7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
BAXTER ACETONE-ALCOHOL PREP PADS, STERILE
FDA 510(k)
FDA Unclassified
·Unknown
FLO-GARD 8100 INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
DEODORANT SUPER MAXITHINS BODY-SHAPED MAXI PADS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ROUND BLAKE HUBLESS SILICON DRAINS - 3/4 FLUTED
FDA Adverse Event
Injury
·ETHICON INC.·Product code KOG·June 25, 2014
SITTER II
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code KMI·November 3, 2010
SMITH AND NEPHEW
FDA Adverse Event
Injury
·SMITH AND NEPHEW·Product code JDI·December 27, 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