70 results · 20ms · 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.

FORTIFY ASSURA DR ICD, US

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code LWS·June 13, 2016

ALINITY I HBSAG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·March 16, 2026

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 10, 2010

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 2, 2014

ARCHITECT HBSAG QUALITATIVE II

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·March 31, 2026

ALINITY I HBSAG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·May 18, 2026

UNIFY ASSURA CRT-D RF HV

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code LWS·March 29, 2019

ARCHITECT HBSAG QUALITATIVE II

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·May 28, 2026

ARCHITECT HBSAG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·March 6, 2026

ALINITY I HBSAG QUALITATIVE II CONFIRMATORY REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·May 22, 2026

ALINITY I HBSAG QUALITATIVE II REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·May 22, 2026

ARCHITECT HBSAG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·February 25, 2026

ARCHITECT HBSAG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·May 26, 2026

ALINITY I HBSAG QUALITATIVE II CONFIRMATORY REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·August 19, 2025

ALINITY I HBSAG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·January 5, 2025

ALINITY I HBSAG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·September 29, 2025

ALINITY I HBSAG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·October 3, 2025

ALINITY I HBSAG QUALITATIVE II CONFIRMATORY REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·October 15, 2025

ARCHITECT HBSAG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·October 29, 2025

ALINITY I HBSAG QUALITATIVE II REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·October 15, 2025