7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
THERMOMETER, SINGLE USE, STRIP, TEMPADOT
FDA 510(k)
FDA Class 1
·General Hospital
SINGLE NEEDLE HEMODIALYSIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Hearing Healthcare Pro
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ITREL II
FDA Adverse Event
Death
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MHY·October 3, 2012
MONARCH II IOL DELIVERY SYSTEM CARTRIDGE - UNK
FDA Adverse Event
Injury
·ALCON PRECISION DEVICE - SINKING SPRING·Product code HQL·December 18, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·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