9 results
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25ms
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Sources: EU EUDAMED, US FDA
SONOS 500 AND SONOS 1000 ULTRASOUND IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
VuePoint
FDA UDI
Nuvasive, Inc.·00887517182418·VuePoint Screw, 4.5x28mm Multi Axial
Stern IC Surgical Kit
FDA UDI
STERNGOLD DENTAL LLC·00841549115264·The Stern IC Surgical Kit consists of various s...
MRT 50A KNEE COIL
FDA 510(k)
FDA Class 2
·Radiology
ONE-LUNG CPAP DEVICE
FDA 510(k)
FDA Class 2
·Anesthesiology
TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO
FDA Adverse Event
Death
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·November 18, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·January 9, 2013
INGENIO
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 1, 2014
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF 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