7 results
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20ms
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Sources: EU EUDAMED, US FDA
OPUS GENTAMICIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MODIFIED TARGET THERAPEUTICS COILS
FDA 510(k)
FDA Class 2
·Neurology
WRAP-AROUND INSTANT SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 28, 2014
MINI-CAP, DISCONNECT W/PVP-1SOLUTION
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·November 23, 2010
MECHANICAL CHAIR/TRANSPORT CHAIR
FDA Adverse Event
GOODBABY·Product code INM·January 9, 2013
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