8 results
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25ms
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Sources: EU EUDAMED, US FDA
COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL
FDA 510(k)
FDA Class 2
·Hematology
Commonwealth Edison - Burn Bag
FDA UDI
Certified Safety Manufacturing, Inc.·00766588233185·Commonwealth Edison - Burn Bag
IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
I-FLOW ELASTOMERIC PUMP WITH BOLUS
FDA 510(k)
FDA Class 2
·General Hospital
ALARIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·November 19, 2010
TENDRIL ST
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 9, 2014
SURGI-WRAP
FDA Adverse Event
Injury
·Product code FTL·November 13, 2006
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