32 results
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10ms
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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 Recall
Terminated
·Biocompatibles U.K., Ltd. Bortoli House Weydon Lane; Old Farnham Lane Farnham United Kingdom·Product code NAW·September 21, 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
SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·March 9, 2016
SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system
FDA Recall
Terminated
·Philips Electronics North America Corporation·Product code LNH·July 6, 2015
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
INFX-8000F Fluoroscopic X-Ray Systems
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code MBQ·December 29, 2017
3.2MM Pellet Insertion Tray Catalog Number: B9743
FDA Recall
Terminated
·Busse Hospital Disposables, Inc.·Product code FBQ·February 22, 2022
SS 4.5MM Pellet Insertion Tray Catalog Number:B8128R1
FDA Recall
Terminated
·Busse Hospital Disposables, Inc.·Product code FBQ·February 22, 2022
4.5 MM Pellet Insertion Tray Catalog Number: B8121R1
FDA Recall
Terminated
·Busse Hospital Disposables, Inc.·Product code FBQ·February 22, 2022
SS 3.5MM Diamond Tip Trocar - Medium Gloves Catalog Number: B1555
FDA Recall
Terminated
·Busse Hospital Disposables, Inc.·Product code FBQ·February 22, 2022