FDA Alerts
FDA Alerts
FDA Issues Proposal to Amend Medical Device Quality System Regulation
Tue Feb 22 2022read article
FDA Alerts
Medtronic Inc. Recalls HawkOne Directional Atherectomy System Due to Risk of Tip Damage During Use
Tue Feb 01 2022read article
FDA Alerts
FDA Issues Draft Guidance on 506J Notifications for Medical Devices
Thu Jan 20 2022read article
FDA Alerts
Datascope/Getinge/Maquet Recalls Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs Due to Risk of Battery Failure
Thu Nov 18 2021read article
FDA Alerts
Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication
Thu Nov 18 2021read article