10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SimplyGo Mini
FDA UDI
Respironics, Inc.·00606959047457·SimplyGoMini, Extended Battery, Japan
STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
KOSTEC MEDICAL GRADE LDC MONITORS
FDA 510(k)
FDA Class 2
·Radiology
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·July 26, 2013
S-ROM M HEAD 36MM +0
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·July 26, 2013
SALTO TALARIS
FDA Adverse Event
Injury
·TORNIER SAS·Product code HSN·May 23, 2013
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 20, 2011
BD SAFETY GLIDE 25 G NEEDLE WITH 3 CC SYRINGE
FDA Adverse Event
Malfunction
·BD·Product code FMI·August 22, 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