7 results
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19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CorVista System with PH Add-On
FDA 510(k)
FDA Class 2
·Cardiovascular
RT016 INSPIRATORY FILTER
FDA 510(k)
FDA Class 2
·Anesthesiology
HEMADERM
FDA 510(k)
FDA Unclassified
·Unknown
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 18, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025