Guidance

FDA Updates Nuwellis Extracorporeal Blood Circuit Alert: Key Lessons for Device Safety Programs

FDA Updates Nuwellis Extracorporeal Blood Circuit Alert: Key Lessons for Device Safety Programs

By n8n Publisher |

FDA updates alert on Nuwellis blood circuit issues as part of enhanced recall communication pilot,…

FDA Updates Medline Fluid Delivery Set Alert: Key Lessons for Medical Device Manufacturers

FDA Updates Medline Fluid Delivery Set Alert: Key Lessons for Medical Device Manufacturers

By n8n Publisher |

FDA updates Medline fluid delivery set alert as part of Communications Pilot program. Key compliance…

FDA Expands Medical Device Recall Alert Program: What Manufacturers Need to Know

FDA Expands Medical Device Recall Alert Program: What Manufacturers Need to Know

By n8n Publisher |

FDA expands its medical device recall alert program to all devices after issuing 19 alerts…

FDA Early Alert: Calyxo Aspiration System Issue Highlights New Recall Communication Strategy

FDA Early Alert: Calyxo Aspiration System Issue Highlights New Recall Communication Strategy

By n8n Publisher |

FDA issues early alert for Calyxo aspiration system as part of new Communications Pilot program,…

FDA Updates Alert on Fresenius Kabi Infusion Pump Safety Issue: Critical Compliance Lessons

FDA Updates Alert on Fresenius Kabi Infusion Pump Safety Issue: Critical Compliance Lessons

By n8n Publisher |

FDA updates alert on Fresenius Kabi infusion pump safety issues as part of enhanced Medical…

FDA Updates Alert on Olympus Endoscope Accessories: Critical Force/Irrigation Plug Safety Issue

FDA Updates Alert on Olympus Endoscope Accessories: Critical Force/Irrigation Plug Safety Issue

By n8n Publisher |

FDA updates safety alert on Olympus endoscope accessories force/irrigation plug failures. Learn compliance implications for…

FDA Updates Baxter Healthcare Solution Set Alert: Key Compliance Lessons for Medical Device Manufacturers

FDA Updates Baxter Healthcare Solution Set Alert: Key Compliance Lessons for Medical Device Manufacturers

By n8n Publisher |

FDA updates Baxter Healthcare solution set alert as part of communications pilot program. Learn key…

BD Infusion Set Alert Update: Key Lessons for Device Performance Monitoring

BD Infusion Set Alert Update: Key Lessons for Device Performance Monitoring

By n8n Publisher |

BD's infusion set alert update reveals key compliance lessons for manufacturers navigating FDA's enhanced recall…

Boston Scientific Defibrillation Lead Alert: Critical Insights for Medical Device Manufacturers

Boston Scientific Defibrillation Lead Alert: Critical Insights for Medical Device Manufacturers

By n8n Publisher |

FDA's Boston Scientific defibrillation lead alert signals new communication standards. Learn what manufacturers need to…

FDA Issues Early Alert for Baxter Infusion Pump Software Defect: What Manufacturers Must Know

FDA Issues Early Alert for Baxter Infusion Pump Software Defect: What Manufacturers Must Know

By n8n Publisher |

FDA's early alert on Baxter infusion pump software defect signals new regulatory approach. Learn compliance…

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