7 results
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18ms
·
Sources: EU EUDAMED, US FDA
STERI-CLENS WOUND CARE KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS
FDA 510(k)
FDA Class 2
·Neurology
TASSAWAY
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
COBAS INTEGRA CALCIUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CIC·October 26, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 7, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·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