11 results
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27ms
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Sources: EU EUDAMED, US FDA
VAN-TEC MEATAL DILATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704282979·RETRACTOR MEYERDING SMALL 17 MILLIMETER X 55 M...
ALP VasQcare Take Home System
FDA 510(k)
FDA Class 2
·Cardiovascular
ENCOR 7 GAUGE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·May 10, 2022
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·June 5, 2014
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·November 26, 2012
RENU (UNKNOWN TYPE)
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code LPN·September 29, 2010
ACUSNARE POLYPECTOMY SNARE SOFT
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·July 13, 2023
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·May 4, 2022
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