7 results
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17ms
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Sources: EU EUDAMED, US FDA
BECTON DICKINSON MODIFIED MENGHINI NEEDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
INJECTION CAPS
FDA 510(k)
FDA Class 2
·General Hospital
EDLICH WOUND MANAGEMENT TRAY
FDA 510(k)
FDA Class 2
·General Hospital
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·June 4, 2014
ZIMMER SKING GRAFT MESHER
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code FZW·January 10, 2013
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code FZP·February 12, 2008
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