9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PreXion 3D Excelsior
FDA 510(k)
FDA Class 2
·Radiology
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00
FDA 510(k)
FDA Class 2
·Cardiovascular
CRITICAL CARE ASSESSMENT
FDA 510(k)
FDA Class 2
·Cardiovascular
SILICONE GEL BREAST IMPLANT
FDA Adverse Event
Injury
·UNK·Product code FTR·December 30, 1998
PIIC CLASSIC UPGRADE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·January 24, 2024
XENFORM
FDA Adverse Event
Other
·TEI BIOSCIENCES INC.·Product code FTM·June 17, 2013
TRAUMA TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FPO·February 4, 2011
AUTODISC 50 TEST STRIPS
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·September 26, 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