7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PRIME PCA AND PCA/CONTINUOUS SYSTEMS
FDA 510(k)
FDA Class 2
·General Hospital
SELECT STIM
FDA 510(k)
FDA Class 2
·Physical Medicine
SYNAPSE 3D BRAIN PERFUSION
FDA 510(k)
FDA Class 2
·Radiology
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·December 13, 2010
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECORE CORP·Product code MVK·December 7, 2012
ACCENT MRI DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 8, 2014
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021