7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION
FDA 510(k)
FDA Class 2
·Microbiology
KRYPTONITE BONE CEMENT
FDA 510(k)
FDA Class 2
·Neurology
IPS e.max CAD Abutment Solutions- extra systems
FDA 510(k)
FDA Class 2
·Dental
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 5, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NIK·October 15, 2012
UROVIEW
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 6, 2010
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025