7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
TECHNICON RA-1000 SYS IRON FOR SERUM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELLIPSE LIGHT SPT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Prelude SNAP Splittable Sheath Introducer
FDA 510(k)
FDA Class 2
·Cardiovascular
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 2, 2014
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
MEDEL S.P.A.·Product code BTI·November 21, 2012
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·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