798 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Prismaflex
FDA UDI
GAMBRO AB·07332414105266·The Prismaflex control unit is a software contr...
Prismaflex
FDA UDI
GAMBRO AB·07332414124236·The Prismaflex control unit is a software contr...
AK 98
FDA UDI
GAMBRO AB·07332414124519·Intended for intermittant haemodialysis and/or ...
MARS Monitor
FDA UDI
GAMBRO AB·37332414106936·The MARS Monitor is a mechanical detoxification...
Mars Treatment Kit
FDA UDI
GAMBRO AB·37332414106950·The MARS Treatment Kit type 1115/1-PrisMARS US ...
MARS TREATMENT KIT TYPE 1116/1 - X-MARS US
FDA UDI
GAMBRO AB·37332414107728·The MARS Treatment Kit Type 1116/1 X-MARS is a ...
Prismaflex
FDA UDI
GAMBRO AB·07332414117702·The Prismaflex control unit is a software contr...
PRISMAFLEX
FDA UDI
GAMBRO AB·07332414126766·The Prismaflex control unit is a software contr...
BICART
FDA Adverse Event
Death
·GAMBRO LUNDIA AB·Product code KPO·February 23, 2011
CARTRIDGE
FDA Adverse Event
Injury
·GAMBRO RENAL PRODUCTS S.A. DE C.V.·Product code FJK·November 13, 2014
POLYFLUX H CAPILLLARY DAILYZER
FDA Adverse Event
Death
·GAMBRO DIAYLSATOREN GMBH·Product code KDI·June 4, 2012
CENTRYSYSTEM 3
FDA Adverse Event
Other
·GAMBRO·Product code FII·June 13, 2008
PHOENIX
FDA Adverse Event
Death
·GAMBRO DASCO·Product code FII·July 31, 2006
Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden.
FDA Recall
Terminated
·Gambro Renal Products, Inc.·Product code KDI·January 4, 2007
9616026-2007-00100
FDA Adverse Event
Malfunction
·Product code MQS·October 26, 2007
PHOENIX
FDA Adverse Event
Injury
·GAMBRO DASCO·Product code KDI·July 6, 2011
PHOENIX
FDA Adverse Event
Injury
·GAMBRO DASCO·Product code KDI·July 6, 2011
*
FDA Adverse Event
Malfunction
·GAMBRO LUNDIA AB, MONITOR DIV.·Product code FII·August 18, 2006
XENIUM XPH
FDA Adverse Event
Injury
·NIPRO CORPORATION *USD*·Product code KDI·August 17, 2011
PRISMAFLEX
FDA Adverse Event
Other
·GAMBRO LUNDIA AB·Product code KDI·September 21, 2007