93 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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
Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
4.5mm x 35mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009
5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Recall
Terminated
·NuVasive Inc·Product code NKB·January 5, 2009