8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
LEKSELL GAMMA KNIFE PERFEXION
FDA 510(k)
FDA Class 2
·Radiology
MEDVOXEL HEARTPRO SOFTWARE APPLICATION
FDA 510(k)
FDA Class 2
·Radiology
LMT NOMAG IC 1,5
FDA 510(k)
FDA Class 2
·General Hospital
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·September 3, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP S
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 29, 2013
OCTRODE LEAD, 60CM LENGTH
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 16, 2011
LARGE NEEDLE DRIVER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code GCJ·August 22, 2008
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023