Guidance

FDA Updates Nuwellis Extracorporeal Blood Circuit Alert: Key Compliance Lessons for Device Manufacturers

FDA Updates Nuwellis Extracorporeal Blood Circuit Alert: Key Compliance Lessons for Device Manufacturers

By n8n Publisher |

FDA updates Nuwellis blood circuit alert under new Communications Pilot. Critical compliance lessons for medical…

FDA Updates Olympus Endoscope Accessories Alert: Critical Compliance Lessons for Device Manufacturers

FDA Updates Olympus Endoscope Accessories Alert: Critical Compliance Lessons for Device Manufacturers

By n8n Publisher |

FDA updates Olympus endoscope accessories alert as part of Communications Pilot program. Critical compliance lessons…

Smiths Medical Endotracheal Tube Urgent Correction: Critical Sizing Issues Affect Patient Safety

Smiths Medical Endotracheal Tube Urgent Correction: Critical Sizing Issues Affect Patient Safety

By n8n Publisher |

Smiths Medical's urgent correction for undersized endotracheal tubes highlights critical quality control failures affecting patient…

FDA Adds Hemodialysis Bloodlines to Medical Device Shortage List: Critical Supply Chain Alert for Manufacturers

FDA Adds Hemodialysis Bloodlines to Medical Device Shortage List: Critical Supply Chain Alert for Manufacturers

By n8n Publisher |

FDA adds hemodialysis bloodlines to shortage list due to supplier issues, creating critical supply chain…

FDA Updates Baxter Infusion Pump Alert: Key Compliance Lessons for Medical Device Manufacturers

FDA Updates Baxter Infusion Pump Alert: Key Compliance Lessons for Medical Device Manufacturers

By n8n Publisher |

FDA's updated Baxter infusion pump alert reveals new regulatory communication standards that medical device manufacturers…

FDA Updates Nuwellis Extracorporeal Blood Circuit Alert: What Manufacturers Need to Know

FDA Updates Nuwellis Extracorporeal Blood Circuit Alert: What Manufacturers Need to Know

By n8n Publisher |

FDA updates Nuwellis blood circuit alert under new Communications Pilot. Learn compliance requirements and actions…

FDA Early Alert: Conavi Diagnostic Intravascular Catheter Safety Issue – What Manufacturers Need to Know

FDA Early Alert: Conavi Diagnostic Intravascular Catheter Safety Issue – What Manufacturers Need to Know

By n8n Publisher |

FDA issues early alert for Conavi intravascular catheters as part of enhanced recall communications pilot…

FDA Early Alert: BD PICC Catheter Defect Highlights New Recall Communication Strategy

FDA Early Alert: BD PICC Catheter Defect Highlights New Recall Communication Strategy

By n8n Publisher |

FDA issues early alert for BD PICC catheters as part of new recall communication pilot…

FDA Early Alert: Medtronic Esophageal pH Monitoring Capsule Safety Issue – What Manufacturers Need to Know

FDA Early Alert: Medtronic Esophageal pH Monitoring Capsule Safety Issue – What Manufacturers Need to Know

By n8n Publisher |

FDA issues early alert on Medtronic esophageal pH capsule safety issue as part of enhanced…

FDA Early Alert: Critical Baxter Infusion Pump Software Issue Requires Immediate Manufacturer Attention

FDA Early Alert: Critical Baxter Infusion Pump Software Issue Requires Immediate Manufacturer Attention

By n8n Publisher |

FDA issues early alert for Baxter infusion pump software defect. Critical guidance for manufacturers on…

1 2