8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DPD-3
FDA 510(k)
FDA Class 2
·Radiology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150775·K-WIRE - SINGLE TROCAR 2.0mm DIA x 230mm
ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
MICRO Arterial Filters
FDA 510(k)
FDA Class 2
·Cardiovascular
VASOVIEW HEMOPRO EVH SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·November 11, 2010
ACCU-CHEK ® ULTRAFLEX INFUSION SET
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FPA·July 17, 2014
LINOX S 75
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code LWS·December 27, 2012
Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
FDA Enforcement
Class I
·Terminated·Cook Inc.·March 2, 2016