9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LUQUE III SPINAL SYSTEM AND LUQUE MINI-SET
FDA 510(k)
FDA Class 2
·Orthopedic
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690189442·Apex Revision Knee System - Revision Tibia Tray...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690189435·Apex Revision Knee System - Revision Tibia Tria...
K3Pro Konus New Abutments and Implants
FDA 510(k)
FDA Class 2
·Dental
BILI BLUE F20T12/BBY AND F40T12/BBY
FDA 510(k)
FDA Class 2
·General Hospital
XCELA PLASTIC/TITANIUM PORT
FDA Adverse Event
Injury
·ANGIODYNAMICS·Product code ---·June 2, 2014
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·October 22, 2010
FORTIFY ASSURA
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·December 28, 2012
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012