7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
SEXTON CYSTOTOMY URINE PUMP (SCUP2)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MM-22 MICROTRON, MM50 MICROTRON
FDA 510(k)
FDA Class 2
·Radiology
PAPILLOTOME
FDA 510(k)
FDA Class 2
·Orthopedic
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·January 9, 2013
CPS DUO
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DQY·November 22, 2010
NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE
FDA Adverse Event
Malfunction
·ZIMMER·Product code MBH·May 28, 2014
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF 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