by MDP Staff | Jul 24, 2025 | Alerts-Device, Corrections, Industry News, Med-Devices, Safety
Updated Use Instructions for Maquet Servo Ventilator Systems Risk in Neonatal Tidal Volume Delivery Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Maquet Servo Ventilator SystemsSource: FDA...
by MDP Staff | Jul 16, 2025 | Alerts, Cardiovascular, Device Warning Letters, FDA Enforcement, FDA Public Information, FDA Warning letters, Industry News, Med-Devices, QSR, Safety
FDA Cracks Down on Insightra Medical Unapproved use and serious quality violations found Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Warning Letter Cites a Number of Serious Violations In a...
by Devices and Pharma | Jul 10, 2025 | Cardiovascular, Implantable Devices, Industry Information, Med-Devices, Products_Devices
Mechanical Circulatory Support (MCS) Devices Product family overview Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Overview of MCS Devices Mechanical Circulatory...
by Devices and Pharma | Jul 10, 2025 | Alerts-Device, Class I Recalls, Med-Devices, MedWatch-System, Product Recalls, Products_Devices, Safety, US-FDA
AirLife/Vyaire Infant Breathing Systems Recall Potential for risk of disconnection Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Class I Recall AirLife and manufacturer Vyaire are recalling...
by Devices and Pharma | Jul 10, 2025 | Alerts-Device, Class I Recalls, FDA Safety Communication, Industry News, Med-Devices, MedWatch-System, Product Recalls, US-FDA
Avanos Recalls Ballard Closed Suction Systems Due to sterilization failure Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact May result in non-sterile devices Avanos Medical, Inc. is recalling its...
by Devices and Pharma | Jul 8, 2025 | Alerts-Device, Class I Recalls, FDA Safety Communication, Med-Devices, MedWatch-System, Product Recalls, Product Safety
FDA Alert: Abiomed Impella Blood Pump Urgent Recall Controller may fail to detect the Impella device Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Abiomed Impella blood pump controllers...