SGY
- Device class
- 2
- Regulation
- 876.5881
- Medical specialty
- Gastroenterology, Urology
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| Italy | 2 |
| United States | 1 |
Makers of Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bridge to Life Ltd | Duluth, GA, United States | Manufacturer, Specification developer | 1 | January 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| Medica S.p.A. | Medolla Modena, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecnoideal S.R.L. | Mirandola Modena, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.