7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
FORCE SENSING ARRAY
FDA 510(k)
FDA Class 1
·Physical Medicine
FO41 BODY MASSAGER
FDA 510(k)
FDA Class 1
·Physical Medicine
BC 1206 IMPLANT - INSERT TYPE
FDA 510(k)
FDA Class 2
·Dental
EYE SURGERY STRETCHER OBS 3/07
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·January 22, 2013
UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER
FDA Adverse Event
Injury
·BECKMAN COULTER, INC.·Product code JJE·December 14, 2010
CANNULATED SCREWDRIVER FOR DELTA BIO-INT SCREW
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code LXH·July 10, 2014
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