7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
iCEWav Neuromonitoring Platform
FDA 510(k)
FDA Class 2
·Neurology
INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V
FDA 510(k)
FDA Class 2
·Radiology
STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
WALLSTENT RX BILIARY ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code FGE·October 1, 2008
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 26, 2013
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·July 29, 2011
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026