9 results
·
24ms
·
Sources: EU EUDAMED, US FDA
2 JET SET
FDA 510(k)
FDA Class 1
·Anesthesiology
STERRAD 100NX STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital
Planmeca Romexis
FDA 510(k)
FDA Class 2
·Radiology
RECIPROC BLUE FILES, 6X, STERILE
FDA Adverse Event
Malfunction
·VDW GMBH·Product code EKS·September 8, 2023
PROMUS ELEMENT? PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·April 24, 2014
OEM UNKNOWN
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code GAW·September 26, 2012
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 27, 2010
STERRAD 100NX STERILIZER 1-DR
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·January 6, 2021
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