12 results
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20ms
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Sources: EU EUDAMED, US FDA
MITEK CONE WASHER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
FDA 510(k)
FDA Class 2
·Microbiology
ARTHREX UNIVERS II CA HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·January 28, 2013
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·December 13, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 12, 2014
VITEK® REVEAL¿ SENSOR PANEL
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·June 23, 2025
VITEK® REVEAL¿ SENSOR PANEL
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·June 24, 2025
VITEK® REVEAL¿ SENSOR PANEL
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·June 23, 2025
VITEK® REVEAL¿ SENSOR PANEL
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·June 24, 2025
VITEK® REVEAL¿ SENSOR PANEL
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·June 24, 2025
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