BEUDAMED
    9 results · 26ms · 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.

    CHARNLEY CONGENITAL HIP FEMUR (85-3061)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STAPLIZER

    FDA UDI
    Conmed Corporation·10845854015780·STAPLIZER BONE STAPLE CARTRIDGE, 16 X 10 MM

    SternaFuse® Fixation System

    FDA UDI
    Fusion Innovations LLC·00810047770145·Variable X Base 4 Rings

    EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SFB & CFB IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Dental

    PROLITE ULTRA MESH

    FDA Adverse Event
    Injury ·ATRIUM MEDICAL CORP.·Product code FTL·April 11, 2014

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 13, 2007

    M2A-MAGNUM PF CUP 52ODX46ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·September 26, 2012

    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