8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Cleerly ISCHEMIA
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDER FREE LATEX EXAM GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
BWMINI EEG, BWMINIHST, BWMINI PSG
FDA 510(k)
FDA Class 2
·Neurology
QUARTET
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·November 6, 2014
GEM PREMIER 4000
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY, CO.·Product code CHL·July 25, 2011
DUR MAR +4 10D LNR 36X58
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·July 17, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025