QLOUnclassifiedLife-sustaining
Immunoadsorption Column For Emergency Use
Unknown
Extracorporeal carbon dioxide removal from blood for use during declared public health emergency.
MDR events27All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
27 adverse event reports on file
- SERAPH 100Aug 26, 2025InjuryExthera Medical Corporation3014015528-2025-00025
- SERAPH 100Aug 26, 2025InjuryExthera Medical Corporation3014015528-2025-00026
- SERAPH 100Aug 26, 2025InjuryExthera Medical Corporation3014015528-2025-00027
- SERAPH 100Jun 18, 2025InjuryExthera Medical Corporation3014015528-2025-00024
- SERAPH 100May 15, 2025MalfunctionExthera Medical Corporation3014015528-2025-00010
- SERAPH 100May 15, 2025InjuryExthera Medical Corporation3014015528-2025-00007
- SERAPH 100May 15, 2025InjuryExthera Medical Corporation3014015528-2025-00012
- SERAPH 100May 15, 2025DeathExthera Medical Corporation3014015528-2025-00016
- SERAPH 100May 15, 2025DeathExthera Medical Corporation3014015528-2025-00006
- SERAPH 100May 15, 2025DeathExthera Medical Corporation3014015528-2025-00009
Event type breakdown
Injury18
Death7
Malfunction2
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.