7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CIRRUS GAMMA CAMERA
FDA 510(k)
FDA Class 2
·Radiology
NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UNKNOWN DEPUY POLY LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·January 14, 2013
ABSOLUTE .035 SELF EXPANDING STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR - VASCULAR SOLUTIONS·Product code FGE·November 12, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 3, 2014
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