37 results
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14ms
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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
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product Usage: The QUADROX oxygenators are intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The devices utilization period is limited to six hours.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·November 7, 2012
StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020
FDA Recall
Terminated
·Cook Inc.·Product code FFK·January 31, 2018
StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)00827002526006
FDA Recall
Terminated
·Cook Inc.·Product code FFK·January 31, 2018
StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827002525993
FDA Recall
Terminated
·Cook Inc.·Product code FFK·January 31, 2018
StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)00827002526006
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 9, 2018
StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827002525993
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 9, 2018
StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 9, 2018
ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code GBQ·June 29, 2015
SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352
FDA Recall
Terminated
·Busse Hospital Disposables, Inc.·Product code FBQ·February 22, 2022
SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354R1
FDA Recall
Terminated
·Busse Hospital Disposables, Inc.·Product code FBQ·February 22, 2022
SS 4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1365R1
FDA Recall
Terminated
·Busse Hospital Disposables, Inc.·Product code FBQ·February 22, 2022
4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1362
FDA Recall
Terminated
·Busse Hospital Disposables, Inc.·Product code FBQ·February 22, 2022
Male SS 4.5MM Pellet Insertion Tray Catalog Number: B9176R1
FDA Recall
Terminated
·Busse Hospital Disposables, Inc.·Product code FBQ·February 22, 2022
SS 4.5MM Pellet Insertion Tray Catalog Number: B9807
FDA Recall
Terminated
·Busse Hospital Disposables, Inc.·Product code FBQ·February 22, 2022
SS 3.5MM Diamond Tip Trocar - Large Gloves Catalog Number: B1547
FDA Recall
Terminated
·Busse Hospital Disposables, Inc.·Product code FBQ·February 22, 2022
SS 4.5MM DIAMOND TIP TROCAR WITH MEDIUM GLOVES Catalog Number: B1560
FDA Recall
Terminated
·Busse Hospital Disposables, Inc.·Product code FBQ·February 22, 2022
3.2MM Pellet Insertion Tray Catalog Number: B1144
FDA Recall
Terminated
·Busse Hospital Disposables, Inc.·Product code FBQ·February 22, 2022
Female SS 3.5MM Pellet Insertion Tray Catalog Number: B9175R1
FDA Recall
Terminated
·Busse Hospital Disposables, Inc.·Product code FBQ·February 22, 2022