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

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    RPM RESPIRATORY GATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    HANK'S BALANCED SALTS (HBSS) CATALOG # 210-3013

    FDA 510(k)
    FDA Class 1 ·Hematology

    SMOOTHSHAPES

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

    ELECTRODE, PACEMAKER, PERMANENT

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code DTB·February 28, 2013

    ALTRX +4 10D 36IDX52OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·January 31, 2011

    CRUTCH

    FDA Adverse Event
    HEALTHPLUS·Product code IPR·August 6, 2014

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 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 include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. Spectrum Infusion Pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user. The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services. 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. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to the physician s directive.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·May 8, 2019