8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
SANA-LUBE
FDA 510(k)
FDA Class 1
·General Hospital
TROCHANTERIC NAIL KIT, TI GAMMA3 11X80MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 17, 2012
DICOM Viewer
FDA 510(k)
FDA Class 2
·Radiology
FIDIS CONNECTIVE 10, MODEL MX006
FDA 510(k)
FDA Class 2
·Immunology
TROPONIN I STAT (SHORT TURN AROUND TIME)
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code MMI·June 6, 2014
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
UNKNOWN·Product code ITJ·December 3, 2012
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·September 29, 2010
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