90 results
·
48ms
·
Sources: EU EUDAMED, US FDA
DC BEADF
FDA Adverse Event
Injury
·BIOCOMPATIBLES U.K. LTD·Product code HCG·October 30, 2014
DC BEAD
FDA Adverse Event
Injury
·BIOCOMPATIBLES U.K. LTD·Product code HCG·October 8, 2014
THERASPHERE
FDA Adverse Event
Injury
·BIOCOMPATIBLES U.K. LTD·Product code NAW·December 18, 2014
DC BEAD
FDA Adverse Event
Injury
·BIOCOMPATIBLES U.K. LTD·Product code HCG·December 3, 2014
DC BEAD
FDA Adverse Event
Death
·BIOCOMPATIBLES U.K. LTD.·Product code HCG·December 1, 2014
DC BEAD
FDA Adverse Event
Injury
·BIOCOMPATIBLES U.K. LTD.·Product code HCG·April 22, 2015
DC BEAD
FDA Adverse Event
Injury
·BIOCOMPATIBLES U.K. LTD.·Product code HCG·April 28, 2015
TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.
FDA Enforcement
Class II
·Terminated·Biocompatibles U.K., Ltd.·October 19, 2016
TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.
FDA Recall
Terminated
·Biocompatibles U.K., Ltd. Bortoli House Weydon Lane; Old Farnham Lane Farnham United Kingdom·Product code NAW·September 21, 2015
TheraSphere Y90 Glass Microspheres 20 GBq
FDA UDI
BIOCOMPATIBLES UK LTD·05060116920338·TheraSphere Yttrium-90 Glass Microspheres 20 GB...
TheraSphere Y90 Glass Microspheres 4.5 GBq (US Commercial)
FDA UDI
BIOCOMPATIBLES UK LTD·05060116921403·TheraSphere Yttrium-90 Glass Microspheres 4.5 G...
TheraSphere Y90 Glass Microspheres 8.0 GBq
FDA UDI
BIOCOMPATIBLES UK LTD·05060116920413·TheraSphere Yttrium-90 Glass Microspheres 8.0 G...
TheraSphere Y90 Glass Microspheres 19.5 GBq (US Commercial)
FDA UDI
BIOCOMPATIBLES UK LTD·05060116921700·TheraSphere Yttrium-90 Glass Microspheres 19.5 ...
TheraSphere Y90 Glass Microspheres 11.0 GBq
FDA UDI
BIOCOMPATIBLES UK LTD·05060116920468·TheraSphere Yttrium-90 Glass Microspheres 11.0 ...
TheraSphere Y90 Glass Microspheres 18.0 GBq (US Commercial)
FDA UDI
BIOCOMPATIBLES UK LTD·05060116921670·TheraSphere Yttrium-90 Glass Microspheres 18.0 ...
TheraSphere Y90 Glass Microspheres 17.5 GBq
FDA UDI
BIOCOMPATIBLES UK LTD·05060116920581·TheraSphere Yttrium-90 Glass Microspheres 17.5 ...
TheraSphere Y90 Glass Microspheres 5.5 GBq
FDA UDI
BIOCOMPATIBLES UK LTD·05060116920376·TheraSphere Yttrium-90 Glass Microspheres 5.5 G...
TheraSphere Y90 Glass Microspheres 14.0 GBq
FDA UDI
BIOCOMPATIBLES UK LTD·05060116920529·TheraSphere Yttrium-90 Glass Microspheres 14.0 ...
TheraSphere Y90 Glass Microspheres 13.5 GBq (US Commercial)
FDA UDI
BIOCOMPATIBLES UK LTD·05060116921588·TheraSphere Yttrium-90 Glass Microspheres 13.5 ...
TheraSphere Y90 Glass Microspheres 4.0 GBq
FDA UDI
BIOCOMPATIBLES UK LTD·05060116920352·TheraSphere Yttrium-90 Glass Microspheres 4.0 G...