9 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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COAGULATION REFERENCE PLASMA, ABNORMAL
FDA 510(k)
FDA Class 2
·Hematology
ANTI-RNP MICROASSAY
FDA 510(k)
FDA Class 2
·Immunology
IMX CMV IGM ANTIBODY ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
LOGIC CR TIB INSERT STD, SZ 5, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 7, 2024
HS III PROXIMAL SEAL
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC.·Product code GEI·January 3, 2013
POSEY STAYSAFE BED
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code FNL·November 12, 2010
OT PING ENHANCED METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 1, 2014
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
FDA Enforcement
Class I
·Ongoing·Zyno Medical LLC·June 18, 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