7 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IRRAflow Active Fluid Exchange System (AFES)
FDA 510(k)
FDA Class 2
·Neurology
exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft
FDA 510(k)
FDA Class 2
·Cardiovascular
SOMATOM DEFINITION
FDA 510(k)
FDA Class 2
·Radiology
MX-PRO R-3 AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·July 13, 2011
VENTRICULAR ASSIST DEVCIE
FDA Adverse Event
Death
·THORATEC CORP.·Product code DSQ·October 31, 2014
PINNACLE MTL INS NEUT36IDX520D
FDA Adverse Event
Injury
·DEPUY INTL., LTD. 8010379·Product code KWA·July 12, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025