18 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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