116 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
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
RENAISSANCE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
PARAMOUNT R IBF DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
HAMILTON-G5
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·November 16, 2023
HAMILTON-G5
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·November 16, 2023
HAMILTON-G5
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·November 15, 2023
HAMILTON-G5
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·November 16, 2023
HAMILTON-G5
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·November 16, 2023
HAMILTON-G5
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·November 16, 2023
HAMILTON-G5
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·November 15, 2023
HAMILTON-G5
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·November 15, 2023
HAMILTON-G5
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·February 7, 2024
HAMILTON-G5
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·October 4, 2023
HAMILTON-G5
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·October 4, 2023
HAMILTON-G5
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·October 4, 2023
HAMILTON-G5
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·October 4, 2023
HAMILTON-G5
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·October 4, 2023
HAMILTON-G5
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·October 4, 2023
HAMILTON-G5
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·October 26, 2023