8 results
·
22ms
·
Sources: EU EUDAMED, US FDA
AESCULAP POWER SYSTEM HANDPIECE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PACING/PSI KIT: 5 FR/6 FR 2-L
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code LDF·April 15, 2015
Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TTC PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
EASYPUMP C-BLOC: 400ML, 5ML/HR + 5ML / 60 MIN
FDA Adverse Event
Malfunction
·I-FLOW, LLC·Product code MEB·June 9, 2014
2520274-2013-10219
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code MNI·February 11, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·January 13, 2011
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