Panels › Gastroenterology, Urology › Product code MSB · Class 2
System And Accessories, Isolated Heart, Transport And Preservation
Regulation 876.5880
1510(k)s in 12 months (14 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in MSB
| Company | 510(k)s | Recalls |
|---|---|---|
| Paragonix Technologies | 5 | 0 |
| TransMedics, Inc. | 2 | 0 |
| Vitrolife AB | 1 | 1 |
| Vitrolife Sweden AB | 2 | 0 |
| Dr. Franz Kohler Chemie GmbH | 1 | 0 |
| INSTITUT GEORGES LOPEZ | 0 | 1 |
| S.A.L.F. Spa | 1 | 0 |
| Sangstat Medical Corp. | 1 | 0 |
| Traferox Technologies, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 30, 2025 | INSTITUT GEORGES LOPEZ Brand Name: Celsior Cold Storage Solution
Product Name: Celsior Cold Storage Solution
Model/Catalog Number: 533682
Product Description: In US Celsior is a class II medical device. Celsior is a clear t Open, Classified |
MSB | K991594 |
| Jul 12, 2011 | Vitrolife, Inc. XVIVO Perfusion AB (Part of Vitrolife), THAM Solution, 3.3 mmol/ml, 50 mL, REF 99019, Sterile, Used to increase the pH of the Perfadex used for perfusion of donor lungs.
Perfadex with THAM kits, Terminated |
MSB | K081997 |
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