10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HemosIL D-Dimer HS 500
FDA 510(k)
FDA Class 2
·Hematology
MP Reconstruction Prosthesis
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575342310·Hip Prosthesis Stem, Anatomical
MP Reconstruction Prosthesis
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575342297·Hip Prosthesis Stem,Anatomical
MP Reconstruction Prosthesis
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575342303·Hip Prosthesis Stem,Anatomical
PIONEER CANNULATED SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DRE VENTURA
FDA 510(k)
FDA Class 2
·Anesthesiology
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 22, 2011
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 17, 2013
SOLETRA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·September 19, 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