9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OPERATIVE CHOLANGIOGRAPHIC CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VuePoint
FDA UDI
Nuvasive, Inc.·00887517182463·VuePoint Screw, 4.5x38mm Multi Axial
Graduated Torque Wrench
FDA UDI
STERNGOLD DENTAL LLC·00841549118180·Tool used to evaluate final torque value of ins...
SELFCATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BOOSTER MOTORIZED THREE WHEELED VEHICLE
FDA 510(k)
FDA Class 2
·Physical Medicine
HIRES 90K ADVANTAGE IMPLANT
FDA Adverse Event
Malfunction
·ADVANCED BIONICS LLC·Product code MCM·May 28, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·January 9, 2013
OSS INTERLOK BOWED IM STEM W/ SCREW 12MM X 150MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·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