BEUDAMED
    11 results · 18ms · Sources: EU EUDAMED, US FDA

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    WILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLE

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

    Bard® Add-A-Foley Tray

    FDA UDI
    C. R. Bard, Inc.·00801741029295·Bard® Add-A-Foley Tray

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756650342·MINOR PACK

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172974001·UniTip High Resolution Catheter 8F

    ACA VANCOMYCIN (VANC) METHOD

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PRIMAPORE I.V.

    FDA 510(k)
    FDA Class 1 ·General Hospital

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 26, 2014

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·November 10, 2010

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 4, 2013

    Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·May 16, 2018

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 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