7 results
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19ms
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Sources: EU EUDAMED, US FDA
WHIRLPOOL BATH MODEL 2270
FDA 510(k)
FDA Class 2
·Physical Medicine
SYSMEX XE-5000
FDA 510(k)
FDA Class 2
·Hematology
MagVita TMS Therapy System
FDA 510(k)
FDA Class 2
·Neurology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 25, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 2, 2012
COAGUCHEK S SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JPA·September 18, 2007
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