7 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo
FDA 510(k)
FDA Unclassified
·Unknown
MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Nerivio, FGD000075-4.7
FDA 510(k)
FDA Class 2
·Neurology
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·November 7, 2008
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 31, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 23, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025