8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LATEX PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756738613·C-SECTION PACK
TOITU DOPPLER FETUS DETECTOR, FD-400D
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MODELS EUROSUN 2400 AND 800
FDA 510(k)VASO VIEW HEMOPRO
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·May 21, 2014
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code DYE·November 12, 2010
DIGITAL RADIOGRAPHY CXDI-70C WIRELESS
FDA Adverse Event
Malfunction
·CANON, INC.·Product code MQB·December 31, 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