15 results
·
19ms
·
Sources: EU EUDAMED, US FDA
VARIAN MULTILEAF COLLIMATOR
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814275·GENUMEDI PT SILVER R IV
XPS® HANDPIECE - VISAO®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·December 9, 2015
XPS® HANDPIECE - VISAO®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·January 8, 2016
GEN-PROBE APTIMA COMBO 2 ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
TrueBeam-TrueBeam STx-Edge
FDA 510(k)
FDA Class 2
·Radiology
XPS HANDPIECE - VISAO
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·November 2, 2021
DRILL 3334800 VISAO 80K HANDPIECE
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code ERL·July 2, 2013
XPS® HANDPIECE - VISAO®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code ERL·December 1, 2017
XPS® HANDPIECE - VISAO®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code ERL·December 1, 2017
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·February 5, 2013
COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 30, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ITI·July 18, 2014
XPS® HANDPIECE - VISAO®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·June 9, 2016
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