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Andexanet Alfa Pulled From US Market

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Andexanet Alfa Pulled From US Market

December 22, 2025

FDA Warns of Air Embolism Risk With Watchman LAAO Access Systems

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FDA Warns of Air Embolism Risk With Watchman LAAO Access Systems

August 06, 2025

Reduced Shock Efficacy With Some Boston Scientific Defibrillation Leads

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Reduced Shock Efficacy With Some Boston Scientific Defibrillation Leads

August 06, 2025

FDA Issues Safety Communication for Some Accolade Pacemakers

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FDA Issues Safety Communication for Some Accolade Pacemakers

December 16, 2024

Asundexian’s Lack of Efficacy Sinks OCEANIC-AF

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Asundexian’s Lack of Efficacy Sinks OCEANIC-AF

November 20, 2023

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

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

September 18, 2023

Class I Recall for 350,000 Medtronic Defibrillators: FDA

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Class I Recall for 350,000 Medtronic Defibrillators: FDA

Michael O'Riordan

July 19, 2023

Generic Dabigatran Lots Pulled for Nitrosamine Impurity

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Generic Dabigatran Lots Pulled for Nitrosamine Impurity

Michael O'Riordan

March 28, 2023

Medical Devices Cleared on Faulty Predicates More Likely to be Recalled

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Medical Devices Cleared on Faulty Predicates More Likely to be Recalled

Michael O'Riordan

January 17, 2023

FDA: Class I Recall of Cobalt and Crome ICDs and CRT-Ds Due to Reduced-Energy Shock

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FDA: Class I Recall of Cobalt and Crome ICDs and CRT-Ds Due to Reduced-Energy Shock

August 19, 2022

FDA: Class I Recall for Seven Models of Medtronic ICDs and CRT-Ds

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FDA: Class I Recall for Seven Models of Medtronic ICDs and CRT-Ds

Yael L. Maxwell

April 12, 2021

FDA Issues Class I Recall for Emblem S-ICD Over Electrode Fractures

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FDA Issues Class I Recall for Emblem S-ICD Over Electrode Fractures

Michael O'Riordan

February 12, 2021

Recall for Mislabeled Cartons of Amiodarone, Tranexamic Acid Injections: FDA

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Recall for Mislabeled Cartons of Amiodarone, Tranexamic Acid Injections: FDA

September 01, 2020

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FDA: Some Stryker Defibrillators Require Fix for Failure to Deliver Shock

January 13, 2020

FDA: Class I Recall for Ellipse ICD Due to Faulty Wires

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FDA: Class I Recall for Ellipse ICD Due to Faulty Wires

August 05, 2019

FDA Warns of Premature Battery Depletion With Certain Medtronic Pacemakers

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FDA Warns of Premature Battery Depletion With Certain Medtronic Pacemakers

Michael O'Riordan

May 07, 2019

FDA Warns of Cybersecurity Vulnerabilities With Some Medtronic Implanted Devices

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FDA Warns of Cybersecurity Vulnerabilities With Some Medtronic Implanted Devices

Michael O'Riordan

March 22, 2019

Some Stryker Defibrillators Under Recall for ‘Freezing’ Issue

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Some Stryker Defibrillators Under Recall for ‘Freezing’ Issue

February 27, 2019

Class I Recall for Certain Medtronic Pacemakers Due to Possible Circuit Error

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Class I Recall for Certain Medtronic Pacemakers Due to Possible Circuit Error

February 15, 2019

More INR Test Strips Recalled Due to Inaccurately High Results

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More INR Test Strips Recalled Due to Inaccurately High Results

December 21, 2018

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