73 results · 23ms · Sources: EU EUDAMED, 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