BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    MEDI-JECTOR II

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AGILE NAIL

    FDA UDI
    ORTHOFIX SRL·18056099648905·AGILE NAIL TI LOCKING SCREW L44MM D4MM STERILE

    EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACS® LD FB Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRECISION®

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 27, 2014

    TI 12-POINT NUT-11MM

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code NKB·November 15, 2012

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·September 14, 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