7 results
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17ms
·
Sources: EU EUDAMED, US FDA
DIDECO-SHILEY BLOOD SEPARATION WASH BOWL
FDA 510(k)
FDA Class 2
·Anesthesiology
NEXGEN TRABECULAR METAL TIBIAL TRAY
FDA 510(k)
FDA Class 2
·Orthopedic
Southern Implants PEEK Abutments
FDA 510(k)
FDA Class 2
·Dental
TRANSVAGINAL MESH
FDA Adverse Event
Injury
·BARD·Product code OTN·June 9, 2014
UNKNOWN HIP STEM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·December 6, 2012
CONSTELLATION
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 14, 2010
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