8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
CT SCOPE
FDA 510(k)
FDA Class 2
·Radiology
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902959066·TRIAL 974-344 CSTONE LORD 13X14X14
SLEEPER MASK SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
QUAD PLATE (4 DIFFERENT MEDIA)
FDA 510(k)
FDA Class 1
·Microbiology
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·January 28, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAB
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·January 21, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 1, 2014
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026