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Class I Recall for Intra-Aortic Blood Pumps

by Devices and Pharma | Mar 18, 2023 | Alerts, Alerts-Device, Class I Recalls, Consumer Safety, Industry News, Med-Devices, Product Recalls, Product Safety, US-FDA

Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Datascope/Getinge IABPs May Malfunction Due to Cable Failure The US Food and Drug Administration (FDA) announced...

Urgent Action Required – Baxter LIFE2000 System

by Devices and Pharma | Mar 17, 2023 | Alerts, Alerts-Device, Class I Recalls, Consumer Safety, Med-Devices, Product Recalls, Product Safety, US-FDA

Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Software issue can cause potential harm or death On March 10, the US Food and Drug Administration (FDA) announced...

FDA Warning Letter to Jackson Clinic

by Devices and Pharma | Mar 12, 2023 | Consumer Information, FDA Enforcement, FDA Warning letters, Industry News, Pharmaceuticals, US-FDA

Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Warning Letter Sites Violations of Law  In early February of this year, the U.S. Food and Drug Administration (FDA)...

FDA Posts Warning Letter to MicroVention Costa Rica 

by Devices and Pharma | Mar 1, 2023 | Alerts, FDA Enforcement, FDA Warning letters, Industry News, Med-Devices, US-FDA

Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Identifies several violations of the FD&C Act and QSR  On February 7, FDA issued a warning letter it had sent to...

FDA Issues Letter to Warn of Abbott Trifecta Valve Risks 

by Devices and Pharma | Mar 1, 2023 | Alerts, Consumer Safety, FDA Public Information, Industry News, Med-Devices, Product Safety, US-FDA

Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Letter outlines risks associated with the heart valve  On February 27, the FDA released a letter to healthcare...
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