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