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Displaying 21 - 40 of 209
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FDA Scolds Abiomed for Not Seeking a PMA for Its Web-Based User Portal
News Daily News

FDA Scolds Abiomed for Not Seeking a PMA for Its Web-Based User Portal

Caitlin E. Cox
Caitlin E. Cox
October 17, 2023
GLP-1 Meds Linked to 265 Reports to FDA of Suicidal Ideation: Reuters
News Daily News

GLP-1 Meds Linked to 265 Reports to FDA of Suicidal Ideation: Reuters

Shelley Wood
Shelley Wood
September 28, 2023
‘Overwhelming Reduction’ in Bleeding With Abelacimab vs Rivaroxaban in AF
News Daily News

‘Overwhelming Reduction’ in Bleeding With Abelacimab vs Rivaroxaban in AF

L.A. McKeown
L.A. McKeown
September 18, 2023
European Regulators Investigating CV Safety of Weight-Loss Drug Mysimba
News Daily News

European Regulators Investigating CV Safety of Weight-Loss Drug Mysimba

Michael O'Riordan
Michael O'Riordan
September 15, 2023
Label for Impella RP Flex Catheters Recalled to Address Anticoagulant Confusion: FDA
News Daily News

Label for Impella RP Flex Catheters Recalled to Address Anticoagulant Confusion: FDA

Caitlin E. Cox
Caitlin E. Cox
August 18, 2023
Cardiosave IABPs—Yet Again—the Subject of a Class I Recall: FDA
News Daily News

Cardiosave IABPs—Yet Again—the Subject of a Class I Recall: FDA

Caitlin E. Cox
Caitlin E. Cox
August 17, 2023
Cardiosave IABPs Recalled Again, This Time Due to Potential Electrical Problems: FDA
News Daily News

Cardiosave IABPs Recalled Again, This Time Due to Potential Electrical Problems: FDA

Michael O'Riordan
Michael O'Riordan
August 10, 2023
FDA: Class I Recall for Left-Sided Impella Pumps Due to TAVI Interaction
News Daily News

FDA: Class I Recall for Left-Sided Impella Pumps Due to TAVI Interaction

Caitlin E. Cox
Caitlin E. Cox
July 27, 2023
Class I Recall for Amplatzer LAAO's Steerable Delivery Sheath
News Daily News

Class I Recall for Amplatzer LAAO's Steerable Delivery Sheath

Shelley Wood
Shelley Wood
July 26, 2023
Class I Recall for 350,000 Medtronic Defibrillators: FDA
News Daily News

Class I Recall for 350,000 Medtronic Defibrillators: FDA

Michael O'Riordan
Michael O'Riordan
July 19, 2023
CMS Issues Proposed Coverage Decision to Broaden Access for Carotid Stenting
News Daily News

CMS Issues Proposed Coverage Decision to Broaden Access for Carotid Stenting

L.A. McKeown
L.A. McKeown
July 12, 2023
FDA: All Restrictions on Paclitaxel Devices for PAD Are Removed
News Daily News

FDA: All Restrictions on Paclitaxel Devices for PAD Are Removed

L.A. McKeown
L.A. McKeown
July 11, 2023
Abiomed Recalls Certain Impella 5.5 Devices Due to Risk of Purge-Fluid Leaks
News Daily News

Abiomed Recalls Certain Impella 5.5 Devices Due to Risk of Purge-Fluid Leaks

Caitlin E. Cox
Caitlin E. Cox
June 05, 2023
Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs
News Daily News

Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

Shelley Wood
Shelley Wood
March 31, 2023
Generic Dabigatran Lots Pulled for Nitrosamine Impurity
News Daily News

Generic Dabigatran Lots Pulled for Nitrosamine Impurity

Michael O'Riordan
Michael O'Riordan
March 28, 2023
FDA Alert: Possible Early Deterioration of Abbott Trifecta SAVR Valves
News Daily News

FDA Alert: Possible Early Deterioration of Abbott Trifecta SAVR Valves

Todd Neale
Todd Neale
February 27, 2023
New IABP Recall: Balloon Catheter Damage Might Cause Bleeding Into Pump
News Daily News

New IABP Recall: Balloon Catheter Damage Might Cause Bleeding Into Pump

Shelley Wood
Shelley Wood
January 25, 2023
Medical Devices Cleared on Faulty Predicates More Likely to be Recalled
News Daily News

Medical Devices Cleared on Faulty Predicates More Likely to be Recalled

Michael O'Riordan
Michael O'Riordan
January 17, 2023
FDA: Endologix AAA Grafts Get New Labeling That Addresses Endoleak Potential
News Daily News

FDA: Endologix AAA Grafts Get New Labeling That Addresses Endoleak Potential

L.A. McKeown
L.A. McKeown
December 06, 2022
Impella RP Mortality Rate No Longer a Concern, FDA Says
News Daily News

Impella RP Mortality Rate No Longer a Concern, FDA Says

Caitlin E. Cox
Caitlin E. Cox
December 05, 2022

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