7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
TERRYCLOTH BIBS
FDA 510(k)
FDA Class 1
·General Hospital
iSR'obot MRI-US Fusion
FDA 510(k)
FDA Class 2
·Radiology
PROSTHESIS, TOTAL HIP-RASP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
COAGUCHEK S SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JPA·July 19, 2007
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code KPE·September 26, 2012
OBTV CLIENT
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code HGM·December 31, 2013
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026