324 results
·
39ms
·
Sources: EU EUDAMED, US FDA
BREATHE RIGHT
FDA Adverse Event
CNS, INC.·Product code LWF·October 18, 1994
BREATHE RIGHT NASAL STRIPS
FDA Adverse Event
Malfunction
·CNS, INC.·Product code LWF·May 12, 2006
BREATHE RIGHT NASAL STRIPS
FDA Adverse Event
Injury
·CNS, INC.·Product code LWF·March 6, 2001
BREATHE RIGHT
FDA Adverse Event
Other
·CNS, INC.·Product code LWF·March 20, 1998
CNS-350 COMPONENT NEUROMONITORING SYSTEM
FDA Adverse Event
Malfunction
·MOBERG RESEARCH, INC.·Product code GWQ·January 26, 2023
CNS-350 COMPONENT NEUROMONITORING SYSTEM
FDA Adverse Event
Malfunction
·MOBERG RESEARCH, INC.·Product code GWQ·January 26, 2023
BREATHE RIGHT
FDA Adverse Event
Other
·GLAXOSMITHKINE/CNS, INC.·Product code LWF·January 26, 2007
CNS-6201A
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·September 27, 2019
CNS-6801A
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·April 20, 2020
CNS-6201A
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·August 27, 2019
CNS-9700A
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·April 2, 2020
CNS-6801A
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·November 8, 2019
Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applications. Both applications manage clinical data of fetal monitoring and uterine activity, and the MFM-CNS additional monitors maternal vital signs. Data are automatically acquired from bedside monitors, for the purpose of collecting. processing and saving the patient and/or clinical data that is normally provided on record papers and/or separate bedside monitors. They provide electronic medical records and operate with off-the-shelf software and hardware. Component: No
FDA Recall
Open, Classified
·Edan Diagnostics·Product code HGM·October 24, 2025
CNS-6201A
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·October 27, 2020
CORTRAK 2 ENTERAL ACCESS SYSTEM
FDA Adverse Event
Death
·AVANOS MEDICAL INC.·Product code KNT·November 1, 2023
NI
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·May 20, 2020
ARTERIAL BLOOD GAS KIT PORTEX LINEDRAW
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC·Product code JKA·December 10, 2024
PULSE GEN MODEL UNKNOWN
FDA Adverse Event
Injury
·LIVANOVA USA, INC.·Product code MUZ·May 1, 2025
CNS-6201A
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·January 15, 2020
CORFLO NG/NI FEED TUBE WITH STYLET, ENFIT CONNECTOR
FDA Adverse Event
Malfunction
·AVANOS MEDICAL INC.·Product code KNT·May 12, 2026