8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
T-CONNECTORS 014500/014501/014502/014503-120
FDA 510(k)
FDA Class 2
·General Hospital
ADJUSTABLE DISPENSOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TIPROTECTOR
FDA 510(k)
FDA Class 2
·General Hospital
INDURA
FDA Adverse Event
Injury
·RICE CREEK MANUFACTURING·Product code LKK·September 21, 2007
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.-8010379·Product code KXA·June 12, 2014
LCS COMPLETE M/B PAT CEM STD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code NJL·October 7, 2010
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·December 12, 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