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

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    TRIANGULAR BANDAGE

    FDA 510(k)
    FDA Unclassified ·Unknown

    3M™ ESPE™

    FDA UDI
    3M COMPANY·30605861030916·3M™ ESPE™ Gold Anodized Crown Refills, First Mo...

    VARIAX

    FDA UDI
    Stryker GmbH·07613327129069·Black Blank Clip

    MODIFICATION TO NITREX NITINOL GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    FDA Adverse Event
    Injury ·HEART VALVES SANTA ANA·Product code LWR·February 3, 2013

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP, MEDICAL DIV·Product code FNL·December 9, 2010

    ARTICULEZE M HEAD 36MM +8.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·July 17, 2014

    Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·May 16, 2018

    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

    Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.

    FDA Enforcement
    Class II ·Terminated·Capintec Inc·April 1, 2020