7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
THE SOUNDVASER DISSECTION SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER
FDA 510(k)
FDA Class 3
·Cardiovascular
ALIGN URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BARD SHANNON LTD·Product code FTL·March 4, 2013
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·February 11, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·August 8, 2014
Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a departmental Picture Archiving and Communications System (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks.
FDA Recall
Terminated
·Agfa Healthcare NV Septestraat 27 Mortsel Belgium·Product code LLZ·August 3, 2018