9 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JAZZY
FDA 510(k)
FDA Class 2
·Physical Medicine
JAW INS. BULLET NOSE GRASPER 5MM 310MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·January 13, 2015
LIFEPAK 300 AUTOMATIC ADVISORY DEFRILLATOR
FDA 510(k)
FDA Class 3
·Cardiovascular
CONFORMING ROLL
FDA 510(k)
FDA Unclassified
·Unknown
MARYLAND GSP.FORCEPS FEN.5/310MM HF CON.
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·February 19, 2014
12MM SILS PORT
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY US SURGICAL·Product code GCJ·January 7, 2013
ADVANCE
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·December 28, 2010
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·July 21, 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