12 results
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19ms
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Sources: EU EUDAMED, US FDA
COSMOPOST
FDA 510(k)
FDA Class 1
·Dental
Astral 100/150
FDA 510(k)
FDA Class 2
·Anesthesiology
NIO 5MP DISPLAY, MODEL E5620
FDA 510(k)
FDA Class 2
·Radiology
BD VACUTAINER PPT PLASMA PREPARATION TUBE K2E 9.0 MG
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·May 7, 2018
BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·April 26, 2018
BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·April 26, 2018
BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·April 26, 2018
GALAXY INTRAVASCULAR ULTRASOUND SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (CE)·Product code IYO·February 21, 2013
TRIM-IT FIXATION SCREW, 2.7 MM X 30 MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·January 28, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
ANIMAS CORPORATION·Product code LZG·August 1, 2014
BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·July 17, 2018
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