67 results · 85ms · Sources: EU EUDAMED, US FDA

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IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074.

FDA Recall
Terminated ·International Remote Imaging Systems Inc·Product code JJW·April 29, 2005

ALLURA XPER FD10

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code IZI·September 27, 2024

AZURION

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·September 11, 2025

ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE

FDA Adverse Event
Malfunction ·AIZU OLYMPUS CO., LTD.·Product code GCJ·November 15, 2023

AZURION

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·January 23, 2026

O-ARM IMAGING SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OXO·January 3, 2019

DIGITALDIAGNOST 4 HIGH PERFORMANCE

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS DMC GMBH·Product code MQB·March 19, 2025

AZURION

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·January 6, 2025

AZURION

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·May 13, 2024

INCISIVE CT

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE (SUZHOU) CO., LTD.·Product code JAK·October 24, 2023

AZURION

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·November 10, 2025

ALLURA XPER FD

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code IZI·December 12, 2025

O-ARM 1000 IMAGING SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·February 23, 2016

O-ARM 1000 IMAGING SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·October 28, 2016

BIOCODE® MDX 3000

FDA Adverse Event
Malfunction ·APPLIED BIOCODE, INC.·Product code OOI·August 18, 2022

BRILLIANCE 64

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code JAK·December 8, 2017

INGENIO

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LWP·December 1, 2023

AZURION

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·February 13, 2025

CERENOVUS ENTERPRISE

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code NJE·February 3, 2026

ALLURA XPER FD

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code IZI·September 23, 2024