8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
LEGIONELLA PNEUMOPHILLA HISTOLOGY CONTROL SLIDES
FDA 510(k)
FDA Class 1
·Microbiology
Archon
FDA UDI
Nuvasive, Inc.·00887517308740·Archon Screw, 4.0x10mm S.D. Fixed
PROPHYflex 4
FDA 510(k)
FDA Class 1
·Dental
SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·October 1, 2010
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CRMD·Product code NVY·January 13, 2014
OCTRODE
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·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