14 results · 28ms · Sources: EU EUDAMED, US FDA

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STARTRACK INFANT GRAPHICS MONITOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

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

RTHawk, HeartVista Cardiac Package

FDA 510(k)
FDA Class 2 ·Radiology

WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER

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

FLAIR ENDOVASCULAR STENT GRAFT

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code MIH·February 1, 2013

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORP.·Product code LZG·February 2, 2011

HIRES 90K IMPLANT

FDA Adverse Event
Malfunction ·ADVANCED BIONICS LLC·Product code MCM·July 3, 2014

XPS® HANDPIECE - VISAO®

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·June 9, 2016

Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024