BEUDAMED
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    LIGHT-CURED ZIONOMER CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    Bard® Foley Tray with Bardex® Lubricath® Tri-Way® Foley Catheter

    FDA UDI
    C. R. Bard, Inc.·00801741024061·Bard® Foley Tray with Bardex® Lubricath® Tri-Wa...

    IRRIGATOR, BODY CAVITY

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

    CardioInsight Cardiac Mapping System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    6.2MM TI DUAL-OPENING SCREW 45MM THRD LENGTH F/6.0MM RODS

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·June 18, 2014

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL CO.·Product code HQL·October 7, 2010

    ASR ACETABULAR CUPS 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·December 20, 2012

    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