9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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T2Candida 1.1 Panel
FDA 510(k)
FDA Class 2
·Microbiology
MULTIBLAST MEDIUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
I-STAT
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE INC.·Product code CHL·April 21, 2023
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·CORDIS NEUROVASCULAR, INC.·Product code NJE·November 4, 2008
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·August 29, 2011
SYS 6 RECIP
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code KIJ·July 18, 2013
PU-681RA
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·June 30, 2025
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