7 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
YRNSORTIP OXIMANOMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
WATCHCHILD
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TSB GROWTH MEDIA
FDA Adverse Event
Malfunction
·Q.I. MEDICAL, INC·Product code JSC·February 20, 2013
SEGURA HEMISPHERE STONE RETRIEVAL BASKET
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code FFL·February 16, 2011
ATTAIN ABILITY PLUS
FDA Adverse Event
Malfunction
·MPRI·Product code OJX·August 8, 2014
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