BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM)

    FDA 510(k)
    FDA Unclassified ·Unknown

    OptiScanner 5000 Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·June 10, 2014

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·October 8, 2010

    GOBED II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·October 31, 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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021