7 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)
FDA 510(k)
FDA Class 2
·Microbiology
BD PLASTIPAK¿ LUER-LOK¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 1, 2018
VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)
FDA 510(k)
FDA Class 2
·Microbiology
Dexcom G6 Continuous Glucose Monitoring (CGM) System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ENDURANT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·November 11, 2014
XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·January 11, 2017
RESOLUTION CLIP CLIPPING DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·July 23, 2013