9 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SECURE-ON-TOUCH
FDA 510(k)
FDA Class 2
·Dental
PressON™
FDA UDI
NEXUS SPINE, L.L.C.·B6788200920·Curved Lenke Probe – Ball Handle (1.8")
LEONE SPA
FDA UDI
LEONE SPA·08033707027492·WEB 1ST MOLAR BANDS UR KIT
PLYMOUTH THORACOLUMBAR PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TEMPHASE
FDA 510(k)
FDA Class 2
·Dental
*
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO·Product code GDM·May 12, 2014
UNKNOWN DEPUY METAL HEAD
FDA Adverse Event
Injury
·Product code JDI·November 6, 2012
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·August 30, 2010
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