8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
SHOWER TROLLEY
FDA 510(k)
FDA Class 1
·General Hospital
EG-3630UR
FDA 510(k)
FDA Class 2
·Radiology
DELTA TT ACETABULAR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 30, 2014
SM104 MSERIES W5TH WHL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·October 24, 2012
XIA II PA SCREWDRIVER SHAFT
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code HXX·September 10, 2010
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·August 29, 2017
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