7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CENTURION SPECIMEN TRAP W/CATHETER
FDA 510(k)
FDA Class 1
·Anesthesiology
Pulse Oximeter
FDA 510(k)
FDA Class 2
·Cardiovascular
S40 CLINICAL ANALYZER, S TEST IP, S TEST UA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 13, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 11, 2010
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 13, 2012
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017