54 results
·
42ms
·
Sources: EU EUDAMED, US FDA
YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL CAMERA
FDA 510(k)
FDA Class 1
·Dental
SIGMA 8000
FDA Adverse Event
Other
·SIGMA INTERNATIONAL·Product code FRN·April 27, 2004
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·November 30, 2012
SIGMA 8000
FDA Adverse Event
Other
·SIGMA INTL.·Product code FRN·April 27, 2004
SIGMA MODEL SPECTRUM
FDA Adverse Event
Death
·SIGMA LLC·Product code FRN·April 26, 2011
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 7, 2012
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 10, 2013
SPECTRUM
FDA Adverse Event
Malfunction
·SIGMA·Product code FRN·May 24, 2013
SIGMA MODEL SPECTRUM
FDA Adverse Event
Malfunction
·SIGMA LLC·Product code FRN·April 29, 2011
SIGMA SPECTRUM
FDA Adverse Event
BAXTER HEALTHCARE CORPORATION·Product code FRN·February 19, 2014
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·SIGMA LLC·Product code FRN·July 31, 2012
SIGMA
FDA Adverse Event
Malfunction
·SIGMA·Product code FRN·September 5, 2006
SIGMA 8002+
FDA Adverse Event
Other
·SIGMA INTL.·Product code FRN·April 5, 2007
SIGMA SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·SIGMA INTERNATIONAL·Product code FRN·September 11, 2008
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Injury
·MEDTRONIC MILACA, INC.·Product code LWP·October 10, 2013
SIGMA MODEL SPECTRUM
FDA Adverse Event
Malfunction
·SIGMA LLC·Product code FRN·January 21, 2011
SIGMA 8000
FDA Adverse Event
Other
·SIGMA INTERNATIONAL·Product code FRN·September 12, 2005
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·October 9, 2013
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·October 10, 2013
PULSE-GENERATOR, PACEMAKER, EXTERNAL
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code DTE·October 10, 2013