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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    DIAL-AWAY PAIN

    FDA 510(k)
    FDA Class 2 ·Neurology

    CUFFED LINDER NASOTRACHEAL AIRWAY

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CONTINUUM KNEE SYSTEM (CKS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARGYLE INFANT HEEL WARMER

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code MPO·June 9, 2014

    MINICAP

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·January 9, 2013

    RADIAL JAW 3 BIOPSY FORCEPS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA·Product code FCL·November 22, 2010

    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