10 results
·
42ms
·
Sources: EU EUDAMED, US FDA
SEDECAL
FDA Adverse Event
Malfunction
·SEDECAL USA, INC.·Product code IZL·November 20, 2017
MOBILEDIAGNOST WDR
FDA Adverse Event
Malfunction
·SEDECAL USA, INC·Product code IZL·March 18, 2014
SEDECAL X PLUS LP PLUS
FDA Adverse Event
Malfunction
·SEDECAL USA·Product code IXY·April 24, 2026
STEPHANIX
FDA Adverse Event
Malfunction
·STEPHANIX·Product code OWB·October 16, 2013
Sedecal SA Mobile Diagnost w DR x-ray system
FDA Enforcement
Class II
·Terminated·Sedecal USA, Inc.·June 15, 2016
Optima URS X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN
FDA Recall
Terminated
·Sedecal USA, Inc.·Product code KPR--·September 24, 2002
Sedecal SP-HF 4.0 Portable X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) Spain
FDA Recall
Terminated
·Sedecal USA, Inc·Product code IZL--·October 27, 2003
Sedecal X-Ray High Voltage Generators and Controls; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN
FDA Recall
Terminated
·Sedecal USA, Inc.·Product code IZO--·September 26, 2002
Sedecal SA Mobile Diagnost w DR x-ray system
FDA Recall
Terminated
·Sedecal USA, Inc.·Product code IZL·March 23, 2015
Easy Moving Motor Driven Mobile X-Ray Unit, Models SM-20HF and SM-30HF; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN
FDA Recall
Terminated
·Sedecal USA, Inc.·Product code IZL--·September 26, 2002