8 results
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18ms
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Sources: EU EUDAMED, US FDA
TRILEX
FDA 510(k)
FDA Class 2
·General Hospital
TMC ELECTRICAL SCOOTER, EASY 321
FDA 510(k)
FDA Class 2
·Physical Medicine
Velox Power Chair
FDA 510(k)
FDA Class 2
·Physical Medicine
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 24, 2014
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·November 14, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·September 10, 2010
Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 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
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018