BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    ADP ANA IFA TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    MLKJ

    FDA UDI
    Weifang Mingliang Electronics Co., Ltd.·06974077940023·

    GLUCOSE TOLERANCE BEVERAGE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GLIDESHEATH SLENDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 31, 2014

    ASR ACETABULAR CUPS 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·November 21, 2012

    GLOBAL ADVANTAGE HUM HD 44X15

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWT·September 20, 2010

    MENTOR TISSUE EXPANDER

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·February 4, 2019

    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