7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
REGULATOR OXYGEN MECHANICAL
FDA 510(k)
FDA Class 1
·Anesthesiology
Legacy™3 Implant
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307102465·3.7mmD x 11.5mmL, 3.5mmD Platform
IQon Spectral CT
FDA 510(k)
FDA Class 2
·Radiology
TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA
FDA 510(k)
FDA Class 2
·General Hospital
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 10, 2014
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 11, 2010
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·November 1, 2012