10 results
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16ms
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Sources: EU EUDAMED, US FDA
VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DURAFILL FLOW
FDA 510(k)
FDA Class 2
·Dental
3 RING ATTACHMENT
FDA 510(k)
FDA Class 2
·General Hospital
DEROYAL
FDA Adverse Event
Malfunction
·GENICON·Product code FMH·May 23, 2014
JOURNEY I BCS
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·February 15, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 20, 2011
TI MATRIXNEURO SCREW SELF-DRILLING 4MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code JEY·May 12, 2016
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H, 150DX16H, 150DX18H, 150DX20H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
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