7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
RADIAL AND FEMORAL ARTERY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Accuray Precision Treatment Planning System
FDA 510(k)
FDA Class 2
·Radiology
RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.0
FDA 510(k)
FDA Class 2
·Radiology
EU PPICC SOLO, 4FR S/
FDA Adverse Event
Injury
·C. R. BARD INC. (BASD)·Product code LJS·February 15, 2013
COLLEAGUE CXE VOLUMETRICINFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 26, 2011
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·UNKNOWN·Product code FNL·July 31, 2014
Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017