8 results
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25ms
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Sources: EU EUDAMED, US FDA
COMBIBAG MANUAL RESUSCITATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
STINGRAY EPIDURAL CATHETER CONNECTOR
FDA 510(k)
FDA Class 2
·Anesthesiology
TRAUS SUS10
FDA 510(k)
FDA Class 2
·Dental
BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER
FDA Adverse Event
Injury
·PRODUCTOS PARA EL CUIDADO DE LA SALUD·Product code EZL·May 23, 2014
RADIOLUCENT RIGHT ANGLE DRIVE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HRX·October 29, 2012
SCULPTRA
FDA Adverse Event
Injury
·SANOFIAVENTIS U.S. LLC·Product code LMH·September 30, 2010
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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