8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RESORBABLE BONE PLUG
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
VuePoint
FDA UDI
Nuvasive, Inc.·00887517182470·VuePoint Screw, 4.5x40mm Multi Axial
SPECIMEX DC
FDA 510(k)
FDA Class 2
·Neurology
LDL-DIRECT CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OXIMAX N-560 PULSE OXIMETER
FDA Adverse Event
Malfunction
·MEDIANA·Product code DQA·May 27, 2014
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·January 9, 2013
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·November 23, 2010
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