7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Mural Perinatal Surveillance
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SS MATRIX
FDA 510(k)
FDA Unclassified
·Unknown
LENSSX LASER SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 23, 2011
LIGAMAX 5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·November 3, 2014
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·July 8, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025