Medical Devices & Diagnostics Regulatory YearbookF-D-C-Development Corporation and F-D-C Reports, Incorporated, 1986 - Medical instruments and apparatus |
Contents
Anesthesiology and Respiratory Therapy | 11 |
FDAs 1985 510k PREMARKET NOTIFICATIONS | 11-1 |
Mallinckrodt | 11-3 |
Copyright | |
21 other sections not shown
Common terms and phrases
Access action additional information American appears to involve approved battery Blood brand catalog Catheter cause CDRH and appears Code Contact Lens Corp Date determination device discussed with mfr Distribution district office electrical entered evaluated and sent evaluated by CDRH expected by CDRH final firm estimates Firm initiated recall firm's follow-up is recommended follow-up or additional followed further glucose Hospital implant indicated information is expected inspect firm inspection inspection scheduled involve a problem Italy labeling Labs Laser leak lenses letter machine manufacturing Medical Model Monitor Nationwide needle noted numbers office has opportunity Open opportunity to inspect oxygen panel patients plastic positive pressure problem Pump Reason received remains on market removed replacement report was evaluated sent to district serial Serious injury Solution Sterile Surgical System telephone Test Text tion tube units units were distributed valve Ventilator