15 results · 19ms · Sources: EU EUDAMED, US FDA

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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