Final User Reporting Regulation Published
Cardiac Cath Lab Closed After Patients Stricken by Endotoxins
Plasmapheresis System Could Allow Test Sample Dilution
Software Coding Error Results in Image Loss
Leakage Exceeds Historical Limits
Dialysis System Could Disable Instrument Alarms
Laser System Manual Lacks Adequate Calibration Procedures
Automated Sphygmomanometer Standard
Diagnostic Electrocardiographic Device Standard
Medical Device Clinical Investigation Standard
Cardiac Valve Prostheses Standard
Blood Oxygenator Standard Proposed
Monitor, Heart Rate Meter & Alarm Standard Proposed
Cardiac Defibrillator Devices Standard
CEN/CENELEC Lung Ventilator Comments Sought
Legislation Would Allow Dissemination of Scientific Information
Infusion Device Analyzer
CDRH to Host Conference on Electronic Adverse Device Reporting