SonarMed Inc Recalls Airway Acoustic Sensors

by Devices and Pharma | Apr 29, 2024 | Alerts-Device, Class I Recalls, Industry News, Med-Devices, MedWatch-System, Product Recalls, Product Safety, US-FDA

SonarMed Inc. Recalls Airway Acoustic Sensors Restriction of inner diameter may impede catheter passage Home About Consumer Medical Devices Pharma AI Regulatory Quality News Enforcement Alerts Innovation Contact Urgent Class I Recall Notice SonarMed Inc. has issued...

FDA Submission and Approval Processes for 510(k)s

by Devices and Pharma | Apr 28, 2024 | Device_Submissions, Industry Information, Med-Devices, New devices, Premarket-Notification-510(k), Reg_Information, US-FDA

Understanding the 510(k) Premarket Notification Learn how the FDA’s 510(k) premarket notification system facilitates the introduction of new medical devices to the market, ensuring safety and compliance. Explore Our Services Streamlining FDA Approval Get Expert...

Class I Recall for Stay-Safe Catheter Extension Sets and Adapters

by Devices and Pharma | Apr 27, 2024 | Alerts, Alerts-Device, Class I Recalls, Consumer Safety, Industry News, Med-Devices, Product Recalls, Product Safety, US-FDA

Fresenius Medical Care Recalls Stay-Safe Catheter Extension Sets and Stay-Safe Adapter High risk of exposure to toxic compound NDL-PCBA Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts...

Abbott/Thoratec Recalls HeartMate II and HeartMate 3 LVAS

by Devices and Pharma | Apr 21, 2024 | Alerts, Alerts-Device, Class I Recalls, Med-Devices, MedWatch-System, Product Recalls, Product Safety, US-FDA

Abbott/Thoratec Corp. Recalls HeartMate II and HeartMate 3 Biological material buildup may obstruct flow Home About Consumer Medical Devices Pharma AI Regulatory Quality News Enforcement Alerts Innovation Contact Recall Alert: HeartMate II and HeartMate 3 Left...

FDA Enforcement

by Devices and Pharma | Apr 18, 2024 | FDA Enforcement, US-FDA

FDA Enforcement Maintaining the safety, efficacy, and quality of regulated products Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact The Food and Drug Administration...

FDA Quality System Regulation – 21 CFR 820

by Devices and Pharma | Apr 18, 2024 | FDA Regulations, Med-Devices, US-FDA

FDA Quality System Regulation (QSR) Regulations for medical device quality systems Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact QMSR Central FDA Quality System...