BEUDAMED
    8 results · 25ms · 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.

    ESTRADIOL RIA KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    4-WAY STOPCOCK W/7CM TUBING,

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Malfunction ·CARROLL HEALTHCARE·Product code FNL·May 5, 2014

    SPRINT FIDELIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012

    EON IMPLANTABLE PULSE GENERATOR

    FDA Adverse Event
    Injury ·ADVANCED NEUROMODULATION SYSTEMS·Product code GZB·August 6, 2010

    MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-767

    FDA Enforcement
    Class II ·Ongoing·Angiodynamics, Inc.·March 27, 2024

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 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 include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. Spectrum Infusion Pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user. The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services. 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. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to the physician s directive.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·May 8, 2019