8 results · 22ms · Sources: EU EUDAMED, US FDA

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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