FLCClass IILife-sustaining
Station, Dialysis Control, Negative Pressure Type
Gastroenterology, Urology · 21 CFR 876.5820
MDR events7All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances4All time
Recent MDR events
7 adverse event reports on file
- ULTRASONIC SCALERJun 17, 2025InjuryUnknownMW5171604
- FRESENIUSMar 18, 1994OtherFresenius Usa, Inc.2243621-1994-00014
- FRESENIUS 2008 BSSMar 18, 1994OtherFresenius Usa, Inc.2243621-1994-00013
- FRESENIUS 2008 BSSMar 18, 1994OtherFresenius Usa, Inc.2243621-1994-00015
- COBE CENTRY 2 RX DIALYSIS CONTROL UNITOct 15, 1992DeathCobe Laboratories, Inc.1551
- CENTRY 2RXAug 6, 1992MalfunctionCobe Laboratories Inc.3568
- REDY 2000Jul 4, 1992MalfunctionOrganon Teknika1077
Event type breakdown
Other3
Malfunction2
Death1
Injury1
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
4 clearances for this product code