BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    SPIRALFUSE PERIPHERAL INFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NEEDLE FILTER 19X1-1/2 TW

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code GAA·March 22, 2024

    BD NEEDLE FILTER 19X1-1/2 TW

    FDA Adverse Event
    Injury ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·December 18, 2025

    NEEDLE FILTER 19X1-1/2 TW

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code GAA·March 25, 2024

    NEEDLE FILTER 19X1-1/2 TW

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code GAA·June 7, 2024

    DIGICAP

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD SYRINGE 1 ML

    FDA Adverse Event
    Malfunction ·BD MEDICAL, MEDICATION DELIVERY SOLUTIONS·Product code FMF·April 18, 2024

    PRECISION MONTAGE MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 25, 2024

    GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·July 30, 2014

    ASR ACETABULAR IMPLANT 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·April 29, 2013

    MEDISENSE OPTIUM

    FDA Adverse Event
    Malfunction ·Product code NBW·May 9, 2011

    ONE TOUCH ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·July 24, 2008

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015