7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
HEARING AID, MAICO DB-POWER
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W
FDA 510(k)
FDA Class 2
·Dental
Flextra Steerable Introducer
FDA 510(k)
FDA Class 2
·Cardiovascular
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·May 14, 2010
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 6, 2014
ADVANCE MALE SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·October 1, 2012
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