BEUDAMED
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    UMBRELLA WALKER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SYSTEM 1 INSTRUMENT STAND

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    PROGRASP FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·May 27, 2014

    TI LOW PROFILE SCREW 6.5X20MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·November 15, 2012

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·September 9, 2010

    Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR 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