32 results · 32ms · Sources: EU EUDAMED, US FDA

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BiWaze Clear System

FDA 510(k)
FDA Class 2 ·Anesthesiology

MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS

FDA 510(k)
FDA Class 2 ·Cardiovascular

EXSALT T7 WOUND DRESSING

FDA 510(k)
FDA Unclassified ·Unknown

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 6, 2025

3611 LITE GLOVE

FDA Adverse Event
Injury ·COVIDIEN·Product code FMC·October 30, 2014

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

INGENIO

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NKE·July 9, 2013

ACTIVA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 31, 2012

CARTO® 3 SYSTEM

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·May 22, 2024

CARTO® 3 SYSTEM

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·December 19, 2023

CARTO 3 SYSTEM

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·June 14, 2024

CARTO® 3 SYSTEM

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·June 3, 2024

CARTO 3 SYSTEM

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·November 27, 2023

CARTO® 3 SYSTEM

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·December 26, 2023

CARTO 3 SYSTEM

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·October 5, 2023

CARTO 3 SYSTEM

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·October 5, 2023

CARTO® 3 SYSTEM

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·October 5, 2023

CARTO 3 SYSTEM

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·November 7, 2023

CARTO 3 SYSTEM

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·November 27, 2023

CARTO® 3 SYSTEM

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·January 10, 2024