BEUDAMED
    11 results · 35ms · Sources: EU EUDAMED, US FDA

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    HDL CHOLESTEROL KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LinkSymphoKnee - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575309375·Knee tibia prosthesis trial - LinkSymphoKnee Sy...

    LinkSymphoKnee - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575309085·Knee tibia prosthesis trial - LinkSymphoKnee Sy...

    LinkSymphoKnee - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575308859·Knee tibia prosthesis trial - LinkSymphoKnee Sy...

    LinkSymphoKnee - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575309207·Knee tibia prosthesis trial - LinkSymphoKnee Sy...

    Zavation Cervical Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AUTOMATED PD SET W/CASSETTE4 PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 25, 2010

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code NVY·January 13, 2014

    PROSIMA PELVIC FLOOR REPAIR KIT

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·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