7 results
·
33ms
·
Sources: EU EUDAMED, US FDA
ACCESS PROLACTIN
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MiRus MoRe Lumbar Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
RENOVOCATH RC120
FDA 510(k)
FDA Class 2
·Cardiovascular
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 18, 2013
MEDISENSE OPTIUM
FDA Adverse Event
Malfunction
·Product code NBW·December 29, 2010
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
UNKNOWN·Product code ILS·July 17, 2014
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026