7 results
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17ms
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Sources: EU EUDAMED, US FDA
CADWELL SIERRA
FDA 510(k)
FDA Class 2
·Neurology
FORCEPS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HIGH SPEED ROTATION STARTER SA-40
FDA 510(k)
FDA Class 1
·Radiology
GPS STRETCHER
FDA Adverse Event
Malfunction
·HILLROM DE MEXICO S DE RL DE CV·Product code FPO·June 17, 2014
EON MINI IPG
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIV·Product code LGW·December 9, 2010
GPS STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·December 14, 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