7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
FLOSSIE
FDA 510(k)
FDA Class 1
·Dental
FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Stabil Orthopaedic Solutions Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code LWS·July 1, 2015
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·February 20, 2014
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·December 21, 2012
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017