7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MODIFIED HR-3000 REUSE ADAPTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KERBOULL-CHARNLEY CUP SPECIAL MODEL
FDA 510(k)
FDA Class 2
·Orthopedic
GASTRIC LAVAGE KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCU-CHEK ® PERFORMA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 12, 2014
RESTORE RECHARGEABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·October 11, 2010
PULSE GEN MODEL 101
FDA Adverse Event
Injury
·CYBERONICS INC·Product code LYJ·December 12, 2012
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020