32 results · 141ms · Sources: EU EUDAMED, US FDA

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SENSITITRE GRAM NEGATIVE IVD AST SENSITITRE PLATE

FDA Adverse Event
Malfunction ·TREK DIAGNOSTIC SYSTEMS, LTD.·Product code JWY·December 5, 2024

3T

FDA Adverse Event
Malfunction ·SORIN GROUP USA, INC.·Product code DWC·May 4, 2017

VENIPUNCTURE NEEDLE-PRO DEVICE

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code JKA·April 8, 2009

COVID-19 AT-HOME TEST

FDA Adverse Event
Malfunction ·SD BIOSENSOR, INC.·Product code QKP·December 28, 2022

PROBECHEK UROVYSION BLADDER CANCER KIT CONTROL SLIDES

FDA Adverse Event
Malfunction ·ABBOTT MOLECULAR, INC.·Product code MMW·February 9, 2012

PROBECHEK UROVYSION BLADDER CANCER KIT CONTROL SLIDES

FDA Adverse Event
Malfunction ·ABBOTT MOLECULAR, INC.·Product code MMW·February 9, 2012

PROBECHEK UROVYSION BLADDER CANCER KIT CONTROL SLIDES

FDA Adverse Event
Malfunction ·ABBOTT MOLECULAR, INC.·Product code MMW·January 16, 2012

PROBECHEK UROVYSION CONTROL SLIDES

FDA Adverse Event
Malfunction ·ABBOTT MOLECULAR, INC.·Product code MMW·May 20, 2011

COBAS(R) TAQSCREEN MPX TEST FOR USE ON THE COBAS S 201 SYSTEM

FDA Adverse Event
Malfunction ·ROCHE MOLECULAR SYSTEMS·Product code MZP·January 26, 2010

RESPIRONICS

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code MNT·May 20, 2025

ACCESS SARS-COV-2 IGM

FDA Adverse Event
Malfunction ·CLARE DISCRETE MFG IO·Product code QKO·April 23, 2021

ELECSYS SYPHILIS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LIP·October 15, 2025

ELECSYS HIV COMBI PT

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code MZF·September 24, 2025

VIROTROL I, CLASS F

FDA Adverse Event
Malfunction ·BIO-RAD LABORATORIES, INC.·Product code KSF·May 18, 2023

LIFESHIELD

FDA Adverse Event
Malfunction ·ICU MEDICAL, INC.·Product code FPA·May 14, 2026

HEATER-COOLER SYSTEM 3T

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWC·July 31, 2017

HEATER-COOLER SYSTEM 3T

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWC·July 31, 2017

HEATER-COOLER SYSTEM 3T

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWC·July 31, 2017

HEATER-COOLER SYSTEM 3T

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWC·July 31, 2017

EVIS EXERA III DUODENOVIDEOSCOPE

FDA Adverse Event
Malfunction ·AIZU OLYMPUS CO., LTD.·Product code FDT·November 4, 2022