8 results
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27ms
·
Sources: EU EUDAMED, US FDA
IMPLEX A-240 HEP ACETABULAR CUP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HCL LABORATORY SYSTEMS 200 -LISA-
FDA Adverse Event
Other
·HYCEL DIAGNOSTICS·Product code JJF·November 8, 2000
SPARK-KIT(TM)
FDA 510(k)POWER TRAINER WITH NEUROMUSCULAR STIMULATION
FDA 510(k)
FDA Class 2
·Physical Medicine
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Injury
·MPRI·Product code NVN·February 15, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·December 22, 2010
2.0MM DRILL BIT/QC/125MM
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HWE·July 29, 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