7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CLOSED SYSTEM URINARY DRAINAGE BAG
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
OBSTETRIC CUP (MODIFICATION)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TOTAL ASR ACET IMP SIZE 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·June 25, 2014
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·January 3, 2013
GENESISRC IMPLANTABLE PULSE GENERATOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 4, 2010
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020