9 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST
FDA 510(k)
FDA Class 1
·Microbiology
PILLING BRUSH VALVULOTOME
FDA 510(k)
FDA Class 2
·Cardiovascular
V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540
FDA 510(k)
FDA Class 2
·Cardiovascular
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·February 15, 2013
634 AFFINITY
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code HDD·December 22, 2010
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
RESPIRONICS INC·Product code BTI·July 29, 2014
DEPUY ASR XL FEM IMP SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·October 7, 2014
TOTAL ASR ACET IMP SIZE 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·October 7, 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