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Sources: EU EUDAMED, US FDA
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Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100601CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FGE·August 29, 2008
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060801CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FGE·August 29, 2008
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090401CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FGE·August 29, 2008
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FGE·August 29, 2008
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080303CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FGE·August 29, 2008
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100301CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FGE·August 29, 2008
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100303CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FGE·August 29, 2008
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070301CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FGE·August 29, 2008
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080301CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FGE·August 29, 2008
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090601CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FGE·August 29, 2008
The LIFEPAK 20 defibrillator/monitor and LIFEPAK 20e. Product part numbers: 3202487-xxx, 3202488-000, U3202487-000, 3202488-015, and U3202488-000. The LIFEPAK 20 defibrillator/monitor and LIFEPAK 20e are acute cardiac care devices used by authorized healthcare providers in hospital and clinic settings. It is commonly found on "code" or "crash" cars in hospital hallways, plugged into AC power. In an emergency the user retrieves the cart, unplugging the monitor, and uses the device with the door closed for easy 1-2-3 operation. When the code team arrives the user will open the door and have access to all functions, including ECG monitoring. In addition to functioning as a semi-automatic defibrillator the LIFEPAK 20/20e provides options for: ECG monitoring, manual mode defibrillation; Non-invasive pacing; synchronized cardioversion; pulse oximetry (SpO2); hard paddles (adult and pediatric) and internal paddle accessories; printing; and backup batter power. The units are biphasic waveform devices
FDA Recall
Terminated
·Physio Control, Inc.·Product code MKJ·May 27, 2010
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100401CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FGE·August 29, 2008
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060303CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FGE·August 29, 2008
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070303CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FGE·August 29, 2008
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070401CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FGE·August 29, 2008
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FGE·August 29, 2008
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100803CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FGE·August 29, 2008
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090301CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FGE·August 29, 2008
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080403CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FGE·August 29, 2008
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090203CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FGE·August 29, 2008