BEUDAMED
    9 results · 29ms · Sources: EU EUDAMED, US FDA

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    DW 236

    FDA 510(k)
    FDA Class 2 ·Dental

    EXPANDED MARKETING OF MODELS IR104 & IR205 LASERS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AVI MODEL 840 DUAL CHANNEL INFUSION PUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD SYRINGE S2 5ML

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·September 9, 2019

    PVAK - 400 MICRON FIBER PROCEDURE KIT

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS·Product code GEX·June 11, 2014

    TENDRIL DX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·January 9, 2013

    UNICEL® DXC 600 PRO SYNCHRON ® CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·November 22, 2010

    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

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023