8 results
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20ms
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Sources: EU EUDAMED, US FDA
STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RIA, TEST SET CENTRIA T3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CAPIK-CANDIDA ALBICANS IDENT. KIT.
FDA 510(k)
FDA Class 1
·Microbiology
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 4, 2014
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 21, 2012
COAPTITE INJECTABLE IMPLANT
FDA Adverse Event
Other
·MERZ AESTHETICS, INC (FORMERLY BIOFORM MEDICAL, INC)·Product code LNM·October 29, 2010
PAEDIATRIC CANNULA, VENOUS
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DWF·June 7, 2023
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