10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FLEXTUBES:9, 20, 26
FDA 510(k)
FDA Class 1
·Anesthesiology
MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
Clyra Wound Irrigation Solution
FDA 510(k)
FDA Unclassified
·Unknown
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·April 30, 2014
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·October 10, 2012
VASOVIEW HEMOPRO
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·July 30, 2010
ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code NIU·April 19, 2016
ZILVER PTX DURING-ELUTING PERIPHERAL STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code NIU·May 15, 2015
ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code NIU·May 15, 2015
Assurity MRI Model Numbers: PM1272, PM2272 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