8 results
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18ms
·
Sources: EU EUDAMED, US FDA
CODMAN SKULL CLAMP
FDA 510(k)
FDA Class 2
·Neurology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613023621·Metzenbaum Scissors, S Curved, Fine, Blunt Tips...
SCANTAC MEMBRANE OR SCANTAC STRIP
FDA 510(k)
FDA Class 2
·Radiology
CERVICAL PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
XMAX MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code ERL·January 8, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 14, 2014
COULTER® LH 500 INSTRUMENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·December 2, 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