18 results · 31ms · Sources: EU EUDAMED, US FDA

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DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

AXON ECLIPSE CONTROLLER

FDA Adverse Event
Injury ·MEDTRONIC XOMED, INC·Product code GWF·October 4, 2013

DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C

FDA 510(k)
FDA Class 2 ·Dental

AART GLUTEAL IMPLANT

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

NIM-ECLIPSE® CONTROLLER

FDA Adverse Event
Injury ·MEDTRONIC XOMED INC.·Product code GWF·February 20, 2018

AXON ECLIPSE CONTROLLER

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED, INC.·Product code GWF·December 2, 2013

NIM-ECLIPSE® PATIENT MODULE

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·December 6, 2017

PROBE SPK1004 SURGEON CONTROLLED

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED, INC.·Product code ETN·May 17, 2013

NIM-ECLIPSE® CONTROLLER

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·December 14, 2015

NIM-ECLIPSE® CONTROLLER

FDA Adverse Event
Injury ·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014

COMPUTER NOTEBOOK (INTERNATIONAL

FDA Adverse Event
Malfunction ·MEDTRONIC (CHANGZHOU) MEDICAL DEVICES·Product code GWF·May 9, 2026

2520274-2013-11082

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code LXH·April 16, 2013

LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·March 18, 2011

PROMOTE RF CRT-D

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·September 4, 2014

CONTROLLER ECLC ECLIPSE

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·May 23, 2014

NIM-ECLIPSE PREAMPLIFIER

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·July 7, 2021

COMPUTER NOTEBOOK (INTERNATIONAL)

FDA Adverse Event
Malfunction ·MEDTRONIC (CHANGZHOU) MEDICAL DEVICES·Product code GWF·April 13, 2026

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015