8 results
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19ms
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Sources: EU EUDAMED, US FDA
TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000
FDA 510(k)
FDA Class 2
·Anesthesiology
VERTEX Nitinol Staple System
FDA 510(k)
FDA Class 2
·Orthopedic
IROOT BP, MODEL IRBP 4609
FDA 510(k)
FDA Class 2
·Dental
VASOVIEW HEMOPRO 2
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·February 22, 2013
TRILOGY 202
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·July 2, 2014
PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·February 9, 2011
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; 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