8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNCHRON SYSTEMS PROPOXYPHENE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CD 3700 SL
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·May 23, 2007
BATTERY PACK #1015NC
FDA 510(k)
FDA Class 2
·General Hospital
ELECTRODE, ION SPECIFIC
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ULTRAFLEX¿ TRACHEOBRONCHIAL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code JCT·February 11, 2013
STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE
FDA Adverse Event
Other
·SORIN GROUP DEUTCHSLAND·Product code DTQ·July 21, 2014
QUICK FLEX LV LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·January 10, 2011
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