7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
EXMOOR AURAL GROMMET AG/T4
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
OPTIDOS
FDA 510(k)
FDA Class 2
·Radiology
APNEA RISK EVALUATION SYSTEM (ARES)
FDA 510(k)
FDA Class 2
·Anesthesiology
HIRES 90K ADVANTAGE IMPLANT
FDA Adverse Event
Malfunction
·ADVANCED BIONICS LLC·Product code MCM·March 21, 2014
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
FIXODENT
FDA Adverse Event
Injury
·PROCTOR & GAMBLE·Product code KOO·August 18, 2010
Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·October 14, 2015