9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Persyst 14 EEG Review and Analysis Software
FDA 510(k)
FDA Class 2
·Neurology
EBCHEK BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HYDROCOIL(R) EMBOLIC SYSTEM (HES)
FDA 510(k)
FDA Class 2
·Neurology
METRIX AIR
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·February 27, 2017
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 17, 2014
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL -NEUROMODULATION·Product code LGW·June 14, 2013
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·July 7, 2011
GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 14 DAY)
FDA Adverse Event
ABBOTT DIABETES CARE INC.·Product code MDS·September 17, 2021
TRUEMETRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·March 23, 2018