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A Look at the CDRH 2024 Innovation Report 

A Look at the CDRH 2024 Innovation Report 

by Bruce Waldon | Apr 18, 2024 | FDA Public Information, FDA Reports, Industry News, Med-Devices, Product-Innovation, US-FDA

CDRH Issues its 2024 Innovation Report Commitment to medical device innovation and safety Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Revolutionizing Medical...
CDRH Issues its 2024 Safety Report 

CDRH Issues its 2024 Safety Report 

by Bruce Waldon | Apr 18, 2024 | FDA Reports, Industry News, Med-Devices, Product Safety, US-FDA

CDRH Issues its 2024 Safety Report Commitment to safety and effectiveness of medical devices Home About Consumer Medical Devices Pharma Biologics Biologics Warning Letters AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact 2024 CDRH Safety...

Fresenius Kabi Recalls Ivenix Infusion Pump Software 

by Bruce Waldon | Apr 17, 2024 | Alerts, Alerts-Device, Class I Recalls, Med-Devices, Product Recalls, Product Safety

Fresenius Kabi Recalls Ivenix Infusion Pump Software Software anamolies could cause patient harm and fatalities Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact...

Urgent Recall for Boston Scientific Obsidio Conformable Embolic 

by Bruce Waldon | Apr 17, 2024 | Alerts, Alerts-Device, Class I Recalls, Med-Devices, MedWatch-System, Product Recalls

Urgent Recall Notice for Boston Scientific Obsidio Conformable Embolic Increased bowel ischemia risk with lower GI bleeding Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation...
FDA – Do Not Use Non-piercing Devices to Measure Blood Glucose

FDA – Do Not Use Non-piercing Devices to Measure Blood Glucose

by Bruce Waldon | Apr 17, 2024 | Consumer Safety, FDA Safety Communication, Med-Devices

FDA Cautions Against Using Uncleared Devices to Measure Blood Glucose Risks associated with using non-piercing devices Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation...

Medos International Recalls CEREBASE DA Guide Sheath 

by Bruce Waldon | Apr 17, 2024 | Alerts, Alerts-Device, Class I Recalls, Consumer Safety, Med-Devices, Product Recalls, Product Safety

Medos International Recalls CEREBASE DA Guide Sheath Due to cracking of its distal catheter shaft Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Urgent Class I...
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