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

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    Cleerly Labs v2.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517568670·CoRoent Ant TLIF Ti, 10x12x28mm 0°

    NuVasive

    FDA UDI
    Nuvasive, Inc.·00195377046543·NTS Standard Tube, 22x80mm

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112656·BARRON CORNEAL PUNCH 8.5MM

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113226·VITRECTOMY KNIFE 20GA (BX/5)

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113233·VITRECTOMY KNIFE 19GA (BX/5)

    PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    STOCKERT CORONARY PERFUSION CANNULAE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    APS INPUT OUTPUT MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JQP·June 12, 2017

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·October 27, 2014

    DAVINCI

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL·Product code NAY·June 25, 2013

    2-DAY INFUSION KIT

    FDA Adverse Event
    Injury ·STRYKER INSTRUMENTS KALAMAZOO·Product code FRN·July 26, 2011

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·May 23, 2022

    STOCKERT CORONARY PERFUSION CANNULAE

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DWF·March 7, 2019

    Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infants.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·February 12, 2014

    GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonates transition to the external environment or to provide a controlled open environment. An optional integrated Sp02 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·March 5, 2014

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025