7 results
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17ms
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Sources: EU EUDAMED, US FDA
BONE SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
Venus Legacy CX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ULTRASOUND SCANNER MINI FOCUS, MODEL 1402
FDA 510(k)
FDA Class 2
·Radiology
PROWLER SELECT MICROCATHETERS
FDA Adverse Event
Injury
·CORDIS NEUROVASCULAR, INC.·Product code KRA·June 2, 2014
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·October 24, 2012
VERSYS HIP SYSTEM FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER INC.·Product code LPH·September 22, 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