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Evoque and Patisiran: A Tale of Two Regulatory Journeys

Sanjay Kaul, MD

March 29, 2024

News Daily News

Biden White House Delays Decision on Menthol Ban

Michael O'Riordan

December 07, 2023

News Daily News

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

Caitlin E. Cox

August 17, 2023

News Daily News

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

Michael O'Riordan

August 10, 2023

News Daily News

FDA: All Restrictions on Paclitaxel Devices for PAD Are Removed

L.A. McKeown

July 11, 2023

News Daily News

Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

Shelley Wood

March 31, 2023

News Daily News

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

Shelley Wood

January 25, 2023

News Daily News

Medical Devices Cleared on Faulty Predicates More Likely to be Recalled

Michael O'Riordan

January 17, 2023

News Daily News

Impella RP Mortality Rate No Longer a Concern, FDA Says

Caitlin E. Cox

December 05, 2022

News Daily News

Fluid Leaks Spark Recall of Cardiosave Hybrid, Rescue IABPs

Todd Neale

December 22, 2021

News Daily News

FDA Reminder: Yearly, Lifelong Surveillance Needed for Endologix AAA Grafts

L.A. McKeown

December 04, 2020

News Daily News

CMS Releases Proposed Updates for Coverage of Transcatheter MV Repair

Todd Neale

July 01, 2020

News Daily News

FDA: Class I Recall for Vascular Solutions’ Dual Lumen Catheters

L.A. McKeown

May 01, 2020

News Daily News

FDA Class I Recall for Boston Scientific’s IMAGER II Angiographic Catheters

L.A. McKeown

April 07, 2020

News Conference News

ACC, EHRA Cancel 2020 Meetings Over COVID-19

Michael O'Riordan

March 09, 2020

News Daily News

FDA: Abbott Recalls NC Trek RX and NC Traveler Coronary Catheters

Shelley Wood

February 24, 2020

News Daily News

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

Todd Neale

January 13, 2020

News Daily News

FDA: Class I Recall for Cook Medical’s CrossCath Support Catheters

L.A. McKeown

December 17, 2019

News Daily News

FDA: Class I Recall for Medtronic’s 6-Fr Sherpa NX Guide Catheter

Michael O'Riordan

October 09, 2019

News Daily News

FDA Expands TAVR Indication to Low-Risk Patients

Michael O'Riordan

August 16, 2019

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Evoque and Patisiran: A Tale of Two Regulatory Journeys

Biden White House Delays Decision on Menthol Ban

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

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

FDA: All Restrictions on Paclitaxel Devices for PAD Are Removed

Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

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

Medical Devices Cleared on Faulty Predicates More Likely to be Recalled

Impella RP Mortality Rate No Longer a Concern, FDA Says

Fluid Leaks Spark Recall of Cardiosave Hybrid, Rescue IABPs

FDA Reminder: Yearly, Lifelong Surveillance Needed for Endologix AAA Grafts

CMS Releases Proposed Updates for Coverage of Transcatheter MV Repair

FDA: Class I Recall for Vascular Solutions’ Dual Lumen Catheters

FDA Class I Recall for Boston Scientific’s IMAGER II Angiographic Catheters

ACC, EHRA Cancel 2020 Meetings Over COVID-19

FDA: Abbott Recalls NC Trek RX and NC Traveler Coronary Catheters

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

FDA: Class I Recall for Cook Medical’s CrossCath Support Catheters

FDA: Class I Recall for Medtronic’s 6-Fr Sherpa NX Guide Catheter

FDA Expands TAVR Indication to Low-Risk Patients

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