Data / Medical devices / System And Accessories, Isolated Heart, Transport And Preservation
System And Accessories, Isolated Heart, Transport And Preservation (MSB): 12 FDA-registered makers in 8 countries
12 establishments in 8 countries are registered with the FDA to make System And Accessories, Isolated Heart, Transport And Preservation (product code MSB, Class 2, 21 CFR 876.5880). 8 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 14 510(k) clearances under this code, the latest on September 16, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MSB
- Device class
- 2
- Regulation
- 876.5880
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| France | 2 |
| Germany | 1 |
| Austria | 1 |
| Italy | 1 |
| Canada | 1 |
| Poland | 1 |
| China | 1 |
Makers of System And Accessories, Isolated Heart, Transport And Preservation
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 |
|---|---|---|---|---|---|---|---|---|
| Transmedics, Inc. | Andover, MA, United States | Manufacturer, Specification developer | 2 | November 18, 2022 | 0 | 0 | 0 | api.fda.gov |
| DR. Franz Kohler Chemie GMBH | BENSHEIM Hesse, Germany | Manufacturer | 1 | April 5, 2004 | 0 | 0 | 0 | api.fda.gov |
| Fresenius Kabi Austria GMBH | GRAZ Steiermark, Austria | Specification developer | 1 | July 29, 2021 | 0 | 0 | 0 | api.fda.gov |
| Institut Georges Lopez | Lissieu Auvergne-Rhone-Alpes, France | Manufacturer | 1 | August 5, 1999 | 0 | 0 | 0 | api.fda.gov |
| Institut Georges Lopez | ST LAURENT DE CHAMOUSSET Rhone, France | Manufacturer | 1 | August 5, 1999 | 0 | 1 | 0 | api.fda.gov |
| Paragonix Technologies, Inc. | Waltham, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | March 30, 2018 | 0 | 0 | 0 | api.fda.gov |
| S.A.L.F. Laboratorio Framacologico | Cenate Scotto Bergamo, Italy | Manufacturer | 1 | August 14, 2019 | 0 | 0 | 0 | api.fda.gov |
| Traferox Technologies Inc. | Mississauga Ontario, Canada | Manufacturer | 1 | September 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| Bridge to Life Ltd | Duluth, GA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carnamedica SP Z O O | Warszawa Mazowieckie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Molding Corporation, Ltd. Dba SMC Ltd. | Santa Rosa, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanbor Medical Xiamen, Inc. | Xiamen Fujian, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 16, 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.