7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POSIDYNE SOLUTION CONTAINER FILTER, RECORDER #96
FDA 510(k)
FDA Class 2
·General Hospital
FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Nutra Face Lift Model PE8050
FDA 510(k)
FDA Class 2
·Neurology
CURLIN INFUSION IV PUMP
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code FRN·March 21, 2014
RESTORATION ADM X3 INS 28/48
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code LZO·November 21, 2012
SUMMIT BROACH SZ8
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LXH·September 28, 2010
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