8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ODYSSEY
FDA 510(k)
FDA Class 2
·Anesthesiology
COMPACT DIGITAL BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
COBRASCAN CR-1 FILMLESS
FDA 510(k)
FDA Class 2
·Radiology
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·September 11, 2019
ENSEAL G2
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY INC.·Product code GEI·June 10, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 13, 2010
ADVIA 1800
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·January 18, 2013
Plastic Pack, part number PSS2462 Plastic Pack, part number PSS3319 Plastic Pack, part number PSS3319(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017