7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
JIMMY JOHN III, COLONIC IRRIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FILTER, NEBULIZER, CUTTER
FDA 510(k)
FDA Class 2
·Anesthesiology
CONMED LINVATEC 300W XENON LIGHT SOURCE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 2, 2014
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 12, 2012
LIGASURE ATLAS HANDSWITCHING 37CM
FDA Adverse Event
Malfunction
·COVIDIEN LLC (SHANGHAI)·Product code GEI·October 12, 2010
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015