10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NITRILE COPOLYMER PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ELITE
FDA UDI
DEPUY INTERNATIONAL LTD·10603295318071·ELITE CUP OGEE - CEMENTED LPW 32mmID 50mmOD
ENDOCLAMP AORTIC CATHETER
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code DXC·June 23, 2006
CELERITY
FDA 510(k)
FDA Class 2
·Dental
1012WCC, 1012WGC
FDA 510(k)
FDA Class 2
·Radiology
STOPCOCK MANIFOLD GANGS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FMG·June 17, 2020
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·February 14, 2013
GORE-TEX SOFT TISSUE PATCH
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code FTL·January 7, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·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