7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DAKO ITA, IMMUNOGLOBULIN A (IGA)
FDA 510(k)
FDA Class 2
·Immunology
Vantage Galan 3T, MRT-3020, V4.0
FDA 510(k)
FDA Class 2
·Radiology
FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
FDA 510(k)
FDA Class 2
·Immunology
SERVO-1
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·April 24, 2014
CARDIFIX
FDA Adverse Event
Injury
·GUIDANT ANGLETON/ST. PAUL·Product code NVN·October 8, 2010
SYMIQ DUAL CHANNEL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·December 5, 2012
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020