7 results
·
34ms
·
Sources: EU EUDAMED, US FDA
SENSOCOR(TM) R-TEST 240 XL
FDA 510(k)
FDA Class 2
·Cardiovascular
NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CATHETER, TRANSLUMINAL BALLOON
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LIGASURE ADVANCE PISTOL GRIP
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GEI·May 27, 2014
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·October 11, 2010
SCREWDRIVER SOLERA RDN MAST
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·December 20, 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