7 results
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26ms
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Sources: EU EUDAMED, US FDA
VERICORD S3
FDA 510(k)
FDA Class 2
·Radiology
WI-38 HUMAN LUNG CELLS
FDA 510(k)
FDA Class 1
·Hematology
RX CBY
FDA 510(k)
FDA Class 2
·Dental
AJUST ADJUSTABLE SINGLE INCISION SLING
FDA Adverse Event
Injury
·BARD SHANNON LIMITED·Product code FTL·December 27, 2012
AC POWER MODULE
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·November 4, 2010
PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNT·February 5, 2014
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