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Mechanical Circulatory Support (MCS) Devices

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...

Recall Alert: AirLife/Vyaire Infant Breathing Systems

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...

Avanos Recalls Ballard Closed Suction Systems

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...

FDA Alert: Abiomed Impella Blood Pump Controller

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...

FDA Alert: Baxter Recalls Spectrum Infusion Pumps

by Devices and Pharma | Jul 4, 2025 | Alerts, Alerts-Device, Class I Recalls, Industry News, Med-Devices, MedWatch-System, Product Recalls, Product Safety

FDA Alert: Baxter Recalls Spectrum Infusion Pumps Software error could result in dangerous dosing Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Baxter Spectrum Infusion Pump Alert Date: July...

How Unsafe Medical Devices Can Slip Through the Cracks

by Devices and Pharma | May 16, 2025 | Consumer Information, Industry Information, Med-Devices, MedWatch-System, Product Safety, Quality Information, Safety, US-FDA

Medical Devices Deemed Unsafe Overseas but Sold in the US A Global Gap in Patient Protection Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Healthcare professionals and the device industry share...
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