7 results
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20ms
·
Sources: EU EUDAMED, US FDA
MINICON
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391
FDA 510(k)
FDA Class 2
·General Hospital
S.I.N. Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
HEARTSTART MRX -EMS DEFIBRILATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 17, 2014
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·May 14, 2010
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 1, 2012
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014