7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
STENOSCOP
FDA 510(k)
FDA Class 2
·Radiology
DRAGON HEART I.V. SET
FDA 510(k)
FDA Class 2
·General Hospital
RF20000a Controller, FLOW 50 Wand
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ADULT CPB
FDA Adverse Event
Malfunction
·DATASCOPE CORP·Product code DWF·March 14, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 22, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·September 24, 2010
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021