7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
ENTECH ENTERAL PUMP AND SET
FDA 510(k)
FDA Class 2
·General Hospital
Quantitative Total Extensible Imaging (QTxI)
FDA 510(k)
FDA Class 2
·Radiology
TRITON MEIDCAL TMED IV-SET
FDA 510(k)
FDA Class 2
·General Hospital
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 14, 2014
ALARIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·October 14, 2010
PULSE GEN MODEL 102R
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·December 14, 2012
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