10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2
FDA 510(k)
FDA Class 2
·Cardiovascular
GC Initial™
FDA UDI
Gc America Inc.·J0228725291·GC Initial™ IQ/Effect Ingot Bleach BO-M, 4 pcs....
GC Initial™
FDA UDI
Gc America Inc.·15400556709594·GC Initial™ IQ/Effect Ingot Bleach BO-M, 4 pcs....
Vivaer ARC Stylus
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRACKPORT
FDA 510(k)
FDA Class 2
·Radiology
LOCKING BLUNT CANNULA 11 GAUGE
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·May 21, 2014
HS III PROXIMAL SEAL
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·December 12, 2012
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·October 8, 2010
Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; 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