8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
3M XP 505 X-RAY FILM PROCESSOR
FDA 510(k)
FDA Class 2
·Radiology
SCANSCOPE XT SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases
FDA 510(k)
FDA Class 2
·Dental
CATH RAPIDTRANSIT 135CM W/EXT
FDA Adverse Event
Malfunction
·CORDIS NEUROVASCULAR, INC.·Product code KRA·December 19, 2012
CE INFUSOR LV10, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·October 22, 2010
ATLAS PLUS VR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014
Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017