8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
ULTRASONIC DENTURE CLEANER
FDA 510(k)
FDA Class 1
·Dental
BELIMED STEAM STERILIZER MODEL TOP 5000 SERIES 24
FDA 510(k)
FDA Class 2
·General Hospital
SANGRAY
FDA 510(k)
FDA Unclassified
·Unknown
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 2, 2014
2010 RACK ELECSYS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code MMI·November 1, 2007
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code LDD·October 4, 2012
8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·September 21, 2022
6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·September 21, 2022