28 results · 33ms · Sources: EU EUDAMED, US FDA

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Accu-Chek Safe-T-Pro Plus Lancing Device

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

HYBRID ARCTICGEL PAD

FDA 510(k)
FDA Class 2 ·Cardiovascular

APEX 800 LASER SYSTEM, MODEL APEX 800

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ALINITY I CMV IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·April 28, 2026

ALINITY I CMV IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·May 4, 2026

LIFEVEST WCD 3000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·October 29, 2008

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·August 23, 2011

ATTAIN LV

FDA Adverse Event
Death ·MPRI·Product code LWP·July 11, 2013

ALINITY I CMV IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·April 2, 2026

ALINITY I CMV IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·April 30, 2025

ALINITY I CMV IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·March 17, 2026

ALINITY I CMV IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·March 17, 2026

ALINITY I CMV IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·November 3, 2025

ALINITY I CMV IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·May 21, 2025

ARCHITECT CMV IGG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·February 19, 2026

COBAS 8000 E 801 MODULE

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

ALINITY I CMV IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·July 14, 2025

ALINITY I CMV IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·August 26, 2025

ALINITY I CMV IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·November 27, 2024

ALINITY I CMV IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·November 14, 2024