7 results
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26ms
·
Sources: EU EUDAMED, US FDA
INSULIN RIA MODULE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VACU-MED BLOOD COLLECTION NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
SOLOASSIST II
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 25, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 4, 2012
LUMAX 300 HF-T
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·July 22, 2010
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