Urgent Recall of Codman Disposable Perforators

by MDP Staff | Jul 16, 2025 | Alerts, Alerts-Device, Class I Recalls, Product Recalls, Product Safety, Safety

Cranial Drill Urgent Recall Alert Serious safety risks Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Urgent Class I Medical Device Recall Integra LifeSciences has issued an urgent recall of...

FDA Cracks Down on Insightra Medical

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...

Recall Alert: AirLife/Vyaire Infant Breathing Systems

by Bruce Waldon | 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...

How Unsafe Medical Devices Can Slip Through the Cracks

by Bruce Waldon | 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...

Study Reveals Delays in Medical Device Adverse Event Reporting

by Bruce Waldon | May 16, 2025 | Industry Information, Med-Devices, Product Safety, Regulatory_Info, Safety

Device Manufacturers Often Delay Reporting Adverse Events Four major manufacturers account for nearly half of late reports Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Healthcare professionals...

Medical Device Labeling

by Bruce Waldon | May 5, 2025 | Industry Information, Labeling, Med-Devices, Medical Device Labeling, Safety

Medical Device Labeling Home Science Function The Role of a Regulatory Professional Labeling Medical Device Labeling FDA QMSR Central EU IMDRF Training Services Topics Risk Management RAPS Contact U.S. Labeling Requirements for Medical Devices In the world of medical...

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