8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY
FDA 510(k)
FDA Class 2
·Physical Medicine
OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
GEMORE OTC TENS
FDA 510(k)
FDA Class 2
·Neurology
CLEARVIEW UTERINE MANIPULATOR
FDA Adverse Event
Injury
·CLINICAL INNOVATIONS, LLC·Product code LKF·June 11, 2024
LEAD MODEL 303
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·February 8, 2013
ACCLAIM ENCORE INFUSION PUMP
FDA Adverse Event
Injury
·HOSPIRA·Product code FRN·December 29, 2010
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·July 22, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021