8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
HICALIQ IVH BAG
FDA 510(k)
FDA Class 2
·General Hospital
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293395·
MICROFLUSH
FDA 510(k)
FDA Class 2
·Cardiovascular
SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE
FDA 510(k)
FDA Class 2
·Cardiovascular
ALTRUA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·April 24, 2014
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·October 4, 2012
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·May 14, 2015
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