inforMED
FKJClass IILife-sustaining

Filter, Blood, Dialysis

Gastroenterology, Urology · 21 CFR 876.5820

MDR events176All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances5All time

Recent MDR events

176 adverse event reports on file

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Event type breakdown

Malfunction85
Injury69
Death16
Other4
Unspecified2

Most-reported manufacturers

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Erika De Reynosa46B. Braun Avitum Ag - Melsungen44Reynosa Manufacturing21B. Braun Avitum Ag - Melsungen8B.braun Avitum Ag8Fresenius Usa8Fresenius Medical Care5Fresenius3

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

2 firms currently registered for this product code

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510(k) clearances

5 clearances for this product code

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