8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
PROTEUS 235 PROTON THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI
FDA 510(k)
FDA Class 2
·Ophthalmic
DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Y EXT SET 20CM MACRO BORE SPIN NUT
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·June 17, 2020
PASSPORT 2 MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code DSI·April 30, 2013
OPTIFLUX F250NRE DIALYZER
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·August 22, 2014
EON MINI RECHARGEABLE IPG
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·April 28, 2011
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·January 28, 2026