8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
AKCESS0CATH KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BRAINSCAN WORKSTATION
FDA 510(k)
FDA Class 2
·Neurology
MEDRAD VARIBLE INFUSION INJECTOR
FDA 510(k)
FDA Class 2
·Cardiovascular
SHARPS CONTAINER
FDA Adverse Event
Malfunction
·POST MEDICAL, INC.·Product code FMI·March 12, 2024
UNIFY CRT-D
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·January 22, 2013
PLUM LC OL CNVRTBL P
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·November 8, 2010
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 10, 2014
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025