31 results · 23ms · Sources: EU EUDAMED, US FDA

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DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

COBAS 6000 E 601 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·January 3, 2018

COBAS E 411 IMMUNOASSAY ANALYZER

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·April 24, 2018

LAS WORKCELL

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·October 20, 2008

COULTER LH 750 HEMTOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·August 5, 2011

TELIGEN

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013

COBAS 8000 E 602 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code DHA·October 31, 2017

1823260-2017-01845

FDA Adverse Event
Malfunction ·August 29, 2017

COBAS 6000 E 601 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·December 6, 2017

1823260-2017-02173

FDA Adverse Event
Malfunction ·October 3, 2017

COBAS E 411 IMMUNOASSAY ANALYZER

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·February 2, 2018

1823260-2017-01327

FDA Adverse Event
Malfunction ·June 23, 2017

1823260-2017-02349

FDA Adverse Event
Malfunction ·October 17, 2017

COBAS 8000 E 602 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 28, 2017

1823260-2017-01637

FDA Adverse Event
Malfunction ·August 8, 2017

1823260-2017-02033

FDA Adverse Event
Malfunction ·September 21, 2017

1823260-2017-01690

FDA Adverse Event
Malfunction ·August 14, 2017

1823260-2017-01624

FDA Adverse Event
Malfunction ·August 7, 2017

1823260-2017-01989

FDA Adverse Event
Malfunction ·September 14, 2017

COBAS 6000 E 601 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·November 22, 2017