60 results
·
33ms
·
Sources: EU EUDAMED, US FDA
Novoste, Beta-Cath 3.5F System, New B-Rail 3.5F Delivery Catheter, with Indicator of Source Train (IST), Novoste Corporate, 3890 Steve Reynolds Blvd, Norcross, GA 30093, Tel: +1770-717-0904, Fax: +1770-717-1283, 1-800-NOVOSTE (1-800-668-6783), www.novoste.com.
FDA Recall
Terminated
·Novoste Corporation·Product code JAJ·January 25, 2002
3.5F BETA-RAIL DELIVERY CATHETER
FDA Adverse Event
Malfunction
·NOVOSTE CORP.·Product code MOU·February 19, 2004
3.5F BETA-RAIL DELIVERY CATHETER
FDA Adverse Event
Malfunction
·NOVOSTE CORP.·Product code MOU·February 19, 2004
3.5F BETA-RAIL DELIVERY CATHETER
FDA Adverse Event
Malfunction
·NOVOSTE CORP.·Product code MOU·February 19, 2004
ALPHA IV REV. 2 40MM ACTIVE TRANSFER
FDA Adverse Event
Other
·NOVOSTE CORP.·Product code MOU·February 6, 2004
30MM BETA-CATH DELIVERY CATHETER
FDA Adverse Event
Malfunction
·NOVOSTE CORP.·Product code MOU·February 28, 2002
30MM BETA-CATH DELIVERY CATHETER
FDA Adverse Event
Malfunction
·NOVOSTE CORP·Product code MOU·February 6, 2002
3.5F BETA-RAIL DELIVERY CATHETER
FDA Adverse Event
Death
·NOVOSTE CORP·Product code MOU·September 18, 2003
3.5F BETA-RAIL DELIVERY CATHETER
FDA Adverse Event
Other
·NOVOSTE CORP.·Product code MOU·September 18, 2003
5F ALPHA IV REV 2 40MM ACTIVE TRANSFER DEVICE
FDA Adverse Event
Malfunction
·NOVOSTE CORP.·Product code MOU·March 11, 2003
ALPHA IV REV.2, 40MM ACTIVE TRANSFER DEVICE
FDA Adverse Event
Malfunction
·NOVOSTE CORP.·Product code MOU·January 31, 2003
3.5F BETA-RAIL DELIVERY CATHETER
FDA Adverse Event
Other
·NOVOSTE CORP.·Product code MOU·March 11, 2003
NOVOSTE
FDA Adverse Event
NOVOSTE CORP.·Product code MOU·January 21, 2003
NOVOSTE
FDA Adverse Event
Malfunction
·NOVOSTE CORP·Product code MOU·January 21, 2003
3.5F BETA-RAIL DELIVERY CATHETER
FDA Adverse Event
NOVOSTE CORP.·Product code MOU·March 11, 2003
5F BETA-CATH SYSTEM
FDA Adverse Event
Malfunction
·NOVOSTE CORP.·Product code MOU·March 14, 2003
40MM BETA-CATH DELIVERY CATHETER
FDA Adverse Event
Malfunction
·NOVOSTE CORP.·Product code MOU·January 2, 2003
3.5F BETA-RAIL DELIVERY CATHETER
FDA Adverse Event
NOVOSTE CORP.·Product code MOU·March 11, 2003
NOVOSTE
FDA Adverse Event
Other
·NOVOSTE CORP.·Product code MOU·September 27, 2004
3.5 BETA-RAIL DELIVERY CATHETER
FDA Adverse Event
Death
·NOVOSTE CORP.·Product code MOU·July 27, 2004