8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Lexa PLUS RIS-311
FDA 510(k)
FDA Class 2
·General Hospital
VOLUSON E6/E8/E8EXPERT/E10
FDA 510(k)
FDA Class 2
·Radiology
TASMIN R
FDA 510(k)
FDA Class 2
·Orthopedic
DISSECTION TIP
FDA Adverse Event
Malfunction
·GUIDANT CARDIAC SURGERY·Product code GEI·October 22, 2008
UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·August 17, 2011
ALIGN TO URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON)·Product code FTL·July 3, 2013
DEKA SMARTPERIO
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code NVK·December 11, 2024
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019