13 results
·
19ms
·
Sources: EU EUDAMED, US FDA
AMYLASE PRODUCTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AXON ECLIPSE CONTROLLER
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code GWF·November 27, 2013
Codent Low Speed Dental Handpieces and Accessories
FDA 510(k)
FDA Class 1
·Dental
ECLIPSE NEUROLOGICAL WORKSTATION
FDA 510(k)
FDA Class 2
·Neurology
NIM-ECLIPSE® ELECTRODE
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code GXZ·May 16, 2016
NIM-ECLIPSE® ELECTRODE
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code GXZ·May 6, 2016
NIM-ECLIPSE® CONTROLLER
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014
IDRIVE ULTRA POWERED HANDLE 1
FDA Adverse Event
Malfunction
·COVIDIEN LP, FORMERLY US SUR·Product code GDW·March 21, 2014
OPTIMA ZS SPINAL FIXATION SYSTEM
FDA Adverse Event
Injury
·U&I CORPORATION·Product code MNI·November 9, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 17, 2015
DIGITAL PREAMPLIFIER
FDA Adverse Event
Malfunction
·MEDTRONIC (CHANGZHOU) MEDICAL DEVICES·Product code GWF·May 9, 2026
CONTROLLER ECLC ECLIPSE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·May 23, 2014
IPC® HANDPIECE - STYLUS TOUCH®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code HBE·December 11, 2019