11 results · 27ms · Sources: EU EUDAMED, US FDA

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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