73 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OWL URF-3AP
FDA 510(k)
FDA Class 2
·Neurology
AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A
FDA 510(k)
FDA Class 2
·Cardiovascular
URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L,
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CONTOUR®
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 19, 2025
CONTOUR TEST STRIPS
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·May 31, 2012
BREEZE2
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·February 18, 2015
CONTOUR NEXT
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·June 13, 2014
ACTIVA
FDA Adverse Event
Injury
·NEURO - VILLALBA·Product code MHY·April 17, 2013
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·June 18, 2008
PAS KIDS D100 NEONATAL OXY
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·April 8, 2011
WALLFLEX DUODENAL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MUM·January 22, 2025
GLIDESHEATH
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DYB·August 7, 2019
CONTOUR
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 5, 2019
CONTOUR® TS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·August 21, 2025
GLIDESHEATH
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DYB·July 7, 2022
GLIDESHEATH
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·December 1, 2020
CONTOUR® TS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·August 21, 2025
RADIFOCUS INTRODUCER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·May 19, 2022
CONTOUR® TS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 15, 2025
CONTOUR®
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 13, 2025