12 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
CARDIOMED
FDA 510(k)
FDA Class 2
·Cardiovascular
23 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 3, 2017
CONCERTO II CRT-D
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NIK·June 8, 2013
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 7, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 11, 2008
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWP·August 9, 2016
ATTAIN ABILITY
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code OJX·August 9, 2016
ATTAIN STARFIX
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code OJX·August 9, 2016
ATTAIN ABILITY PLUS
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code OJX·August 9, 2016
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023