10,000 results · 697ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

COBAS® MPX - 480T

FDA Adverse Event
Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 29, 2025

EPOC BLOOD ANALYSIS SYSTEM

FDA Adverse Event
Death ·EPOCAL INC.·Product code CGL·December 1, 2017

EPOC READER

FDA Adverse Event
Death ·EPOCAL INC.·Product code CHL·April 21, 2023

VIDAS® CMV IGM

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code LKQ·July 6, 2018

VIDAS® CMV IGM

FDA Adverse Event
Malfunction ·BIOMERIEUX, SA·Product code LKQ·September 8, 2017

VIDAS® CMV IGM

FDA Adverse Event
Malfunction ·BIOMERIEUX, S.A.·Product code LKQ·September 7, 2017

VIDAS® CMV IGM

FDA Adverse Event
Malfunction ·BIOMERIEUX, S.A.·Product code LKQ·September 14, 2017

VIDAS® CMV IGM

FDA Adverse Event
Malfunction ·BIOMERIEUX, S.A.·Product code LKQ·September 7, 2017

VIDAS® CMV IGM

FDA Adverse Event
Malfunction ·BIOMERIEUX, S.A.·Product code LKQ·September 14, 2017

VIDAS® CMV IGM

FDA Adverse Event
Malfunction ·BIOMERIEUX, SA·Product code LKQ·September 6, 2017

EPOC READER

FDA Adverse Event
Death ·EPOCAL INC.·Product code CHL·April 21, 2023

VIDAS® CMV IGM

FDA Adverse Event
Malfunction ·BIOMERIEUX, S.A.·Product code LKQ·September 6, 2017

VIDAS® CMV IGM

FDA Adverse Event
Malfunction ·BIOMERIEUX, SA·Product code LKQ·September 6, 2017

VIDAS® CMV IGM

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code LKQ·September 6, 2017

UTERINE MANIPULATOR TIP L

FDA Adverse Event
Malfunction ·COOPERSURGICAL, INC.·Product code LKF·January 16, 2022

EPOC READER

FDA Adverse Event
Death ·EPOCAL INC.·Product code CHL·April 3, 2023

EPOC READER

FDA Adverse Event
Death ·EPOCAL INC.·Product code CHL·April 3, 2023

MKEVORKIAN-PACIFIC PUNCH

FDA Adverse Event
Malfunction ·COOPERSURGICAL, INC.·Product code HFB·October 6, 2020

VITROS IMMUNODRAGNOSTIC PRODUCTS TROPONIN I REAGENT

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·May 27, 2004

6600

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 5, 2009