BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    INTRAVENOUS CATHETERS MODIFICATIONS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471122918·K-WIRE - DOUBLE TROCAR 1.2mm DIA x 125mm

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·August 9, 2021

    SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ARTISTETM SOLUTION WITH SYS VCIO

    FDA 510(k)
    FDA Class 2 ·Radiology

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·January 17, 2013

    KAPPA 900 DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·December 13, 2010

    ECHELON FLEX 60 ENDOPATH STAPLER RELOAD

    FDA Adverse Event
    Malfunction ·ETHICON ENDOSURGERY, LLC·Product code GDW·July 8, 2014

    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