ONW

Product Code: ONW


Products Classified as ONW

2080Hemodialysis System For Home UseHigh Permeability Hemodialysis System.

Total Product Life Cycle (TPLC) Devices

2080Hemodialysis System For Home UseHigh Permeability Hemodialysis System.

Pre-market Notifications for ONW

K1240352008K@HOME HEMODIALYSIS MACHINEFRESENIUS MEDICAL CARE NORTH AMERICA
K121421FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
K070049FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTORFRESENIUS MEDICAL CARE NORTH AMERICA

Global Unique Device Identification Database

10840861100337Hemodialysis system for home use
00840861101023Hemodialysis system for home use
00840861100965Hemodialysis system for home use
00840861100958Hemodialysis system for home use
00840861100941Hemodialysis system for home use

Maude Adverse Events

2008K@HOME HEMODIALYSIS SYSTEMCONCORD MANUFACTURING2020-02-28
MEMODIALYSIS MACHINEFRESENIUS MEDICAL CARE NORTH AMERICA /ERIKA DE REYNOSA, S.A. DE C.V.2019-07-31
2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAGCONCORD MANUFACTURING2019-07-29
2008K@HOME HEMODIALYSIS SYSTEMCONCORD MANUFACTURING2019-07-11
2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAGCONCORD MANUFACTURING2018-08-28
2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAGCONCORD MANUFACTURING2018-08-16
HOME HEMO COMBI SET FOR CANADAERIKA DE REYNOSA, S.A. DE C.V.2018-07-24
HOME HEMO COMBI SET FOR CANADAERIKA DE REYNOSA, S.A. DE C.V.2018-07-24
HOME HEMO COMBI SET FOR CANADAERIKA DE REYNOSA, S.A. DE C.V.2018-07-24
2008K@HOME HEMODIALYSIS SYSTEMCONCORD MANUFACTURING2018-05-31
2008K@HOME MACHINECONCORD MANUFACTURING2018-05-14
UNKNOWN- FMC PRODUCTCONCORD MANUFACTURING2018-05-11
2008K@HOME MACHINECONCORD MANUFACTURING2018-05-11
HOME HEMO COMBI SET FOR CANADAERIKA DE REYNOSA, S.A. DE C.V.2018-04-02
2008K@HOME MACHINE,SHORT CAB,OLC/DP,HPCONCORD MANUFACTURING2018-02-06
2008K@HOME HEMODIALYSIS SYSTEMCONCORD MANUFACTURING2018-01-29
2008K@HOME MACHINE,SHORT CAB,OLC/DP,HPCONCORD MANUFACTURING2017-12-26
HOME HEMO COMBI SET FOR CANADAERIKA DE REYNOSA, S.A. DE C.V.2017-11-24
2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAGCONCORD MANUFACTURING2017-11-17
2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAGCONCORD MANUFACTURING2017-11-06
COMBI-SET TRUE FLOW SERIESFRESENIUS MEDICAL CARE NORTH AMERICA, RENAL THERAPIES2017-11-02
2008K@HOME HEMODIALYSIS SYSTEMCONCORD MANUFACTURING2017-08-07
2008K@HOME MACHINECONCORD MANUFACTURING2017-08-01
2008K@HOME MACHINE,SHORT CAB,OLC/DP,HPCONCORD MANUFACTURING2017-05-11
2008K@HOME MACHINE,SHORT CAB,OLC/DP,HPCONCORD MANUFACTURING2017-05-03
2008K@HOME MACHINE,SHORT CAB,OLC/DP,HPCONCORD MANUFACTURING2017-02-22
2008K@HOME MACHINE,SHORT CAB,OLC/DP,HPCONCORD MANUFACTURING2017-02-08
2008K@HOME MACHINE,SHORT CAB,OLC/DP,HPCONCORD MANUFACTURING2016-12-29
2008K@HOME MACHINE,SHORT CAB,OLC/DP,HPFRESENIUS MEDICAL CARE NORTH AMERICA2016-08-26
HOME HEMO COMBI SETFRESENIUS MEDICAL CARE NORTH AMERICA2016-08-19
2008K@HOME MACHINE,SHORT CAB,OLC/DP,HPFRESENIUS MEDICAL CARE NORTH AMERICA2016-08-03
FRESENIUS 2008K@HOMEFRESENIUS MEDICAL CARE NORTH AMERICA2016-07-15
HOME HEMO COMBI SET FOR CANADAFRESENIUS MEDICAL CARE NORTH AMERICA2016-07-01
K@HOMEFRESENIUS MEDICAL CARE NORTH AMERICA2016-06-07
FRESENIUS 2008K@HOMEFRESENIUS MEDICAL CARE NORTH AMERICA2016-06-06
FRESENIUSFRESENIUS MEDICAL CARE NORTH AMERICA2016-05-25
FRESENIUS K@HOME HEMO W/ PRIME BAGFRESENIUS MEDICAL CARE NORTH AMERICA2016-05-04
2008K@HOME MACHINE,SHORT CAB,OLC/DP,HPFRESENIUS MEDICAL CARE NORTH AMERICA2016-04-06
HOME HEMO COMBI SETREYNOSA PLANT2016-03-11
FRESENIUS 2008K@HOME HEMODIALYSIS SYSTEM WITH BIBAGFRESENIUS MEDICAL CARE NORTH AMERICA2016-02-18
FRESENIUS HOME HEMO WITH PRIME BAGFRESENIUS MEDICAL CARE NORTH AMERICA2016-02-05
HOME HEMO COMBI SETFRESENIUS MEDICAL CARE NORTH AMERICA2016-02-04
FRESENIUS 2008K@HOMEFRESENIUS MEDICAL CARE NORTH AMERICA2016-01-14
FRESENIUS 2008K@HOMEFRESENIUS MEDICAL CARE NORTH AMERICA2016-01-06
FRESENIUS 2008K@HOMEFRESENIUS MEDICAL CARE NORTH AMERICA2016-01-06
PRISMAGAMBRO RENAL PRODUCTS, INC.2016-01-06
K MACHINEFRESENIUS MEDICAL CARE NORTH AMERICA2015-12-30
FRESENIUS 2008K@HOMEFRESENIUS MEDICAL CARE NORTH AMERICA2015-12-16
FRESENIUS K@HOME HEMO W/PRIME BAGFRESENIUS MEDICAL CARE NORTH AMERICA2015-11-20
FRESENIUS K@HOME HEMO W/PRIME BAGFRESENIUS MEDICAL CARE NORTH AMERICA2015-11-20
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